July 19 - 25, 2014 CORPORATE INTAS LAUNCHES … · INTAS LAUNCHES CHEAPER GENERIC BLOOD CANCER DRUG...

July 19 - 25, 2014

CORPORATE

INTAS LAUNCHES CHEAPER GENERIC BLOOD CANCER DRUG

Economic Times, 20 July, 2014

Homegrown drug maker Intas Pharmaceuticals has launched a generic version of blood cancer drug

Azacitidine at one-fifth of the price of currently available drug for the disease. The company's product

Azadine, which is a generic version of US-based Celgene Corporation's Vidaza, is used for treating MDS

(Myelodysplastic Syndrome) and AML (Acute Myelogenous Leukemia) types of cancer. "Treatment with

Azadine would cost around Rs 50,000 for a months dosage while treatment with the imported drug for the

same dosage currently costs in the range of Rs 2-2.5 lakh per patient," Intas Pharmaceuticals India Head,

Marketing & Sales Vijayesh Gupta told PTI. He claimed oncologists had to rely on the imported drug,

which costs in the range of Rs 15-18 lakh for the entire treatment schedule due to lack of alternatives. "With

Azadine the cost of the complete treatment would be around Rs 3 lakh," he said. MDS is a type of cancer in

which the bone marrow does not make enough healthy blood cells and there are abnormal cells in the blood

and/or in the bone marrow. Advanced stages of MDS may lead to AML. Azacitidine is the only drug which

has been shown to prolong overall survival duration and time to transformation into AML, increase

response rate, reduce transfusion burden and improve quality of life. Intas is manufacturing Azadine at its

Ahmedabad facility, which operates in compliance with global regulatory standards like USFDA, MHRA

and ANVISA. The company has a portfolio of drugs catering to various therepeutic segments including

central nervous system (CNS), cardiovascular system (CVS) and diabetes.

ELI LILLY TO EXPAND DIABETES TREATMENT PORTFOLIO IN INDIA


In its bid to enhance diabetes treatment portfolio in India, one of its important markets in Asia, US pharma

major Eli Lilly and Company plans to launch a new product by the end of next year. The company that sells

a range of medicines and drug delivery devices in the diabetes segment is awaiting regulatory approval for

the new product. "We expect to launch a new product in the diabetes segment in India by the end of 2015. It

has been submitted for regulatory approval," Eli Lilly and Company India Pvt Ltd Managing Director

Edgard A Olaizola told PTI. Two months ago, the company introduced drug Trajenta Duo used for treating

diabetes in the country. Diabetes is a core segment for the company here, he added. "Early in the year, we

had introduced Savvio an insulin delivery device in India. The launch of Savvio marked an important

milestone for the company," Olaizola said. Eli Lilly and Company India in January this year had launched

Humapen Savvio, its original research product in India. Commenting on the significance of the Indian

market, he said, "it is a very important market for the company in Asia specially in diabetes. Though the

biggest market for the company globally are the US, Europe and Japan." Eli Lilly and Company India

currently has products available to treat diabetes, cancer, cardiovascular diseases, osteoporosis and growth

disorder in the country. When asked about the growth the company is looking at in the country, Olaizola

said: "We are very happy with the performance we have made in India in last two to three years specially in

diabetes. Our vision is to be a powerhouse in diabetes." Besides the diabetes, the company is also present in

other segments such as osteoporosis, cardiovascular, oncology and growth hormones in India.

IPCA LABS STOPS API EXPORTS TO US FROM RATLAM FACILITY

Pharmabiz, 24 July, 2014

Ipca Laboratories, a Rs.3,200 crore pharma major from Mumbai, has stopped shipment of APIs from its

Ratlam facility to US after receiving certain inspection observations in Form 483 from the US Food and

Drug Administration (FDA). This will have impact on the company's formulations export business to the

US market as the company use the APIs manufactured from Ratlam facility. Ipca scrip declined sharply on

BSE by over 12 per cent or Rs.102 to Rs.735 in the afternoon session today. The company's consolidated

net sales for the year ended March 2014 increased by 16.7 per cent to Rs.3,282 crore from Rs.2,813 crore in

the previous year. Its international sales improved to Rs.2,095 crore from Rs.1,751 crore and domestic sales

went up to Rs.1,186 crore from Rs.1,062 crore. The company exports of APIs to Americas improved 20.4

per cent to Rs.165 crore from Rs.137 crore and its formulations sales to Americas increased by 18.1 per

cent to Rs.254 crore from Rs.215 crore. The company has stepped-up investments in R&D to keep pace

with the changing domestic and global scenario. The company has R&D centers at Mumbai, Ratlam, Athal

and Indore, duly recognized by the Government of India, Ministry of Science and Technology, Department

of Scientific & Industrial Research (DSIR). Ipca is setting up a new research centre at Kandivli, Mumbai

for biotech research & development activities The company is also in the process of setting-up a new R&D

Centre at Village Ranu, Tehsil Padra, District-Vadodara, Gujarat. Both these R&D centres shall commence

their operations in the current financial year. It has stepped up its R&D expenditure from Rs.100.74 crore

(3.68 per cent of the turnover) in the previous year to Rs.123.24 crore (3.87 per cent of the turnover) in the

year ended March 2014. It has filed 40 ANDAs in respect of generic formulations with US FDA and

received approval for 18 ANDAs so far. The company also filed 52 DMFs in US.

LUPIN MAY BID FOR GSK'S OLDER DRUGS RANGE

Mint, 23 July, 2014

Generics firm Lupin Ltd, some US drug makers looking for a tax-saving deal in Europe and private equity

funds are planning to bid for a range of older drugs being auctioned by GlaxoSmithKline Pic (GSK), five

people familiar with the matter said. GSK is looking to divest the mature products in a bid to improve its

growth profile and wants to dispose of off-patent drugs marketed in North America and western Europe

with annual sales of around Rs1 billion (around ?10,200 crore). Chief executive officer Andrew Witty said

in April that GSK was reviewing its portfolio of mature drugs, and in May the group invited sector players

and private equity firms to consider bidding. Non-binding offers are expected before the end of the month,

according to several people with knowledge of the matter, who asked not to be named because the talks are

private. GSK brands up for sale include antidepres-sant Paxil, migraine treatment Imitrex, Zantac for

stomach acid and Zofran for nausea. Officials at GSK, which is being advised on the auction by La-zard

Ltd, declined to comment. One person with direct knowledge of the matter said on Tuesday that Lupin was

seriously looking at the GSK assets and was in talks with the British drug maker. Lupin chief executive

Vinita Gupta has said for some months that the company wanted to enhance its branded generics business in

the US and a company official confirmed it was looking for deals, while declining to comment on specific

targets. "For these billion-dollar companies like GSK, such fringe products add flab.

CIPLA TO BUY 51% STAKE IN YEMEN COMPANY

Western Times, 21 July, 2014

Cipla, announced that it had signed agreements to buy 51 per cent stake in a pharmaceu-ticals manfuatmg

and distributions business in Yemen, owned by a UAE-based parent company. Cipla said it would pay $21

million for the transaction, with aditinah considerations to be paid over the next three years on

achievements of agreed milestones, given the recent preference to local manufacturing, this secures Cipla's

presence in a fat growing market as it already has a leading position in Yemen with over 200 products,

according to the statement.

SUN PHARMA-RANBAXY $4-B DEAL PASSES MUSTER AT NSE, BSE


have approved the merger of Ranbaxy Laboratories with Sun Pharmaceutical, clearing at least one

regulatory hurdle facing consummation of the country's largest in-bound pharma deal inked four months

ago. The approval of the BSE and the National Stock Exchange will allow Sun to delist Ranbaxy shares

from the two exchanges, two people familiar with the matter told ET. The exchanges approved the $4-bil-

lion merger deal last week, one of these people said. This marks the first big milestone in a series of

regulatory approvals that Sun andRanbaxy need to conclude the deal. The two companies will still need

clearances of the high courts of Gujarat and Punjab & Haryana, besides the Competition Commission of

India to close the deal by the end of year as planned. Spokespersons of Sun Pharma and Ranbaxy

Laboratories said they have no comments to offer. Sun had, in April, announced its plan to acquire rival

Ranbaxy from its Japanese parent, Daiichi Sankyo, in an all-stock deal valued at $4 billion, including $800

million of debt. The transaction valued Ranbaxy at 2.2 times its $1.8-billion revenue for 2013, or about

Rs457 per share. Shareholders of Ranbaxy, including Daiichi, which owns a 63.5% stake, will get 0.8

shares of Sun for every share they hold. Post-deal, Daiichi will become Sun's largest shareholder after

founder and managing director Dilip S Shanghvi, with 9 % stake and a seat on the company's board. Soon

after the deal was announced, two retail investors filed a petition before the Andhra Pradesh High Court,

alleging that Silver Street, a limited-liability partnership firm owned by subsidiaries of Sun Pharma, was

involved in insider trading of Ranbaxy shares. In the six trading days preceding the announcement of the

deal, Ranbaxy shares had jumped on the bourses.

APOLLO HOSPITALS REJIGS TOP-LEVEL MANAGEMENT

Western Times, 21 July, 2014

Apollo Hospitals Group has gone in for a major reorganization of tis top leadership with the twin objective

of accelerating growth and furthering its strategical goals. As part of the re-jig process, four executive

directors have been redesig-nated and assigned greater roles. Preetha Redyd, managing Director and

Shobans Kaminent, Executive Director Special Initiatives, have been redesignated as executive Vice

Chairpersons of Apollo Hospitals Enterprises Limited. Suneeta Redyd,Joint Managing Director, is now

redesignated as the Managing Director of the company Sangita Reddy, Executive Director Operations will

be the ne,yv Joint Managing Director. Terming these changes as a strategic realignment, Prathap C Reddy,

Chairman of the Apollo Hospitals Group said that these were necessitated in the light of, expansion of the

healthcape within the country and outside. This strategic realignment will enable Apollo to focus on growth

opportunities in hospitals, pharma-ceutics,clinics and health insurance while furthering its clinical

leadership and service exceeding, he added. Dr. Redyd said Apollo would deepen its focus in each of these

verticals, at the same time, it would drive synergies between then using technology and an eco-system

focussed on wellness, innovation and productivity. The removal, he said , was designed to maximize the

growth as envisaged in J:he strategy, which was developed in close coordination will all stakeholders

including external a consultants. Our greatest asset is the trust that forty million patients form 120 countries

have reposed in our clinical acumen sinceourinception. This,in turn, increase our responsibility to deliver

even greater care to our patients and customers as well as our committed family of over 70,000 members

along with a team of over 8000 highly skilled doctors, Dr. Reddy said.

WOCKHARDT PROMOTERS RECAST SHAREHOLDING

Business Standard, 21 July, 2014

As part of pharmaceutical company Wockhardt's succession plan, 71-year-old founder Habil Khorakiwala is

gearing up to make way for the next generation. The Khorakiwala family has made significant restructuring

of its shareholding in the company, with son Murtaza getting a significant share of the family wealth.

Murtaza Khorakiwala, 41, is also managing director of the company and runs its day-today operations. The

drug firm, which had gone through financial turmoil in 2009-10 after its derivative bets went wrong, had to

seek a debt restructuring from banks earlier. The Khorakiwala family owns a 74 per cent stake in

Wockhardt, worth Rs4,800 crore by Friday's BSE closing stock price of Rs586 a share. The company's

shares have been transferred to partnership companies controlled by Murtaza and his father byway of a gift

deed, according to disclosures made to the stock exchanges. In a rare gesture, Habil's other son, Huzaifa, is

reported to be against taking any share in the family wealth and is planning to concentrate on corporate

social responsibility. Khorakiwala's daughter, Zahabiya, will continue to manage the unlisted hospital

business. When contacted, a spokesperson for Wockhardt said the company would not comment on the

issue as it was "an internal family affair". According to stock exchange statistics, family firms Humuza

Consultants, HNZ Consultants, Lysithea Consultants and Amalthea Consultants acquired the shares from

the family's promoter companies between June 30 and July 8.

INTAS LAUNCHES CHEAPER GENERIC BLOOD CANCER DRUG


Homegrown drug maker Intas Pharmaceuticals has launched a generic version of blood cancer drug Azaci-

tidine at one-fifth of the price of currently available drug for the disease. The company's product Azadine,

which is a generic version of US-based Celgene Corporation's Vidaza, is used for treating MDS

(Myelodysplastic Syndrome) and AML (Acute Myelogenous Leukemia) types of cancer. "Treatment with

Azadine would cost around Rs50,000 for a month's dosage while treatment with the imported drug for the

same dosage currently costs in the range of Rs2-2.5 lakh per patient," Intas Pharmaceuticals India head of

marketing & sales Vijayesh Gupta said.—PTI

INDIAN FIRMS TO TARGET GENERIC OPPORTUNITIES IN US

Financial Chronicle, 21 July, 2014

INDIAN generic firms would continue to target niche, complex generic opportunities in the US, given that

the patent cliff is gradually coming off while domestically, we expect the growth rates to moderate as the

NPPA tries to bring in non-controlled drugs under price control. In a recent move, NPPA has fixed the price

of 108 non-scheduled formulation packs of 50 anti-diabetes and cardiac drugs by invoking Para 19 of drug

prices control order (DPCO). Further, they have also hinted that the scope can also expand to other

therapies like anti-cancer, respiratory, HIV TB, malaria, cardiac, diabetic and immunological. We believe

this can limit multiple expansion in the medium term. Emerging markets would continue to remain a key

growth driver, as most of these markets are similar to domestic market (branded generics, out-of-pocket

expenses) and Indian generics can leverage on their past experience. We believe Indian generics would

continue to scout for acquisition opportunities in the US and emerging markets to fill in portfolio gaps or

for technological advantage. On the R&D side, we believe the focus will continue to be on filing niche,

complex generics as well as FTF products in the US. On the negative side, we believe the USFDA and other

authorities will continue to tighten their noose on the regulatory front, increasing scrutiny on Indian generic

companies and thereby increasing their compliance costs (Case in point: Ranbaxy, Wockhardt).

WEST PHARMA SETS FOOT IN INDIA

News Today, 21 July, 2014

'About 35 per cent of exports comes through Special Economic Zones(SEZ)', said Development

Commissioner, Sri City SEZ, Government of India, A K Choudhary. Speaking at the inauguration of the

manufacturing plant of West Pharmaceutical Services in Sri City Special Economic Zone (SEZ), Choudhary

said, 'Pharmaceutical industry is a major thrust area for both Central and State governments. SEZs play an

important role in the development of the country with their employment opportunities'. President, West

Pharma (Asia Pacific region), Warwick Bedwell said 'With the opening of this plant, West expands its

presence in Asian markets. This is our first plant in India and the fourth in Asia. With more and more

pharmaceutical customers establishing operations in India, West's new plant will meet market demand. It

further establishes the company's presence in the growing and dynamic market of seals used in primary

packaging for injectable medicines'. 'We had invested $15 million for the plant and the facility will meet the

growing demands of customers in India and Asia Pacific region. There are future plans to expand

production at the site to include West's elastomer component business. Sri City was selected based on the

suitability of land, availability of utilities, labor suitability, logistics and quality of life', he added.

BAFNA PHARMA TO SELL BRANDED GENERICS BUSINESS TO STRIDES ARCOLAB


Bafna Pharmaceuticals Limited (Bafna), a Rs.185 crore Chennai based pharma company, has entered into a

definitive agreement for the sale of majority stake in its India branded generics business to Strides Arcolab

Limited (Strides). India branded generics business of Bafna is engaged in sales and marketing of branded

pharmaceuticals products in niche therapeutic segments of haematinic, women healthcare, paediatric care in

India and includes the flagship brand ‘Raricap’ and 7 other brands. The business has presence in 17 states in

India with a field force of about 400 people and had revenue of Rs.25 crore for the financial year ended

March 31, 2014. Pursuant to the transaction, Bafna will transfer entire India branded generics business as a

going concern on a slump sale basis to Strides and will receive a cash consideration of Rs.48 crore and 26

per cent equity in a SPV, where Strides will hold 74 per cent.

TELANGANA GOVERNMENT TO SET UP PHARMA CITY NEAR HYDERABAD


Telangana Government is mulling to set up a 'Pharma City' near the state capital in about 8,000 acres. The

City will include industries as well as residential colony, and a power plant with 500 MW capacity will be

set up adjacent to the pharma city to provide captive, dedicated and uninterrupted power supply to the

industry, a press release from the chief minister's office said today. "The required land, infrastructure

facilities, communication facility, power supply, water supply etc. will be provided by the government...," it

said. The pharma city is expected to accommodate about five lakh employees besides their families in the

residential colony touching about twenty lakh over a period," the release quoted Chief Minister K

Chandrasekhar Rao as saying. The Chief Minister has suggested to a delegation of Drugs Manufacturers'

Association that an international consultancy organisation with expertise in developing industrial estates

should be contacted to design the pharma city. The Association also requested the chief minister to create an

exclusive department for pharma subject to which he responded positively, the release further said.

INDOCO REMEDIES' STERILE AND SOLID DOSAGE FACILITIES IN GOA RECEIVES US

FDA APPROVAL


Indoco Remedies Ltd., a Mumbai-based fully integrated, research-oriented pharma company, has received

approval from US Food and Drug Administration for its sterile facility (plant-II) and solid dosage facility

(plant –III) located at Verna in Goa. The approval follows the inspection of both these facilities last year by

the US Food and Drug Administration between August 22-30, 2013. With this approval, Indoco now has six

of its facilities, approved by the US FDA. The six US FDA approved facilities include, three for finished

dosages, two for APIs and one for analytical. “The approval will now facilitate the generic (ANDAs)

approvals in the US market and subsequent product launches there. Without doubt, it will also boost the

high-margin revenues of Indoco from the remunerative market of US and placing Indoco in the elite league

with other International and Indian pharmaceutical companies,” said Suresh G Kare, chairman, Indoco

Remedies Ltd. Indoco Remedies, that derives 93 per cent of its revenues from formulations and the balance

through APIs, has export revenues worth 35 per cent in its overall annual net revenue pie of Rs.730 crore

for the year ended March 31, 2014.

SOUTH ARICAN FIRM LIFE HEALTHCARE TO INVEST RS 794 CRORE TO UP STAKE IN

MAX HEALTHCARE


South Africa's Life Healthcare will invest up to Rs 794 crore to up stake in its JV with diversified group

Max India, a move that would lead to equal shareholding among the partners in Max Healthcare. According

to the pact, Max India would divest up to 13.3 per cent of existing equity stake held in the JV (Max

Healthcare) at Rs 67.50 per equity share, for an aggregate consideration of upto Rs 356 crore in favour of

Life Healthcare. Further, Max Healthcare will make fresh equity issuance to the South African partner on a

preferential basis, for an aggregate consideration of up to Rs 397 crore. Currently, Max India's stake in Max

Healthcare stands at 65.86 per cent, Life Healthcare holds 26 per cent while International Finance

Corporation ( IFC) holds 7.5 per cent. The balance 0.64 per cent is held by the ESOP holders. The actual

amount of investments by Life Healthcare will depend on IFC's decision on its stake. The South African

company will invest about Rs 41 crore for this. "Max India and Life Healthcare's joint venture has evolved

into a mutually beneficial partnership with a clear meeting of minds on critical decisions such as business

development, growth strategies and talent management. Life Healthcare will invest upto Rs 794 crore for

this," Max India MD Rahul Khosla told reporters here today. The deal is expected to close by August-end or

the first week of September, Khosla added. Post the deal, Max India and Life Healthcare would each hold

46.4 per cent stake in the healthcare joint venture.

RB INDIA LAUNCHES NEW RINGGUARD ADVANCE FOR FAST RELIEF FROM

RINGWORM INFECTIONS


Monsoon showers offer a respite from the prickly heat, but they also lead to a host of skin problems. RB

formerly known as Reckitt Benckiser, has launched the all new RingGuard Advance for faster relief from

ringworm infections. The third generation advance antifungal cream contains terbinafine- an antifungal

agent that is faster, more effective and reduces the chances of the infection returning. The new formulation

provides an effective therapy in a shorter span of time and also treats fungal infection of skin and nails.

RingGuard Advance priced at Rs. 60 for 12 grams pack will be available across India at all leading medical

stores. Nitish Kapoor, general manager, RB India said, “As an organisation focussed on health and hygiene,

we pay a lot of emphasis on research and development to give our consumers more reliable solutions for

their daily lives. With the launch of new RingGuard Advance, we will further strengthen our market

position in this segment and provide our consumers with a more effective and faster solution to ring worm

infections.”

INFOSYS RECOGNIZED AS LEADER & STAR PERFORMER IN LIFE SCIENCES IT

OUTSOURCING


Infosys has been rated as a leader and star performer in life sciences IT outsourcing (ITO) in the Everest

Group Peak Matrix Assessment 2014. The Bengaluru-based company which is already a global leader in

consulting, technology and outsourcing solutions has now been recognized for its contribution in the

Everest Group report on IT outsourcing in life sciences industry– service provider landscape with Peak

Matrix Assessment 2014. The Everest Peak Matrix for Life Sciences had evaluated 18 IT services

providers, selected on the basis of their success in large life sciences ITO relationships. Service providers

were grouped into three high-level categories based on their capability, service offerings and market

success. Infosys scored high in terms of the size and growth of its life sciences revenues in 2013, global

delivery capability and overall market success. This was aided by investments in proprietary solutions and

an expanding portfolio of offerings in the life sciences space. This portfolio includes solutions that support

drug discovery, clinical trials, sales force effectiveness, digital marketing, ERP, supply chain

transformation, management of complex compliance processes and solutions to track and trace. Infosys’

clients in the sector include global and mid-sized pharmaceutical companies, biotech organizations, medical

devices manufacturers, and drug distributors.

UNIQUE PHARMA RECALLS STERILE DRUG PREPARATIONS FROM US MARKET


Unique Pharmaceuticals, an FDA-registered 503 B compounding pharmacy outsourcing facility dedicated

to improving quality of life and providing trusted compounded preparations for clinics, hospitals and

surgery centers throughout the US, announced a voluntary nationwide recall of all sterile drug preparations

compounded by the outsourcing facility that have not reached the expiration date listed on the products.

Unique is initiating the recall due to US FDA's concerns associated with Unique's compounding facilities

and compounding processes that FDA contends present a lack of sterility assurance and were observed

during recent FDA inspections. In the event a sterile product is compromised, patients are at risk for serious

and possible life-threatening infections. To date, Unique has received no reports of injury or illness

associated with the use of its sterile preparations. Patient safety is Unique's highest priority, and Unique has

proceeded with this voluntary action out of an abundance of caution. The recall includes all sterile

compounded preparations that Unique has supplied to its customers within expiry. Non-sterile preparations

are not affected by this recall.

ICLINIC HEALTHCARE SET TO RAISE RS.25 CRORE TO EXPAND OPERATIONS ACROSS

INDIA


Start-up enterprise iClinic Healthcare Pvt. Ltd. is in aggressive talks with leading private equity companies

and individuals to raise the first tranche to the tune of Rs.25 crore. The company was initially funded by its

directors with an initial outlay of around Rs.5 crore. It is now looking to raise Rs.20-25 crore through direct

placement by individuals and institutions. The company was founded jointly by Sanjoy Mukerji, ex-chief

commercial officer of Vodafone India and Varun Berry, managing director, Britannia Industries to make

quality healthcare a reality in India. It will now use the equity infusion to rapidly expand its operations to

most of the potential 1,000 towns that have broadband and 3G connection to extend this benefit to working

population and their families. Its pilot unit in Lagos will also become a centre to enter the potential African

market with lack of specialist infrastructure even more severe than in India. The clinic aims to provide

specialist care to patients in semi urban towns to have access to specialists and super specialists in metro

locations with the help of the local doctor and consult them for diagnosis, advice and treatment. The

consultation will happen over an online video call with easy exchange of the patient’s reports over the web

after which a the doctor’s consultation summary and a prescription will be disseminated.

USFDA GIVES NOD TO INDOCO REMEDIES FACILITIES IN GOA


Pharma player Indoco Remedies today said it has received a nod from United States' drug regulator for two

of its facilities in Goa. The US Food and Drug Administration (US FDA) has approved the sterile facility

(plant-II) and solid dosage facility (plant -III) located at Verna in the adjoining coastal state, a company

release said here. "The nod will facilitate the generic approvals in the US market and subsequent product

launches there," Indoco Chairman Suresh G Kare said. It will also boost high-margin revenues from the

highly remunerative US market, the world's largest player in pharma space, he added. Officials from

USFDA visited the facilities in August last year. With this, the number of Indoco facilities having USFDA

approvals has gone up to six, it said. These are three for finished dosages, two for APIs or active

pharmaceutical ingredients and one for analytical, it added. The company derived 35 per cent of its

revenues from exports in 2013-14.

INTERNATIONAL

ASTRAZENECA REVEALS PROPOSED DESIGNS FOR NEW GLOBAL R&D CENTRE IN

CAMBRIDGE, UK


AstraZeneca revealed the proposed designs for its new Global R&D Centre and Corporate Headquarters in

Cambridge in the UK. The plans for the new facility, which will be located on the Cambridge Biomedical

Campus (CBC), include designs for the Global Centre, an R&D Enabling Building and an Energy Centre1.

Key features of the site include: Science at the heart – the high technology labs on the site will be separated

from other work spaces by glass walls to promote ‘visible science’, ensuring scientific innovation is the

primary focus for all staff, both in R&D and other functions; Fostering collaboration –the site will feature a

number of open spaces and thoroughfares to encourage collaboration not only within AstraZeneca, but also

with the wider scientific community within the CBC and beyond; Reflecting the character of the City – the

unique characteristics of Cambridge’s historic centre have influenced the shape of the buildings. The site

will be low rise and will include a central courtyard reflecting the colleges of Cambridge University; An

environmental build –AstraZeneca is seeking Building Research Establishment Environmental Assessment

Methodology (BREAAM) Excellent status for the site, which will feature labs that represent best practice in

low energy design and the largest ground source heat pump in Europe. “Green Roofs” will also be installed

across the majority of the site. Mene Pangalos, executive vice president, innovative medicines & early

development at AstraZeneca said: “We are very excited to be able to reveal the plans for our new site in

Cambridge today. Our aim is to create an open, welcoming and vibrant centre that will inspire our teams

and partners to push the boundaries of scientific innovation.” The new site will bring together

AstraZeneca’s small molecule and biologics research and development activity, opening up opportunities to

exploit the promise of biologics and small molecule combinations. The CBC will be the new UK home for

biologics research and protein engineering carried out by MedImmune, AstraZeneca’s biologics arm.

MedImmune already employs around 500 people at Granta Park, to the south east of the city. “With our

combined AstraZeneca and MedImmune portfolios we are already uniquely positioned to explore the

promise of combination therapies in transforming the way patients are treated,” said Dr. Bahija Jallal,

executive vice president, MedImmune.

US FDA GRANTS BREAKTHROUGH THERAPY DESIGNATION TO INTERMUNE'S

PIRFENIDONE TO TREAT PATIENTS WITH IPF


The US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to

InterMune, Inc's pirfenidone, an orally active, anti-fibrotic agent. This designation is reserved for drugs that

are intended to treat a serious or life threatening disease or condition and preliminary clinical evidence

indicates that the drug may demonstrate substantial improvement over existing therapies on one or more

clinically significant endpoints. As described in the FDA Fact Sheet: Breakthrough Therapies, "If a drug is

designated as breakthrough therapy, FDA will expedite the development and review of such drug." In May,

InterMune resubmitted its New Drug Application (NDA) for pirfenidone and noted a target FDA review of

six months under the Prescription Drug User Fee Act. Pirfenidone is an investigational treatment for adult

patients with idiopathic pulmonary fibrosis (IPF). "The Breakthrough Therapy Designation underscores the

significant need to help patients with this irreversible and ultimately fatal disease, particularly as no FDA-

approved therapies are currently available," said Dan Welch, chairman, chief executive officer and president

of InterMune. "We are pleased that the FDA recognized the importance of pirfenidone as a potential new

therapy for IPF, a disease with great unmet medical need." Pirfenidone is an orally active, anti-fibrotic agent

that inhibits the synthesis of TGF-beta, a chemical mediator that controls many cell functions including

proliferation and differentiation, and plays a key role in fibrosis. Pirfenidone also inhibits the synthesis of

TNF-alpha, a cytokine that is known to have an active role in inflammation.

UN BODY, 7 COS IN PACT FOR HIV DRUGS

Times of India, 19 July, 2014

Medicine Patent Pool (MPP), a UN-backed organization, has forged its first sub-licensing agreement with

seven pharma companies, including Cipla, for manufacturing two generic HIV medicines — atazanavir

(ATV) and dolutegravir (DTG). This will speed up access to low-cost, generic medicines in developing

countries. MPP has forged its first agreement with a Chinese manufacturer Desano, and with Cipla, Mylan

and Micro Labs, while it has extended collaborations with Aurobindo, Lauras Labs and Emcure. The

announcement comes three days before the start of the 20th International AIDS conference in Melbourne,

Australia. "With licences signed today, four new manufacturers are joining us to speed the availability of

crucial medicines, ATV and DTG, to developing countries. This almost doubles our network of generic

partners to 10 companies," said Greg Perry, executive director, MPP "Increased generic competition will

ultimately bring prices down and increase availability to allow national treatment programmes to treat many

more people in their countries."

ADBI INKS PARTNERSHIP WITH ABIA TO BRING E-QURE BST WOUND HEALING DEVICE

TO US MARKET


ADB International Group Inc. (ADBI), a company was formerly engaged in the business of distributing

water treatment products in the US, Canada, Australia and New Zealand, announced a partnership with

Austen BioInnovation Institute in Akron (ABIA), for the purpose of bringing ADBI's E-QURE BST, a

bioelectrical signal therapy device, to the US market. The Institute, which has significant expertise in

wound healing, clinical trial development and regulatory operations, will conduct a clinical trial that will

include 70 patients in a double-arm, controlled, randomized, multi-center study to assess the safety and

efficacy of the E-QURE BST device in subjects with pressure and venus stasis ulcers. The company's E-

QURE BST device currently is marketed in Europe for similar indications. It aims to accelerate healing of

hard-to-heal chronic wounds by delivering electrical stimulation to an injury site and thus effectively

mimicking the electrical currents of chronic wounds in order to enhance the body’s natural healing

mechanisms. The company's management selected ABIA’s Product Innovation and Commercialization

Division to spearhead its pre-market clinical trial programme, which is necessary to apply for regulatory

approval from the FDA to distribute in the United States.

CELSION GETS $1 MN CAREER DEVELOPMENT AWARD GRANT FROM NIH FOR

GLIOBLASTOMA RESEARCH WITH THERMODOX AND HIFU


Celsion Corporation, a leading oncology drug development company, announced that its ongoing

collaboration with Dr. Costas Arvanitis of Brigham and Women's Hospital, a teaching affiliate of Harvard

Medical School, has been expanded through the recent award of a $1 million Career Development Award

from the National Institutes of Health's Center for Biomedical Imaging and Bioengineering (NIBIB). The

grant will support preclinical studies evaluating ThermoDox, the company's heat-activated liposomal

encapsulation of doxorubicin, in combination with High Intensity Focused Ultrasound (HIFU), for the

treatment of brain tumours. The grant, titled "Controlled Delivery and Release of Chemotherapy in Brain

Tumours with FUS" provides on average of $200,000 in annual funding for five years, and will be used to

advance preclinical development of ThermoDox for the treatment of brain cancers, including GBM, under

the company's January 2014 collaboration with Brigham and Women's Hospital, Harvard Medical School.

"This peer-reviewed grant award builds upon our ongoing collaborative work to explore treatments for

brain tumours," said Costas D. Arvanitis, Ph.D., Brigham and Women's Hospital, Harvard Medical School.

"Delivering chemotherapeutic agents across the blood-brain barrier is particularly challenging, but in recent

years we have discovered that this could be achieved using focused ultrasound, including enhanced delivery

of liposomal doxorubicin. We are hopeful that this grant will allow us to determine the potential utility of a

promising therapeutic application for one of the most insidious cancers – glioblastoma."

SHIRE, ARMAGEN INK WORLDWIDE LICENSING PACT FOR ENZYME REPLACEMENT

THERAPY


Shire plc, the global specialty biopharmaceutical company, and US-based privately held biotechnology

company, ArmaGen announced a worldwide licensing and collaboration agreement for AGT-182, an

investigational enzyme replacement therapy (ERT) for the potential treatment of both the central nervous

system (CNS) and somatic manifestations in patients with Hunter syndrome (MPS II). This collaboration

strengthens Shire’s rare disease pipeline of innovative therapies where there is high unmet need, and

underscores the company’s long standing commitment to the Hunter syndrome community. Under the terms

of the agreement, Shire will obtain worldwide commercialization rights for AGT-182 in exchange for

payments of approximately $225 million to ArmaGen, including an initial upfront payment of $15 million

in cash and equity, an additional equity investment, R&D funding, development milestones and sales

milestones, in addition to royalty payments. As part of the agreement, ArmaGen will be responsible for

conducting and completing the phase I/II study which it expects to initiate before the end of 2014, after

which point Shire will be responsible for further clinical development, including phase III trials, and

commercialization.

MYLAN WINS MOTION FOR TEMPORARY RESTRAINING ORDER AGAINST APOTEX FOR

AUTHORIZED GENERIC OF PAXIL CR


Mylan Inc., a global pharmaceutical company committed to setting new standards in health care, announced

that the US District Court for the District of New Jersey granted its motion for a temporary restraining order

against Apotex Inc. and Apotex Corporation in litigation relating to Paroxetine CR, the authorized generic

of GlaxoSmithKline's Paxil CR. The District Court ordered Apotex to immediately discontinue all sales and

supply of Paroxetine CR. Mylan previously obtained an order enjoining GlaxoSmithKline from supplying

Paroxetine CR to Apotex. In addition, the District Court ordered Apotex to immediately recall all product

from its direct customers that was shipped since the injunction was entered on July 16, 2014. Mylan has an

exclusive license to an Orange Book patent pertaining to Paxil CR which expires in July 2016, with

paediatric exclusivity extending until January 19, 2017. Mylan further believes that it is the only company

to have filed an abbreviated new drug application for generic Paxil CR that contains a paragraph IV

certification.

MORPHOSYS, GALAPAGOS ADVANCE JOINT ANTIBODY PROGRAMME N

INFLAMMATORY DISEASES INTO PRECLINICAL DEVELOPMENT


MorphoSys AG and Galapagos NV announced that the first programme from their strategic alliance has

advanced into preclinical development. MOR106 was realised based on a novel Galapagos target and

MorphoSys' next-generation antibody library Ylanthia and will now be jointly developed in inflammatory

diseases. "It is gratifying that the first development programme from our alliance with Galapagos has

entered the preclinical development stage. The novel mode of action for MOR106 remains undisclosed.

Furthermore, we are applying Ylanthia in a growing number of existing and new alliances and an increasing

proportion of our pipeline is based on this next-generation platform," commented Dr. Marlies Sproll, chief

scientific officer of MorphoSys AG. "Our SilenceSelect target discovery platform delivered the novel target

against which this antibody is directed. MOR106 is the first antibody in the pipeline of Galapagos, and we

are excited to develop this programme further in close collaboration with our friends at MorphoSys,"

commented Onno van de Stolpe, chief executive officer, of Galapagos. MOR106 arises from the alliance

initiated by Galapagos and MorphoSys in 2008, in which both companies contribute their core technologies

and expertise. Galapagos provides the disease-related biology including the target and cellular assays. The

targets are discovered using Galapagos' SilenceSelect adenoviral target discovery platform. MorphoSys

contributes its Ylanthia antibody technology to generate fully human antibodies directed against the target.

Galapagos and MorphoSys will continue to equally share the research and development costs, as well as all

future revenues.

CCBC, CORDLIFE TEAM UP TO ASSIST ASIA-BASED PATIENTS WITH CORD BLOOD

STEM CELL THERAPY


China Cord Blood Corporation (CCBC), China's leading provider of cord blood collection, laboratory

testing, hematopoietic stem cell processing, and stem cell storage services, and Cordlife Group Limited

(Cordlife), a multi-product healthcare company catering to the mother and child segment, have joined

forces in assisting patients across the PRC, Singapore, Hong Kong, Indonesia, India, the Philippines and

Malaysia to identify suitable cord blood matching units for stem cell therapy. Under the Memorandum of

Understanding signed between the two companies, Cordlife, on behalf of its patients who are in need of

cord blood stem cell therapy, can facilitate the process by providing relevant information to CCBC, who

will then perform searches for possible matching units among its donated cord blood samples in the PRC.

For patients who reside in the PRC, CCBC may seek Cordlife's assistance or contacts to source possible

cord blood unit matches in the relevant public cord blood registries in the regions where Cordlife operates,

which include Hong Kong, Singapore, India, Indonesia, the Philippines, and Malaysia. Mr. KAM Yuen,

chairman of China Cord Blood Corporation commented, "Both CCBC and Cordlife share a common vision

which is to enhance people's lives through the widening of umbilical cord blood stem cells application

services.

BOSTON SCIENTIFIC INTRODUCES POLARIS IMAGING SYSTEM


Boston Scientific Corporation, a global medical technology leader, has launched the new Polaris Imaging

System. This system will support the Boston Scientific family of intravascular ultrasound (IVUS) catheters,

including coronary, peripheral and intra-cardiac echo products. The Polaris System offers enhanced ease-of-

use and more powerful processing capabilities. Its modular design would also support the planned release of

new Boston Scientific imaging products including a fractional flow reserve (FFR) wire, a new family of

IVUS catheters, enhanced software features and better system control tools. Working in collaboration with

physicians, nurses, technicians and software design experts, Boston Scientific identified a need to improve

the experience for customers involved in intravascular imaging procedures. Common challenges included

confusing work flows, increased procedure times, and difficult image interpretation. Boston Scientific has

developed a system that simplifies intravascular guidance. The Polaris System is designed to be smart, fast

and accurate. The user interface and workflow have been redesigned and enhanced to provide for greater

ease of use, while providing the necessary information to guide clinical decisions. The Polaris System has

CE Mark and FDA 510(k) clearance. It has been evaluated in numerous hospitals in the U.S. and Europe,

and was showcased during live cases at the EuroPCR conference in May. "The Polaris System is an advance

for intravascular imaging," said Lowell Satler, M.D., director of Coronary Interventions, MedStar

Washington Hospital Center in Washington, D.C.

US FDA ACCEPTS MEDICINES360'S NDA FOR LEVOSERT IUC


Medicines360, a non-profit women's health pharmaceutical company, and Actavis plc, a leading global

specialty pharmaceutical company, announced that the US Food and Drug Administration (FDA) has

accepted for filing Medicines360's New Drug Application (NDA) for Levosert (levonorgestrel), a hormonal

intrauterine contraceptive (IUC) for use by women to prevent pregnancy. In June 2013, Medicines360 and

Actavis announced that they had entered into a partnership that will make Levosert available in the US

commercially and at an affordable price in US public sector clinics. As part of this agreement, Actavis

licensed the US commercial rights for Levosert, and Medicines360 retained rights to market the product in

the US public sector, including family planning clinics that provide services to low-income women. The

acceptance for filing means the FDA has determined that the application is sufficiently complete to permit a

substantive review. The acceptance for filing does not provide any assurance that the FDA will ultimately

approve the NDA. Under the Prescription Drug User Fee Act (PDUFA), the FDA's goal under standard

review is to review and act on the NDA by February 28, 2015. Medicines360 is a non-profit women's health

pharmaceutical company and social enterprise. Through a unique operating model, Medicines360 reinvests

profits generated through commercial sales revenue into advocacy, education, research and development

with the goal of providing innovative, affordable, and sustainable medical solutions for women.

SINOVAC BIOTECH TO SUPPLY HEALIVE VACCINE FOR EXPANDED PROGRAMME OF

IMMUNIZATION IN BEIJING


Sinovac Biotech, a leading provider of biopharmaceutical products in China, has been selected by the

Beijing Health Bureau as the sole supplier of inactivated hepatitis A vaccine in pre-filled syringe dosage to

the Expanded Programme of Immunization (EPI) for Beijing. The tender is valued at approximately 16

million RMB. The vaccines purchased by the Beijing Health Bureau will be used for the period from 2014

to 2016. The company expects to begin delivery in the coming months upon the demand. Weidong Yin,

chairman, president and chief executive officer, of Sinovac, commented, "We are pleased to have been

selected again as the only supplier of the inactivated hepatitis A vaccine in PFS presentation to the EPI in

Beijing. With superior safety profile and proven efficacy, Healive will continue to be administered to

newborns using our easy-to-use, pre-filled syringes. We look forward to continuing to collaborate with

government agencies to control and prevent diseases with top-quality vaccines both in China and around the

world." Healive is the first inactivated hepatitis A vaccine developed, produced and marketed by a China-

based manufacturer. Healive was launched by Sinovac in 2002 and is currently available in adult and

paediatric dosages. The hepatitis A vaccine has been included in China's national immunization Programme

since February 2008.

SYNTHETIC BIOLOGICS' COLLABORATOR TO PRESENT NOVEL MAB COMBINATION

FOR TREATING PERTUSSIS AT GORDON RESEARCH CONFERENCE


Synthetic Biologics, Inc., a developer of novel anti-infective biologic and drug candidates targeting specific

pathogens that cause serious infections and diseases, announced that Jennifer Maynard, Ph.D., of The

University of Texas at Austin's McKetta Department of Chemical Engineering will highlight Synthetic

Biologics' SYN-005 monoclonal antibody (mAb) combination for the treatment of Pertussis (whooping

cough) in a poster presentation. Dr. Maynard is scheduled to present at the Microbial Toxins &

Pathogenicity conference held by Gordon Research Conferences on July 20-25, 2014, in Waterville Valley,

New Hampshire, United States. Synthetic Biologics is developing SYN-005 through its Exclusive Channel

Collaboration with Intrexon Corporation (NYSE: XON) and academic researchers at The University of

Texas at Austin to target and neutralize the pertussis toxin in order to reduce morbidity and mortality in

infected infants. Pertussis is a highly contagious disease caused by the bacteria Bordetella pertussis (B.

pertussis) with symptoms that may include chronic coughing and subsequent breathing difficulties.

According to the World Health Organization, there are approximately 50 million worldwide cases of

whooping cough each year, leading to an estimated 300,000 deaths, primarily among young, unvaccinated

infants. The poster, titled "Rational Design in Immunotherapeutics to Treat Disease Caused by Bordetellae,"

will describe the rationale and design of Synthetic Biologics' proprietary combination of synergistic

humanized monoclonal antibodies, known as SYN-005, which is intended to target and neutralize the

pertussis toxin. Dr. Maynard will also present the data from murine and non-human primate models of

Pertussis using the unique SYN-005 antibody combination. In April 2014, Synthetic Biologics reported

positive preclinical results from non-human primate, Pertussis studies of SYN-005, which were associated

with favorable decreases in white blood cell counts within two days of treatment and the achievement of

nearly normal levels within one week.

INC RESEARCH DRIVES SITE CONNECTIONS THROUGH STRENGTHENED STUDY

START-UP EFFORTS


INC Research, a leading global phase I to IV clinical research organization (CRO), announced the

promotion of Carol Aliyar to senior vice president, Study Start-Up. Aliyar will be responsible for leading

the company's global site engagement and study start-up efforts, including study start-up operations, site

identification, site start-up and activation, ethics and regulatory submissions/approval and patient

recruitment. She brings more than two decades of clinical operations experience to her new role, including

broad therapeutic expertise and experience in leading large-scale global clinical development programs. As

senior vice president, Study Start-Up, Aliyar will focus on fostering strong site relationships to optimize

timelines and deliver rapid study start-up for global clinical trials, establishing the foundation for successful

collaboration across the duration of a study. Developing long-lasting relationships with clinical research

sites is critically important to our ability to deliver best-in-class clinical development solutions for our

customers, said Alistair Macdonald, chief operating officer, INC Research. Study start-up is an essential

phase in this process because it serves as the initial interaction point with sites and customers and defines

the relationship for the duration of the trial.

THERMO FISHER SCIENTIFIC TO SELL COLE-PARMER CHANNEL BUSINESS TO GTCR

FOR $480 MN


Thermo Fisher Scientific Inc, the world leader in serving science, has signed a definitive agreement to sell

its Cole-Parmer channel business to private equity firm GTCR, LLC for $480 million in cash. Cole-Parmer,

based in Vernon Hills, Illinois, is a provider of fluid handling, test and measurement, and electrochemistry

products and services with 400 employees globally. The business had approximately $230 million in

revenues for full year 2013 and is part of Thermo Fisher’s Laboratory Products and Services Segment.

Thermo Fisher anticipates closing the transaction in the third quarter, subject to customary closing

conditions and applicable regulatory approvals. The company expects an immaterial impact to 2014

adjusted earnings per share and will update annual guidance in its second quarter earnings release on July

23.

J&J BUYING BACK $5 BILLION WORTH OF ITS SHARES

Businessweek, 21 July, 2014

Johnson & Johnson, the world's biggest maker of health care products, plans to buy back up to $5 billion of

the company's common stock. The maker of prescription drugs, medical devices and Tylenol said Monday

that its board of directors had approved the stock buyback program. The program has no time limit and

could be discontinued at any time, the company said it a statement. Johnson & Johnson's shares have risen

strongly over the past two years, from about $68 to a July 7 all-time closing high of $106.47. They ended

Monday down 53 cents to $101.27 and were up 75 cents at $102.02 in after-market trading following the

announcement of the buyback program.

J&J PARTNER ADURO GRABS AN FDA 'BREAKTHROUGH' NOD FOR ITS IMMUNO-

ONCOLOGY COMBO

Fierce Biotech, 21 July, 2014

joined the short list companies outside Big Pharma to pick up the FDA's coveted breakthrough therapy

designation, impressing the agency with strong mid-stage results for its combo cancer therapy. An FDA

breakthrough tag entitles Aduro to a speedy review and access to senior agency staff as it works through the

regulatory process with CRS-207 and GVAX, two immunotherapies designed to battle pancreatic cancer in

tandem. The regulatory victory comes on the heels of positive Phase II data for the combination, in which

Aduro's cocktail beat out GVAX alone in 93 patients with metastatic pancreatic cancer. Median overall

survival on the combo came in at 6.1 months, a statistically significant improvement over GVAX's 3.9

months. Now Aduro is working through an expanded Phase IIb trial, enrolling about 240 patients into three

treatment arms: one receiving the combination treatment, one taking CRS-207 alone and another on

standard chemotherapy. The study's primary endpoint is overall survival, and Aduro hopes it'll back up the

safety, immune response and efficacy CRS-207 and GVAX have demonstrated thus far. The biotech expects

to complete enrollment in that trial by the end of next year with an estimated completion date of December

2016. And with the FDA's promise of special attention, Aduro is optimistic about the future for its oncology

combo, CEO Stephen Isaacs said.

WELLNESS

FMCG'S OPERATING PROFIT TAKES A HIT

The Hindu Business Line, 22 July, 2014

The last time rainfall turned scanty, in 2009, fast-moving consumer goods companies did keep up sales

growth. Rural demand didn’t buckle completely; Hindustan Unilever, Dabur, and Godrej Consumer saw

rural demand outpacing urban. But high food inflation resulted in consumers buying cheaper products. As

competition increased, companies also dropped price points in some segments. For instance, HUL dropped

prices in its bread-and-butter laundry segment towards the end of 2009. Sales growth improved from five

per cent in the September 2009 quarter to eight per cent by March 2010, helped also by a good personal

care division. Marico too cut entry-level prices of Parachute by around 15 per cent in the December 2009

quarter to keep up the shift from loose oils to branded oils, delivering a good boost to sales volume

expansion. For listed FMCG companies, sales growth improved from 11 per cent in the June 2009 quarter

to 15 per cent by the June 2010 quarter. This apart, prices of inputs such as palm oil, milk, tea, barley and

maize were up, sending costs higher for almost all companies. Besides this, increase in ad spends resulted in

operating profit margins declining from 16.8 per cent in the June 2009 quarter to 14.8 per cent by March

2010. This time around too FMCGs will benefit from a low share-of-wallet and their less discretionary

nature. If agri-inputs turn pricey due to a poor monsoon, companies may scrimp on ad spend to maintain

operating profits as they did when input costs rose in 2011.

INDUSTRY AND ECONOMY

PRICE CUT: DRUG MAKERS' PROFITABILITY MAY COME UNDER PRESSURE


With the Drug Price Control Order (DPCO) coverage extending to almost 40 per cent of the industry, the

profitability in the domestic business of pharma companies is likely to come under pressure, rating agency

ICRA said here. Last week, the National Pharmaceutical Pricing Authority (NPPA) announced that it plans

to bring an additional 50 drugs belonging to the cardiovascular and anti-diabetic segment under price

control. This is in addition to the 348 drugs that were brought under price control following the

implementation of the new DPCO in July 2013. "With DPCO coverage extending to almost 40 per cent of

the industry, the profitability in the domestic business of pharma companies is likely to come under

pressure. We expect companies to therefore turn their focus on cost control measures, new product

introductions to circumvent the impact of pricing policy and lay greater emphasis on field force

productivity initiatives," ICRA Research said in its report. Among the domestic pharma majors, Sun

Pharma, Cadila Healthcare, Torrent Pharma, Lupin, Ranbaxy and USV will see the most impact on their

domestic business owing to their relatively sizeable exposure to the CVS and anti-diabetic segments and

premium pricing strategies. Among MNCs, Sanofi Aventis, Abbott and Pfizer are also likely to be affected

owing to their sizeable share exposure on anti-diabetic segment and Indian market in general, the report

said. Sun Pharma has 19 per cent cardiovascular and 11 per cent anti diabetic segments exposure. Among

other players, Lupin has 23 per cent, Cadila Healthcare 17 per cent, Torrent Pharma 36 per cent and

Unichem 54 per cent exposure in cardiovascular segment, according to Icra Research data. In 2013-14, the

Indian pharmaceutical industry grew by 6.2 per cent, decelerating from the 11.9 per cent growth that it

recorded in the previous year. Much of this slowdown was attributable to the implementation of the new

drug pricing policy, which resulted in price cuts on 348 essential drugs and subsequently led to supply chain

disruptions between industry and trade channel over trade margins.

NATIONAL DRUG EARLY WARNING SYSTEM TO MONITOR EMERGING DRUG TRENDS

FOR HEALTH EXPERTS


An innovative National Drug Early Warning System (NDEWS) is being developed to monitor emerging

trends that will help health experts respond quickly to potential outbreaks of illicit drugs such as heroin and

to identify increased use of designer synthetic compounds. The system will scan social media and Web

platforms to identify new trends as well as use conventional national- and local-level data resources. The

University of Maryland’s Center for Substance Abuse Research (CESAR) will receive five years of funding

from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health, to develop

NDEWS. “NDEWS will generate critically needed information about new drug trends in specific locations

around the country so rapid, informed, and effective public health responses can be developed precisely

where needed,” said NIDA Director Dr. Nora D. Volkow. “By monitoring trends at the local level, we hope

to prevent emerging drug problems from escalating or spreading to surrounding regions.” Information about

designer synthetic drugs – including different ways to possess and use them – is rapidly spread to millions

of people through the Internet and social media. Also, other drug trends may quickly change. An example is

the recent increases in heroin use among many regions across the country. Conventional methods to monitor

drug trends may not ask about emerging drugs, do not always provide information about the types of drugs

used at the community level, and may need a year or more to collect and report information. Currently,

NIDA conducts local-level surveillance on drug use through the Community Epidemiology Work Group

(CEWG) network.

HEALTHCARE COSTS FORCE GOVTS TO CUT DRUG PRICES


It is not the Indian regulator who is the only one after drug companies to cut prices. Across the world,

pharmaceutical companies are coming under pressure to reduce prices as concerns over growing healthcare

costs force governments to target drugmak-ers. Countries like Germany, the UK and the US are all

monitoring the prices of life-saving drugs. Last week, India's National Pharmaceutical Pricing Authority

decided to slash the prices of more than 100 diabetes and heart-disease drugs under a provision that allows

the government to cut prices in extraordinary circumstances. "Governments have realised that pricing policy

of drug companies has no relation to their actual cost, including no relation to research cost," said S

Srinivasan of the All India Drug Action Network, a nongovernmental organisation working to increase

access and improve the rational use of essential medicines. "Thispresentpricingmodel of companies needs to

go." Germany - it was the first one to announce massive price cuts in Europe - wants drugmakers to publish

the list of rebates that they pass on to insurance providers. With Germany being a reference market for

many governments to fix drug policy, pharma companies fear this might push them to cut prices elsewhere.

In the UK, the National Institute for Health and Care Excellence, the body that advises the country's drug

regulator, has proposed to introduce a "value-based assessment" that would look at the burden of disease

and wider social benefit while fixing the price of new drugs. It had earlier proposed a value-based pricing

which would consider possible benefits of a drug, instead of its production cost.

INDIA MAKES SIGNIFICANT PROGRESS AGAINST HIV/AIDS, LAGS BEHIND IN FIGHTING

TB AND MALARIA


Fewer people in India are dying from HIV/AIDS, tuberculosis, and malaria than a decade ago, but Indians

still face enormous health threats from the three diseases, according to a new, first-of-its-kind analysis of

trend data. The pace of decline in deaths and infections has accelerated since 2000, when the Millennium

Development Goals (MDGs) were established worldwide to stop the spread of these diseases by 2015. Of

the three diseases, India has made the most progress against HIV/AIDS. The Indian annual rate of decline in

new infections since 2000 was more than four times that of the worldwide rate, a decrease of 16.3% per

year compared to the global drop of 3.9%. Gains during the same time period for TB and malaria were only

slightly higher than the worldwide average. Published in The Lancet on July 22, the study, “Global,

regional, and national incidence and mortality for HIV, tuberculosis, and malaria during 1990–2013: a

systematic analysis for the Global Burden of Disease Study 2013,” was conducted by an international

consortium of more than 1,000 researchers from 106 countries, and was led by the Institute for Health

Metrics and Evaluation (IHME) at the University of Washington. The research consortium included nearly

20 experts in India. The GBD 2013 study provides a consistent and comprehensive approach to estimating

the impact in India and around the world of HIV, TB, and malaria from 1990 to 2013. In a novel approach,

IHME analyzed and triangulated incidence, prevalence, and deaths over time. Special emphasis was also

given to incorporating new data, more rigorously identifying sources of uncertainty, and accounting for

biases that may be present in various data sources. “This massive new study, on the eve of the end of the

MDG era, documents impressive recent progress against HIV and malaria, in particular, but it also shows

that much more needs to be done,” said Dr. Alan Lopez, Melbourne Laureate Professor at the University of

Melbourne and co-founder of the GBD study.

DOUBLE DIGIT GROWTH FOR PHARMA INDUSTRY IN JUNE

The Hindu, 22 July, 2014

The Indian pharmaceutical industry, grappling with the addition of more than a 100 formulations in the

National List of Essential Medicines (NLEM), which caps the price of drugs, is encouraged by data that the

industry grew in double digits in June 2014. AIOCD figures show the industry grew at 10.4 per cent, the

first time it has grown in double digits in a year. Further, domestic pharmaceutical companies grew 12.8 per

cent while multinational (MNC) pharma players grew at 2.8 per cenL during the month. Interestingly, while

Indian companies grew 15.3 per cent in the non-NLEM category, MNC pharma firms grew at 5.8 per cent.

There are worries regarding the sustainability of this growth in the light of the fact that the new price caps

are in.major therapeutic areas of cardiac and anti-diabetic drugs. S. V. Veeramani, President, India Drug

Manufacturers Association (IDMA), felt that the growth parameters were positive for the industry. "There

would certainly be some dampening effect on growth because of the expanded list. We are hopeful that the

industry continues to grow at 10 per cent plus but it is still too soon and the impact remains to be seen."

GaurangShah.VP-Research, Geojit BNP Paribas, felt that there could be an impact on the margins of

companies. "There would be lag effect of the impact of expansion of the NLEM list and there may be some

hit on the margins, particularly for MNCs." Mr. Shah felt that there could be fewer new investments by

MNCe and they would review their portfolios. Due to price caps, profit margins will be reduced and

'breathing space' for the industry has been effectively reduced. Manufacturers are expected to re-work their

portfolios to include controlled and non-controlled drugs. Larger Indian players had been acquiring assets

overseas at attractive valuations as there was better scope there, said Mr. Veeramani. Players like Cipla, Sun

and Glenmark have been expanding their presence in . different categories but there is a possibility of

further consolidation in the domestic market. Owing to competitive pressures, smaller companies with

weaker portfolios will be looking to get out, industry experts felt.

AHMEDABADMAY GET TESTING LAB FOR. PHARMA SECTOR


The city is likely to get a testing laboratory for the pharma ma-chinery and medical devices sec-tor if the

Gujarat Government, makes a proper representation to the Centre in this regard, a senior, official said on

Friday. "If the Gujarat government makes a proper representation, then Ahmedabad will probably get a

testing lab for the pharma and medical device sector," Union Commerce and Industries Minis try's Joint

Secretary Ravi Capoor said while answering queries by stakeholders of the sector. Capoor assured that

small manufacturers would benefit if such H lab is established. Speaking at a meeting of the newly-formed

panel of the Engi neering Export Promotion Council (EEPC), Capoor promised stakeholders of the sector

that actiori would be taken against low-quality products being dumped into the country. Union Commerce

and Industries Ministry's Joint Secretary Sudhanshu Pandey emphasised on a global policy for the

development of the sector.

PHARMA INDUSTRY CONCERNED ON CENTRE'S DRUG PRICE CONTROL


The drug manufacturing industry has raised concern against the Centre's move to control the prices of

diabetes and cardiovascular medicines. The move to reduce the prices of these drugs would impact industry

revenues worth Rs 600 crore, said SV Veerramani, president of Indian Drug Manufacturers Association

(IDMA). However, the IDMA has sought the government to hold the move till the industry takes up a

detailed study on the full impact. Speaking to reporters on the sidelines of inauguration of Pharmac South

2014, a trade exhibition of South Indian Pharmaceutical Industry, he said, "The anti-diabetic and

cardiovascular drugs market is around Rs 6,000 crore and the reduction in prices would impact around Rs

600 crore revenues to the industry." He added that more than the loss and the business impact, industry is

worried if this would be a common trend. The DPCO Act, 2013, empowers the National Pharmaceutical

Pricing Authority (NPPA) to fix a ceiling on retail price of a drug "in extraordinary circumstances" for the

public interest. "It came as a shock to us. We are afraid this would set a precedence and the government

may bring in control on more drugs using the clause in future, which would leave us in a situation where we

don't have a breathing space," said Veerramani. He said the association has made a representation to the

department of Pharmaceuticals and had approached the NPPA asking them to hold the decision till the

association would look into it. The association would also meet the Union Minister for Chemicals and

Fertilisers Ananth Kumar with the request, he added. "We are trying our best to convince the government

the move would affect the industry badly. Otherwise, we might have to look at various options including the

legal," he added.

FAKE DRUGS LIKELY TO CROSS $10 BILLION IN THREE YRS: ASSOCHAM

Political Business Daily, 19 July, 2014

GROWING at a compounded annual growth rate (CAGR) of about 25%, the fake drugs market in India is

likely to cross US$ 10 billion mark by 2017 from the current level of about worth US$ 4.25 billion,

according to a study. A study recently conducted by Industry body Assocham on "Fake and Counterfeit

Drugs In India -Booming Biz" reveals that "India, the world's largest manufacturer of generic drugs, has

become a busy center for counterfeit and substandard medicines which stuffed in slick packaging and often

labeled. The size of domestic drug market today is pegged at around $14-17 billion. The drives trade in fake

drugs is a lack of adequate regulations, shortage of drug inspectors and a lack of lab facilities to check

purity of drugs as the key reasons, adds the Assocham paper. Shockingly, the biggest centre of spurious

drugs seems to be the national capital region, which includes Delhi and its suburbs of Gurgaon, Faridabad

and Noida. It is a growing problem and estimates indicate that (fake drugs) constitute nearly 1/3 of all drugs

sold in NCR, adds the paper. The concentration of fake drugs manufacturers can largely be found out in

locations such Bahadurgarh, Ghaziabad, Aligarh, Bhiwadi, Ballabhgarh, Sonepat, Hisar and Punjab etc.

Agra is also increasingly becoming a hub for fake drugs in India. The fake drugs are available in the

popular medicines like Crocin, Voveran, Betadine, injections of calcium and syrups like Cosavil. The fake

drugs businesses are also turned into a massive racket and witnessed the availability of fake drugs to the

extent of 25% in India, revealed the study. — PTI

FINANCIALS

GLAXOSMITHKLINE NET EARNINGS DIPS BY OVER 35% IN Q2


plc has suffered heavy setback during the second quarter ended June 2014 due to stiff competition in US

respiratory market and generic competition to Lovaza. Its net earnings declined sharply by 35.2 per cent to

£702 million from £1,084 million in the similar period of last year. Its net sales also declined by 16 per cent

to £5,561 million from £6,618 million. With lower net profit, EPS worked out to 13.6 pence as against 21.5

pence in the last period. R&D expenditure declined by 22.9 per cent to £809 million from £1,049 million.

The pharmaceutical & vaccines sales declined by 12.5 per cent to £4,539 from £5,185 million in the

corresponding quarter of last year. Its sales in US declined sharply by 17.1 per cent to £1,193 million from

£1,439 million and that in Europe moved down by 3.9 per cent to £1,019 million from £1,060 million. It

also suffer minor setback in emerging markets and its sales declined by 2.1 per cent to £187 million from

£229 million. Similarly the sales of established products declined to £696 million from £1,018 million. The

sales of respiratory division declined by 8 per cent to £1,559 million as the sales of Seretide/Advair

declined by 12 per cent to £1,095 million. The sales of oncology division improved by 39 per cent to £295

million. For the first half ended June 2014, GSK's net earnings declined by 32.7 per cent to £1,421 million

from £2,113 million in the same half of last year. Its net sales also went down by 14.6 per cent to £11,174

million from £13,089 million as sales of pharmaceutical and vaccines declined by 11.4 per cent to £9,025

million from £10,189 million in the similar half of last year. The company's net sales in US declined by 16.5

per cent to £2,323 million from £2,781 million and that in Europe declined by 1.6 per cent to £2,043 million

from £2,077 million. Its sales in Emerging market declined by 5.8 per cent to £1,513 million from £1,606

million. The sales of established products decreased by 25.3 per cent to £1,510 million from £2,021 million.

The R&D expenditure declined to £1,668 million from £1,953 million.

GRANULES INDIA'S NET PROFIT JUMPS BY 56% IN Q1


Granules India, a Rs.1,000 crore plus Hyderabad based pharma major, has posted strong growth in sales and

profit during the first quarter ended June 2014. Its consolidated net profit went up sharply by 55.7 per cent

to Rs.22.87 crore from Rs.14.69 crore in the corresponding period of last year. Earnings before

depreciation, interest, taxation and adjustments touched to Rs.53.23 crore as against Rs.31.57 crore, a

strong growth of 68.6 per cent. Its consolidated net sales also moved up 36.2 per cent to Rs.311 crore from

Rs.228 crore. With impressive jump in profits, its EPS improved to Rs.11.27 from Rs.7.30 in the last period.

Granules scrip went up sharply by 1.7 per cent after the announcement of financial performance and

touched to Rs.643 on BSE. The scrip touched to 52-weeks highest level at Rs.705 on July 22, 2014. The

consolidated numbers include performance from Auctus, an API manufacturer acquired in February 2014.

Auctus contributed Rs.26.1 crore during the quarter with an EBDITA of Rs.2.2 crore and a net loss of

Rs.2.8 crore.

GLENMARK NET PROFIT SURGES BY 43.7% IN Q1


Glenmark Pharmaceuticals, a Rs.5,980 crore plus pharma major, has registered impressive growth in profit

during the first quarter ended June 2014. Its consolidated net profit has taken a jump of 43.7 per cent to

Rs.148.85 crore from Rs.128.68 crore in the corresponding quarter of last year. Its net sales also moved up

by 19.4 per cent to Rs.1477.82 crore from Rs.1237.88 crore. The EPS moved up to Rs.6.82 from Rs.4.75 in

the last period. Its formulations sales in India went up by 20.9 per cent to Rs.397.16 crore from Rs.328.58

crore in the similar period of last year. Similarly, Glenmark Generics Inc., USA, registered revenue from the

sale finished dosage formulations of Rs.488.67 crore as compared to Rs.446.95 crore. Its revenues in

Africa, Asia and CIS region improved by 20.7 per cent to Rs.211.31 crore from Rs.175.12 crore. Its

European revenue improved by 34.5 per cent to Rs.97.73 crore from Rs.72.65 crore. Its API sales increased

y 13.7 per cent to Rs.144.53 crore. Glenmark received Rs.29.91 crore for out-licensing income during the

quarter under review.

SANOFI Q2 NET INCREASES 12.3% TO RS57.5 CRORE

Financial Express, 24 July, 2014

Drug firm Sanofi India has reported 12.30% increase in its net profit at Rs57.5 crore for the sec-ond quarter

ended June. The company had posted a net profit of Rs51.2 crore during the same period last year.Net sales

of the company went up by 18.7% to Rs486.7 crore during the quarter under review against Rs 410crore

during the same period a year ago, Sanofi India said. Overall expenses stood at Rs431.9 crore in the quarter

against Rs 370.4crore in the correspond-ing period of the previous year. The company's board, which met

today, recommended an interim dividend of Rs10 per equity share.

PATENTS

DEPOMED ANNOUNCES US DISTRICT COURT ORDER IN ANDA LITIGATION


Depomed, a specialty pharmaceutical company that commercializes products for pain and neurology related

disorders, announced that on July 17, 2014, Judge Joel A. Pisano of the US District Court for the District of

New Jersey entered an order preliminarily enjoining Actavis Elizabeth LLC and Actavis Inc. from

marketing a generic version of Gralise (gabapentin) prior to the Court's issuance of an opinion in the matter.

The order indicates the Court expects to issue an opinion in short order. The patents asserted in the lawsuits

expire between September 2016 and February 2024 and include US Patent Nos. 6,635,280; 6,488,962;

7,438,927; 7,731,989; 8,192,756; 8,252,332; and 8,333,992. On May 20, 2014, a bench trial was completed

before Judge Pisano in the patent litigation between Depomed and defendants Actavis Elizabeth LLC and

Actavis Inc. related to an Abbreviated New Drug Application filed by Actavis seeking to market generic

versions of 300mg and 600mg dosage strengths of Gralise prior to the expiration of the patents asserted in

the litigation.

MORPHOSYS' NEW ANTIBODY PLATFORM YLANTHIA RECEIVES ADDITIONAL

PATENTS IN US & CHINA


The US Patent and Trademark Office (USPTO) and the State Intellectual Property Office of China have

granted additional patents covering the MorphoSys' latest antibody platform Ylanthia. "Our new antibody

platform Ylanthia is being used in a rising number of therapeutic relationships including our recent alliances

with Merck Serono and Temple University. In addition to building a track record on the commercial side,

robust patent protection is important for our new technology platform and today's patents further strengthen

our position around Ylanthia in our core markets and in the emerging markets," commented Dr. Marlies

Sproll, chief scientific officer of MorphoSys AG. The newly granted US patents (US 8,685,896 and US

8,728,981) cover an antibody library with superior biophysical properties and methods of selecting

antibodies from such a library. Similar subject matter is covered in the new Chinese patent (ZL 2010 8

0022793.7). The patents have scheduled expiry dates of 2030 and 2031. MorphoSys's Ylanthia antibody

library comprises more than 100 billion distinct, fully human antibodies, which makes it the industry's

largest known antibody Fab library. It uses 36 fixed, naturally-occurring heavy and light chain framework

combinations, which translates into unprecedented structural diversity. The library's diversity is expected to

result in antibodies against previously inaccessible target molecules and in unique epitope coverage.

Ylanthia's antibody frameworks were pre-selected for favorable expression levels, stability and aggregation

behavior. A shift towards higher stability and stress tolerance will increase shelf life and serum stability of

resulting antibody products, making them more cost-effective to produce and administer. A higher solubility

in turn opens up the path for more convenient ways of administration, to the benefit of patients. When

needed, antibodies from the Ylanthia library are optimised using MorphoSys's proprietary Slonomics

technology.

AGILE THERAPEUTICS' SKINFUSION TRANSDERMAL TECHNOLOGY RECEIVES

ADDITIONAL US PATENT


Agile Therapeutics, a women's health specialty pharmaceutical company focussed on the development and

commercialisation of new prescription contraceptive products, announced that the US Patent and

Trademark Office has issued a Notice of Allowance recently for additional patent claims covering dosing

regimens using the company's lead product candidate Twirla (ethinyl estradiol and levonorgestrel

transdermal system (AG200-15)), currently in phase 3 development. The allowed patent, which is published

as US Patent Application 20140072615, is based on Agile's prior patent, US 7,384,650, covering the

formulation for Twirla. "We believe the allowance of this patent represents another step towards our goal of

protecting Twirla, and future product line extensions," said Al Altomari, chief executive officer and

president of Agile. "We intend to continue our efforts to expand our intellectual property portfolio

protecting our proprietary Skinfusion transdermal technology." Agile will submit information regarding this

patent to the FDA for inclusion in the FDA's Orange Book if the Company's New Drug Application for

Twirla is approved. The company has multiple additional patents and applications on file, all relating to

further advances in Skinfusion transdermal delivery system.

MCCORD RESEARCH ENDOTHELIAL CELL TREATMENT RECEIVES US PATENT


McCord Research, Inc., a research company supporting better health through science, was recently granted

a second US patent (US Patent No. 8,796,315). This patent describes a method for accelerating wound

closure to improve wound healing. According to the inventor, Dr McCord, this method includes

administering or transplanting to individuals who require wound healing, a composition of an effective

amount of hydroxytyrosol and oleuropein and cells derived from umbilical cord blood, such that the

administration of the combination reduces the time required for wound healing by at least approximately

30% in comparison to treatment with just cells derived from umbilical cord blood alone. Endothelial cells

form the inner lining of a blood vessel and provides an anticoagulant barrier between the vessel wall and

blood. Endothelial cells have a vital role in wound repair especially for patients with vascular disease and

diabetes. The restoration of these cells allows for vital nutrients to be delivered to the skin and wound

through the small network of capillaries that form at the dermal epidermal junction. The endothelial cells

additionally regulate hemostasis, vasomotor tone, angiogenesis and vasculogenesis and immune and

inflammatory responses. In addition, the endothelial cell plays a pivotal role in wound care. "Endothelial

cell injury is the genesis of many pathologic states including atherosclerosis, loss of semi-permeable

membrane function, and thrombosis. Restoring the viability of endothelial cells has far reaching health

implications," stated Dr McCord. McCord Research is seeking worldwide patent protection for its wound

care technology and looks forward to healing wounds on a global basis. The technology is currently being

licensed under the Olivamine 10 brand name in the United States and Asia for the treatment of wounds in

humans and animals.

USPTO GRANTS PATENT TO OPKO'S RAYALDEE TO TREAT SHPT IN PATIENTS WITH

STAGE 3/4 CKD & VITAMIN D INSUFFICIENCY


United States Patent and Trademark Office (USPTO) granted OPKO Health a patent covering Rayaldee, the

company's product to treat secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic

kidney disease (CKD) and vitamin D insufficiency. The new patent (US Pat. No. 8,778,373) provides

OPKO with additional intellectual property protection covering controlled release administration of a

vitamin D compound. OPKO is on schedule to announce top-line results from the first pivotal phase 3 trial

for Rayaldee in the third quarter of 2014 and file a New Drug Application (NDA) with the FDA in the first

quarter of 2015. Rayaldee is a first-in-class oral vitamin D prohormone treatment being developed for

SHPT in stage 3 and 4 CKD patients with vitamin D insufficiency. It has a proprietary modified-release

formulation designed to gradually and reliably raise serum total 25-hydroxyvitamin D (prohormone)

concentrations to targeted levels (at least 30 ng/mL) while avoiding upregulation of CYP24, a cytochrome

P-450 enzyme that reduces the PTH lowering potency of current vitamin D supplements. Activation of

calcifediol, the active ingredient in Rayaldee, by the kidney is tightly regulated, preventing excessive

elevation of serum calcium and related side effects which encumber current vitamin D hormone therapies

and promote vascular and renal calcification. Once approved, Rayaldee is expected to address an

approximate 4 million CKD stage 3 and 4 patients in the US and many more, elsewhere, with SHPT and

vitamin D insufficiency. OPKO is a multinational biopharmaceutical and diagnostics company that seeks to

establish industry-leading positions in large, rapidly growing markets by leveraging its discovery,

development and commercialization expertise and novel and proprietary technologies.

POLICY AND REGULATIONS

UNION HEALTH MINISTER DR HARSH VARDHAN CALLS FOR EUTHANASIA DEBATE


Union health minister Harsh Vardhan here on Sunday said there should not be any rush to decide on

euthanasia and efforts should be made for a national consensus on it. "A consensus should be developed on

whether to allow killing of terminally-ill people with no chances of revival. It is a complex issue. There

should not be any hurry to decide on this highly emotive subject," the minister said, responding to a query

on the July 16 Supreme Court decision to adjudicate legality of euthanasia. The Times of India has initiated

a campaign favouring active euthanasia with strict safeguards (www.toi.in/endtrauma). "There should

be a healthy countrywide discussion on the topic involving medical professionals and society at large with

an open mind. Since people's emotions are deeply associated with it, the same must be given prime

importance," said Vardhan, a doctor. He was addressing a news conference, wrapping up his three-day

Odisha visit. Asked about his personal views, the minister said, "Personal opinion has no relevance. There

can't be an instant yes or no. Before making any comment we have to examine whether society is prepared

for such a move, all its pros and cons and the rights of terminally-ill people. Our social and cultural issues

should also be kept in mind."

Odisha doctors divided

UN STRENGTHENS NORMS ON LEAD IN INFANT FORMULA, ARSENIC IN RICE


Adopting new standards to protect consumer health worldwide, UN food standards body Codex

Alimentarius Commission has set out maximum acceptable levels of lead in infant formula and of arsenic in

rice. The Commission, jointly run by the United Nation's food agency FAO and the World Health

Organisation (WHO), sets global food safety and quality standards to promote safer and more nutritious

http://www.toi.in/endtrauma

food for consumers worldwide. Codex standards serve in many cases as a basis for national legislation and

provide the food safety benchmarks for international food trade. In an annual meeting held this week, FAO

said, "The Commission adopted a recommendation that no more than 0.01 mg per kg of lead should be

permitted in infant formula as consumed." Lead occurs in the environment and trace amounts can end up in

the ingredients that are used in the production of infant formula.

MODI GOVERNMENT VOWS CLAMPDOWN ON HEALTHCARE GRAFT


The health minister called for tougher laws on Tuesday after a media report alleged that laboratories had

offered kickbacks to doctors who referred patients to their diagnostic centres. Harsh Vardhan has lashed out

several times in recent days against bribery in the $74 billion healthcare sector, signalling that the new

government will make tackling the corruption that blighted the outgoing administration a priority. An

undercover investigation by Hindi news channel News Nation that ran on Monday showed footage

purportedly of reputed private laboratories offering commissions as high as 50 per cent to doctors who

referred patients to their diagnostic centres. Officials at one laboratory visited by the channel's undercover

reporters said they had kickback arrangements with 10,000 doctors, with monthly payments running into

tens of thousands of rupees for some doctors. Himself a doctor with a reputation for probity, Vardhan last

week called the country's drug approval agency a "snake pit of vested interests." Speaking in parliament on

Tuesday, he said a panel of doctors and lawyers would advise on changes to the law specifically to prohibit

kickbacks. With about 40,000 laboratories in India, the diagnostic market is the fastest growing segment of

India's healthcare industry, according to PwC, with the segment forecast to grow to $17 billion by 2021

from $3.4 billion in 2011. Vardhan ordered an inquiry into News Nation's findings and asked the TV

channel to submit a copy of the sting operation. He also directed the Medical Council of India to hold an

emergency meeting of its ethics committee.

GOVT TO CHANGE PROCUREMENT METHOD FOR VITAL DRUGS


The Government is set to revamp the method of procuring vital drugs. It proposes to source drugs through

Central Medical Stores adopting an IT-based system, a senior official in the Ministry of Health and Family

Welfare told Business Line. The new system will be in place by 2015-16. The Ministry had faced criticism

after it failed to procure sufficient drugs to treat tuberculosis (TB) in 2012, since tendering for procurement

had been done late. The issue had spilled over to 2013 as well, creating fears of shortage of the first-line

drugs such as Rifampicin and Isonia-zid used to treat TB. "The Ministry had got into arrangements with

RITES and others to do the procurements for us, which did not work out satisfactorily. So, now we will do

through our own Central Medical Stores (CMSs). It is expected from 2015-16 the procurement will start

there," said the official. This will be an IT-driven procurement system under which the exact position of

every State will be known and would further help the Centre decide which drugs need to be pushed first.

The procurement of drugs to treat certain diseases such as TB and malaria are done by the Centre itself,

since the prevalence of these diseases is high in the country and take several lives. India also runs a DOTS

(Directly Observed Treatment, short-course) programme to combat TB and it is important for patients to

complete their DOTS course to prevent any chances of either developing drug-resistant TB or losing their

lives. This is one of the vital reasons the Government procures TB drugs directly to ensure sufficient supply

in Government hospitals and enable treatment of all TB-affected patients. Other than TB and malaria, the

Union Government also procures important vaccines used under the Universal Immunisation Programme.

NATIONAL PHARMACEUTICAL PRICING AUTHORITY CUTS PRICES OF DIABETES &

HEART-DISEASE DRUGS


It is not the Indian regulator who is the only one after drug companies to cut prices. Across the world,

pharmaceutical companies are coming under pressure to reduce prices as concerns over growing healthcare

costs force governments to target drugmakers. Countries like Germany, the UK and the US are all

monitoring the prices of life-saving drugs. Last week, India's National Pharmaceutical Pricing Authority

decided to slash the prices of more than 100 diabetes and heart-disease drugs under a provision that allows

the government to cut prices in extraordinary circumstances. "Governments have realised that pricing policy

of drug companies has no relation to their actual cost, including no relation to research cost," said S

Srinivasan of the All India Drug Action Network, a nongovernmental organisation working to increase

access and improve the rational use of essential medicines. "This present pricing model of companies needs

to go." Germany - it was the first one to announce massive price cuts in Europe - wants drugmakers to

publish the list of rebates that they pass on to insurance providers. With Germany being a reference market

for many governments to fix drug policy, pharma companies fear this might push them to cut prices

elsewhere. In the UK, the National Institute for Health and Care Excellence, the body that advises the

country's drug regulator, has proposed to introduce a "value-based assessment" that would look at the

burden of disease and wider social benefit while fixing the price of new drugs.

SHORTAGE OF DOCTORS IN EMPLOYEES' STATE INSURANCE HOSPITAL: MINISTER


Labour and Employment Minister Narendra Singh Tomar today said senior officers will be deputed to

investigate complaints that some doctors of Bhubaneswar ESI hospital were engaged in private practice.

Replying to suplementaries in Rajya Sabha, he said if doctors are engaged in private practice it is a matter

of serious concern and "I will be certainly deputing senior officers to investigate". He said this when

Pyarimohan Mohapatra (Ind) raised the issue during Question Hour. The Employees' State Insurance (ESI)

Hospital in Bhubaneswar is being run by the Odisha government. Tomar admitted there was shortage of

doctors and other paraphernelia in ESI and other government hospitals. The Minister, however, said

government always makes efforts to ensure availability of doctors of all faculties in hospitals. He further

informed that Employees' State Insurance Corporation (ESIC) has taken up a project for up-gradation of the

Bhubaneswar ESI hospital from 50 beds to 100 beds. The project would be completd by March 2015, he

said. Meanwhile, replying to a question on rehabilitation package for people affected by Kosi river floods of

2008, Home Minister Rajnath Singh said whatever fund was required has been given. Singh, however, said

the Bihar government has not spent the entire World Bank grant of USD 220 million in this regard. The

Department of Economic Affairs had facilitated the external assistance package of USD 220 million for

taking up reconstruction and rehabilitation works after the Kosi floods.

TAKE STOCK OF ENCEPHALITIS SITUATION IN WEST BENGAL: SS AHLUWALIA TO

GOVERNMENT


The issue of people dying in West Bengal due to encephalitis echoed in the Lok Sabha today with some

members alleging the state government was not doing much to control the situation. Raising the issue

during Zero Hour, BJP member from Darjeeling SS Ahluwalia said the state government was not doing

anything even as many people were dying. The government should set up a high-powered committee to

look into the matter and also send a special medical team to the state, he said. Congress member Adhir

Ranjan Chowdhury said many people have died and many more are infected. There is not enough medical

facilities to deal with the situation, the member said. Urging the Union Health Ministry to take stock of the

situation in West Bengal, he said the state government was "apathetic" on the matter. Trinamool Congress

member Sultan Ahmed said the state government has taken up the encephalitis matter seriously. Jagdambika

Pal (BJP) drew the attention of the government to the growing problem of the disease in eastern Uttar

Pradesh.

PRODUCT APPROVALS

US FDA GRANTS 510(K) CLEARANCE TO BAUSCH + LOMB’S VICTUS FEMTOSECOND

LASER PLATFORM FOR LENS FRAGMENTATION PROCEDURE


Valeant Pharmaceuticals International, Inc.'s wholly owned subsidiary, Bausch + Lomb has received 510(k)

clearance from the US Food and Drug Administration (FDA) for the VICTUS Femtosecond Laser Platform

for laser-assisted lens fragmentation during cataract surgery. The fragmentation procedure, which follows a

capsulotomy, uses the femtosecond laser to split the cataractous lens into sections. This is followed by

phacoemulsification for cataract removal. The VICTUS platform offers a number of different lens

fragmentation patterns depending on the cataract grade and user preference. “Valeant is committed to

innovation in healthcare and continues to fund important R&D programmes that will bring benefits to

physicians and the patients they serve,” stated J Michael Pearson, chairman and chief executive officer,

Valeant Pharmaceuticals International, Inc. “We will continue to invest in important advancements that will

broaden our eye health product offerings and further enhance the strength of the Bausch + Lomb brand.”

“Academic research has shown that cataracts pre-treated with lens fragmentation can require less

phacoemulsification energy for removal,” said Y. Ralph Chu, M.D., founder and director of the Chu Vision

Institute, Bloomington, MN. “In lower grade cataracts, we have seen up to a 50 per cent reduction in the

phaco energy required to remove the lens following lens fragmentation with the laser, compared with

standard phaco.” Bausch + Lomb has been installing VICTUS platforms in leading surgery centers globally

since it received CE mark in November 2011 and the FDA clearances in July 2012. It is now one of the only

femtosecond lasers in the US with clearance for the creation of a corneal flap in patients undergoing LASIK

surgery, anterior capsulotomy during cataract surgery, penetrating arcuate cuts/incisions in the cornea and

laser-assisted lens fragmentation during cataract surgery.

STRIDES ARCOLAB GETS USFDA APPROVAL FOR TACROLIMUS CAPSULES


Pharma firm, Strides Arcolab today announced that it has received approval from the United States Food &

Drug Administration (USFDA) for marketing of Tacrolimus capsules, used as immuno-suppressant. "We

have received approval from the USFDA for Tacrolimus capsules USP, 0.5 mg, 1 mg, and 5 mg and (they)

will be launched immediately," company statement said here. The product will be manufactured at the

company's oral dosage facility at Bangalore and marketed directly by Strides in the US market. According

to IMS data as on September 2013, the US market for generic Tacrolimus is approximately $ 676 million.

Tacrolimus capsule is an immunosuppressant and is used for preventing organ rejection in certain patients

following liver, kidney, or heart transplant. It may be used along with other medicines. It blocks the action

of certain blood cells that can cause the body to reject the transplanted organ.

CTI BIOPHARMA'S PIXUVRI RECEIVES ISRAELI APPROVAL TO TREAT PATIENTS WITH

MULTIPLY RELAPSED/REFRACTORY AGGRESSIVE B-CELL NHL


CTI BioPharma Corp, a biopharmaceutical company, focussed on the acquisition, development and

commercialisation of novel targeted therapies, has received approval from the Israeli Ministry of Health

(MOH) for Pixuvri (pixantrone). Pixuvri in Israel is indicated as monotherapy for the treatment of adult

patients with multiply relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (aggressive B-cell

NHL) who have received not more than three previous courses of treatment. The benefit of pixantrone

treatment has not been established in patients when used as fifth line or greater chemotherapy in patients

who are refractory to last therapy. In Israel, Pixuvri will be distributed and marketed by the Neopharm

Group, Israel's second largest pharmaceuticals and health products marketer, once Pixuvri is included in the

Israeli National Health Basket of drugs by the MOH.

US FDA CLEARS GALMED'S ARMACHOL IND TO TREAT FATTY LIVER DISORDERS


The US Food and Drug Administration, (US FDA) has cleared Galmed Pharmaceuticals' Investigational

New Drug (IND) application which will permit the company to conduct clinical trials of its product

candidate, aramchol, in the United States for the treatment of fatty liver disorders. Galmed is initially

developing aramchol for the treatment of non-alcoholic steato-hepatitis, or NASH. According to scientific

literature, NASH is a chronic disease that affects approxiately12 per cent of the population in United States

and in certain European Union nations and its prevalence is expected to increase in parallel with increased

rates of obesity and diabetes. There are currently no approved drugs to treat NASH. In connection with the

FDA's clearance of Galmed's IND application, Galmed submitted a request to the FDA for the approval of a

Fast Track Designation for aramchol. Fast Track Designation is a designation by the FDA that facilitates the

development, and expedites the review, of drugs which treat a serious or life-threatening condition and fill

an unmet medical need. "We believe that the IND application clearance serves as an additional validation

for our development program and will allow us to perform clinical studies for our primary indication,

NASH, as well as additional proof of concept studies of aramchol in the United States in the future," said

Allen Baharaff, Galmed's chief executive officer. "We further believe that the indications we are seeking to

address with aramchol are increasingly relevant public health issues as they are major causes of

cardiovascular and liver-related morbidity and mortality, with no approved treatment currently available."

Aramchol, a conjugate of cholic acid and arachidic acid, is a first in class member of a novel family of

synthetic Fatty-Acid / Bile-Acid Conjugates or FABACs. FABACs are composed of endogenic compounds,

orally administrated with potentially good safety and tolerability parameters.

US FDA APPROVES RUCONEST TO TREAT HEREDITARY ANGIOEDEMA


The US Food and Drug Administration (US FDA) has recently approved Ruconest, the first recombinant

C1-Esterase Inhibitor product for the treatment of acute attacks in adult and adolescent patients with

hereditary angioedema (HAE). Hereditary angioedema, which is caused by having insufficient amounts of a

plasma protein called C1-esterase inhibitor, affects approximately 6,000 to 10,000 people in the United

States. People with HAE can develop rapid swelling of the hands, feet, limbs, face, intestinal tract, or

airway. These acute attacks of swelling can occur spontaneously, or can be triggered by stress, surgery or

infection. Swelling of the airway is potentially fatal without immediate treatment. “Hereditary angioedema

is a rare and potentially life-threatening disease,” said Karen Midthun, M.D., director of the FDA’s Center

for Biologics Evaluation and Research. “Today’s approval provides an important treatment option for these

patients.” Ruconest is a human recombinant C1-esterase inhibitor purified from the milk of genetically

modified (transgenic) rabbits. Ruconest is intended to restore the level of functional C1-esterase inhibitor in

a patient’s plasma, thereby treating the acute attack of swelling. The safety and efficacy of Ruconest was

evaluated in a multicentre controlled clinical trial. Forty-four adult and adolescent patients with acute

attacks were treated with Ruconest. The most common adverse reactions reported in patients treated with

Ruconest were headache, nausea and diarrhoea. Ruconest received orphan-drug designation for acute

attacks by the FDA because it is intended for treatment of a rare disease or condition.

ACCESS PHARMA'S PROCTIGARD RECEIVES US FDA MARKETING APPROVAL


Access Pharmaceuticals, an emerging bio-pharmaceutical company, and a developer of new products for

oncology supportive care, has received 510(K) marketing clearance from the US Food and Drug

Administration (US FDA) for ProctiGard, its novel treatment for symptomatic management of rectal

mucositis. The company indicated its development of ProctiGard is a direct response to dialogue with the

oncology community that is looking for better, more effective treatment options for rectal mucositis and

radiation proctitis, a debilitating oncology side effect. Access believes that ProctiGard is a first-in-class

treatment option that addresses a significant unmet medical need. Access currently holds global

commercialization rights for ProctiGard. "This second FDA marketing clearance is an important milestone

for Access following the decision to focus on the development and commercialisation of a portfolio of

follow-on proprietary products," said Jeffrey Davis, chief executive officer, of Access Pharmaceuticals. He

continued, "Rectal mucositis and radiation proctitis, presenting as inflammation and damage to the lower

part of colon, is a common adverse event of the radiotherapy of tumours in the abdominal and pelvic region

with no well-established effective standard of care. With the introduction of ProctiGard, we look forward to

providing cancer patients with an important treatment that manages this debilitating disease."

STRIDES ARCOLAB GETS USFDA NOD FOR TACROLIMUS CAPSULES


Strides Arcolab has received approval from the United States Food & Drug Administration (US FDA) for

Tacrolimus Capsules USP, 0.5 mg, 1 mg, and 5 mg. This is an immunosuppressant used for preventing

organ rejection in certain patients following liver, kidney, or heart transplant. It may be used along with

other medicines. It blocks the action of certain blood cells (eg, T lymphocytes) that can cause the body to

reject the transplanted organ. The product will be manufactured at the company’s Oral dosage facility at

Bengaluru and marketed directly by Strides in the US Market. According to IMS data as on September

2013, the US market for generic Tacrolimus is approximately US$ 676 million. Strides Arcolab develops

and manufactures a wide range of IP-led niche pharmaceutical products from its 5 manufacturing facilities.

The company has a presence in more than 75 countries in developed and emerging markets.

CLINICAL TRIALS

PHASE IV EMANATE TRIAL ENROLLMENT BEGINS TO ASSESS EFFECTIVENESS &

SAFETY OF ELIQUIS IN NVAF PATIENTS UNDERGOING CARDIOVERSION


Bristol-Myers Squibb Company (BMS), a global biopharmaceutical company, and Pfizer Inc. announced

that the first patient has been enrolled into a phase IV clinical trial called EMANATE (Eliquis evaluated in

acute cardioversion coMpared to usuAl treatmeNts for AnTicoagulation in subjEcts with NVAF) assessing

the effectiveness and safety of Eliquis in patients with nonvalvular atrial fibrillation (NVAF) undergoing

cardioversion. Eliquis is currently approved to reduce the risk of stroke and systemic embolism in patients

with NVAF. Cardioversion (administered through electric shock to the chest or with medication) is a

commonly used, effective method of converting atrial fibrillation to a normal rhythm, allowing the heart to

pump more effectively. Traditionally, anticoagulation is administered for a minimum of three weeks prior to

cardioversion and for four weeks afterward. In some patients, early cardioversion can be performed on the

same day or within days of new-onset NVAF, usually after imaging, to confirm the absence of a pre-existing

thrombus in the heart, which could be dislodged during the cardioversion procedure and cause a stroke.

EMANATE, a randomized, open-label clinical trial, will assess the effectiveness and safety of Eliquis

compared with usual care (parenteral heparin and/or oral anticoagulation with a vitamin K antagonist)

initiated in patients with NVAF expected to undergo cardioversion after short-term anticoagulation, in a

clinical practice setting. In NVAF patients presenting at least 48 hours after the onset of NVAF, early

cardioversion will be performed after excluding a thrombus by imaging, on the same day or within a few

days. In NVAF patients presenting within 48 hours of the onset of NVAF, cardioversion will be performed

promptly without prior imaging. In all patients, Eliquis or usual care will be initiated prior to cardioversion

and continued for up to 30 days post-cardioversion. The EMANATE trial is anticipated to enroll 1,500

eligible patients from the US, Canada, Europe and Asia. Patients will be randomized 1:1 to Eliquis or usual

care, to be administered for up to 30 days following early cardioversion or 90 days post randomization if

cardioversion is not performed within this timeframe. The primary efficacy endpoints are the occurrence of

acute stroke, systemic embolism and all-cause death. Primary safety endpoints are major bleeding and

clinically relevant non-major bleeding.

US FDA ACCEPTS AVANIR PHARMA'S IND APPLICATION FOR PHASE II STUDY OF AVP-

786 FOR ADJUNCTIVE TREATMENT OF MDD


The US Food and Drug Administration (FDA) has accepted Avanir Pharmaceuticals, Inc.'s Investigational

New Drug (IND) application for a phase II study assessing the safety and efficacy of AVP-786, Avanir's

next generation compound. The company plans to initiate this study evaluating AVP-786 for the adjunctive

treatment of major depressive disorder (MDD) during the third calendar quarter of 2014. "The endorsement

of this phase II study by the division of Psychiatry Products at the FDA lends support for the expedited

development path for AVP-786 and is allowing us to reference the extensive data generated during AVP-923

development programmes. This is an important moment for the company, as this will be our first clinical

study evaluating AVP-786 in patients," said Joao Siffert, MD, chief medical officer at Avanir

Pharmaceuticals. "There are millions of patients with MDD who do not respond adequately to existing

therapies. With a mechanism of action addressing multiple neurotransmitter systems involved in depression,

AVP-786, if approved, could offer a potential new treatment option for these patients. We look forward to

initiating our clinical research programme in the coming months." The filing of this IND represents the first

step in Avanir's plan to develop AVP-786 for a broad array of neurological and psychiatric conditions. This

multicenter, randomized, double-blind, placebo-controlled proof-of-concept phase II study will evaluate the

efficacy and safety of AVP-786 in patients suffering from MDD who have had an inadequate response to

commonly prescribed antidepressants, including selective serotonin reuptake inhibitors (SSRIs) and

serotonin-norepinephrine reuptake inhibitors (SNRIs). The study is expected to enroll approximately 200

patients in the United States. The study will utilize innovative methodologies to reduce the placebo

response, which is commonly observed in depression trials. Eligible patients will be randomized to receive

either AVP-786 or placebo for 10 weeks. The main efficacy measure is the Montgomery-?sberg Depression

Rating Scale (MADRS) total score, a standard clinical measure of depression. Secondary outcome measures

include assessments of disease severity, activities of daily living, and quality of life. Pharmacokinetics and

standard safety assessments will also be conducted.

BIOTRONIK COMPLETES PATIENT ENROLLMENT IN SFA ARM OF BIOFLEX-I CLINICAL

TRIAL


, a leading manufacturer of cardiovascular medical devices, announced the completion of patient enrollment

in the superficial femoral artery (SFA) arm of its BIOFLEX-I clinical trial, an FDA-approved investigative

device exemption (IDE) trial evaluating the use of self-expanding nitinol stents in treating peripheral artery

disease. A total of 296 patients were successfully implanted with the Astron Pulsar and Pulsar-18 stents at

34 centers in the US, Canada and Europe. The investigational Pulsar-18 is currently the only self-expanding

stent with 4F introducer sheath compatibility for stent diameters of up to 7 mm and lengths of up to 200

mm. It represents a major advance in the minimally invasive treatment of lower limb disease. Pulsar-18 is

designed to have high bending and axial flexibility. Its sufficient chronic outward force and crush resistance

are intended to support the vessel while minimizing the risk of inflammatory response that can be triggered

by excessive chronic outward force. "The ability to deliver an SFA stent through a 4F sheath expands the

possibilities for patient treatment," commented Dr. Carlos Mena, Yale New Haven Hospital, New Haven,

Connecticut. Mena is the first US physician to implant a Pulsar-18 stent through a 4F sheath. "The flexible

Pulsar-18 has a low crossing profile that is advantageous, allowing use not only through the 4F sheath, but

also in tight lesions of the SFA." Pulsar-18 has CE mark and is sold in over 50 countries globally. The

Pulsar-18 and 4F approaches to lower limb interventions were validated in several independent studies,

including the 4EVER study, which showed excellent technical success, safety and efficacy for up to two

years. In this study, the primary patency of Pulsar-18 was 73.4 percent at 12 months and 69.7 per cent at 24

months. More recently, the Pulsar-18 stent showed 79.5 per cent primary patency 12-month results in the

PEACE I all-comers registry. "Completion of enrollment in the SFA arm of this study represents a major

milestone for Biotronik as we strive to bring the full portfolio of Biotronik Vascular Intervention products to

the US," explained Dr. Daniel Bühler, president, Biotronik Vascular Intervention. "Achieving this

enrollment goal in the BIOFLEX-I study brings us one step closer to having these novel products available

to US physicians for the treatment of lower limb disease," remarked principal investigator Dr Mark W.

Burket, University of Toledo Medical Center, Toledo, Ohio. "The Pulsar-18 and Astron stents will give

physicians greater opportunity to treat peripheral vascular disease, thereby improving patient quality of

life." Pulsar stents feature an innovative, highly flexible design coated with proBIO, a silicon carbide layer

that improves the stent's hemocompatibility and biocompatibility - which is believed to contribute to its

excellent clinical results. Pulsar-18 comes in diameters of 4 7 mm and lengths of 20-200 mm, all deliverable

through a 4F sheath.

AMGEN'S PHASE 3 STUDY EVALUATING AMG 416 TO TREAT SHPT IN PATIENTS WITH

CKD MEETS PRIMARY AND SECONDARY ENDPOINTS


Amgen announced that a phase 3 study evaluating AMG 416 (formerly known as velcalcetide) for the

treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD),

receiving hemodialysis, met its primary and all secondary endpoints. The primary endpoint was the

proportion of patients with > 30 per cent reduction from baseline in parathyroid hormone (PTH) levels

during an Efficacy Assessment Phase (EAP) defined as the period between weeks 20 and 27. Amgen

obtained AMG 416 as part of the acquisition of KAI Pharmaceuticals, Inc. in July 2012 and these are the

first results to be reported from the Phase 3 programme. In the AMG 416 group, 75.3 per cent of patients

achieved a > 30 per cent reduction from baseline in PTH compared with 9.6 per cent in the placebo arm, a

statistically significant result. Secondary endpoints included the per cent change from baseline during the

EAP in serum phosphorus (P) concentration (mean changes of -9.63 and 1.60 per cent among patients in the

AMG 416 and placebo arms, respectively) and corrected calcium (cCa) concentration (mean changes of -

6.69 and 0.58 per cent among patients in the AMG 416 and placebo arms, respectively). Both of these

secondary endpoint results were statistically significant. "Secondary hyperparathyroidism can be a

challenging disease to manage and control. There is an important role for an effective calcimimetic that can

be administered intravenously with hemodialysis to help treat this disease," said Sean E. Harper, M.D.,

executive vice president of research and development at Amgen.

TRIALS OF INDIGENOUS CHOLERA VACCINE SUCCESSFUL SO FAR

Deccan Herald, 22 July, 2014

An indigenous cholera vaccine has been found safe and effective in the second stage clinical trial,

prompting the scientists to plan for the last round of the trial on 1,000 people to firmly establish its

potential. Developed by researchers at the National Institute for Cholera and Enteric Diseases (NICED),

Kolkata, the single dose oral vaccine has been found better than a Rs 400 two-dose vaccine, available in the

market. Cholera continues to be a public health threat in South East Asia including India, Africa and parts of

the South America. It affects more than 100,000 Indians and kills 8000-10,000 every year pri-An

indigenous cholera vaccine has been found safe and effective in the second stage clinical trial, prompting

the scientists to plan for the last round of the trial on 1,000 people to firmly establish its potential.

Developed by researchers at the National Institute for Cholera and Enteric Diseases (NICED), Kolkata, the

single dose oral vaccine has been found better than a Rs 400 two-dose vaccine, available in the market.

Cholera continues to be a public health threat in South East Asia including India, Africa and parts of the

South America. It affects more than 100,000 Indians and kills 8000-10,000 every year primarily among the

poor in West Bengal, Tamil Nadu, Maharashtra and Andhra Pradesh.

GSK'S PHASE III STUDY OF TRAMETINIB AND DABRAFENIB COMBO SHOWS SURVIVAL

BENEFIT COMPARED TO VEMURAFENIB


GlaxoSmithKline announced that the Independent Data Monitoring Committee (IDMC) recommended

COMBI-v (MEK116513), a phase III study of its MEK inhibitor, trametinib (Mekinist), in combination

with its BRAF inhibitor, dabrafenib (Tafinlar), compared to vemurafenib in patients with BRAF V600E or

V600K mutation-positive unresectable or metastatic cutaneous melanoma be stopped early. This IDMC

recommendation is based on an interim analysis which demonstrated an overall survival benefit for the

trametinib and dabrafenib combination compared to vemurafenib that crossed the pre-specified efficacy

stopping boundary. The safety profile of the trametinib and dabrafenib arm was consistent with the safety

profile of the combination observed to date. The IDMC recommendation is based on headline data; further

analysis of safety and efficacy data is underway and will be completed in the coming months. Eligible study

patients who were randomised to the vemurafenib arm will be allowed to cross over to receive treatment

with the trametinib and dabrafenib combination. Dr. Rafael Amado, Head of Oncology R&D at GSK, said:

“Today’s headline results for the combination of dabrafenib and trametinib add to the body of evidence our

phase III programme has provided thus far, which we hope will more fully characterise the efficacy and

safety profile of this combination for patients with BRAF V600-mutant metastatic melanoma. We will

continue to analyse this data versus vemurafenib over the coming months and look forward to sharing these

with the scientific community once the analysis is complete.”

METAMAX ENROLLS FIRST PATIENT IN PHASE 1/2A STUDY OF ANTI-CANCER DRUG

MM-D37K


Following approval by the Russian Ministry of Health, Russian biotechnology company MetaMax will

begin the trial of its lead anticancer compound MM-D37K. The first patients have been enrolled in a phase

1/2a clinical trial of a promising approach to treat malignant neoplasms. MetaMax is financed by Maxwell

Biotech Venture Fund, set up with the participation of RVC. The trial will enroll 21 patients with advanced

solid malignancies, including glioblastoma and gastrointestinal tumours. The clinical trial of MM-D37K is

being conducted at some of the major Russian oncology centers with a strong 1/2a phase cancer clinical

trials background. The main goal of the trial is to investigate safety, tolerability and pharmacokinetics of

multiple use of the study drug in different dose levels, to assess the tumor response to the therapy.

Additionally the trial will evaluate the correlation of the therapeutic effect with biomarker levels to select

patient populations for further clinical trials of MM-D37K. Vladimir Bozhenko, Scientific Advisor of

MetaMax says “Inhibition of cyclin-dependent kinase 4/6 is one of the most promising approaches in

treatment of malignant diseases. This is due to the fact that tumor cells frequently lose the endogenous

inhibitors of cyclin-dependent kinases. This leads to an uncontrolled division of the cells. We hope that

MM-D37K, by means of recovering the lost functions, will activate the controlled death of the tumor cells,

and prevent metastasing to other organs”. MetaMax LLC is a private biotech company founded in 2010 to

develop innovative biopharmaceutical drugs targeting the most prevalent and dangerous systemic diseases.

ISIS BEGINS PHASE 2 STUDY OF ISIS-APO(A) RX IN ATIENTS WITH HIGH LP(A)


Isis Pharmaceuticals, announced the initiation of a phase 2 study evaluating ISIS-APO(a)Rx in patients with

high lipoprotein(a), or Lp(a), an independent risk factor for cardiovascular disease. Patients with high levels

of Lp(a) have an increased risk of atherosclerosis, coronary heart disease, aortic stenosis, heart attack and

stroke. ISIS-APO(a)Rx is designed to reduce Lp(a) by inhibiting the production of apolipoprotein(a). Isis

plans to develop ISIS-APO(a)Rx to treat patients with high Lp(a) levels who are at high risk of

experiencing life-threatening cardiovascular events. "Until recently, the importance of evaluating Lp(a) as

an independent risk factor for cardiovascular disease was largely underappreciated. Fortunately, there is a

growing awareness within the cardiology community about Lp(a) and its role in cardiovascular disease. In

fact, there are many patients who, despite having normal levels of LDL-cholesterol, have cardiovascular

disease that is primarily caused by high Lp(a) levels. Because elevated Lp(a) is a genetically determined

condition that is not responsive to lifestyle changes, patients are unable to adequately control their Lp(a)

levels through improved diet or increased physical activity. Although Lp(a) can be measured by a routine

lipid blood panel, the lack of drugs to effectively lower Lp(a) has made treating patients with Lp(a)-driven

cardiovascular disease difficult," said Sotirios Tsimikas, M.D., Professor of Medicine and Director of

Vascular Medicine at the University of California San Diego and vice president of Clinical Development

and Leader of Cardiovascular Franchise at Isis. "By inhibiting the production of apolipoprotein(a), ISIS-

APO(a)Rx is designed to directly reduce a patient's Lp(a) level, thereby offering a unique and specific

approach to treating patients who have high cardiovascular risk due to high Lp(a) levels." The Phase 2 study

is a randomised, placebo-controlled, dose-titration study evaluating the safety and efficacy of ISIS-

APO(a)Rx.

REGENERON ANNOUNCES 2-YEAR RESULTS FROM PHASE 3 VIVID-DME TRIAL OF

EYLEA INJ TO TREAT DME SHOW SUSTAINED IMPROVEMENT IN VISION


Regeneron Pharmaceuticals, Inc.,a leading science-based biopharmaceutical company, announced that in

the phase 3 VIVID-DME trial of Eylea (aflibercept) Injection for the treatment of diabetic macular edema

(DME), Eylea 2 milligrams (mg) dosed monthly (2Q4) and Eylea 2 mg dosed every two months (after 5

initial monthly injections, 2Q8) showed a sustained improvement from baseline in best corrected visual

acuity (BCVA) at week 100 (2 years), compared to laser photocoagulation. The 52-week results (primary

analyses) from this study have been previously reported. Patients in the VIVID-DME trial were randomized

to receive either Eylea 2Q4 (n=136), Eylea 2Q8 (n=135), or the comparator treatment of laser

photocoagulation (n=132). After two years, patients receiving Eylea 2Q4 had a mean change from baseline

in BCVA of 11.4 letters (10.5 letters at 52 weeks, P less than 0.0001 vs. laser). Patients receiving Eylea 2Q8

had a mean change from baseline in BCVA of 9.4 letters (10.7 letters at 52 weeks, P less than 0.0001 vs.

laser). Patients in the laser photocoagulation treatment group had a mean change from baseline in BCVA of

0.7 letters (1.2 letters at 52 weeks). Additionally, 31.1 per cent of patients receiving Eylea 2Q8 achieved an

increase of greater than or equal to 15 letters, or approximately 3 lines of vision, from baseline (P = 0.0001),

and 38.2 percent receiving Eylea 2Q4 achieved an increase of greater than or equal to 15 letters from

baseline (P less than 0.0001 vs. laser), compared with 12.1 per cent of patients in the laser control arm

achieving similar vision gains. "These data showed that treatment with Eylea in this trial improved vision

and maintained the improvement over two years in patients with diabetic macular edema," said George D.

Yancopoulos, M.D., Ph. D., chief scientific officer of Regeneron and president of Regeneron Laboratories.

In this trial, Eylea had a similar overall incidence of adverse events (AEs), ocular serious AEs, and non-

ocular serious AEs across the Eylea treatment groups and the laser control group. The most frequent ocular

AEs observed in the VIVID-DME trial included conjunctival hemorrhage, cataract, and increased

intraocular pressure. The most frequent non-ocular AEs included nasopharyngitis and hypertension. Arterial

thromboembolic events as defined by the Anti-Platelet Trialists' Collaboration (non-fatal stroke, non-fatal

myocardial infarction, and vascular death) were similar across the treatment groups and the laser control

group with events occurring in 8 out of 136 patients in the Eylea 2Q4 group, 5 out of 135 patients in the

Eylea 2Q8 group, and 3 out of 133 patients in the laser group. Four out of 136 patients died in the Eylea

2Q4 group, 6 out of 135 patients in the Eylea 2Q8 group, and 1 out of 133 patients in the laser treatment

group. Full two-year data from the VIVID-DME trial will be presented at upcoming medical conferences.

Both the VIVID-DME and VISTA-DME trials will continue as planned up to 148 weeks. Eylea was

approved in the United States for the treatment of neovascular (wet) Age-related Macular Degeneration

(AMD) in November 2011 and for Macular Edema following Central Retinal Vein Occlusion (CRVO) in

September 2012.

GLIDE PHARMA COMPLETES PROOF-OF-CONCEPT STUDY WITH NOVEL SOLID DOSE

FORMULATION OF OCTREOTIDE


Glide Pharma, a specialty pharmaceutical development and device company, announced that its novel solid

formulation of octreotide acetate achieved successful results in a pre-clinical proof-of-concept study

comparing it with the currently marketed liquid product (Sandostatin). Based on these results, the company

intends to transfer the formulation production process to a contract manufacturing organisation (CMO), and

to advance Glide octreotide delivered with the needle-free Glide solid dose injector (SDI) into clinical trials

in 2015. The pre-clinical study compared the pharmacokinetic profile of the most widely used clinical dose

of Sandostatin (100 mcg) with that of Glide’s octreotide solid dose formulation. The results demonstrated

that there was no statistical difference between the two profiles (p<0.05). Octreotide products are currently

approved for use in the treatment of acromegaly and certain neuroendocrine tumours with the market for

immediate release liquid formulations estimated to be in excess of $150 million. Dr Mark Carnegie-Brown,

Glide Pharma’s CEO, commented, “These results represent a significant milestone, both in the development

of our final clinical formulation for Glide octreotide and of our scale-up capabilities. Together, these enable

us to transfer the formulation manufacturing process to a CMO later in the year. This progress is mirrored in

our device scale-up programme, and as a result we plan to complete an octreotide clinical proof-of-concept

study with our Glide SDI device in 2015.” Glide Pharma is a specialty pharmaceutical development and

device company developing products for the easy, safe and convenient delivery of solid dose therapeutics

and vaccines using its proprietary Glide SDI - the Solid Dose Injector.

RESEARCH

PFIZER'S NEW FOGO SURVEY REVEALS FEAR OF GETTING OLD PUT PRESSURE ON

PHYSICAL ABILITY


Life expectancy continues to climb up to more than 81 years for women and 76 years for men but many of

us have concerns around aging. Pfizer is challenging Americans to address their FOGO Fear of Getting Old

as the next phase of Get Old, an initiative by Pfizer around aging, encouraging honest conversations and

celebrating getting “old” at whatever stage of life you are. “We want people to Get Old with a new attitude.

If you address fears or concerns today you can work to make the right health and lifestyle choices that will

impact how you age tomorrow,” said Freda Lewis-Hall, M.D., chief medical officer at Pfizer. “People of all

ages should start thinking about how they want to age, and turn fears into healthy actions.” A recent survey,

conducted online by Harris Poll on behalf of Pfizer’s Get Old, found that 87 per cent of Americans have at

least one fear when they think about getting old. Decline in physical ability is the most feared by 23 per

cent of Americans, followed by memory loss at 15 per cent and having a chronic disease or running out of

money at 12 per cent each all of which are higher than the fear of dying at 10 per cent. Additionally, a

separate social research study found that the majority 62per cent of the 4.2 million Tweets posted about

aging in the last 12 months were negative. In the analysis, health and wellness were the most commonly

discussed Tweet topics and were up 48 per cent in 2014 versus 2013. A study by Pew Research suggested

that these aging concerns may be unnecessary. In the study, those over 65 experienced less issues like

memory loss and illness than were expected by those under 65. Get Old’s refresh will tackle these fears

head-on by bringing wit and wisdom to aging through a social and digital initiative. Educational content on

topics such as health and wellness, family and relationships and love and sex These educational efforts are

supported by more than a dozen Get Old partners, including National Council on Aging, American Sexual

Health Association and Men’s Health Network. “Like everything worthwhile in life, aging successfully

requires attention and effort. Taking charge of good health habits, finances, positive attitudes and social ties

pay huge benefits for the rest of your life,” said Daniel Perry, founder of the Alliance for Aging Research.

Get Old, developed by Pfizer in 2012, is an ongoing initiative to foster candid conversation around aging,

redefine what it means to “get old” and encourage individuals to make healthy behaviours to age the way

they want.

RESEARCHERS IDENTIFY GENE LINKED TO FATAL INFLAMMATORY DISEASE IN

CHILDREN


Investigators have identified a gene that underlies a very rare but devastating autoinflammatory condition in

children. Several existing drugs have shown therapeutic potential in laboratory studies, and one is currently

being studied in children with the disease, which the researchers named STING-associated vasculopathy

with onset in infancy (SAVI). The findings appeared online in the New England Journal of Medicine. The

research was done at the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS),

part of the National Institutes of Health. “Not only do these discoveries have profound implications for

children with SAVI, but they could have a broader impact by helping us to understand other, more common

inflammatory conditions,” said NIAMS Director Stephen I. Katz, M.D., Ph.D. “Diseases such as lupus

share some characteristics with SAVI, so this work may lead to novel insights and possibly new treatments

for these debilitating conditions, as well.” The senior author of the study, Raphaela Goldbach-Mansky,

M.D., and the co-lead authors, Yin Liu, M.D., Ph.D., Adriana A. Jesus, M.D., Ph.D., and Bernadette

Marrero, Ph.D., are in the NIAMS Translational Autoinflammatory Disease Section. Autoinflammatory

diseases are a class of conditions in which the immune system, seemingly unprovoked, becomes activated

and triggers inflammation. Normally, the inflammatory response helps quell infections, but the prolonged

inflammation that occurs in these diseases can damage the body. In 2004, Dr. Goldbach-Mansky was called

upon to advise on a patient with a baffling problem — a 10-year-old girl with signs of systemic

inflammation, especially in the blood vessels, who had not responded to any of the medications her doctors

had used to treat her. She had blistering rashes on her fingers, toes, ears, nose and cheeks, and had lost parts

of her fingers to the disease. The child also had severe scarring in her lungs and was having trouble

breathing. She had shown signs of the disease as an infant and had progressively worsened. She died a few

years later. By 2010, Dr. Goldbach-Mansky had seen two other patients with the same symptoms. She

suspected that all three had the same disease, and that it was caused by a genetic defect that arose in the

children themselves, rather than having been inherited from their parents, who were not affected. Her hunch

suggested a strategy for identifying the genetic defect. By comparing the DNA of an affected child with the

DNA of the child’s parents, scientists would be able to spot the differences and possibly identify the

disease-causing mutation.

PARACETAMOL NO BETTER THAN PLACEBO FOR LOW BACK PAIN: STUDY


Paracetamol, a painkiller universally recommended to treat people with acute low back pain, does not speed

recovery or reduce pain from the condition, according to the results of a large trial published on Thursday. A

study published in The Lancet medical journal found that the popular pain medicine was no better than

placebo, or dummy pills, for hastening recovery from acute bouts of low back pain or easing pain levels,

function, sleep or quality of life. Researchers said the findings challenge the universal endorsement of

paracetamol as the first choice painkiller for lower back pain. "We need to reconsider the universal

recommendation to provide paracetamol as a first-line treatment," said Christopher Williams, who led the

study at the University of Sydney in Australia. Lower back pain is the leading cause of disability

worldwide. In the United States alone, costs relating to the condition are estimated to be more than $100

billion a year. Currently, every back pain treatment guideline in the world recommends paracetamol as the

first-line analgesic and Williams said this was despite the fact that no previous studies have provided robust

evidence that it works in this condition. In his trial, 1,652 people from Sydney with acute low back pain

were randomly assigned to receive up to four weeks of paracetamol, either in regular doses three times a

day, or as needed, or to receive placebos. All those involved received advice and reassurance and were

followed up for three months.

A CONTACT LENS TO MONITOR DIABETES


Google announced a partnership with the European drug maker Novartis to develop a smart contact lens

with the potential to monitor the wearer's blood sugar levels. The agreement is among recent moves into the

health care sector by technology giants including Apple and Samsung as they develop devices and mobile

applications to track people's daily lives. Novartis said that Alcon, its eye care unit, has struck a deal to

license so-called smart lens technology from one of Google's research divisions. Financial terms have not

been disclosed. As part of the agreement, Alcon said it would look to create products from Google's

prototype smart contact lens, which uses miniature sensors and a radio antenna thinner than a human hair to

track glucose levels. The companies have not specified how the data would be transmitted. Information

about blood sugar levels, which is particularly useful for people with diabetes, could be uploaded to

smartphone devices and used by doctors and patients to monitor the data almost in real time, according to a

statement from Google issued when the company released its prototype in January. Joe Jimenez, the chief

executive of Novartis, acknowledged in an interview that many previous attempts to develop non-invasive

glucose tests had failed, noting that the company previously tried — and failed — to develop its own

glucose-monitoring contact lenses several years ago. What makes this case different is the involvement of

Google's engineers, he said. "One of the biggest hurdles was miniaturisation, and that's one of the biggest

benefits that Google X brings," he said.

NEW CANCER CASES TO REACH 1.9 MILLION BY 2035


New cancer cases are expected to reach around 1.9 million in the year 2035, government today said. At the

same time, mortality due to cancer cases is estimated to be at 0.8 million, Health Minister Harsh Vardhan

told the Rajya Sabha in a written reply. "As per the Indian Council of Medical Research (ICMR), based

upon the data provided by National Cancer Registry Programme, the estimated number of incidence (new

cancer cases) for the year 2035 is about 1.9 million (based on reports on Time Trend in Cancer Incidence

Rates 1982-2010 and 2009-2011 Population Based Cancer Registry Reports)," he said. According to the

data provided by ICMR, the mortality due to cancer cases is estimated to be 0.8 million for the year 2035.

He said that there was no central data available to ascertain the quantum of shortage of cancer specialists in

the country. However, to increase the number of seats in Super Speciality course in Medical Onology,

Surgical Oncology and broad speciality courses in Radiotherapy, the ratio of number of Post Graduate (PG)

teachers to the number students to be admitted has now been increased to 1:3 for a professor subject to a

maximum 6 PG seats per unit per academic year, he said. He said that while Human Resource Development

is also in focus under Pradhan Mantri Swasthya Suraksha Yojna (PMSSY), the National Cancer Institute at

Jhajjar and second campus of Chittaranjan National Cancer Institute in Kolkata also have a mandate for

capacity building. The mandate of State Cancer Institutes (SCI) and Tertiary Care Cancer Centres (TCCC)

supported under National Programme for Prevention and Control of Cancer, Diabetes, Cardiovascular

Disease and Stroke (NPCDCS) includes enhancing of trained manpower for cancer, he added.

NIH STUDY SHOWS SCHIZOPHRENIA’S GENETIC RISING TO A NEW LEVEL


The largest genomic dragnet of any psychiatric disorder to date has unmasked 108 chromosomal sites

harboring inherited variations in the genetic code linked to schizophrenia, 83 of which had not been

previously reported. By contrast, the “skyline” of such suspect variants associated with the disorder

contained only 5 significant peaks in 2011. By combining data from all available schizophrenia genetic

samples, researchers supported by the National Institutes of Health (NIH) powered the search for clues to

the molecular basis of the disorder to a new level. “While the suspect variation identified so far only

explains only about 3.5 per cent of the risk for schizophrenia, these results warrant exploring whether using

such data to calculate an individual’s risk for developing the disorder might someday be useful in screening

for preventive interventions,” explained Thomas R. Insel, M.D., director of the NIH’s National Institute of

Mental Health, one funder of the study. “Even based on these early predictors, people who score in the top

10 per cent of risk may be up to 20-fold more prone to developing schizophrenia.” The new found genomic

signals are not simply random sites of variation, say the researchers. They converge around pathways

underlying the workings of processes involved in the disorder, such as communication between brain cells,

learning and memory, cellular ion channels, immune function and a key medication target. The

Schizophrenia Working Group of the Psychiatric Genomic Consortium (PGC) External Web Site Policy

reports on its genome-wide analysis of nearly 37,000 cases and more than 113,000 controls in the journal

Nature, July 21, 2014. The NIMH-supported PGC represents more than 500 investigators at more than 80

research institutions in 25 countries. Prior to the new study, schizophrenia genome-wide studies had

identified only about 30 common gene variants associated with the disorder. Sample sizes in these studies

were individually too small to detect many of the subtle effects on risk exerted by such widely shared

versions of genes. The PGC investigators sought to maximize statistical power by re-analyzing not just

published results, but all available raw data, published and unpublished. Their findings of 108 illness-

associated genomic locations were winnowed from an initial pool of about 9.5 million variants. A

comparison of the combined study data with findings in an independent sample of cases and controls

suggest that considerably more such associations of this type are likely to be uncovered with larger sample

sizes, say the researchers. There was an association confirmed with variation in the gene that codes for a

receptor for the brain chemical messenger dopamine, which is known to be the target for antipsychotic

medications used to treat schizophrenia. Yet evidence from the study supports the view that most variants

associated with schizophrenia appear to exert their effects via the turning on and off of genes rather than

through coding for proteins.

DRUG COMBO SPEEDS UP TB TREATMENT


In a breakthrough, scientists have found that a new combination of drugs can cure drug-resistant TB in as

little as four months, instead of two years. The drug combination, known as PaMZ, killed more bacteria

than standard treatment and was effective in treating drug-resistant tuberculosis, according to results of the

study presented at the International AIDS conference here. "This shows its potential to shorten therapy for

drug-sensitive and some forms of multi-drug-resistant TB," said Dr Mel Spigelman, chief executive of the

New York-based Global Alliance for TB Drug Development (TB Alliance) which created the drug

combination. "Seventy-one per cent of people treated with PaMZ were cleared of bacteria at the end of two

months when evaluated with the most sensitive diagnostic methods available," researchers said. "Only 38

per cent of people treated with standard therapy were clear at eight weeks," they said. PaMZ is a three-drug

regimen including two candidate drugs not licensed for use against TB. PA-824 (Pa) and moxifloxacin (M),

and one existing antibiotic used in TB treatment, pyrazinamide (Z), 'abc.net.au' reported. Earlier study

results show PaMZ's potential to treat both drug-sensitive and drug-resistant patients and to dramatically

shorten treatment times for some patients. The third phase of the clinical drug trial, which could start by the

end of this year, will span some 50 study sites across Africa, Asia, Eastern Europe, and Latin America.

GENETIC CAUSE OF COMMON BREAST TUMOURS IN WOMEN IDENTIFIED


Scientists have uncovered the molecular basis of fibroadenoma, one of the most common benign breast

tumours diagnosed in women of reproductive age. A multi-disciplinary team of scientists from the National

Cancer Centre Singapore, Duke-NUS Graduate Medical School Singapore, and Singapore General Hospital

used advanced DNA sequencing technologies to identify a critical gene called MED12 that was repeatedly

disrupted in nearly 60 per cent of fibroadenoma cases. Fibroadenomas are the most common benign breast

tumours in women of reproductive age, affecting thousands of women in Singapore each year, researchers

said. Worldwide, it is estimated that millions of women are diagnosed with fibroadenoma annually.

Frequently discovered in clinical workups for breast cancer diagnosis and during routine breast cancer

screening, clinicians often face of challenge of distinguishing fibroadenomas from breast cancer. To

facilitate this diagnostic question, the team embarked on a study to identify if there are any genetic

abnormalities in fibroadenomas that may be used to differentiate them. By analysing all the protein-coding

genes in a panel of fibroadenomas from Singapore patients, the team identified frequent mutations in a gene

called MED12 in a remarkable 60 per cent of fibroadenomas.

CURE FOR HEPATITIS C IN HIV PATIENTS ON THE CARDS


A combination drug therapy is effective in treating chronic Hepatitis C in patients infected with HIV,

scientists have found. A multicenter team of researchers report that in a phase III clinical trial, a

combination drug therapy cures chronic hepatitis C in the majority of patients co-infected with both HIV

and hepatitis C. "In many settings, hepatitis C is now a leading cause of death among HIV co-infected

patients," said Mark Sulkowski, from the Johns Hopkins University School of Medicine. Approximately

one-third of HIV patients in the US have hepatitis C, with an estimated 7 million co-infected patients

worldwide. Because of poor tolerability to the previous standard of treatments for hepatitis C, including

injections of interferon-alpha and medications that can have interactions with anti-retroviral medications

used to treat HIV, this population of co-infection patients has been considered difficult to treat. Researchers

and doctors enrolled study participants from the US and Puerto Rico through 34 academic, private practice

and community health centres. In total, doctors administered sofosbuvir and ribavirin to a total of 223 HIV-

1 patients chronically co-infected with hepatitis C (genotypes 1, 2 or 3) either for 12 weeks (for treatment-

naive patients with genotype 2 or 3) or for 24 weeks (for treatment-naive patents with genotype 1 or

treatment-experienced patents with genotype 2 or 3). Twelve weeks after treatment ended, researchers

tested patients again for hepatitis C infection to determine if treatment was effective. For treatment-naive

patients, 76 per cent with genotype 1, 88 per cent with genotype 2 and 67 per cent with genotype 3 were

cured. "We've always termed this to be 'sustained virologic response, but we now know that means hepatitis

C has been cured," said Sulkowski. Treatment-experienced patients had even better cure rates: 92 per cent

for patients with genotype 2 and 94 per cent for patients with genotype 3. Seven patients discontinued

treatment because of adverse events, but there were no observed adverse effects on HIV or its treatment.

"The likelihood that a patient with chronic, long-standing hepatitis C infection would have spontaneous

cure is near zero, so if these patients had not been treated, none would have been cured," said Sulkowski.

The finding was published in The Journal of the American Medical Association.

ORAL CANCER CLAIMS ONE LIFE EVERY SIX HOURS IN INDIA


One person dies every six hours due to oral cancer in the country, signalling an alarming rise in the

incidence of the disease, according to a top orthodontist. The situation could be still graver as many cases of

the disease went unreported, Secretary-General of the Indian Dental Association Dr Ashok Dhoble told PTI

from Mumbai. "Cases of the disease and deaths resulting from it in rural areas and among the poorer

sections of society are hardly registered," he noted. He pointed out that with the high prevalence of smokers

and widespread use of other chewable tobacco products, India has seen a steep growth in the number of oral

cancer patients in the past decade. In fact, Dr Dhoble said, oral cancer approximated to 40 per cent of all

cancer-related disease in the country with the Northeastern states mostly affected. "All Northeastern states

are badly affected by the disease. The states like West Bengal, Andhra Pradesh, Gujarat and Tamil Nadu are

also affected," he said, adding every third person in these states used tobacco-related products. Talking

about measures to curb the prevalence of the deadly disease, he said that nothing short of a total ban on the

use of tobacco was the only way.

LAX ANTIBIOTIC CONTROLS RAISE FEARS OF KILLER DISEASE


A pharmacist swiftly pulls white boxes of powerful antibiotics from neatly stacked shelves behind him, and

hands them over the counter without asking for a doctor's prescription. Faronem and Linospan, drugs used

to fight acute bacterial infections such as severe pneumonia and bronchitis, are supposed to be remedies of

last resort. Their sale is illegal without a prescription under a law introduced last year. But an AFP reporter

easily bought them this week for about 700 rupees ($12) from a busy pharmacy in an upmarket New Delhi

suburb. Doctors and other health experts say such easy access to antibiotics in India, home to 1.2 billion

people, is stoking bacterial resistance to drugs, a global problem that could see long-treatable diseases

become killers once again. "Growing resistance to antibiotics is a terror for the health of our people," the

country's chief drugs regulator GN Singh told AFP. "Misuse, overuse should not happen, else there will

come a time when the simplest illnesses will be hard to cure," said Singh, the Drugs Controller General of

India. But he was "not surprised" the drugs were easy to obtain, saying cracking down on chemists and

over-prescribing doctors and educating patients about the dangers of overusing them was an uphill battle. A

study published this month by Princeton University said India and other major developing countries were

largely to blame for overuse of antibiotics. India's $12.4 billion pharmaceutical industry manufactures

almost a third of the world's antibiotics. The country's growing middle class is increasingly popping

antibiotics as a quick-fix rather than allowing their immune systems to fight common illnesses. Doctors also

wrongly prescribe antibiotics for viral infections against which they are wholly ineffective, said Sudeep

Khanna, a Delhi-based gastroenterologist.

SMOKERS AT HIGHER SUICIDE RISK


Irrespective of whether they are suffering from psychiatric disorders or not, cigarette smokers are more

likely to commit suicide than people who do not smoke, a study shows. Researchers at Washington

University's school of medicine in St Louis found that smoking itself may increase suicide risk and that

policies to limit smoking reduce suicide rates. "Suicide rates declined up to 15 percent in US states that

implemented higher taxes on cigarettes and stricter policies to limit smoking in public places," said lead

researcher Richard A Grucza, an associate professor of psychiatry from Washington University. The results

showed that each dollar increase in cigarette taxes was associated with a 10 percent decrease in suicide risk.

"Indoor smoking bans also were associated with risk reductions," Grucza added. Using statistical methods,

researchers compared rates of suicide in states with stricter tobacco policies to rates in states with more

lenient laws and lower taxes. They also determined whether people who had committed suicide were likely

to have smoked. They learned that suicide risk among people most likely to smoke was associated with

policies related to tobacco taxes and smoking restrictions. Grucza now wants e-cigarettes to come under

scanner which deliver nicotine but release vapour rather than smoke. Nicotine is a plausible candidate for

explaining the link between smoking and suicide risk, Grucza said. Like any other addictive drug, people

start using nicotine to feel good, but eventually they need it to feel normal. "And as with other drugs, its

chronic use can contribute to depression or anxiety, and that could help to explain the link to suicide,"

RED WINE, DARK CHOCOLATES BOOST MEMORY


For red wine lovers, some good news is around the bar. An anti-ageing substance found in red wine and

dark chocolates may enhance memory too. "The findings suggest that regular, high-level intake of

resveratrol - a compound found in red wine and dark chocolate - may convey protective effects on cognitive

functions, a hypothesis that now needs to be evaluated in large-scale clinical trials," Veronica Witte, a

neuroscientist at the Charite-Universitatsmedizin Berlin in Germany, was quoted as saying. In a study

involving overweight adults, those who took resveratrol supplements for six months had better short term

recall than their counterparts who took a placebo. The people who took the supplement also had more

connections among brain areas involved in memory. Aside from red wine and dark chocolate, sources of

resveratrol include red grapes, peanuts, blueberries and Japanese knotweed. In the new study, Witte and her

colleagues tested 46 participants who were overweight but otherwise healthy. Half of the volunteers were

randomly assigned to take 200 milligrams of resveratrol daily for six months. Those who received

resveratrol supplements remembered more words on a list that they had seen 30 minutes previously than

those who received the placebo. "More research is needed to confirm resveratrol's brain-boosting effects,"

researchers added.

PERMANENT HAIR DYE CAN BE CANCEROUS


Permanent hair dyes and perming treatments at salons may contain banned aromatic amines called

toluidines that have carcinogenic properties, researchers warn. A new study from Lund University in

Sweden has found that hairdressers may still be exposed to these carcinogens. Permanent hair dyes, also

called oxidative dyes, are the ones most dangerous to hairdressers and its users. For their study, the

researchers looked at o-toluidine levels in the blood, along with levels of seven other potentially

carcinogenic aromatic amines. o-toluidine (ortho-toluidine) has actually been confirmed as a carcinogenic.

Researchers measured its levels in the blood of 295 female hairdressers, 32 regular hair dye users and 60

people who had not used any of these products. They found that hairdressers were indeed exposing

themselves to o-toluidine and meta-toluidine (m-toluidine). A similar trend was seen for perming treatments

in respect of o-toluidine levels. "The ingredients of hair dyes and perming products should be analysed to

find out if these products continue to be potential sources of toluidine exposure," researchers said.

Hairdressers should protect themselves from the risk of absorbing these products through their skin by

wearing gloves.

HEART ATTACKS KILL YOUNGER WOMEN FASTER THAN MEN


Aakriti Gupta, an Indian-origin researcher at the Yale School of Medicine, has found that women have

longer hospital stays and are more likely than men to die in the hospital after a heart attack. "Younger

women are a vulnerable yet understudied group with worse cardiac risk profiles and worse outcomes after a

heart attack as compared with younger men," Gupta contended. In the study, Gupta and her team analysed

230,684 hospitalisations for heart attack in patients age 30 to 54 in a national database from 2001 to 2010.

The study found that heart attack hospitalisation rates for patients under age 55 have not declined as quickly

as they have for Medicare-age patients, which have seen a 20 percent drop. Men were more likely to have

high cholesterol while women, especially black women, were more likely to also have hypertension,

diabetes and heart failure. "This shows that we need to raise awareness of the importance of controlling

cardiovascular risk factors like diabetes, high blood pressure and smoking in younger patients," Gupta said.

Younger women may benefit from more aggressive control of modifiable cardiovascular risk factors,

including early identification and treatment of high blood pressure, high cholesterol, obesity, smoking and

diabetes, researchers concluded.

'REVOLUTIONARY' ANTIBIOTICS TO TACKLE TB


Why mycobacteria - a family that includes the microbe that causes tuberculosis (TB) - survive oxygen

limitation has long been a mystery but not any more. A discovery could lead to a revolutionary class of

antibiotics to tackle TB. Researchers have found that hydrogen is a key factor that enables mycobacteria to

survive oxygen-limitation over long periods. "Mycobacteria grow through combusting their preferred

carbon-based fuel sources using oxygen. However, they can also somehow survive for months or years

when their oxygen supply is exhausted," said Greg Cook, a professor from University of Otago in New

Zealand. "For example, in people with latent TB infections, mycobacterium tuberculosis bacteria are walled

in by clumps of immune and other body cells in what is thought to be an extremely low oxygen

environment. However, such patients must be monitored for rest of their lives in case the bacteria become

active again," he added. The bacterium is able to quickly switch its cellular metabolism from a primarily

oxygen-based one over to one that uses fermentation for energy production instead. This metabolic mode

depends on the production and recycling of molecular hydrogen, a high-energy fuel and diffusible gas.

These cells produce hydrogen to ensure their survival until they once again have access to sufficient oxygen

for growth. The researchers established that mycobacterium smegmatis metabolises molecular hydrogen

using three enzymes called hydrogenases. One hydrogenase produces hydrogen, whereas the other two

consume it. These hydrogenases are activated under oxygen starvation by a master regulator called DosR.

The researchers found that strains of mycobacterium smegmatis in which the genes for the hydrogenases or

the regulator DosR had been 'knocked out' experienced a hundred-fold reduction in the long-term survival

compared to the normal bacterium.

NEW CELL STUDY MIGHT HELP FIGHT CANCER


A new cell study has mapped one of the most important proteins in cell division that has a fundamental

process in life and the development of cancer, which might also help fight against it. A team from The

Institute of Cancer Research, London, and the Medical Research Council Laboratory of Molecular Biology

in Cambridge produced the first detailed images of the anaphase-promoting complex (APC/C). Images of

the gigantic protein in unprecedented detail would transform scientists' understanding of exactly how cells

copy their chromosomes and divide, and could reveal binding sites for future cancer drugs. The APC/C

performs a wide range of vital tasks associated with mitosis, the process during which a cell copies its

chromosomes and pulls them apart into two separate cells. Mitosis is used in cell division by all animals

and plants. Discovering its structure could ultimately lead to new treatments for cancer, which hijacks the

normal process of cell division to make thousands of copies of harmful cancer cells. The resolution was so

fine that it allowed the researchers to see the secondary structure, the set of basic building blocks which

combine to form every protein. Alpha-helix rods and folded beta-sheet constructions were clearly visible

within the 20 subunits of the APC/C, defining the overall architecture of the complex. Dr Kat Arney,

Science Information Manager at Cancer Research UK, said that shaping out how the fundamental molecular

"nuts and bolts" of cells work was critical because better understanding about what goes wrong in cancer

cells was required and figuring out more effective ways of tackling them. Revealing the intricate details of

biological shapes was a hugely important step towards identifying targets for future cancer drugs.

NEW DRUG COCKTAIL CAN SPEED UP TB CURE

Mint, 22 July, 2014

An experimental cocktail of three drugs can dramatically shorten the time it takes to treat patients infected

with tuberculosis (TB) strains that are hard to cure with conventional antibiotics, according to research

presented at an ongoing world AIDS forum. Dubbed the PaMZ regimen, the drugs killed more TB bacteria

than standard therapy and at a faster rate in a so-called Phase lib trial, usually the penultimate step in vetting

new treatments for safety and effectiveness, investigators said. If funding is found, PaMZ will move to

Phase III tests by the end of the year, its backers, TB Alliance, said. Doctors are deeply worried by the

emergence of TB bacteria that fail to respond to front-line antibiotics. These resistant strains are especially

dangerous for people co-infected with the human immunodeficiency virus (HIV), which causes AIDS. HIV

attacks CD4 immune cells, leaving the body exposed to opportunistic microbes. PaMZ comprises two

candidate drugs that are not yet licensed for use against TB, called Pa-824 and moxifloxarin, deployed with

an existing treatment, pyrazinamide. The treatment, which is administered as tablets, was formulated

specifically for patients believed to have TB strains that can be targeted by these drugs. The trial, reported at

the 20th International AIDS Conference in Melbourne, Australia, entailed testing PaMZ against standard

drugs—isoniazid, rifampicin, pyrazinamide and ethambu-tol—among 207 volunteers in South Africa, a

fifth of whom were co-infected with HIV. Of these, 181 were sensitive to the PaMZ drugs while 26 were

multidrug-resistant (MDR), meaning that they had failed to respond to conventional antibiotics. It found

that 71% of people treated with PaMZ were cleared of TB bacteria in their sputum within two months. By

comparison, only 38% of those on standard therapy were clear at eight weeks. The MDR patients all took

PaMZ and were treated within four-six months, compared to two years for standard treatment Another boon

was that PaMZ showed no signs of interfering with commonly-used antiretrovial treatments to suppress

HIV. "TB remains the largest killer of people with AIDS, causing one in five HIV-related deaths globally.

Yet often TB and HIV therapies cannot be given together because of side effects, making it difficult to treat

both diseases simultaneously," TB Alliance said. AFP

NEW AND GENERIC DRUG APPROVALS

US FDA site

Drug Name Strength Dosage Form / Route Marketing

Status

Company

Fiorinal 325mg; 50mg; 40mg Tablet;Oral Discontinued Watson Labs Inc

Fiorinal 325mg; 50mg; 40mg Capsule;Oral Prescription Watson Labs Inc

Qvar 40 0.04mg/Inh Aerosol,

Metered;Inhalation

Prescription Teva Branded Pharm

Qvar 80 0.08mg/Inh Aerosol,

Metered;Inhalation

Prescription Teva Branded Pharm

Brompheniramine

Maleate;Pseudoephedrine

Hcl;Dextromethorphan

Hydrobromide

2mg; 30mg; 10mg/5ml Syrup;Oral Prescription Vintage Pharms

Pennsaid 2.00% Solution;Topical Prescription Mallinckrodt Inc

Solu-Cortef Eq 100mg Base/Vial;

Eq 250mg Base/Vial;

Eq 500mg Base/Vial;

Eq 1gm Base/Vial

Injectable;Injection Prescription Pharmacia And Upjohn

Solu-Medrol Eq 40mg Base/Vial;

Eq 125mg Base/Vial;

Eq 500mg Base/Vial;

Eq 1gm Base/Vial;

Eq 2gm Base/Vial

Injectable;Injection Prescription Pharmacia And Upjohn

Cytoxan 100mg/Vial;

200mg/Vial

Injectable;Injection Discontinued Baxter Hlthcare

Cytoxan (Lyophilized) 500mg/Vial;

1gm/Vial;

2gm/Vial

Injectable;Injection Prescription Baxter Hlthcare

Cytoxan (Lyophilized) 500mg/Vial;2gm/Vial;

1gm/Vial;

100mg/Vial;

200mg/Vial

Injectable;Injection Discontinued Baxter Hlthcare

Lotensin Hct 5mg; 6.25mg;

10mg; 12.5mg;

20mg; 25mg;

20mg; 12.5mg

Tablet;Oral Prescription Us Pharms Holdings I

Claritin Hives Relief Reditab 10mg Tablet, Orally

Disintegrating;Oral

Over-The-

Counter

Schering Plough

Claritin Reditabs 10mg Tablet, Orally

Disintegrating;Oral

Over-The-

Counter

Schering Plough

Teveten Eq 300mg Base Tablet;Oral Discontinued Abbvie

Teveten Eq 400mg Base;

Eq 600mg Base

Tablet;Oral Prescription Abbvie

Xeloda 150mg; 500mg Tablet;Oral Prescription Hoffmann La Roche

Teveten Hct 600mg; 12.5mg;

600mg; 25mg

Tablet;Oral Prescription Abbvie

Desonate 0.05% Gel;Topical Prescription Bayer Hlthcare

Claritin Reditabs 5mg Tablet, Orally

Disintegrating;Oral

Over-The-

Counter

Schering Plough

Tacrolimus Eq 0.5mg Base;

Eq 1mg Base;

Eq 5mg Base

Capsule;Oral Prescription Strides Arcolab Ltd

Zoledronic Acid 5mg/100ml Injectable;Injection None

(Tentative

Approval)

Sun Pharma Global

Otezla 10mg; 20mg; 30mg Tablet;Oral Prescription Celgene Corp

Ryanodex 250mg Suspension;Injectable Prescription Eagle Pharms

Targiniq Er 10mg; 5mg;

20mg; 10mg;

40mg; 20mg

Tablet, Extended

Release;Oral

Prescription Purdue Frederick

Zydelig 150mg Tablet;Oral Prescription Gilead Sciences Inc

***

July 19 - 25, 2014 CORPORATE INTAS LAUNCHES … · INTAS LAUNCHES CHEAPER GENERIC BLOOD CANCER DRUG...

Documents

Transcript of July 19 - 25, 2014 CORPORATE INTAS LAUNCHES … · INTAS LAUNCHES CHEAPER GENERIC BLOOD CANCER DRUG...