A News review for global Otsuka community Jun 10. 2015

The OIAA Chronicle

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Korea Otsuka receives Gold Prize at 2015 Effie Awards

Korea Otsuka Pharmaceuticals received the Gold Prize at the 2015 Effie Awards Korea with the men’s cosmetic brand UL·OS for the campaign “Change Cosmetics, Not the Man.” The campaign, done in 2014, was successful in gaining the interest of average Korean men and received gold at the world famous Effie Awards ...

UL·OS adult refreshing sheet has newly released in Japan

New SOYJOY with more fruit! Renewed Strawberry and Blueberry Versions Contain More FruitOn March 9, Otsuka

Pharmaceuticals newly released UL·OS adult ...

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Otsuka’s JINARC® the First-Ever Treatment Approved in Europe for Adults Living with ADPKD, a Chronic Genetic Kidney Disease

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Otsuka Ranked Top 5 Among Mid-sized Sponsors Rated by Investigative Sites in New CenterWatch Survey

BOSTON--(BUSINESS WIRE)--More than 1,900 global investigative sites rate the best biopharmaceutical ...

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OIAA PV/Clinical/RA workshop in Bali 2015

The OIAA PV/Clinical/RA workshop was held in Bali, Indonesia March 16 to 19, 2015. For four days 95 people from 21 companies attended the workshop.During the PV/Clinical session held on the 16th and 17th updates on each function of Global PV and the new plan for the globally harmonized clinical procedure ...

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The OIAA PV/Clinical/RA workshop was held in Bali, Indonesia March 16 to 19, 2015. For four days 95 people from 21

companies attended the workshop.

During the PV/Clinical session held on the 16th and 17th updates on each function of Global PV and the new plan for the

globally harmonized , and also inspection/audit readiness training was held.

The RA session on the 18th and 19th discussed the information for each product to share on the major projects and to

establish the strategy for OIAA registration.

Recent updates on Global PV and topics regarding harmonization of the global and OIAA regions were presented on

the 16th, by each global PV functional heads. Also, each affiliate’s individual issues and needs were introduced and

discussed in regards to new processes. In the 4-hour Inspection/Audit readiness training held on the same day, five key

topics were explained with the procedures and essential points which are required for Inspection/Audit from the aspect

of inspector or auditor. Through group discussion on the five key topics, participants had time to share their discussion

outcomes with other teams.

The second day of the workshop started with introduction to Global Clinical Quality Management, which is an increasingly

emphasized area. Sessions regarding global issues such as global SOP transition were held, as well as group discussion

on CAPA plan preparation.

It was a good opportunity to enhance the interest and cooperation of everybody when the subject of 'Global RA - 2015

"Delivering Regulatory Excellence" was discussed for one hour on the 18th. During which time the information about global

RA structure and ongoing activities were shared with OIAA. Lee aPMM of the Busulfex Team attended the workshop and

said, “The shape of Otsuka growing as a global company as the system is gradually established.”

KOIAA and each local affiliate’s RA team have worked hard to speed up the process in order for the business to grow as

planned. It provided a chance to strategically share good information for the Marketing Team.

Cho aPMM of the Mucosta Team said “As many departments are related so that the information collection through

sufficient prior discussion among departments is important to problem solving.” He called attention to the necessity of

cooperation among relevant departments.

The great achievements of the workshop will be exposed in the progress of the registered current project such as Abilify

Maintena, the US FDA’s approval of Brexpiprazole, and the information sharing of updates on new projects such as

Inclusig which will be introduced in OIAA this year. Furthermore, it gave a chance to interact with other departments

doing GPV, OIAA-QA, IPD, and ITD with the full readiness of the RA and MA Teams of KOIAA so that better interaction

with other departments were actively pursued in this workshop through discussion and a stronger Q&A session compared

to the previous workshop.

In regards to global changes and alterations throughout recent years, this workshop indeed contributed to sharing

updates with recent PV, Clinical, and RA issues and strategies for the overall OIAA region. Lectures concerning

various topics added valuable information for everybody, and experiences shared from affiliates contributed to higher

understandings about local circumstances. Dedicated sessions on special topics such as Inspection/Audit readiness, were

appraised as a great opportunity for enhancing knowledge on important topics.

Also, ideas for improvement on future workshops were raised. Since global changes affect local procedures, hearing

more voices from the affiliate’s side may be a good option for better understanding. Although the 2015 workshop was

evaluated as having stronger Q&A sessions, even more participation may be a productive way to raise improvements and

innovative ideas.

OIAA PV/Clinical/RA workshop in Bali 2015

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Korea Otsuka Pharmaceuticals received the Gold Prize at the 2015 Effie

Awards Korea with the men’s cosmetic brand UL·OS for the campaign

“Change Cosmetics, Not the Man.” The campaign, done in 2014, was

successful in gaining the interest of average Korean men and received

gold at the world famous Effie Awards that celebrates effective marketing

campaigns that lead to actual sales.

The campaign was a major success of brand recognition through

advertising. After launching the total men skincare brand UL•OS in 2012

the Cosmetic Team of Korea Otsuka realized that brand recognition didn't

lead to sales. They wondered why customers knew about UL•OS but

didn't find a reason to select it. Currently, Korea is the top-ranked male

cosmetics market in the world. Under these circumstances, the flood of

current male cosmetic brand advertising focuses on the 10% grooming class which is more concerned with skin care than

average females. The cosmetic team planned UL·OS as a campaign to empathize with the other 90% of Korean men.

The total skincare brand UL·OS reflects the skin health and lifestyle of men who think skin control is inconvenient and a

dull matter. The empathy campaign in 2014 showed the simplicity and product power of UL·OS in the daily life of men by

advertising “Change Cosmetics, Not the Man.” Rising against the present market with step intensive skincare products

and by speaking to the 90% average Korean men; the campaign was a success.

A clear-cut separation from current male cosmetic brands was pursued so that brand value and sales increased at

the same time. As the campaign aired in February 2014, sales increased by 280% from the previous year, and brand

awareness were enhanced by 8 ranks from 13th to 5th by the end of 2014. Furthermore, sales share in the male cosmetics

market of major distribution channels also rose sharply to the 1st and 2nd. The successful campaign resulted in the gold

prize at the “2015 Effie Awards Korea”.

Shin, Eun Hee, CEO of Nielson Korea and Co-Chairperson

of the Review Board, expressed the reason for the award

selection on April 23, 2015, “The campaign was done with

a relatively small budget among participating brands but

achieved a great result in brand index and sales, as well

as through clear target specification and positioning.”

Director of the Healthcare Business Division at Korea

Otsuka and product leader of UL·OS, Mr. Chin-Kyung

Chung commented, “I am happy that UL·OS is recognized

as the brand properly reflecting the needs and desires of

male consumers. I will endeavor to cultivate the brand and

consumers to have Korean males make healthy skin through UL·OS.”

The Effie Awards is a prestigious award ceremony being held in 44 countries worldwide. It is a ceremony that spotlights

domestic and overseas marketing communication showing effective advertising campaigns that resolve current brand

issues in the market. Evaluation of campaigns at the Effie Awards differs from other advertising awards that consider

creativity as the main assessment factor. “Effie” is an abbreviation for “effectiveness” which refers to the awards

focus on campaigns that increase sales. The Effie Awards was started in the United States in 1968. Korea celebrated its

first award ceremony in 2014.

Korea Otsuka receives Gold Prize at 2015 Effie Awards

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– JINARC® (tolvaptan) is the first approved pharmaceutical therapy available in Europe for patients with autosomal

dominant polycystic kidney disease (ADPKD) that targets the underlying pathophysiology of the disease

– ADPKD is a chronic and progressive genetic disease, which causes cyst proliferation and growth in the kidneys, leading

to an increase in kidney size and resulting in complications that include chronic and acute pain, hypertension and

kidney failure, necessitating dialysis or renal transplant

– In a Phase III clinical trial of patients with ADPKD over a three-year period, the rate of total kidney volume (TKV)

increase over 3 years was significantly less for tolvaptan-treated subjects than for subjects receiving placebo: 2.80%

per year vs 5.51% per year, respectively

– ADPKD is thought to affect between 3-4 people per 10,000 – as many as 205,000 people in Europe

Otsuka Pharmaceutical Co., Ltd. announced May 28th that the European Commission has granted marketing authorisation

for JINARC® (tolvaptan) for the treatment of ADPKD in adults who have chronic kidney disease (CKD) stage one to three

at initiation of treatment with evidence of rapidly progressing disease. In receiving this marketing authorisation, tolvaptan

becomes the first pharmaceutical therapy to be licensed in Europe for the treatment of the underlying pathophysiology

of ADPKD.

“Until now, healthcare professionals have focused on treating the signs and symptoms of ADPKD, with no specific

treatment available to treat the disease,” said Professor Ron T. Gansevoort, University Medical Centre Groningen,

the Netherlands, an expert in the field of polycystic kidney disease. “Tolvaptan represents a significant medical

breakthrough in the management of ADPKD. For the first time, healthcare professionals can modify the progression

of the disease and preserve kidney function, with the potential to improve patients’ quality of life and long-term

outcomes.”

The marketing authorisation for tolvaptan is based on the findings of the pivotal Phase III randomised, double-blind and

placebo-controlled TEMPO 3:4 trial – the largest clinical study conducted in ADPKD to date. In the three-year study, the

rate of TKV increase over 3 years was significantly less for tolvaptan-treated subjects than for subjects receiving placebo:

2.80% per year vs 5.51% per year, respectively (ratio of geometric mean 0.974; 95% CI 0.969 to 0.980; p <0.0001); these

data demonstrate an approximate 50% significant reduction in the annual increase in TKV versus placebo. Furthermore,

tolvaptan showed a statistically significant reduction in the risk of multiple events of worsening kidney function, kidney

pain, hypertension or albuminuria (hazard ratio=0.87, 95% CI: 0.78-0.97, p=0.0095). The result of the key secondary

composite endpoint is primarily attributed to effects on worsening kidney function (61.4% less likely with tolvaptan than

with placebo) and medically significant kidney pain (35.8% less likely in tolvaptan-treated patients).

Other than side effects associated with the mechanism of action of tolvaptan (eg thirst, polyuria, polliakuria), most side

effects observed in ADPKD patients administered tolvaptan were comparable with those administered placebo. However,

a risk of liver injury was identified in patients with ADPKD taking tolvaptan. Elevation of alanine transaminase (ALT) was

observed in 4.4% of patients on tolvaptan and 1.0% of patients on placebo.*3 Two (2/957, 0.2%) tolvaptan treated-

patients, as well as a third patient from an extension open label trial, exhibited clinically significant increases in ALT with

concomitant elevations in total bilirubin. While these concomitant elevations were reversible with prompt discontinuation

of tolvaptan, they represent a potential for significant liver injury and patients taking tolvaptan will have to undergo

monthly blood tests for the first 18 months of treatment with tolvaptan and three-monthly thereafter to mitigate this

risk. Tolvaptan treatment must be initiated and monitored under the supervision of physicians with expertise in managing

ADPKD and a full understanding of the risks of tolvaptan therapy including hepatic toxicity and monitoring requirements.

“The progressive and hereditary nature of ADPKD is a physical and emotional burden on those living with the condition,

as well as their families and loved ones,” said Tess Harris, President of PKD International. “This approval is welcomed by

the ADPKD community as it represents a step forward for the thousands of patients and carers throughout Europe who

are affected by the disease.”

“It is a great honour to deliver the first treatment for ADPKD in Europe,” said Tatsuo Higuchi, President and

Representative Director of Otsuka Pharmaceutical Co., Ltd.. “This approval is testament to the invaluable endeavours of

the researchers and patients involved in the discovery and development of tolvaptan.”

Tolvaptan was first approved for patients with ADPKD in Japan in March 2014 and was approved for ADPKD in Canada

in February 2015. Following this European marketing authorisation, Otsuka will continue to work with local authorities in

countries throughout Europe to help ensure that eligible ADPKD patients are able to access tolvaptan.

Original article website link:

http://www.otsuka.co.jp/en/company/release/detail.php?id=2985&date=2015-05-28

Otsuka’s JINARC® the First-Ever Treatment Approved in Europe for Adults Living with ADPKD,

a Chronic Genetic Kidney Disease

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BOSTON--(BUSINESS WIRE)--More than 1,900 global investigative sites rate the best biopharmaceutical companies with

which to work in a new survey conducted by CenterWatch, a leading provider of global clinical trials information. The

survey results were released in the March issue of The CenterWatch Monthly newsletter.

Investigative sites rated sponsor companies on more than three-dozen individual relationship attributes. The top

five highest-rated large sponsors—those with 2014 R&D spend greater than $10 billion—were Novo Nordisk, Takeda,

GlaxoSmithKline, AstraZeneca and Janssen. The top five mid-sized and small sponsors—with 2014 R&D spend less than

$10 billion—were Servier, Celgene, Biogen Idec, Otsuka and Forest Laboratories (acquired by Actavis last year).

Today’s industry-wide focus on patient centric clinical trials has driven sponsors to invest more time and resources in

their investigative site relationships with the ultimate goal to better engage and enhance study volunteer participation

experiences. To achieve this goal, sponsors have implemented a number of initiatives to reduce protocol complexity and

improve study feasibility, efficiency and convenience. These initiatives are beginning to pay off. The new survey marks

one of the few times in almost two decades that such strong improvement was observed in sponsors narrowing their

performance gaps across relationship attributes that sites rate as most important in defining relationship effectiveness.

These include quality of monitors, study support and easily accessible staff to resolve problems.

“Sponsors are taking the sites’ feedback to heart, as we have seen strong progress since our last global site survey in

2013,” said Joan Chambers, COO of CenterWatch. “Effective sponsor-site relationships are key to accurate, on-time and

on-budget clinical trial conduct, as well as to a successful patient engagement and experience.”

The CenterWatch Global Investigative Site Relationship Survey was first launched in 1997. This year’s survey was

conducted online between October 2014 and January 2015, and asked principal investigators, sub-investigators and

study coordinators to rate the sponsors with whom they worked during the past two years on 38 relationship attributes,

from study planning to innovation, and to rate the importance of those attributes as well. A total of 24 sponsors with

sufficient sample sizes were profiled in the analysis.

About CenterWatch Since 1994, CenterWatch, has been the recognized global leader in providing clinical trials

information to a broad and influential spectrum of clinical research professionals ranging from top sponsors and CROs

to research sites and niche providers, as well as an engaged population of patients interested in clinical research and

volunteering. For more information, visit www.centerwatch.com.

Original article website link:

http://www.businesswire.com/news/home/20150302005054/en/Novo-Nordisk-Takeda-Servier-Celgene-Top-Sponsors.

VPUBdHysW4g#.VW0Trmcw_IU

Otsuka Ranked Top 5 Among Mid-sized Sponsors Rated by Investigative Sites in New CenterWatch Survey

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On March 9, Otsuka Pharmaceuticals newly released

UL·OS adult refreshing sheets for the body and face

in Japan. UL·OS is a men skin care brand.

Adult refreshing sheets have a function of masking

unwanted body odor with natural scents and

neutralizes body odor for a pleasing effect.

By introducing new products to the men's sheets

market, Otsuka will strive to further grow our men's

skin care business.

These two products were originally launched in 2011

as "medicinal refresh sheets" used for cleanliness and

moisturizing effects. The products were renewed and

re-launched as two different types in March as part

of the UL·OS brand; one for the body and one for

the face.

The thickness, size, and ingredients of the products have been upgraded from the previous sheets which make it easier

to use and mask unwanted body odor more effectively. Also, moderate cool feeling was added to use all year round

and AMP (adenosine phosphate) to maintain the body temperature after wiping it off. The 2014 men's cosmetics market

is expected to increase 10% compared to 2009 in Japan (Fuji Economic Research). Men’s refreshing sheets market has

shown significant growth of 13% in five years (February 2010 - January 2015 survey). Last year, the trend was likely high

only in summer but now expected to grow with awareness of all year round care for sweat and smell.

Original article website link:

http://www.otsuka.co.jp/en/product/ulos/sheet/index.html

Check out recent TV and radio commercials for UL•OS in Japan:

http://www.otsuka.co.jp/adv/ulo/

UL·OS adult refreshing sheet has newly released in Japan

UL·OS Adult Facial Sheet UL·OS Adult Facial SheetAdult Body Sheet

(Quasi-drug: underarm odor inhibitor)

SOYJOY is made from 100% soybean flour and gives all the nutrition of soybeans. In

late March, SOYJOY has renewed its Strawberry and Blueberry flavors in Japan. The

amount of soybean is the same but it contains more fruit than before. SOYJOY is a low

GI food making it slow in carbohydrate absorption which helps protect against weight

gain. It also fits into a number of healthy diets including gluten-free, vegetarian, and

carbohydrate controlled eating plans. Currently it has launched in 11 countries and

regions. With 12 different flavors the current retail price is 115 Japanese yen(excluding

tax).

Original article website link:

http://www.otsuka.co.jp/en/company/release/2015/0310_01.html

New SOYJOY with more fruit! Renewed Strawberry and Blueberry Versions Contain More Fruit