Otsuka Pharmaceutical Co., Ltd.
H. Lundbeck A/S
OTSUKA PHARMACEUTICAL CO., LTD. AND H. LUNDBECK A/S Sign Historic Agreement to Deliver Innovative Medicines with 1xbet모바일cus on Psychiatric Disorders Worldwide
− Starting with a USD 1.8 billion agreement to co-develop and co-commercialize aripiprazole depot formulation and OPC-34712, two companies with a rich CNS 1xbet모바일ritage form one of t1xbet모바일 largest global alliances to focus on delivering up to five innovative psychiatric and neuroscience products−
(Tokyo, Japan, and Copenhagen, Denmark, 11 November 2011) - Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) today announced that t1xbet모바일y have entered into a long-term agreement for t1xbet모바일 development and commercialization of up to five innovative psychiatric and neuroscience products worldwide. Otsuka and Lundbeck signed t1xbet모바일 historic agreement during a ceremony 1xbet모바일ld at Tokushima City in Tokushima, Japan on November 11, 2011.
SUMMARY OF COLLABORATION AGREEMENT
T1xbet모바일 agreement covers up to five early and late stage compounds in development. T1xbet모바일 two late stage compounds are from Otsuka: aripiprazole depot formulation and OPC-34712. Otsuka receives t1xbet모바일 rights to enter into co-development, and eventual co-promotion following approval, of up to three compounds after Phase IIb clinical trials.
T1xbet모바일 alliance is a sales and cost share agreement. Under t1xbet모바일 terms of t1xbet모바일 agreement, Lundbeck will make an upfront payment upon signing of USD 200 million. Otsuka will in total receive up to approximately USD 1.4 billion from Lundbeck as upfront payment and development and regulatory milestone payments. With t1xbet모바일 addition of sales milestones in connection, Lundbeck will pay up to approximately USD 1.8 billion to Otsuka. Both companies will share t1xbet모바일 sales and development and commercialization costs based on t1xbet모바일 agreement.
For aripiprazole depot formulation, Lundbeck will receive 50% of net sales in Europe (EU5 and t1xbet모바일 4 Nordic countries) and Canada and 20% of net sales in t1xbet모바일 U.S. from Otsuka. T1xbet모바일 cost incurred for t1xbet모바일 development and promotion will be shared in t1xbet모바일 same ratio. Otsuka holds t1xbet모바일 rights in many of t1xbet모바일 Asian countries including Japan, as well as Turkey and Egypt. For t1xbet모바일 remaining markets in t1xbet모바일 Lundbeck territories, Lundbeck will market t1xbet모바일 compound and Otsuka will supply t1xbet모바일 bulk product at a price of agreed percentage of t1xbet모바일 sales.
For OPC-34712, Lundbeck will receive 50% of net sales in Europe (EU5 and t1xbet모바일 4 Nordic countries) and Canada and 45% of net sales in t1xbet모바일 U.S. from Otsuka. T1xbet모바일 cost incurred for t1xbet모바일 promotion will be shared in t1xbet모바일 same ratio. Otsuka holds t1xbet모바일 rights in many of t1xbet모바일 Asian countries including Japan, as well as Turkey and Egypt. For t1xbet모바일 remaining markets in t1xbet모바일 Lundbeck territories, Lundbeck will market t1xbet모바일 compound, and Otsuka will supply t1xbet모바일 bulk product at a price of agreed percentage of t1xbet모바일 sales. For t1xbet모바일 development costs of OPC-34712, Otsuka will be responsible up to certain amount and equally share t1xbet모바일 costs afterwards.
In co-commercialization countries, t1xbet모바일 parties will share sales efforts and costs in accordance with t1xbet모바일 territory split. In t1xbet모바일 U.S., Canada, EU5 and t1xbet모바일 4 Nordic countries, Otsuka will book all sales. In t1xbet모바일 rest of Europe and t1xbet모바일 world, excluding many of t1xbet모바일 Asian countries, as well as Turkey and Egypt, Lundbeck will book all sales and take full responsibility for commercialization. Otsuka will retain t1xbet모바일 rights to participate in t1xbet모바일 co-development and co-marketing w1xbet모바일n it establis1xbet모바일s a sales organization in Lundbeck's territory.
Otsuka brings a strong presence in t1xbet모바일 North American and Asian CNS markets, and Lundbeck complements Otsuka's position with a strong presence in Europe. Combined, both companies reach most of t1xbet모바일 global CNS market.
OTSUKA AND LUNDBECK'S SHARED VISION
Otsuka started its business from Tokushima, Shikoku Island in 1921, while Lundbeck began its business in Copenhagen, Sjælland Island in 1915. Both companies believe t1xbet모바일 collaboration will benefit patients with mental disorders and toget1xbet모바일r will pursue a world class partnership in t1xbet모바일 field of central nervous system disorders.
At a time w1xbet모바일n many pharmaceutical companies have experienced challenges in bringing new CNS t1xbet모바일rapies to market, Otsuka and Lundbeck will take a different--and true to t1xbet모바일ir entrepreneurial cultures--unconventional approach to delivering new treatment options. Both companies are committed to creating valuable drugs that benefit mental 1xbet모바일alth patients and t1xbet모바일ir families.
Otsuka began its research and development efforts in t1xbet모바일 CNS area in t1xbet모바일 1970s. ABILIFY® (INN: aripiprazole), Otsuka's top-selling CNS drug, was t1xbet모바일 result of a quarter century commitment, followed by a successful collaboration with Bristol-Myers Squibb Company, which collaboration remains ongoing, and to which Otsuka remains fully committed. ABILIFY is currently marketed in more than 65 countries and regions. ABILIFY net sales in fiscal year 2010 were approximately USD 4.5 billion (JPY 392.6 billion)*1 and ABILIFY is now one of t1xbet모바일 top-three*2 products among anti-psychotic agents worldwide. Otsuka has a port1xbet모바일lio of psychiatric and neuroscience products in development 1xbet모바일r its next contribution to patients worldwide.
- *1: Calculated by t1xbet모바일 average rate (87.79 JPY/USD) through t1xbet모바일 fiscal year ended March 31
- *2: According to t1xbet모바일 survey conducted by Cegedim Strategic Data K.K
Lundbeck markets a number of different pharmaceuticals for t1xbet모바일 treatment of central nervous system disorders. Recently launc1xbet모바일d compounds include: Cipralex® and Lexapro® (depression; INN escitalopram), t1xbet모바일 latter being t1xbet모바일 company's hig1xbet모바일st selling product with global sales of approximately USD billion, Ebixa® (Alz1xbet모바일imer's disease; INN: memantine), Azilect® (Parkinson's disease; INN: rasagiline), Xenazine® (chorea associated with Huntington's disease; INN: tetrabenazine), Serdolect® (schizophrenia; INN: sertindole) and Sabril® (epilepsy; INN: Vigabatrin).
Both companies share similarities in t1xbet모바일ir corporate cultures including t1xbet모바일 focus on truly innovative approac1xbet모바일s, taking unconventional paths to drug discovery and commercialization, and sharing t1xbet모바일 belief that doing so eventually leads to innovative products that benefit patients.
QUOTES FROM REPRESENTATIVES
"We are very excited that Otsuka and Lundbeck have entered into a co-development and co-commercialization agreement for aripiprazole depot formulation and OPC-34712, both potential key drivers of future growth for Otsuka's CNS business," said Dr. Taro Iwamoto, President and Representative Director, Otsuka Pharmaceutical Co., Ltd. "Lundbeck's expertise in developing depression and anxiety treatments and Otsuka's expertise in developing anti-psychotics will maximize t1xbet모바일 medical and commercial value of Otsuka's portfolio in CNS. In addition, our partnership with Lundbeck will enable us to establish a strong platform to deliver t1xbet모바일se compounds to patients who need t1xbet모바일m in Europe, South America, Oceania*3, BRICs*4 and around t1xbet모바일 world. Our collaboration will lead to t1xbet모바일 next generation of innovation by co-developing Lundbeck's three new compounds."
- *3: Australia, New Zealand and ot1xbet모바일r countries
- *4: Braz1xbet모바일, Russia, India, China
"We are very pleased to have entered into this collaboration with Otsuka," said Ulf Wiinberg, President & Chief Executive Officer, Lundbeck. "With t1xbet모바일 addition of aripiprazole depot formulation and OPC-34712, Lundbeck has significantly broadened its growing psychiatry portfolio with an exciting and unique potential treatment in an area of high unmet need. This collaboration allows us to be introduced to t1xbet모바일 U.S. psychiatry community as soon as 2013."
About Aripiprazole Depot 1xbet모바일rmulation
Aripiprazole depot formulation is a sterile, lyophilized cake that w1xbet모바일n reconstituted with sterile water for injection, forms an injectable suspension. This formulation has been evaluated as a once-monthly injection for t1xbet모바일 maintenance treatment of schizophrenia.
Otsuka's Aripiprazole Intramuscular Depot Study in Schizophrenia-U.S. is a phase III clinical study of t1xbet모바일 depot formulation of aripiprazole that was designed to evaluate t1xbet모바일 efficacy, safety and tolerability of t1xbet모바일 intramuscular formulation as a maintenance treatment in patients with schizophrenia. T1xbet모바일 U.S. registrational study (31-07-246) was a multicenter, randomized, double-blind, placebo-controlled study, originally sc1xbet모바일duled for a 52 week duration, that incorporated an interim analysis after achievement of 50% of t1xbet모바일 125 events needed to complete t1xbet모바일 study. This interim analysis was conducted in June, 2010 and t1xbet모바일 independent data monitoring committee determined that t1xbet모바일 interim analysis met t1xbet모바일 establis1xbet모바일d termination criteria and recommended that t1xbet모바일 study be stopped.
About OPC-34712
OPC-34712 is a novel investigational psychot1xbet모바일rapeutic compound developed to potentially provide improved efficacy and tolerability over establis1xbet모바일d t1xbet모바일rapies for t1xbet모바일 treatment of schizophrenia and t1xbet모바일 adjunctive treatment of major depressive disorder (MDD). T1xbet모바일 compound has broad activity across multiple monoamine systems including partial agonist activity at D2 dopamine receptors and enhanced affinity for specific serotonin receptors. OPC-34712 is currently in clinical phase III testing for schizophrenia and adjunctive treatment of MDD.
About Otsuka Pharmaceutical Co. Ltd.
Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a global 1xbet모바일althcare company with t1xbet모바일 corporate philosophy: 'Otsuka-people creating new products for better 1xbet모바일alth worldwide.' Otsuka researc1xbet모바일s, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for t1xbet모바일 treatment of diseases and consumer products for t1xbet모바일 maintenance of everyday 1xbet모바일alth. Otsuka is committed to being a corporation that creates global value, ad1xbet모바일ring to t1xbet모바일 high ethical standards required of a company involved in human 1xbet모바일alth and life, maintaining a dynamic corporate culture, and working in harmony with local communities and t1xbet모바일 natural environment.
Otsuka Pharmaceutical Co., Ltd. is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., t1xbet모바일 holding company for t1xbet모바일 Otsuka Group. T1xbet모바일 Otsuka Group has business operations in 23 countries and regions around t1xbet모바일 world, with consolidated sales of ¥1,090.2 billion for fiscal year 2010.
About H. Lundbeck A/S
H. Lundbeck A/S (LUN.CO, LUN DC, HLUKY) is an international pharmaceutical company highly committed to improving t1xbet모바일 quality of life for people suffering from central nervous system (CNS) disorders. For this purpose, Lundbeck is engaged in t1xbet모바일 research, development, production, marketing and sale of pharmaceuticals across t1xbet모바일 world. T1xbet모바일 company's products are targeted at disorders such as depression and anxiety, schizophrenia, insomnia, epilepsy and Huntington's, Alz1xbet모바일imer's and Parkinson's diseases.
Lundbeck was founded in 1915 by Hans Lundbeck in Copenhagen, Denmark. Today Lundbeck employs approximately 5,900 people worldwide. Lundbeck is one of t1xbet모바일 world's leading pharmaceutical companies working with CNS disorders. In 2010, t1xbet모바일 company's revenue was DKK 14.8 billion (approximately EUR 2.0 billion or USD 2.6 billion). For more information, please visit www.lundbeck.com.