Post on 01-Jan-2017
Chapter VI
Lupin In The Pharma Market
Begining in 1968, Lupin has travelled a long way in becoming the fastest
growing among the Top 5 India pharma companies. Lupin laboratories Pvt. Ltd.
was incorporated in (1972). Lupin commissioned a Formulations plant and an
R&D centre at Aurangabad in (1980). Ethambutol production started in (1981).
Cephalexin plant at Mandideep and the Ankleshwar plant went on stream in
(1987). Lupin Human Welfare and Research Foundation (LHWRF) was founded in
(1988). Ankleshwar and Mandideep received US FDA approvals in (1989).
Injectable Cephalosporins was commissioned at Mandideep in (1992).
Fermentation plant was established at tarapur in (1992). Lupin Chemicals
(Thailand) Ltd. was established in (1989). Injectable Cephalosporins Production
initiated at Mandideep in (1991). Fermentations plant of Lupins chemicals was
established at tarapur, in Maharastra in (1992). Three plants-Mandideep, Tarapur
and Ankleshwar got US FDA approvals in (1997). Mandideep plant obtained UK
MCA approval in (1997). In 2001 Lupin commenced supply of Cephaloshporin
bulk active to its partners in the US.
Lupins Recent Milestones Are Listed Bellow:
Year Milestones
2009 Lupin acquired its majority state in multicare pharmaceuticals
Philippines Inc.
2008 Lupin expanded its product basket in japan-Kyowa and received ten
products approval from ministry of Health & Labour Welfare, Japan.
Lupin acquired Hormosan Pharma GmbH, a Generic Company in
Germany.
Lupin acquired stake in Generic Health Pty Ltd. in Australia.
Lupin acquired Pharma Dynamics in South Africa.
2007 Lupin acquired Vadodara based Rubamin Laboratories Ltd
(rechristened to Novodigm Ltd.)
Lupin acquired Kyowa Pharmaceutical Industry Company Limited, a
leading Generic Company in Japan.
Commercial production was started at the new finished dosage facility
at Jammu.
Lupin received "Best new manufacturer of the year" award from
Amerisouce Bergen.
2006 A New facility was set up at Jammu.
Maiden Bonus share were issued in the ratio of 1.1
Maiden are issues of Foreign Currency Convertible Bonds (FCCB)
aggregating US & 100 mn, which are listed on Singapore Stock
Exchange.
2005 Maiden Employees Stock Option Plan was implemented.
US FDA and MHRA (UK) approvals were received for Goa.
New Lovastatin plant at Tarapur was approved by the US FDA.
2004 WHO approval was received for State of the art formulation Plants at
Goa and Aurangabad.
2003 Lupin had successfully implemented SAP ERP across the Company to
unify all business functions and processes.
Introduced collaborative massaging and workflow solution are on the
internet.
Oral Cefaclor injectible Plant at Mandideep was approved by US
FDA.
Lupin Pharmaceuticals Inc. USA, was formed for trading, marketing
and development activities in the US.
2002 Exports to the Advanced Markets crossed Rs. 1000 mn.
Rising are trend of exports as a% of total revenue-up 33% year-over-
year.
Patent filings crossed 100.
Five ANDAs were filed.
New Anti-TB facility was commissioned at Aurangabad.
As listed below during the last five years, Lupin has won several awards
for its outstanding performance as a major pharma company
Year Awards
2010 Indian Pharmaceutical Company of the Year 2010" by Frost &
Sullivan India Excellence in Healthcare Awards
2010 Best Drug Development Company, Asia by The New Economy
Pharmaceutical & Healthcare Awards 2010
2009 International Excellence Award by Institute of Economic studies.
Outstanding Expert Performance by Pharmexcil (Pharmaceuticals
Export Promotion Council of India)
2008 Amerisource Bergen, one of the largest and leading wholesalers in the
US Conferred the "Best New Manufacturer of the Year, Generics Rx"
to Lupin Pharmaceuticals Inc.
Cardinal Health conferred two awards- the "Trade Representative of
the Year" and the "Quality Supplier Award" to Lupin Pharmaceuticals
Inc.
In previous years Lupin received numerous awards as listed bellow:
Awards and Achievements:
Some of the milestones of LHWRF are:
Year Awards
1990 Merit certificate by the District Administration for Excellent Social
Service & Rural Development of Independence Day.
1991 FICCI Award outstanding achievement in rural development by prime
Minister of India.
1992 ICMA Award for innovative and purposeful programs for social
progress.
1993 PHD chamber of commerce award for Corporate Citizen.
1994 Jamuna Lal Bajaj Award for outstanding contribution in Rural
Development.
1995 Bhamashah Award for contribution in the field of Education by Chief
Minister of Rajasthan .
1996 World Bank recognized LHWRF as specialist social assessment
Agency.
1997 Represented NGO's from India to present Indian NGO scene, at
United Nations.
1998 Merit certificate by the Chief Minister of Rajasthan for voluntary and
social services.
1999 RMK recognized LHWRF as a Nodal Agency for Northern India for
micro credit for women.
2000 Nominated as Member of the State level Grant-in -Aid Committee at
lok jumbish.
2001 Nominated in FICCI and CII's Rural Development care Group.
2002 Nominated in CAPART's governing body.
2003 Business world FICCI-SEDF Corporate Social Responsibility Award
2003 by Ex-President of India Shri KR Narayanan.
2004 Appointed as outreach office of Rashtriya Mahila Kosh.
2005 Selected by CII for representing India on Strengthening of South
Asian Alliance for Responsibility Business (SARB) at Kathmandu.
Selected by State is Government as lead NGO for Jal Abhiyan (Water
Compaing) for Bharatpur division.
2006 FICCI Ladies Organization Award-Outstanding Institution for
Women Welfare by FICCI's Secretary General shri Amit Mitra and
FLO's president Mrs Usha Agarwal.
Best NGO Award from NABARD for Significant work done in area
of SHG formation and Bank Linkages.
RMK selected Lupin as one of the member of the delegation to
participate the Global micro Credit Summit 2006 at Halifax, Canada.
Selected as the specialist NGO Member in the State level Committee
of jal Abhiyan Water Campaign) Phase-2
2007 Amer Source bergen declared Lupin the "Best new manufacture of the
year Generix Rx"
2008 Wal mart's supplier Award of exulince.
2010 Indian Pharmaceutical Company of the year 2010. Best Drug
Development Company Asia, by the New Economy Pharmaceutical
and Health care.
Lupin: An Overview:
As a socially responsible organization, Lupin strive to take care of the less
privileged sections of our society. We extend our expertise to transform the lives of
our people and make a difference to the society. Lupin is committed to the
challenging task of becoming a proactive partner in nation building through the
lupin Human Welfare & Research Foundation (LHWRF). Lupin Human Welfare
& Research Foundation was set up on October 2, 1988 with the objective of
providing an alternative model of rural development in the country, which is
sustainable, replicable and ever evolving. Initiating the program of Rural
Development within a small number of 35 villages, LHWRF has now succeeded in
ravitalizing revamping and recreating life in 2,200 villages in Rajasthan, Madhya
Pradesh, Maharashtra and Uttarakhand States of India, which has led to LHWRF
emerging as one of the largest NGO in the country. The Foundation has been
successful in making a big difference in the development of poverty-ridden
villages, and especially in the life of the poorest of the poor and empowerment of
large number of women in these areas. Today LHWRF on its part is a catalyst, and
an observer of self-evolving, self-sustaining spectacular transformation.
Background:
Lupin Human Welfare & Research Foundation is an independent entity of
Lupin implementing Lupin CRS activities all over India. This organization has
been registered under Societies act/trust acts and exempted under 35 AC and 80G.
LHWRF is also entitled to take foreign funding through its FCRA account.
LHWRF has staff of 65 permanent employees along with the 700 project based
employees. CSR staff of LHWRF is engaged fully & Singularly for CSR activities.
Objectives:
Social
* To develop proper social, cultural, scientific and spiritual attitudes amidst
the rural community.
* To instill in villagers, especially women, children youth and older people an
urge, and keenness to work for their own development.
* To develop an attitude towards living a healthy life and taking concrete steps
in that direction.
Economic:
* To help create more job opportunities particularly for unemployed youth and
women.
* To strengthen primary occupations like agriculture and animal husbandry
through higher output and value addition.
* To strengthen secondary occupations such as cottage industry, handicrafts
and service sector through quality enhancement and wider market acceptability.
Infrastructure:
* To create basic infrastructure facilities
* Provision for drinking water
* Building internal roads
* Basic Sanitation
* Formal Education
* Community centers
* Electrification
* Training cum production centers etc.
Scale Up Strategy:
The Company believes that to have visible impact of its CSR operations
scalability is important. Therefore, company closely works with Central or State
Government departments as well as with international organizations to achieve its
objectives. The convergence and collaborations are the integral part of its strategy.
Funding:
The investments made in the CSR activity are mobilized from the company
and from Central and State Governments. The monitoring is being carried out by
the resource giving agencies which are mobilized from Central and State
Government are being audited by respective government departments.
* The Company has also carried out its social audit from the external
organization like Deloitte & Touche, for all the resources deployed from State or
Central Government departments & the Company.
Initiatives:
Lupin HWRF has taken following innovative and new initiatives under its
CSR activities.
* Building local level institutions- LGVP
* Convergence for scalability
* Identification of potential areas for futuristic development
* Conversion of problems into potentials
Institution Building: Lupin Gram Vikas Panchayat:
To implement & execute the activities at village level, local level institutions in
the name of lupin Gram vikas panchayat (LGVP) (Village Development
Committee) have been formed. LGVP consists of representatives from different
village communities, who are dedicated to the cause of service and village
development. Impact: The world Bank has replicated our model under the program
of District poverty Initiative Program (DPIP) by forming Common Interest Groups
of the pattern of the LGVP.
Civil & Infrastructure work:
The contribution in the form of man, material and cash is must for any
developmental work. Villagers were motivated to contribute certain percentage of
estimated cost of the work, rest of the money come from Lupin and Government.
This work of infrastructure was executed by the committee of villagers namely
LGVP. Their contribution and execution of work by them gave a sense of
ownership to the developmental activities.
Impact:
Government has announced a policy intervention in the name of Apna Gaon
Apna Kam. Lupin's pattern of working with community's contribution has
impressed the State Government
Lupin's Branding And Marketing Strategy :
During the last ten years, Lupin has been building brands that are key driver's
for value creation. In 2006, the Company witnessed a healthy growth in sales to
Rs. 2233 million, for its finished dosages in the us markets effected through Lupin
pharmaceuticals, Inc. (LPI), a wholly owned subsidiary.
The advanced markets, particularly those of the US and the EU, are the
Company's Key growth drivers for the future. As part of the global strategy to
increase its Participation in the high-margin and high-value regulated markets, over
the years, Lupin has created appropriate infrastructure by upgrading its facilities in
conformity with global regulatory standards. It has also invested in Research and
created capability of filing and introducing a steady stream of products specific to
market requirements. Further, to strengthen its US focus, LPI was expanded in
terms of strength. LPI is committed to developing a branded pharmaceutical
presence for the paediatric practice in the US market and become a leading
generics powerhouse.1
The regulated markets continued to witness strong growth momentum in sales,
driven by higher off take of its branded generic product and launch of 7 new
1 Lupin Limited Annual Report 2005-06, P. 30
generic formulation products, in 2006 In March 2004, Lupin launched its maiden
branded generic "Suprax" (Cefixime)' in the US for the paediatric segment. After a
steady start, Suprax has seen its prescription rate increase significantly to over
5000 new scrips per week. This base has now created a launch pad for the branded
generics business in the US for the Company.
Lupin's maiden branded generic Suprax has seen its prescription rate increase
to over 5000 new scrips per week. This base has provided a launch pad for a strong
branded generic business in the US. "LPI" hit a very important milestone in 2005
commencing its own direct-to-market presence. Led by a focussed team, it is now
well poised to capitalise on the generic opportunities with increased filings and
approvals, the US business was all set to grow.
Lupin's Goa and Tarapur facilities were also inspected in 2009 and found to be
acceptable. The US FDA also inspected Lupin's Aurangabad (Liquids) & Indore
(Oral Solids and Oral Contraceptives) sites. Both inspections were found
acceptable and these inspections bring the Company a step closer to launching
liquids and Oral Contraceptive in the US market. With these recent inspections, all
Lupin's facilities catering to Advanced Markets have now been inspected in the
past year and have been found to be in good shape and in line with the expectations
of regulators across the world.
US Branded Business:
Lupin's Branded business contributed 37% of the overall US revenues with a
turnover of USD 127 million, growing by 72% during FY 2010 as compared to
USD 74 million during the last fiscal. 2010 saw Lupin expanding its branded
portfolio by acquiring the worldwide rights for the intra-nasal steroid (INS)
product, Aller Naze TM (triamcinolone) Nasal Spray, 50 mcg, from Collegium
Pharmaceutical, Inc. The US FDA has already approved Aller Naze TM, an
aqueous based intranasal steroid indicated for the once daily treatment of nasal
symptoms associated with both seasonal allergic rhinitis (SAR) and perennial
allergic rhinitis (PAR) in adults and children above 12 years of age and older.
AllerNaze TM offers a quality intranasal steroid option to physicians as they deal
with adherence and compliance issues when treating allergic rhinitis. The
intranasal steroid market generated USD 2.5 billion in annual sales in the United
States alone (IMS). During 2010 the Company made its second branded
acquisition by obtaining US rights for Antara ® (Fenofibrate Capsules 43 mg and
130 mg) from Oscient Pharmaceuticals under the procedures of the US Bankruptcy
Court. Antara® recorded net sales of USD 70 million for 2008 (IMSDec'08)
Antara ® hasstrong brand equity with primary care physicians and is prescribed for
treatment of hypercholesterolemia (high blood cholesterol) and hyper trigly
Ceridemia (high triglycerides). In the US Fenofibrate product market, at around
USD 1.9 billion, Antara® has 4.5% share of the market and grew 20% in revenue
in the past year. The Company's experience, sound market understanding and
effective marketing strategies are reflected in the success of our flagship brand,
Suprax® During FY 2010. Suprax® continued its upward growth trajectory. The
Suprax basket now encompasses Suprax® (Cefixime)for Oral Suspension
100mg/5ml, 200mg/5ml and Suprax® 400mg Tablets. The Compnay has
strengthened its portfolio of offerings by value-added line extensions and will
continue to invest in developing new products and product line extensions using its
proprietary controlled release and taste making platforms.
Reaching the Market world Wide:
Lupin’s Advanced markets business in US and Europe continued its upward
growth momentum during the year with total sales of INR 18,570 million, up from
INR 13,567 million during the previous fiscal, a growth of 37%. The company's
Formulations sales in the US market grew to INR 16,497 million during Fy 2010,
Up from INR 11,894 million during the previous Year. The Company continues to
register impressive growth in the European Market where Formulations sales grew
36% to INR 1,395 million for FY 2010 up from INR 1,023 million during Fy 2009.
US Market:
Riding high on the momentum built up in our branded Business and sustained,
consistent growth in Generics, Lupin's Formulations business in the US emerged as
the Key growth driver for the Company, recording sales of INR 16,497 million
during FY 2010 as compared to INR 11,894 million in FY 2009, up 39%.
US Generics:
The Company's Generics business reported growth of 16% in the US, up from
USD 187 million in FY 2009 to USD 217 million in FY 2010. Today, Lupin is the
8th
largest Generic player in the US in terms of prescriptions. The Company is also
the fastest growing Top 10 Generic player in the US for the second year running,
growing at 51% by prescriptions (IMS Health). "The company now has 26 generic
products in the US out of which 13 are market leaders. Lupin also holds Top 3
positions for 25 of these 26 products”
Top the US Generic Drug Manufacturers Market share by Prescription (Tolat
Rxs):
Manufacturer Total Rxs %change (2009) %Share
Teve 634,415 1.70% 25.20%
Mylan 331,562 11.90% 13.60%
Watson 251,970 6.40% 10.30%
Sandoz 218,891 10.90% 9.00%
Qulitest 109,802 11.30% 4.50%
Greenstone 102,316 24.80% 4.20%
Apotex 99,841 4.80% 4.10%
Lupin 92,757 51.10% 3.80%
Malinckdrodt 90,824 -4.90% 3.70%
Actavis-purepac 73,524 -10% 3.00%
Source: Ims Data
Source: Ims Data
Market leaders, ranked No.1 by market share. Lupin holds the Top 3 positions
in terms of market share for 25 of the 26 marketed products (IMS Health). What
has been unique about Lupin is its ability to increase and build on existing market
shares for most of the 26 marketed products in the US on the back of flawless
execution and excellent relationships with trade partners, all serviced by an agile
and responsive supply chain. The Company continues to record the highest per
product revenues amongst its Indian peers. The Company received 7 approvals
from the US FDA during Fy 2010, out of which 3 were tentative approvals. The
approvals received in the year were Levofloxacin Tablets, Ethamlrtol Tablets,
Mewantine Tablets, Perindopril Tablets, Amlodipine and Benazepril Capsules,
Imipramine Tabelets and Eszopiclone Tablets. Lupin's exemplary success has
prompted Vinita Guptta, Group president and CEU Of Lupin USA to boast, Lupin
has Clearly broken away from the vest to emerge as the 8th largest and the fastest
growing Top 10 generic business in the US (in RXS)- the only Indian pharma
major to even achieve this feat"2
Europe:
Lupin has developed a solid foundation to grow its Formulations business in
the European markets with a robust product pipeline. Having built its presence
across- select EU markets through a blend of direct-to market initiatives,
acquisitions and strategic partnerships, the Company is today well placed to
address the unique demands of the fragmented and diverse EU market. During
2010, the Company's Formulations business in Europe recorded a growth of 36%
additionally, during the Year, Lupin filed as many as 11 MAAs and 3 EDMFs and
2 Luptin, Annual Report 2009,P. 14
COSs across Europe. The total cumulative finished product filings within the EU
stands at 65, with 31 total approvals.
Germany:
Lupin made strategic inroads into the German Market by acquiring Hormosan
Pharma Gm bH (Hormosan), a German Generics company, specialized in the
supply of pharmaceutical products. Hormosan enjoys a strong brand identity in
Germany, especially in the CNS area with the change to a Substitution-driven
market, the Company has completely realigned its focus and is now geared towards
capitalising on the right Generic opportunities. Hormosan registered a growth of
over 100% during 2010.
UK:
Lupin's direct-to-market initiative has worked well in the UK, which is evident
from the success of the company's flagship brand, Lisinopril that commands a
market share in excess of 15% Lupin is now looking at introducing several new
value-added products. The Company has a strong pipeline of 22 filings in the UK
and received approvals for Valsartan Tablets and Perindopril+Indapamide tablets
during 2010.
France:
Having built successful partnership over the past year, Lupin continues to make
inroads into the French market with its Cefpodoxime Proxetil tablets, accounting
for over 72% market share. The Company also launched Cefpodoxime Proxetil
Suspension in 2010. Overall Lupin is well on its way to grow its direct-to-market
business as well as its partnered business in Europe. In addition to UK, Germany
and France, the Company is also focused on building its position in the markets of
Italy, Spain, Portugal, Poland, Czech Republic, Hungary and Turkey. During 2010
Lupin received approval for two dosscirs through its 100% subsidiary Lupin
Australia. The company is planning to introduce value added generic initiative into
the Australian market.
UK-Direct to Market:
Lupin launched its direct to-market initiative under its own label during the
year. Its flagship product Lisinopril has been well received and has achieved
market share of 15% in the first four months of product introduction.3
The Company has a strong pipeline of 21 MAAs for various products. The
Company expects to repeat the successful launch of lisinopril with a host of
additional offering. Lupin launched its direct-to-market initiative in UK under its
own label, during the year. Its flagship product lisinopril has been well received
and has achieved a market share of 15% in the first four months or product
introduction.
France and other European Markets:
Lupin is forging ahead in France and other markets, leveraging its partnership
business model. During the year, Cefpodoxime proxetil tablets introduced in
France through multiple partners garnered over 50% market share. The Company
is looking forward to replicate this success with the launch of Cefpodoxim proxetil
powder for suspension amongst other products.
Additional Sale of IP:
3 Lupin Limited Annual Report 2007-08, P. 25
Lupin also received Euro 20 Mn for the sale of additional, patent as
applications on perindopril toLaboratoires Servier of France. Having set its foot on
European soil, the Company is considering every avenue of value creation. As a
result, it has entered into several out-licensing arrangements for its products across
the region. Lupin has planned 10-15 dossier filings and an estimated 5-7 launches
in the European Union in the near term.
Russia and Nightbars:
Though fragmented, the CIS region continues to be a very lucrative market,
with an estimated market size of USS 16.4 Bn. On account of their steadily
increasing per capita income, the fast emerging, economies of Azerbaijan, Russia
and Ukraine, in particular, have played a deciding role in increasing Lupin's
business into these regional markets within CIS. With Lupin all set to tap the
markets in Tajikistan, Turkmenistan, Kyrgyzstan (TTK), the prospects look even
better going forward. Changing lifestyles, an ageing population and increased
Government spend makes it a lucrative market. Lupin's product portfolio for the
CIS market is a very judicious mix of volume as well as value business. With an
eye on future potential, the Company has entered into synergistic partnerships with
leading local players in respective regional markets within CIS, as well as
selectively following a direct to market strategy. During 2008-09, the Company's
CIS business recorded sales to the tune of Rs. 503 Mn, a growth of 33% over
2007-08. Considering changing trends Lupin is laying added emphasis on Brand
building exercises for its products such as IXIME, Dr. KASHEL, SOFTOVAC,
RIBAVIN, ONE BE and GATISPAN. The Company's branded business recorded
a healthy growth over the previous year. Brands such as One Be and Gatispan are
fast gaining market share in the region.
Lupin continues to strengthen its base in the CIS region by continuously
working on increasing its field force, forging trade relationship and enhancing its
distributor networks across the CIS with its filings. The Company is looking
forward to building new brands that will drive value in the years to come.
Looking towards Latin America:
In a bid to scale greater heights in the next few years, AAMLA has a focused
approach to establish on-shore presence in promising emerging markets and
geographies by way of planned organic growth, acquisitions or by forging strategic
alliances and partnerships. Brazil and Mexico have been identified as two of the
emerging markets for an onshore presence. The Brazilian market is valued at
around USD 15.4 billion and great 15% (IMD Dec 2009). The market presents
attractive opportunities in high growth, specialty segments like gynaecology,
cardiology, Oral Contraceptives and biotechnology. The Mexican Pharma market
is currently pegged at MS 140 billion (USD 11.4 billion).
During 2010, Lupin's business from these markets accounted for 16% of our
total consolidated revenues. Ex-India operations along with our subsidiaries
Kyowa-Japan, Pharma Dynamics-South Africa and Multicare-Philippines,
recorded revenues of INR 7,741 million, a growth of 32% from the previous year.
The Company started filing DMF's of in house API's for Japan, sourced 18 new
products for the Philippines and negotiated better sourcing rates for its products in
South Africa. The division also introduced value added, differentiated and novel
products in multiple therapy areas across various countries. These concerted efforts
are already resulting in success across key geographies, specifically in advanced
markets such as japan and Australia as well as the emerging markets of South
Africa and South East Asia.
Lupin's current formulations business within these markets addresses chronic
therapies and lifestyle segments like Cardiovascular, Paediatric, Central Nervous
System, Gastro Intestinal and women's Health as well as Anti-Infectives, Anti-
Asthma, and Anti-TB treatments. In a span of four years our achievements in the
AAMLA geographies have already helped build strong foundations for the
sustainable future growth of the Company.
JAPAN:
Valued at USD 75 billion, Japan is the second largest pharmaceutical market in
the world. Almost 100% of Japanese citizens are covered through National Health
Insurance, funded by the Japanese Government. To reduce the health care
expenditure burden, the Government has introduced a series of reforms that would
expand Generic penetration to 30% of the overall Japanese pharmaceutical market
by 2012 with an estimated market size of USD 6.5 billion. Kyowa, Lupin's 100%
subsidiary in Japan focuses on tapping into this emerging opportunity and has
identified Neurology, Cardiovascular, Gatroenterology and Respiratory segments
as core therapeutic areas of focus for drug development and marketing. Kyowa is
amongst the fastest growing generic pharmaceutical companies in Japan. Today, it
markets over 200 products through its 75 strong sales and marketing team. Kyowa
is one of the largest generic players in the Neurology segment with 95 products
and covers 94% of psychiatry with 95 products and covers 94% of psychiatry
hospitals in japan.
For 2010, Kyowa reported consolidated sales of JP 10.4 billion (INR 5,341
million) contributing to 11% of Lupin's consolidated revenues a growth of 9% over
the previous fiscal. Kyowa's conscious drive for cost optimisation through API
prices has resulted improvement in gross margins by 4%.
In FY 2010, Kyowa launched 6 new products and filed applications for an
additional 8 products. With a view to augment product filings and optimise R&D
costs, Lupin has also started developing products in-licensing arrangements and
strategic alliances with various Japanese, European and Indian companies to
introduce new products into the Japanese market. APIs have been identified as a
key area synergy between Lupin and Kyowa and the Company has started
developing and filing the APIs required by Kyowa. The Company filed and
received approvals for 2 Drug master Files for the Japanese market during 2010.
The supply of these APIs to Kyowa would commence shortly and would help
Kyowa achieve significant savings and better margins. The Company is already
working on augmenting the pipeline of APIs from India and many more DMFs will
be filed in the next few years.
The global Active Pharmaceutical Ingredients (API) space is driven by the two
Asian giants China and India. While India has fewer API Players than China, it is
more prolific than its counterpart in the API industry largely because of India's
Quality and credentials as the best manufacturer of generic formulations
worldwide. Lupin is one of the select few API players from India that have made
an indelible mark on the global stage. Lupin is also amongst one of the very few
pharmaceutical companies globally that are strong players on both fronts of the
pharmaceutical business-APIs and Formulations. This makes Lupin a fully-
integrated global pharmaceutical company.
In 2010, the Company's API business generated INR 7,772 million in revenues,
representing growth of 9% YOY. This was achieved by focus on improving
operational efficiencies with a careful and meticulous product selection strategy. 4
4 Lupin Limited Annual Report 2010
By maintaining cost leadership and competitiveness in its chosen therapeutic
domains, Lupin's API business has been ensuring the profitability and growth of
the Company's Formulation business.
Lupin's AAMLA:
(Asia, Africa, Middle East & Latin America) Division helped the company. In
its pursuit to be an innovation led transnational pharmaceutical company, Lupin
has ventured and penetrated into chosen markets represented by its AAMLA
Initiatives taken in the past two years have fortified the Company's position and
paved the way for accelerated growth in this region. The focus in most of these
markets is to offer world-class products with key differentiation, niche value-added
generics and products from therapeutic segments of Anti-TB, Anti-Infective and
Cardiovascular. Sales for this division in 2006 are increased by 2.5 times over the
previous year. The Company has adopted the strategy of entering into alliances,
joint ventures and synergistic partnership with some of the leading players in the
respective markets. These efforts have enabled the Company to breach the
otherwise high entry barriers as well as the gestation period for starting off in these
markets. The AAMLA geographies provide unique challenges and opportunities.
On one hand, there are highly regulated markets such as Japan, Australia, South
Korea, Mexico, U.A.E., Saudi Arabia etc., while, on the other, there are less
regulated markets such as Myanmar, Nigeria, Kenya and Peru. TB has recently
been declared an emergency in Africa, where 1500 TB deaths occur everyday. This
disease kills half a million African people every year, largely young men and
women. Africa is the only continent, where incidence of TB is increasing and in
just 15 years, it has more than doubled in high HIV areas. Lupin's alliances with
Ranbaxy laboratories Ltd. ans Aspen Pharmacare Holdings Ltd. are directed
towards Lupin's quest to make available TB drugs to geographies most afflicted
with the disease. The Company's formulations have reached more than 30
countries through GDF procurement and play a vital role in treatment of TB
patients in high burden countries identified by the WHO.
South Africa:
For FY 2010, Pharma Dynamics recorded revenues of ZAR 218 million (INR
1,328 million) registering a growth of 34% over the previous fiscal. The growth
was achieved by a planned focus on growing market shares in key therapy
segments such as Cardiovascular (CVS) and the OTC segments. Pharma Dynamics
remains the fastest growing Top 10 Generics player in the South African Market
and is the 6th largest Generic Company in the country.
Lupin plans to improve the consolidated entity's profitability and margins
through backward integration and and back ending production into our
manufacturing facilities in India as well as supporting pharma Dynamics in terms
of patent issues, regular reliable supplies and overall process optimisation and
control.
PHILIPPINES:
The Philippines market is valued at about USD 2.7 billion. Lupin's subsidiary,
Multi Care Pharmaceuticals is a premium branded generics company with a strong
position in the women's health and childcare segments. With strength of 165 highly
trained sales personnel, Multi Care has created significant brand equity and a
commendable franchise with the medical fraternity in the Philippines, which is
further augmented by strong distribution alliances. For FY 2010, Multi Care
recorded revenues of PHP 328 million (INR 328 million) More importantly Multi
Care pharmaceutical emerged as the 10th largest and the fastest growing Top 10
generic pharma company in the Philippines.
AUSTRALIA:
With an estimated size of USD 11 billion and a growth rate of around 7% the
Australian market presents a significant opportunity for Lupin. The Australian
Generics industry accounts for around 10 % of the total market. Top selling
medicines expected to go off patent are opening avenues for new business
opportunities. Also, there is active generic substitution by pharmacists and one in
every four prescription presented to pharmacists in Australia is now filled with
Generic medicines.
An ageing Australian population, are an expanding OTC market combined
with almost all citizens being covered by the National Health Insurance further
make this an interesting generic market. It is estimated that over half of the Top
100 selling prescription medicines in Australia are expected to come off patent in
the next 4 years. In a move to consolidate its position, Lupin increased its stake in
Generic Health Pty. Ltd. to 49.9% in FY 2010 from erstwhile 36.6% .
To circumvent the geographic and product portfolio risk, the Company has
ventured into various regions of the world, covering advanced and developing
markets. It aims to capitalise its strengths in API, by converting them into value
added finished dosages for the advanced markets, thereby enhancing product
competitiveness through lower cost. Lupin's traditional strength has been in Anti-
TB segment. To circumvent the risk of over dependence on a few therapeutic
segments, the Company has developed products catering to a wide range of
therapeutic segments.
The long term alliances with leading global players, relationship driven model,
qualitative products manufactured by internationally accredited plants, product
offerings in niche therapeutic segment and value added products, add sustainability
to sales and provide a strong hedge to sales risk.
Lupin consciously adopts the de-risking strategy of having multiple suppliers
of raw materials, services and finished goods such that inability of any supplier
does not affect delivery schedules of quality expectations. The Company has an
effective quality control system to ensure adherence to quality standards.
Through focus on value added generics, accent on introduction of products
based on modified release and NDDS platforms, extending the brand franchise in
Advanced Markets through introduction of line extensions, accent on cost control
through backward integration, timely launches and prudent product selection, the
Company believes that it can limit the risk, of price erosion of generics by
enhancing its competitive position.
To mitigate the regulatory risk Lupin has a dedicated regulatory department
staffed by a competent team, well versed with the diverse regulatory requirements.
The Company hedges its risk from exchange contracts and derivatives. It is also
conscious of its role in protection of environment and has adopted suitable policies
and measures to secure safety and health of the environment in which it operates.
Diversified Portfolio:
According to Naresh Gupta, President API & Global TB section, Lupin
successfully retained its global leadership position in the Anti-TB segment, during
the current fiscal. With products such as Rifampicin, Pyrazinamide and
Ethambutol as well as Cephalosporins such as Cephalexin, Cefaclor and their
Intermediates, the Company has written its success story in the Anti-TB space and
Cephalosporins space for the years to come.5
In 2008-09 two mainstay Cephalosporins intermediates 7 ADCA and 7 ACCA
recorded significant growth in volumes. Further, Lupin continued to remain a
strategic supplier of TB products to the Global Drug Facility (GDF).
Novodigm - A Prominent API/Crams Player in the Making:
The 2008-09 marked the first full year of operations for Lupin's subsidiary,
Novodigm. Despite a global downturn, Lupin has effectively transformed
Novodigm into a profitable entity that is of course a steady and defined growth
path. Novodigm sales doubled during 2008-09.
Having identified products that are growth drivers, Lupin significantly
revamped Novodigm's product portfolio to develop a concerted and differentiated
approach. The Company also infused its expertise at the operational level to
enhance efficiency. With integrated strengths in terms of manufacturing, marketing
and sales, Novodigm is expected to emerge as a prominent API and CRAMS
player in the years to come. A case at hand is Novodigm’s progress in the
Optically Active Building Blocks (OABB) segment during the bygone fiscal, an
amalgamation of assets resulted in a unique and efficient process for the
development of intermediates belonging to the Cetam family.
Lupin has also effectively enhanced the safety, compliance and documentation
standards as well as the GMP practices at Novodigm. Primarily a company that
produces intermediates, Novodigm has upgraded its basket of offering to initiate
the production of new APIs. As a key research asset, Novodigm is also engaging in
5 Lupin Annual Report 2009, P. 44
B 2B opportunities of supplying value added solutions to other pharmaceutical
companies that manufacture finished dosages.
In a bid to chart greater heights in times to come, the Company has a focused
marketing approach for its API business by establishing an on-shore presence in
select geographies in the near future. It plans to launch severd new API Products
along with PZP finished product In a bid to tap into the lucrative Chinese market,
Lupin is exploring strategic joint venture opportunities in China. Lupin's Indian
Formulations business continues to witness exemplary growth, where the
Company continues to outpace and outperform the Indian Pharmaceutical, Market
(IPM). During 2008-09, Lupin's domestic Formulations business recorded sales of
Rs. 11,412 Mn, as compared to Rs. 9,496 Mn (FY 2008-09), registering a growth
of over 20% which was twice that of the IPM, which grew at just 10% (ORG IMS
Man 09). The Company continues to gain at just 10% (ORG IMS Mar 09). The
Company continues to gain wide market acceptance, with most of its flagship
products being market leaders in their respective segments. Six of Lupin's products
are amongst the top 300 brands in the country. Riding high on gains made during
the year, Lupin improved its ranking to No. 5 in the IPM (ORG IMS Mar 09)
moving up one notch from No. 6 in Fy 2007-08. The Company today is the fastest
growing company amongst the top 5in the IPM, with an overall market share of
2.73% (ORG IMS Mar 09)
Top Ten Lupin Brands
PRODUCTS THERAPEUTIC SEGMENT
SEGMENT RANKING
TONACT CVS 2
GLUCONORM ANTI-DIABETIC 3
RCINEX ANTI-TB 1
RABLET GASTRO INTESTINAL 1
AKT ANTI-TB 2
RAMISTAR CVS 2
CLOPITAB CVS 1
L-CIN LEVOFLOXACIN 1
ODOXIL ANTI-INFECTIVE 1
LUPENOX CVS 2
New medicines through Formulation Research:
The Company's expertise in product research has translated into accelerated
regulatory filings. Barely four years from the initial filing of 2 and as in FY 2002,
Lupin has come a long way in producing tangible results in expanding its generics
dosages portfolio. The Company not only succeeded in ramping up the number of
regulatory filings, but also developed expertise to penetrate newer geographies,
hitherto unexplored due to complex regulatory requirements.6
Through the NDDS route, it aims to move up the value chain by offering value
added products for our branded initiatives as well as for licensing our. The
Company has already created capabilities in oral controlled release systems that
would help delivering products offering convenience and patient compliance,
which helps reduce the risk of drug resistance. It has created a dedicated
'Innovation Cell' to focus on this section of its research.
While Lupin has created capabilities in controlled release systems, which is the
biggest space in drug delivery, the aim is to move up the value chain beyond
6 Lupin Limited Annual Report 2005-06 P. 38
controlled release to other delivery systems, through the Innovation Cell. The
creation of intellectual property through New Chemical Entity (NCE) research is
one of the pillars of the Company's strategic growth plans and it has the distinction
of having four NCE molecules in various stages of clinical trials, addressing three
different disease areas of Migraine Psoriasis and Tuberculosis. The Company has
further advanced on its programmes in the areas of Diabetes (Synthetic & Herbal),
Anti-bacterial & Rheumatoid arthritis.
IN- LICENSING:
Partnership and in-licensing arrangements are integral to the Company's India
Region Formulations growth strategy. Successful in-licensing deals have enabled
Lupin to emerge as the 'first-to-market' for several important products.
Recognising the importance of in-licensing to its growth objectives, the Company
has set up a dedicated team to identify and pursue novel and potential in-licensing
opportunities.
In the last few years, the Company has introduced 19 in-licensed products and
of these, 6 products were first of their kind to be introduced into the Indian market.
During FY 2010, five in-licensed products were launched covering the
Gynaecology, Arthritic, Anti-Asthmatic and the Anti-Phrombotics segments.
Lupin within the Medical Community:
Lupin has always focused on working with the medical fraternity to creating
knowledge sharing platforms to keep them abreast of the latest technological
advances and breakthroughs. 2010 marks the 5th year of the acclaimed
International Symposium on Diabetes (ISD), a Platform created by Lupin in
association with faculty from the JOSLIN Diabetes Centre, USA. ISD continues to
be the largest platform for Indian doctors to exchange and share thoughts with
renowned Diabetologists from the Joslin Diabetes Centre. The event is attended by
up to 5,00 doctors from across India. The Symposium clearly highlights Lupin's
endeavor in keeping doctors abreast the latest developments and practices in
medical science. Lupin was the first to enable Indian doctors to tap into the vast
knowledge resource of Global medical institutions such as the European
Neurological Society (ENS) and the American college of Cardiology (ACC).
Novel Drug Discovery And Development:
The essence and the soul of Lupin's vision in the Novel Drug Discovery and
Development (NDDD) space is to discover, develop, out-license and
commercialise novel drugs that address disease areas with significant unmet
medical need. Having made its mark in the Generics space, the Company has
consistently invested in NDDD over the last few years to make a similar impact in
this field. The Company is in the process of creating new molecular entities for
accelerated development in identified markets globally. These novel products
would utilise Lupin's newly acquired strengths in drug discovery and development
complemented by Lupin's drug delivery expertise. A slew of such exclusive
products will provide the bridge for the Company's transition from a generic
powerhouse to an innovative drug discovery and development organisation. During
FY 2010, the Company completed its overhaul of the NDDD setup. Lupin has now
built very sophisticated infrastructure, has acquired cutting-edge technologies and
has built the right pool of talented scientists with the necessary skillsets to make
this endeavor a success. It has identified molecular targets from which 9 new
research programs have been initiated. In FY 2010, the Company created a new
Medicinal Research facility at Hinjewadi, in Pune. It also initiated the validation of
its new biology facility at Lupin Research Park, where highly sophisticated robotic
'FLIPR' Functional Assaying machines and high Throughput Screening (HTS)
capacities were also commissioned. Proud of these successes Dr. Rajender
Kamboj, President of Drug division has declared. "Our goal is to be world class in
any of the therapy and target areas that we work in”.7
Therapy Segments:
As a result lupin's growth rate has been remarkable shown below.
Therapeutic Segments Market Growth Lupin Growth
Rate (%) Rate (%)
CVS 20 20
Anti Tb -2 7
Anti Asthma 21 34
Anti Infective 15 15
GI 17 20
CNS 20 36
Anti Diabetic 24 44 (ORG
IMS Mar 10)
Industry: During FY, 2010 Lupin continued to witness growth across all key
business divisions and therapy segments. Some of these segments are:
Lupin Respira:
The Company's entry into Anti-Asthma, Allergy and Respiratory Tract
Infections and COPD Medicine is spearheaded by the Lupin Respira division. With
eight new brands launched in FY 2010, it continues to garner market share in the
Indian Anti-Asthma Market, registering a growth of 34% in FY 2010 as against the
Market growth of 21%.
7 Lupin Annual Report 2010, P.39
Pinnacle CVS:
Lupin's specialised division that focuses on the Cardiac market continued to
post strong results growing at 20% in FY 2010 commanding a 5.2% share of the
overall Indian Cardiac market. The division also launched a neutraceutical in the
year, Harty (Resveratrol). Five new brand were launched during FY 2010,
Lupin Diabetes Care:
The Diabetes Care division posted yet another year of exemplary growth
garnering 3.3% market share of the overall Indian diabetes market. In FY 2010, the
Company's Diabetes business grew at 44% as against the Industry growth rate of
around 24 %. Lupin is ranked 8th overall in the (Oral+Insulin) diabetic market
growing at twice the market rate. The division launched two new brands during FY
2010.
Lupin Femina:
The Lupin Femina division was launched in FY 2009 to spearhead the
Company's entry into the women's health care segment. Lupin Femina registered a
dynamic growth of 134% and launched seven new brands during FY 2010. Lupin
Femina also launched two in-licensed products in the Gynaecology segment during
the year, namely Faa-20 and luprolide
Endeavour:
This multi-specialty division is responsible for the Anti-infective and
Cephalosporin business for Lupin. It focuses on acute therapy areas with a product
portfolio comprising Antibiotics, pain management, Gastrointestinal and Anti-
osteoporosis products. Lupin grew at an outstanding rate of 20% in the GI space in
Fy 2010. Lupin's Anti-infective business in India grew by 15 % in the same
timeframe. Endeavour made a strategic entry into the anti-arthritic segment with
the launch of its first in-licensed brand Hyalgan for Osteoarthritis. Hyalgan is a
research product of Fidia, Italy.
Maxter:
One of the youngest division within Lupin's India formulations business. It
focuses on the Critical Care segment as well as making inroads into the field of
Wound Management. Some of Maxter's products like Tazar and Merotrol are
market leaders in their categories. Maxter is the fastest growing player in the
critical-care segment with special focus on high-end injectables as well as other
life-saving medicines and products. The division recorded a growth rate of 11% in
FY 2010.
Lupin CVN:
2010, witnessed the launch of Lupin CVN, Lupin's Super Speciality Division
catering to the nenphrology segment. Already 7 of 11 Lupin CVN brands feature in
the market.
Endeavor:
A multi-specialty division-this division is responsible for driving the Anti-
infectives and Cephalosporin Business for Lupin within the IPM. It focuses on
acute therapy areas with a product portfolio comprising Antibiotics, pain
management, Gastrointestinal; Anti Osteoporosis products Lupin grew at an
outstanding rate of 30.4% in the GI space, whereas the market grew by just 8.2%
in FY 2008-09. Lupin's Anti-infective business in India grew by 22.1% as against a
market growth rate of just 9.8% (ORG IMS Mar 09).
Lupin:
Responsible for the Company's focus on the semi-acute therapy, Lupin
continues to maintain market leadership status in the Anti TB segment, with an
overall market share of 48.3% (ORG IMS Mar 09),
Maxter:
One of the youngest divisions within Lupin's India Formulations business, this
division focuses on the Critical Care segment of the IPM and has also made a foray
into the field of Wound management. Some of Maxter's products like Tazar
(piperacilin Tazobactam) and merotrol (Meropenem) are market leaders in their
categories already. (ORG IMS Mar 09).
INCREASED PRODUCT OFFERINGS:
The Company brought as many as 54 new products into the market in FY
2008-09. These have the potential to be accountable for significant growth and
market share gain in the years to come.
Segments in Which Lupin Outperformed the Market
Therapeutic Market Growth
Rate (%)
Lupin Growth
rate (%)
CVS 13.2 25.5
Anti-TB -5.9 5.6
Anti-Asthma 13.1 48.8
Anti Infective 9.8 22.1
GI 8.2 30.4
CNS 10.4 48.7
Anti-Diabetic 16.7 53.0
AN EXPANDING PASSIONATE FIELD FORCE:
As part of its sales strategy to enhance market reach and penetration, the
Company has augmented its field staff to over 3,000 medical representatives. The
Company conducts extensive training programs at the induction as well as
refresher levels. As a result, Lupin's India sales and marketing personnel have
adopted a more consultative approach towards the medical fraternity. Replete with
up-to date medical and technical knowledge, the Company's competent, credible
field force has emerged as a qualitative differentiator in the marketplace. A well-
trained field force has succeeded in adding depth as well as reach to Lupin's
Formulations business.
IN-LICENSING-THE WAY AHEAD:
Partnership and in-licensing arrangements are integral to the Company's
growth strategy. Successful in-licensing deals have enabled Lupin to emerge as the
first-to-market' company when introducing several new drugs from different
corners of the world, ensuring that the Indian marketplace has access to some of
the latest and best healthcare options. Recognising the importance of in-licensing
to its growth objectives, the Company has set up a dedicated team to identify and
pursue novel and potential in-licensing opportunities. In the last three years, the
Company has introduced 12in-licensed products of these , 5 products were the first
to be introduced to the Indian markets. The Company successfully launched
Lupisulin (Recombinant DNA Human Insulin), Ismigen (Polyvalent Mechanical
Bacterial Lysate), and Faximab (Abciximab) in Fy 2008-09.
FY 2010 saw the addition of development in new therapeutic areas such as
Ophthalmics, not to mention the Company expanding the number of filings for oral
contraceptives to 23 ANDAs to date. Furthermore, the cumulative first-to-file and
exclusive opportunities now stand at 12.
ADVANCED DRUG DELIVERY SYSTEMS:
The Advanced Drug delivery Systems (ADDS) initiative has emerged as a key
growth driver within the Company's R&D program. Over the last 5 years, Lupin
has made strategic investments towards strengthening its ADDS research
capabilities. FY 2010 was a landmark year primarily because Lupin successfully
out-licensed its proprietary drug delivery technology based Rifaximin product to
Salix Pharmaceuticals for the US Market. Lupin and Salix entered into an
agreement under which the two companies will collaborate in the development and
commercialisation of an extended release product incorporating Rifaximin and
utilizing Lupin's proprietary bioadhesive technology. Lupin and salix have also
entered into an exclusive agreement for supply of Rifaximin Active
Pharmaceutical Ingredient (API). Salix made a USD 5 million up-front payment to
Lupin and will make additional regulatory milestone payments. Furthermore, Salix
will pay royalties on net sales of the bioadhesive Rifaximin product to Lupin.
This alliance further validates Lupin's growing capabilities in the drug delivery
space. The Company now has a host of drug delivery platforms that have already
been developed. These include.
* Bio-adhesive Extended Release
* Laser-drilled Extended Release
* Matrix/Coated Extended Release
* Taste Masking Technologies
* Improved Bioavailability through Solubilisation and Nano- particle
technology.
As part of its current strategy, the Company aims to license its ADDS products
to innovator companies whilst also developing niche brands for itself.
ANALYTICAL RESEARCH:
The Analytical Research Group ensures that all processes and products
transferred to Lupin's plants meet regulatory requirements and expectations
through the development and validation of the right testing methods. LRP houses a
sophisticated analytical facility supporting both process Research and
pharmaceutical Research. The facility is also equipped to study physical properties
such as polymorphism in both, API and drug products, using powder X-ray
Diffraction, Solid State NMR and Differential Scanning Calorimetry. Additionally,
isolation/synthesis and characterisation of impurities in APIs and drug products is
conducted with the latest LC/MS-MS systems and automated preparative HPLC
techniques and instrumentation.
LUPIN BIO RESEARCH CENTER:
Lupin Bioresearch Center (LBC) was started early in 2009 and has both
Clinical and Bioanalytical capabilities. LBC successfully completed 31 full studies
in FY 2010. This independent center in Pashan, Pune, houses 2 clinics with a total
of 56 beds, a bioanalytical lab with 7 state-of-the-art LC/MS-MS systems and its
own clinical chemistry lab amongst several other capabilities. 2010 was a record
year for the Company's generics process research program. During the Year, the
Company filed 19US DMF filings taking the cumulative total to 104 DMF filings
and 118 EDMFs/ CoSs, featuring several unique and complex APls. The last three
years have been landmark years for Lupin in the generic Pharmaceutical Research.
In Fy 2010, Lupin Pharmaceutical research Group filed 37 Abbreviated New Drug
Applications (ANDAs) with the United States Food and Drug Administration.
Lupin not only registered one of the highest number of ANDA filings amongst its
Indian peers but also emerged as one of the Top 10 ANDA filers globally. The
cumulative number of ANDA filings now stands at 127 with 40 approvals,
including 6 tentative approvals granted by the US FDA to date. The Total
cumulative filings within the EU stands at 65, with 31 total approvals. The NDDD
Research group is committed to creating innovative new drug molecules that will
change the way dozens of diseases have been treated so far. Working with a
targeted drug design approach with proven biological mechanisms that alter
disease process will be a sure-fire recipe for success in this otherwise high-risk,
capital intensive field.
BIO TECHNOLOGY RESEARCH:
The vision of the Biotechnology Research group based out of Pune is to
develop and commercialise Bio-Similar and New Biological Entities for the
Company. Lupin's state-of-the-art Biotech research & Manufacturing facility has
already been approved by the Institutional Bio Safety Committee (IBSC) for
research on recombinant DNA. Furthermore, This facility has also been accredited
as a Biotech Centre by the Bioinformatic Centre of the University of Pune. Today,
Lupin has 7 proteins in different stages of development.
In FY 2010, the Company commissioned cGMP facilities for microbial as well
as mammalian cultures. The Company has also filed 5 patents for the technologies
developed in-house and published 6 research articles last year. Lupin is now
looking to launch its first Biological in the Indian market in 2011. It is also
exploring collaborative opportunities in the field of new biological formulations
and New Biological Entities.
TECHNOLOGY ABSORPTION RESEARCH AND DEVELOPMENT
(R&D):
Specific areas in which R&D was carried out by Company:
The state-of -the-art Research park at Pune was at the epicentre of the
Company's R&D initiatives which focussed broadly on Generics Research
comprising Process and Formulations Research, Advanced Drug Delivery Systems
(ADDS), Novel Drug Discovery and Development (NDDD) and Biotechnology
Research. It was a prolific year for generics process research programmes wherein
focus was on process and formulations research. The ADDS program emerged as a
key growth driver and area of strategic focus within the overall R&D program.
With significant investments being channelised towards strengthening its ADDS
research capabilities, different drug delivery platforms were developed. Bio-
adhesive and gastro retentive technologies were deployed in building unique
products, based on which, differentiated extended release products are currently in
advanced stages of development. There was a strong accent on controlled release
and exclusive, unique first-to-file niche fillings. The Company's state-of-the-art
Biotech research & manufacturing facility has been approved by the Institutional
Bio Safety Committee for research on recombinant DNA and also accredited as a
Biotech Centre by the Bioinformatics Centre of the University of Pune. Lupin Bio
Research Center's (LBC) state-of-the-art CGCP and CGLP facilities for Bio-
Availability and Bio-Equivalence (BA/BE) Clinical studies spread over 23500
square feet with a capacity of 56 beds, become fully operational. The said facility
carries out pilot and pivotal BE and Clinical end-point studies, including
inspections. DCGI DSIR and NABL pre-assessments. Necessary infrastructure was
built and pre-requisite technologies and skill-sets acquired. Targets were identified
research programs initiated and back-up programs evaluated for prospective
research areas. The medicinal chemistry facility was activated which would
ascertain the rationale, feasibility, IP Commercial potentials for clearly defining
milestones and decisions. Validation process for the new biology facility was
initiated where, highly sophisticated robotic Functional Assaying machines and
high Throughput Screening Capacities were commissioned.
Benefits derived as a result of the above R&D:
The company emerged as one of the top 10 ANDA filers in the US market.
During the year, the Company filed 19 US DMFs taking the cumulative total to
104 and 4 EDMFs/ AU DMFs, featuring several unique and complex APIs such as
Prostaglandins for Oral Contraceptives. The formulations research group filed 37
Abbreviated New Drug Applications (ANDAs) with the USFDA and received 7
approvals, out of which 3 were tentative approval. The cumulative number of
ANDA filings stands at 127, with 40 approvals, including 6 tentative approvals till
date. The total cumulative filing within the EU stands at 65, with 31 approvals till
date. Filings were made in new therapeutic areas such as Opthalmics and
Dermatology in addition to expanding the number of filings for Oral
Contraceptives to 22 ANDAs till date. The Cumulative first-to-file and exclusive
opportunities now stand at 12. The company successfully out licensed its Bio-
adhesive Technology platform to Salix Pharmaceutical, a US major for use with
Rifaximin. This validates the investment that the Company made in the ADDS
program over the years as also it's growing capabilities in the drug delivery space.
The Company filed 26 Fromulations patents, 84 API/ Process patents and 14 NCE
patents. Approvals were received for 4 Formulations patents and 31 NCE patents.
The Company has filed 5 Patents for the technologies developed by bio-technology
research and published 6 research articles. The Company has a pipeline on 4
Investigational New Drugs for addressing migraine, Psoriasis and Tuberculosis and
the same remain in various phases of clinical development.
Future Plan of action:
Efforts are being directed towards developing, discovering and
commercializing novel drugs to address disease areas with significant unmet
medical need. The Company plans to launch its first Biological in the Indian
market and is exploring collaborative opportunities in the field of new biological
formulations and biological entities. The Company aims to license its ADDS
products to innovator companies whilst also developing niche brands for itself.
Plans are afoot to commission CGMP facilities for microbial as well as
mammalian suites.
Research and development:
2010, was a landmark year for Research and Development at Lupin’s Research
program not only witnessed heightened activity but also gathered momentum
across the entire R&D value chain, be it intellectual Property Management,
Generics Research, Advanced Drug Delivery Systems Research, the newly recast
Novel Drug Discovery and Development Program or the Company’s
Biotechnology Research. The state-of-the-art Lupin Research Park at Pune,
Lupin’s global R&D hub, was the epicenter of all these rapid changes as the Group
went about creating new infrastructure and launching new development initiatives
and programs. Lupin Research Park today houses a pool of over 800 scientists,
compared to 550 research scientists last year. During FY 2010, the Company
invested 8.7% of its net sales for R&D and related spends, amounting to INR 4,119
million. Lupin Research and Development covers the following broad areas:
* Generics Research
Process Research
Pharmaceutical Research
* Advanced Drug Delivery Systems (ADDS) Research
* Intellectual Property Management
* Novel Drug Discovery and Development (NDDD)
* Biotechnology Research
In 2010, the Company's Research Program was firing on all cylinders. The
Group filed an unprecedented 37 ANDAs, 19 DMFs and 11 European applications.
The Company also licensed out its drug delivery technology based Rifaximin
product to Salix pharmaceuticals for the US. The Company also completed the
restructuring and staffing of its Novel Drug Discovery and Development Program.
GENERICS RESEARCH:
Lupin's Generic Research program develops APIs and Pharmaceutical Products
for US, Europe, Japan and other Advanced Markets. The Program comprises
process Research, Pharmaceutical Research, Analytical support and Bio-Clinical
Research.
INTELLECTUAL PROPERTY MANAGEMENT:
Lupin's Intellectual Property Group identifies new therapy areas and products
for the Company's research to develop. Working in conjunction with the research
teams, marketing as well-as external agencies it puts in place a well differentiated,
high-value product pipeline, with a strong accent on controlled release, exclusive
and unique first-to-file filings.
During FY 2010, the Company filed a record 37 New drug Applications
(ANDAs), with as many as 4 first-to- file opportunities with the US. The Company
had 4 first to-files for the generic versions of Glumetza®, LO Seasonique®,
Ciprofloxacin® and Ranexa® Lupin has 55 Para IV Filings with the US FDA so
far, out of which 24 were filed during FY 2010. Furthermore, the cumulative first-
to-file and exclusive opportunities now stand at 12. In FY 2010, Lupin also sold its
first-to-file ANDA for the generic version of Antara® (Fenofibrate tablets) to Dr.
Reddy's before acquiring the brand Antara® from Oscient Pharmaceutical in the
US. The Company's Ip group is also responsible for protecting the intellectual
wealth generated by the Company's research in addition to leading patent
challenges across the globe.
In 2010 the Company demonstrated its capabilities on the Intellectual Property
front by successfully settling all ongoing litigation with Novartis on Lotrel®
(Benazepril/Amlodipine) capsules and then launching the product in the American
Market. The Company successfully litigated and settled all ongoing litigation
relating to Memantine tablets, Lupin's generic version of Forest Laboratories Inc's
Alzheimer disease treatment "Namenda® Tablets. Namenda® tablets have US
sales of USD 949 million on 2009 (IMS Data). Lupin and Natco limited
established an alliance to jointly commercialise generic equivalents of Shire Plc's
FOSRENOL® (Lanthanum Carbonate) tablets. Natco is one of the first-to-files on
the product. Fosrenol® tablets achieved sales of USD 131 million (IMS Data).
During the course of the year, Lupin filed 26 Formulation patents, 84 API/Process
patents and 14 NCE patents. It also received approval for 4 Formulation patents
and more importantly 31 NCE Patents.
LUPIN AND THE MEDICAL COMMUNITY PARTNERS IN PROGRESS:
Lupin has always focused on building its relationship with the medical
fraternity by creating knowledge sharing Platforms to keep them abreast with
advantages and breakthroughs in the medical world. FY 2008-09 marks the fourth
year of the acclaimed International Symposium on Diabetes (ISD), a Platform
created by Lupin in association with visiting faculties from the renowned JOSLIN
Diabetes Centre, USA. Year after year, ISD continues to achieve its objective of
providing a platfrom for doctors to exchange their thoughts and listen to some of
the world-renowned Diabetologists from the Joslin Diabetes Centre. The event is
attended by as many as 5,000 doctors from across the country. The Symposium
clearly accentuates the quality and inputs Lupin has imparted into the marketplace
in terms of keeping doctors abreast with the latest developments and practices in
medical science. Additionally, Lupin has been the first company to enable Indian
doctors to tap into the vast knowledge resource of institutions such as the European
Neurological Society (ENS) and the American college of Cardiology (ACC).
Lupin's Joint Airway Initiative (JAI) is aimed at disseminating Knowledge
about Asthma and Chronic Obstructive Pulmonary Disease (COPD). Under this
initiative, the Company conducts free diagnostic campus to detect asthma and
COPD and also spreads awareness through mass media.
Human Resources:
At the very heart of Lupin and our phenomenal growth story is our biggest-our
people.
We are proud of their passion and commitment to the company and the
alignment of their aspirations and dreams to our shared vision. Our growth and
successes are met equally by even greater steps to ensure that we not only comply
but lead in areas of processes and human relations to unleash and harness
innovation at every level within the organisation. It is the behavior of our
leadership team and our people, their shared wisdom, which has gone into creating
the business democracy that is Lupin-a Company where entrepreneurship and
innovation thrive.
As a closely knit team of over 10,500 employees globally, we have
outperformed the Industry over the last 6 years. It is against this backdrop that the
Human resources founction assumes a strategic and critical role. HR has gone
beyond traditional employee engagement talent and leadership internally, but also
develops platforms that help identify potential talent by creating opportunities to
learn, perform and succeed.8
NURTURING LEADERSHIP:
Through customised training programs, Lupin has today ensured the creation
of a reservoir of leaders. During the last financial year, Learning and Development
was focused on creating world-Class development opportunities and provided
inputs for the largest ever number of employees across location levels, functions
and geographies. Team capabilities were also strengthened through collective
experience based training programs. Lupins strategic tie-ups with leading
management institutes such as IIM Ahmedabad, NMIMS Mumbai and leading
technology institutions such as the Birla institute of Technology and Science (BITS
Pilani), University of Pune and Manipal University helped our employees pursue
their academic interests concurrently while working at Lupin.
Managing Multiculturalism:
Managing a diverse workforce is no longer a choice but an imperative. In an
age of cultural Pluralism, Multiculturalism is needed to manage diversity
effectively. Lupin realises that managing diversity means acknowledging people's
differences and recognising differences as valuable. This enhances good
management practices by preventing discrimination and promoting inclusiveness.
8 Lupin Annual Report 2010, P.43
It stems from an understanding that we all operate on a single stage. The goal has
been to create a workplace that truly values diversity. a workplace built around the
core values of meritocracy and innovation. There has been a visible rise in the
number of women professionals in core of the Company such as R&D, Regulatory
and Quality Compliance. The Company has also set up management and
leadership programs to help promote talent within the women workforce of the
organisation. Today, around 18% of Lupin's worldwide workforce are women, one
of the highest in the generic pharmaceutical industry up from 6% in 2004.
The agenda now is to enhance mindsets that enable our people to consistently
think global and act local structured well designed induction program aimed at
mentoring new employees for their effective settling-in and assimilation of our
corporate values are in place. These programs ensure that every employee is not
only clear about their role and expected contribution but also aligned to the overall
corporate growth objectives. Today, HR has become a critical catalyst for
continuous transformation during a phase of rapid growth and transition shaping
not only processes, people and mindsets, but creating a culture that typifies Lupin
and unleashes innovation at every level within the organisation
INFORMATION TECHNOLOGY:
During FY 2010, Lupin invested in upgrading its SAP and Business
Intelligence platforms. With the new upgraded Enterprise Resource Planning
system in place, the Company is well equipped to leverage its existing technology
investments to ensure operational and transactional control and compliance across
the organization. . The new systems are expected to create a global standardised,
scalable and flexible platform for Lupin's global supply chain program and would
help achieve operational efficiencies to support the Company's growth objectives
globally.
RISKS CONCERNS & THREATS:
Over the Years, the Company has consciously adopted prudent risk
management measures and practices to mitigate environmental, Operational and
business risks. The Company believes that it has the requisite competencies to
handle varied risks and is continually evolving proactive strategies to counter
them.
Price erosion within the global generic markets is one of the key threats faced
by all generic players. Due to its vertically integrated model, in which the
Company's strengths in API and Intermediates play a crucial role in maintaining
the competitive position of its Formulation products, and our focus on value added
products. Lupin is well positioned to thrive in a highly competitive environment,
consistently gaining market share and enjoying quality earnings. Lupin's
acquisition philosophy is predicated on the need to enter into certain markets
which are of strategic interest. The acquisitions have been carried through in such a
way that there were no disruptions to extant managements. All our acquisitions
were well evaluated and deliberated internally and were prudent in terms of
outlays. The Drug Price Control Order (DPCO) continues to challenge the entire
Indian Pharmaceutical Industry. However over the years, Lupin's basket of
products and the chosen markets and segments it operates in, have meant that
DPCO directives are becoming increasingly less material to the overall business of
the Company. The Volatility in Pen G prices, a Key raw material input to APIs, is
a recurring phenomenon stemming from the vagaries in the supply and demand
positions with primarily Chinese manufacturers. These situations tend to be short
term in nature, nevertheless contribute to the volatility in the price movement of
this key input. Over the years, the Company has gained experience and expertise in
dealing with such volatility and mitigating its impact on the business.
It has been seen recently that regulatory authorities globally are becoming
more vigilant on pharmaceutical players with respect to compliance to standards
and regulations. Lupin believes in being compliant in all respects at all times. The
Company takes all its compliance requirements extremely seriously and maintains
rigorous systems to withstand scrutiny at all times. Lupin is committed to doing
whatever is necessary to meet and exceed norms laid by global regulatory
authorities.
Quality & regulatory Compliance:
Lupin has always identified Quality and Regulatory Compliance as a true
enabler and the critical differentiator between market leader and the rest-the
mainstay of long-term competitiveness over the years; we have built and nurtured
an environment around deep respect for quality and compliance, in line with global
best practices. We believe that quality not only has to be embedded in the product
but into the very way an employee thinks and works. This instills and engineers
quality and compliance into the culture of the organisation. Today, this culture is
ingrained in the Lupin Brand DNA and embraced by all Lupin personnel. FY 2010
was a landmark year for Lupin in terms of Quality and Compliance. Lupin
received official communication from the US FDA on the satisfactory resolution of
the Warning Letter issued earlier to its Mandideep site. The facility was re-
inspected in November 2009 and the Company was able to satisfactorily address
all of the concerns related to the Warning Letter and the site compliance status
was found to be acceptable. Earlier in the year, the UK MHRA and the Australian
TGA conducted a joint inspection of the Mandideep facility and found it
acceptable as well. The US FDA also inspected two new sites of the Company at
Aurangabad (Liquids) & Indore (Oral Solids and Oral Contraceptives). Both
inspections were found acceptable and these inspections bring the Company a step
closer to launching Liquids and Oral Contraceptives in the US. In addition, the
Company's Tarapur and Goa facilities were inspected by the US FDA in 2009 and
found acceptable. Goa was re-inspected in early 2010 by the US FDA and again
found to be compliant. Lupin's API Plant at Tarapur was also audited by the UK
MHRA and found to be compliant with c GMP.
2010 also saw the introduction of Lupin's Global pharmacovigilance Cell.
Pharmacovigilance involves the monitoring of the safety profile of medicinal
products form clinical trials to the pre-marketing period, when the drug is
introduced to the general population and thereafter-it continues throughout the life
cycle of the product. The aim of Pharmacovigilance is to protect and safeguard
public health by identifying, evaluating and minimising safety issues to ensure that
the overall benefits of medicines for outweigh the risks.
A dedicated global QC team spread across all manufacturing locations,
globally, is engaged in driving the quality philosophy of the organization. The
team also develops and implements the Quality policy and Guidelines for Key
systems and processes within the Company. Corporate Quality Assurance is
enforced and supported by a team of over 700 personnel comprising the quality
and regulatory functions at all Lupin sites
Financial Performance:
Come a long way from being a manufacturer and supplier of APIs, to
becoming a fully integrated global pharmaceutical company recent year have been
momentous landmark in Lupin journey. Impressive growth, noteworthy profits and
meaningful acquisitions- 2007-08 witnessed it all to aptly qualify as an action
packed year.
Lupin closed the year 2007-08 with Consolidated Revenues at (Rs. 27,730 Mn
717 Mn-FY 2006-07) recording a growth of 34% its consolidated Net profit for the
year increased by 32% to Rs. 4,083 Mn (Rs. 3,086 Mn-FY 2006-07). This year's
performance was driven by all round robust growth recorded by each of the
Company's business segments. The US as well as India business in particular were
significant growth drivers in last five years.
Financial situation 2010:
Lupin has shown a sound financial situation in last several years.9
It scaled newer heights and benchmarks in terms of sales and profits of the
Year ended march 31, 2010. Consolidated sales at Rs. 47678.4 mn., grew by 25%
over Rs. 38237.8 mn. of the previous year. International markets accounted for
67% of the revenues. Net Profit at Rs. 6816.3 mn., as against Rs. 5015.4 mn,
registered a growth of 36%. Earning per share was higher at Rs. 79.18 as compared
with Rs. 60.84 for the previous year.
Share Capital:
In 2010, the paid-up equity share capital of the Company rose by Rs. 61.2 mn,
Consequent to:-
(a) Allotment of 5816742 equity shares of Rs. 10/- each upon conversion
of foreign currency convertible bonds aggregating Us $ 17.3 mn and
9 Lupin Annual Report 2010, P.55
(b) Allotment of 307541 equity shares of Rs. 10/- each to eligible
employees under the 'Lupin Employees Stock option plan 2003, Lupin Employees
stock option plan 2005 and Lupin subsidiary employees stock option plan 2005.
Share Holders:
Over 4600 of Lupin’s shareholders come from nearly all states of India. In 2010 they received Rs.
13.5 per equity share absolving Rs. 1400 mn. The following tables give a detailed of their profile.10
Shareholding Profile
10
Lupin Report 2010, P.76
Geographical presence of shareholders as on March 31, 2010
Dividend Profile
Net Profit:
In 2010 Lupin recorded on operating profit before working capital changes of Rs. 8023 mn, up 26%
from previous year. The net cash generated was Rs. 5325 mn, up 25% Cash flow statement11
from the
previous year.
11
Lupin Report 2010, P.86
Consolidated Profit and Loss Account:
A five year statement of consolidated profit and loss is given below to show Lupin’s steady growth
in recent years.12
12
Lupin Report 2010, P.53
ADDITIONAL FINANCIAL STATES:
Sub-division of Shares:
In 2010 The Board of Directors recommended the sub-division of one share of
the face value of Rs. 10/- each into five shares of the value of Rs.2/- each.
Foreign Currency Covertible bonds (FCCBs):
Of the FCCBs of US $ 100 mn., issued by the Company in january 2006,
Bonds aggregating US $ 98.6 mn., were converted (including Bonds of US $ 71.3
mn. during the year) at a pre-determined price of Rs. 567.04 per share in
accordance with the terms of the issue. The balance FCCBs for US $ 1.4mn., were
redeemed during the year. There are no Bonds outstanding as on March 31, 2010.
Credit Rating:
ICRA Limited reaffirmed its "A1+" (pronounced A one plus) rating for your
company's short-term debt (including Commercial paper) Programme of Rs. 2500
mn. This rating is the highest-credit-quality rating assigned by ICRA for such
borrowings.
ICRA Limited assigned "LAA+" (pronounced" L Double A Plus") rating for
your Company's Non Convertible Debenture programme of Rs. 5000 mn. This
rating is the high-credit-quality rating assigned by ICRA for long-term debt
instruments.
Subsidiary Companies:
As on March 31, 2010 the company had 14 subsidiaries. During the year,
Lupin (Europe) Ltd. U.K. and Lupin Pharma Canada Ltd. Canada were
incorporated on June 5, 2009 and june 18, 2009 respectively. Lupin Holdings,
B.V., the Netherlands transferred its holdings in Max Pharma Pty. Ltd. Australia, a
wholly-owned subsidiary of the Company to Generic Health Pty. Ltd. Australia, an
associate of the Company upon which Max Pharma Pty. Ltd. ceased to be a
subsidiary of the company w.e.f. May 31, 2009.
Amalgamation:
With a view to achieving synergies of operations, optimum utilisation of
resources and control costs, the Board of Directors decided to amalgamate
Novodigm Ltd., Lupin Pharma care Ltd. and Lupin Herbal Ltd. (wholly-owned
subsidiaries of the Company) with Lupin Limited w.e.f. April 1, 2009 i.e. 'the
Appointed Date'.
The Hon' ble high Court of judicature at Bombay, by its Order dated January 8,
2010, sanctioned the scheme of amalgamation between Lupin Pharmacare Ltd. and
Lupin Herbal Ltd. with the Company subject to the order to be passed by the High
Court of Gujarat sanctioning the scheme of amalgamation between Novodigm Ltd.
HEALTHY CASH FLOWS & EFFECTIVE RESOURCE PLANNING:
Despite spending on brand acquisitions in the US and capacity expansions in
most of its facilities in addition to creating several new plants during the year, the
cash flow position of the Company remains healthy. Thanks to judicious financial
planning, the ability of the Company to raise credit remains unparalleled. Lupin's
short-term debt program continues to receive the highest rating from ICRA. In fact,
Subsequent to the global financial meltdown, Lupin's FCCB bonds were amongst
the few that continued to be quoted well above par, and all the residual bonds have
been already redeemed or converted into shares. In 2010 the Net Working Capital
increased by only 4% whilst the sales of the Company increased by 25%. The
working capital optimisation exercise that we have currently undertaken will yield
even greater results in the days to come. Overall interest payments were INR 385
million for FY 2010, reflecting an average cost of borrowing of 4% for the year.
The total debt at the year-end stood at INR 11,399 million and the Debt Equity
Ratio improved to 0.44 as on 31 st March 2010 from 0.62 as on 31st March 2009.
CAPITAL EXPENDITURE:
During 2010, the Company invested INR 4,433 million on capital expenditure.
The Company has set up multiple new API plants and a new ophtal formulation
facility.
DIVIDENDS AND TAXATION:
The Company recorded Earnings per Share of INR 79.18 during 2010, up 30%
from the previous year. The Board recommended a dividend of 135%, an
aggregate amount of INR 1,400 million, inclusive of tax on Dividend. This record
step-up in the dividend rate is strong indicator of the confidence that the Board of
Directors have in the financial strength of the Company. The Company has
implemented several tax saving initiatives to optimise its taxation in various parts
of the world. In the Indian context, the aggregate tax obligations of the Company
were lower as compared to the previous year due to higher turnovers from Tax
exempt production zones. The effective tax rate for the consolidated financials for
FY 2010 was 16%.
The Company has increased its reserves and surplus by INR 11,369 million to
INR 24,789 million during FY 2010.
INTERNAL CONTROL SYSTEMS:
The Company has in place sound internal control systems commensurate to its
size, scale of business and complexity of operations. Clearly defined policies,
procedures and inbuilt checks and controls, supplement the internal control
procedures. A well established and empowered system of internal audits and
control procedures independently reviews the financial and operational controls
and reports deviations, if any.
Corporate Social Obligation:
Over the years, The Lupin Human Welfare & Research Foundation (LHWRF)
has been successful in creating and undertaking well-planned sustainable and
integrated rural development programs-social and economic initiative that continue
to touch and transform the lives of over two millions rural folk in over 2,200
villages spread across 4 states in India-Rajasthan, Madhya pradesh, Maharashtra
and Uttarakhand. The Foundation through its work has emerged as a social and
economic catalyst empowering rural communities.
The Foundation continues to work on enriching the lives of the poorest of the
poor. Our focus is on uplifting people and families below the poverty line as well
as women empowerment. Today, as many as 56,000 families are covered under the
aegis of the Foundation through agriculture, animal husbandry and the rural
industry activities of LHWRF.
ECONOMIC DEVELOPMENT:
LHWRF's principal focus is on creating employment and employability by
imparting skills and creating programs that would create job opportunities -
specifically for the youth and women. During FY 2010, the Foundation worked on
strengthening areas like agriculture and animal husbandry by working on programs
that would yield higher output and offer value addition to help improve the overall
economic retaliation of the rural communities. The Foundation also emphasised on
promoting secondary occupations such as the local cottage industry, handicrafts
and services sector by creating fairs and promoting them. It also worked on
introducing better technologies and best practices with a view to improve quality
and market acceptability for these products in new markets.
SOCIAL DEVELOPMENT:
LHWRF has always aimed at the development of proper social, cultural,
scientific and spiritual attitudes amidst the rural community. The endeavor is to
instill an urge to not only work but be responsible for their own development in
villagers, especially women, children, the youth and older people. Significant
social development initiatives undertaken during 2010 were in the areas of Health,
Women Empowerment, Infrastructure Development and Renewable Energy. The
Foundation aims to continue bringing qualitative and quantitative improvement in
the Health services across areas that are bereft of medical facilities. LHWRF has
been working on establishing health centers and mobile health units to provide
medical care to the poor populace, targeting women and children residing in slum
and rural areas. The Foundation is planning 100% coverage to ensure that all
children are fully immunized and vaccinated in these areas.
The foundation has always believed that creating the right infrastructure is the
key to progress and prosperity. LHWRF Programs were focused on building
internal roads and basic sanitation facilities in various districts in Rajasthan. It also
focused on strengthening and revamping formal education and community centers
and training and production centers in various States.
THE NEXT STEPS:
LHWRF has always believed that any business has a direct social obligation to
the community and society it exists and works with, and its role cannot remain
restricted to returns to stockholders or its customers. After 22 years of having
served rural communities, LHWRF today is not only focused on bringing the
benefits of a knowledge- based economy to the poor and the needy but it stands for
ensuring better public health services and for creating scalable and replicable
programs that would ensure Education and Employability for rural India.
“Amark of recent achiever it is Lupin's branded business which contributed
37% of the overall US revenues with a turnover of USD 127 million, growing by
72% during Fy 2010"
Fy 2010 was marked with several examples where the Company was able to
leverage its intellectual property capabilities into driving organisation growth.
During the year, the company settled all ongoing litigation with Novartis on Lotrel
(Benazepril/Amlodipine) capsules and then launched the product in the US Market.
The Company also settled all litigation relating to Memantine tablets, Lupin's
generic version of Forest Laboratories Inc.'s Alzheimer disease treatment
"Namenda"® Tablets. In addition, the Company sold its first-to-file ANDA on
Antrara® (Fenofibrate) Tablets to Dr. Reddy's before buying the brand for the US.
Lupin and Natco Limited have an alliance to jointly commercialise generic
equivalents of shire's FOSRENOL (lanthanum carbonate) Tablets. natco is one of
the first-to-file on the product.
During FY 2010, the company filed 37 Abbreviated New Drug Applications
(ANDAs) with the United States Food and Drug Administration. Lupin not only
clocked in one of the highest number of ANDA filings amongst its Indian peers but
also emerged as one of the Top 10 ANDA filers globally. The cumulative number
of ANDA filings now stands at 127, with 40 approvals to date. Lupin has 55 para
IV filings with the US FDA, out of which 24 were filed during Fy 2010. The
cumulative first-to-file and exclusive opportunities now stand at 12. On the Drug
delivery front, in FY 2010 Lupin and Salix entered into an agreement under which
the two companies will collaborate in the development and commercialisation of
Lupin's extended release Rifaximin product for the US Market. Lupin will also
supply Rifaximin API to Salix. Salix made a USD 5 million up-front payment to
Lupin and the alliance also envisages typical milestone and royalty payments.
By insuring quality and global regulatory requirements, Lupin's has assured the
global standards of good manufacturing.
LUPIN'S GROWING STATUS:
Lupin is one of India's top 10 pharmaceutical companies and one the most
prolific introducer of new products in the Indian market place. As a leading global
player in the Anti-TB, Cephalosporin and Cardiovascular segments, the Company
operates in vital segments with global footprints in over 70 countries, through its
onshore presence and business alliances. Today, Lupin globally ranks No.1 in
Anti-TB and is a dominant Player in Cephalosporins and Prils. It is also developing
strong competencies in the Anti-Diabetic and Anti-Asthma segments. Through a
prolific R&D centre, the Company routinely develops novel, non-infringing, cost
effective and eco-friendly technologles for its products. The foundation of the
Company's success originates from its rock solid manufacturing infrastructure.
With 11 of its sites approved by the US FDA and two by the UK MHRA, Lupin
operates one of the largest capacities in india, meeting stringent international NCE
research, with four promising molecules under various stages of development. As a
highly integrated company, with an amply competent workforce it ahead in
multiple markets, Lupin is certainly a force to reckon with in the global
pharmaceutical marketplace.
Branding in Indian Pharmaceuticals Industry: With Special Reference to
LUPIN
Up until the 1970s India's Pharmaceutical market was mainly supplied by large
international corporations. Only cheap bulk drugs were produced domestically by
state owned companies founded in 1950s and 60s with the help of World Health
Organisation (WHO). These state run firms provided the foundation for the sector's
growth since the 1970s. Back then, Indian Government aimed to reduce the
country's strong dependence on pharmaceuticals imports by flexible patent
legislation and to create a self reliant sector. In addition, it introduced high tariffs
and limits on imported medicines and demanded that foreign pharmaceutical
companies reduce their shares in their Indian subsidiaries to two fifths. This made
India a less attractive location for international companies many of which left the
country as a consequence.
Especially India Drugs and Pharmaceuticals Limited (IDPL) is credited with
speeding up the development of a national pharmaceutical industry. Several IDPL
staff have successfully founded their own firms, which now belong to the top
group among India's Pharmaceutical companies. In the 1980s, however, the decline
of the state-run companies began-among other things because of increasing Central
Government bureaucracy and insufficient corporate governance. Today, there are
no (entirely) state owned pharmaceutical companies left. By contrast, the
weakening of the patent system and numerous protectionist measures speed up the
development of a major national pharmaceutical industry on a private-sector basis,
which made it possible to provide a large number of drugs.
India's Pharmaceutical industry has been in transition for several years. As a
consequence of major changes to India's drug patent legislation, the country's
Pharmaceutical industry is undergoing a process of reorientation. Its new focus is
increasingly on self developed drugs contract research and /or production for
western drug companies. Between 1996 and 2006, nominal sales of
pharmaceuticals in the Indian subcontinent were up 9% per annum and thus
expanded much faster than the global pharmaceutical market as a whole (+7% p.a.)
Indian companies strongly expanded their capacities, making the country by and
large self sufficient. Nevertheless, with total sector's sales of roughly EUR 10 bn,
India commands a less than 2% share in the world's pharmaceuticals market. This
puts the country in twelth place internationally, even behind Korea, Spain and
Ireland and before Brazil, Belgium and Maxico. Among the Asian countries,
India's Pharmaceuticals Industry ranks fourth at 8% but has lost market share to
China, as sales growth there was nearly twice as high and sales volumes nearly
four times higher than India.
India's Pharmaceutical industry currently comprises about 20000 licensed
companies employing approx 500000 staff. Besides many very small firms, these
also include internationally well-known companies such as Ranbaxy, Cipla,
LUPIN and Dr. Reedy. All in all, the Indian Pharma industry produces about
70000 different drugs which are higher than the number produced in many
Western countries. In 2006, India's Pharma industry exported products worth EUR
3bn, up from only EUR 650 m in 1996, which was due to the fact that demand for
low cost generic drugs is strongly on the rise, above all in the US, Europe and
Japan.
LUPIN: A Profile
Lupin Limited, established in 1968 with headquarter in Mumbai, has
successfully positioned itself as a transnational pharmaceutical company, with a
wide global footprint. The Company develops and markets a wide range of quality,
affordable generic and branded formulations and APIs in multiple markets across
the world. The Company has gained recognition as the world's largest
manufacturer of Tuberculosis drugs. Over the years, the Company has moved up
the value chain and has not only mastered the business of certain intermediates and
APIs, but has also leveraged its strengths to build a formidable formulations
business. It has a significant presence in Cephalosporins. Cardiovasculars (Prills
and statins), Diagetology, Asthama and NSAIDs therapy segments. Over the last
four years, the Company's business mix has improved with close to 70% of its
revenues coming from formulations and 30% from APIs.
Global Footprint:
The Company has a wide onshore and offshore presence with its products
available in close to 70 countries. In terms of overall revenues, the overseas
business constitutes close to 55% while the balance comes from the domestic
market. Lupin has retained a stronghold in India growing ahead of the industry and
has achieved a formidable position in many segments leveraging its sound
marketing prowess and a wide product basket. The US is Lupin's largest market
overseas where it has developed a robust branded and generic business. Over a
period of four years, Lupin has developed a business of US $ 200 mn in the US
and has been recognized as one of the fastest growing Companies in this market.
The Company aspires to replicate this success in other Advanced Markets such as
Europe, Japan and Australia. During 2007, Lupin fast tracked its growth trajectory
through two acquisitions. While the acquisition of Kyowa positioned the Company
amongst the top ten generic pharma Companies in Japan; another acquisition in
India provided it a springboard to leap ahead in the CRAMS space.
Manufacturing & Research:
Lupin's manufacturing facilities, spread across India, play a critical role in
enabling the Company realize its global aspirations and benchmark to international
standards. These facilities are approved by international regulatory agencies like
US FDA, UK MHRA, TGA Australia. WHO and MCC South Africa. The
Company has leveraged its strong vertical integration in building a global
pharmaceutical powerhouse. The Company's intellectual pool of over 400
scientists is constantly engaged in path breaking research.
l