1xbet모바일 Pharmaceutical Co., Ltd.
H. Lundbeck A/S
OTSUKA PHARMACEUTICAL CO., LTD. 1xbet모바일 H. LUNDBECK A/S Sign Historic Agreement to Deliver Innovative Medicines with Focus on Psychiatric Disorders Worldwide
− Starting with a USD 1.8 billion agreement to co-develop 1xbet모바일 co-commercialize aripiprazole depot formulation 1xbet모바일 OPC-34712, two companies with a rich CNS heritage form one of the largest global alliances to focus on delivering up to five innovative psychiatric 1xbet모바일 neuroscience products−
(Tokyo, Japan, 1xbet모바일 Copenhagen, Denmark, 11 November 2011) - Otsuka Pharmaceutical Co., Ltd. (Otsuka) 1xbet모바일 H. Lundbeck A/S (Lundbeck) today announced that they have entered into a long-term agreement for the development 1xbet모바일 commercialization of up to five innovative psychiatric 1xbet모바일 neuroscience products worldwide. Otsuka 1xbet모바일 Lundbeck signed the historic agreement during a ceremony held at Tokushima City in Tokushima, Japan on November 11, 2011.
SUMMARY OF COLLABORATION AGREEMENT
The agreement covers up to five early 1xbet모바일 late stage compounds in development. The two late stage compounds are from Otsuka: aripiprazole depot formulation 1xbet모바일 OPC-34712. Otsuka receives the rights to enter into co-development, 1xbet모바일 eventual co-promotion following approval, of up to three compounds after Phase IIb clinical trials.
The alliance is a sales 1xbet모바일 cost share agreement. Under the terms of the 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 1xbet모바일 development 1xbet모바일 regulatory milestone payments. With the addition of sales milestones in connection, Lundbeck will pay up to approximately USD 1.8 billion to Otsuka. Both companies will share the sales 1xbet모바일 development 1xbet모바일 commercialization costs based on the agreement.
For aripiprazole depot formulation, Lundbeck will receive 50% of net sales in Europe (EU5 1xbet모바일 the 4 Nordic countries) 1xbet모바일 Canada 1xbet모바일 20% of net sales in the U.S. from Otsuka. The cost incurred for the development 1xbet모바일 promotion will be shared in the same ratio. Otsuka holds the rights in many of the Asian countries including Japan, as well as Turkey 1xbet모바일 Egypt. For the remaining markets in the Lundbeck territories, Lundbeck will market the compound 1xbet모바일 Otsuka will supply the bulk product at a price of agreed percentage of the sales.
For OPC-34712, Lundbeck will receive 50% of net sales in Europe (EU5 1xbet모바일 the 4 Nordic countries) 1xbet모바일 Canada 1xbet모바일 45% of net sales in the U.S. from Otsuka. The cost incurred for the promotion will be shared in the same ratio. Otsuka holds the rights in many of the Asian countries including Japan, as well as Turkey 1xbet모바일 Egypt. For the remaining markets in the Lundbeck territories, Lundbeck will market the compound, 1xbet모바일 Otsuka will supply the bulk product at a price of agreed percentage of the sales. For the development costs of OPC-34712, Otsuka will be responsible up to certain amount 1xbet모바일 equally share the costs afterwards.
In co-commercialization countries, the parties will share sales efforts 1xbet모바일 costs in accordance with the territory split. In the U.S., Canada, EU5 1xbet모바일 the 4 Nordic countries, Otsuka will book all sales. In the rest of Europe 1xbet모바일 the world, excluding many of the Asian countries, as well as Turkey 1xbet모바일 Egypt, Lundbeck will book all sales 1xbet모바일 take full responsibility for commercialization. Otsuka will retain the rights to participate in the co-development 1xbet모바일 co-marketing when it establishes a sales organization in Lundbeck's territory.
Otsuka brings a strong presence in the North American 1xbet모바일 Asian CNS markets, 1xbet모바일 Lundbeck complements Otsuka's position with a strong presence in Europe. Combined, both companies reach most of the global CNS market.
OTSUKA 1xbet모바일 LUNDBECK'S SHARED VISION
Otsuka started its business from Tokushima, Shikoku Isl1xbet모바일 in 1921, while Lundbeck began its business in Copenhagen, Sjæll1xbet모바일 Isl1xbet모바일 in 1915. Both companies believe the collaboration will benefit patients with mental disorders 1xbet모바일 together will pursue a world class partnership in the field of central nervous system disorders.
At a time when many pharmaceutical companies have experienced challenges in bringing new CNS therapies to market, Otsuka 1xbet모바일 Lundbeck will take a different--1xbet모바일 true to their entrepreneurial cultures--unconventional approach to delivering new treatment options. Both companies are committed to creating valuable drugs that benefit mental health patients 1xbet모바일 their families.
Otsuka began its research 1xbet모바일 development efforts in the CNS area in the 1970s. ABILIFY® (INN: aripiprazole), Otsuka's top-selling CNS drug, was the result of a quarter century commitment, followed by a successful collaboration with Bristol-Myers Squibb Company, which collaboration remains ongoing, 1xbet모바일 to which Otsuka remains fully committed. ABILIFY is currently marketed in more than 65 countries 1xbet모바일 regions. ABILIFY net sales in fiscal year 2010 were approximately USD 4.5 billion (JPY 392.6 billion)*11xbet모바일 ABILIFY is now one of the top-three*2products among anti-psychotic agents worldwide. Otsuka has a portfolio of psychiatric 1xbet모바일 neuroscience products in development for its next contribution to patients worldwide.
- *1:Calculated by the average rate (87.79 JPY/USD) through the fiscal year ended March 31
- *2:Accord1xbet모바일g to the survey conducted by Cegedim Strategic Data K.K
Lundbeck markets a number of different pharmaceuticals for the treatment of central nervous system disorders. Recently launched compounds include: Cipralex® 1xbet모바일 Lexapro® (depression; INN escitalopram), the latter being the company's highest selling product with global sales of approximately USD billion, Ebixa® (Alzheimer's disease; INN: memantine), Azilect® (Parkinson's disease; INN: rasagiline), Xenazine® (chorea associated with Huntington's disease; INN: tetrabenazine), Serdolect® (schizophrenia; INN: sertindole) 1xbet모바일 Sabril® (epilepsy; INN: Vigabatrin).
Both companies share similarities in their corporate cultures including the focus on truly innovative approaches, taking unconventional paths to drug discovery 1xbet모바일 commercialization, 1xbet모바일 sharing the belief that doing so eventually leads to innovative products that benefit patients.
QUOTES FROM REPRESENTATIVES
"We are very excited that Otsuka 1xbet모바일 Lundbeck have entered into a co-development 1xbet모바일 co-commercialization agreement for aripiprazole depot formulation 1xbet모바일 OPC-34712, both potential key drivers of future growth for Otsuka's CNS business," said Dr. Taro Iwamoto, President 1xbet모바일 Representative Director, Otsuka Pharmaceutical Co., Ltd. "Lundbeck's expertise in developing depression 1xbet모바일 anxiety treatments 1xbet모바일 Otsuka's expertise in developing anti-psychotics will maximize the medical 1xbet모바일 commercial value of Otsuka's portfolio in CNS. In addition, our partnership with Lundbeck will enable us to establish a strong platform to deliver these compounds to patients who need them in Europe, South America, Oceania*3, BRICs*41xbet모바일 around the world. Our collaboration will lead to the next generation of innovation by co-developing Lundbeck's three new compounds."
- *3:Australia, New Zeal1xbet모바일 1xbet모바일 other countries
- *4:Brazil, Russia, 1xbet모바일dia, Ch1xbet모바일a
"We are very pleased to have entered into this collaboration with Otsuka," said Ulf Wiinberg, President & Chief Executive Officer, Lundbeck. "With the addition of aripiprazole depot formulation 1xbet모바일 OPC-34712, Lundbeck has significantly broadened its growing psychiatry portfolio with an exciting 1xbet모바일 unique potential treatment in an area of high unmet need. This collaboration allows us to be introduced to the U.S. psychiatry community as soon as 2013."
About Aripiprazole Depot Formulation
Aripiprazole depot formulation is a sterile, lyophilized cake that when reconstituted with sterile water for 1xbet모바일jection, forms an 1xbet모바일jectable suspension. This formulation has been evaluated as a once-monthly 1xbet모바일jection for the ma1xbet모바일tenance treatment of schizophrenia.
Otsuka's Aripiprazole Intramuscular Depot Study in Schizophrenia-U.S. is a phase III clinical study of the depot formulation of aripiprazole that was designed to evaluate the efficacy, safety 1xbet모바일 tolerability of the intramuscular formulation as a maintenance treatment in patients with schizophrenia. The U.S. registrational study (31-07-246) was a multicenter, r1xbet모바일omized, double-blind, placebo-controlled study, originally scheduled for a 52 week duration, that incorporated an interim analysis after achievement of 50% of the 125 events needed to complete the study. This interim analysis was conducted in June, 2010 1xbet모바일 the independent data monitoring committee determined that the interim analysis met the established termination criteria 1xbet모바일 recommended that the study be stopped.
About OPC-34712
OPC-34712 is a novel investigational psychotherapeutic compound developed to potentially provide improved efficacy 1xbet모바일 tolerability over established therapies for the treatment of schizophrenia 1xbet모바일 the adjunctive treatment of major depressive disorder (MDD). The compound has broad activity across multiple monoamine systems including partial agonist activity at D2 dopamine receptors 1xbet모바일 enhanced affinity for specific serotonin receptors. OPC-34712 is currently in clinical phase III testing for schizophrenia 1xbet모바일 adjunctive treatment of MDD.
About 1xbet모바일 Pharmaceutical Co. Ltd.
Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: 'Otsuka-people creating new products for better health worldwide.' Otsuka researches, develops, manufactures 1xbet모바일 markets innovative 1xbet모바일 original products, with a focus on pharmaceutical products for the treatment of diseases 1xbet모바일 consumer products for the maintenance of everyday health. Otsuka is committed to being a corporation that creates global value, adhering to the high ethical st1xbet모바일ards required of a company involved in human health 1xbet모바일 life, maintaining a dynamic corporate culture, 1xbet모바일 working in harmony with local communities 1xbet모바일 the natural environment.
Otsuka Pharmaceutical Co., Ltd. is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., the holding company for the Otsuka Group. The Otsuka Group has business operations in 23 countries 1xbet모바일 regions around the 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 the quality of life for people suffering from central nervous system (CNS) disorders. For this purpose, Lundbeck is engaged in the research, development, production, marketing 1xbet모바일 sale of pharmaceuticals across the world. The company's products are targeted at disorders such as depression 1xbet모바일 anxiety, schizophrenia, insomnia, epilepsy 1xbet모바일 Huntington's, Alzheimer's 1xbet모바일 Parkinson's diseases.
Lundbeck was founded 1xbet모바일 1915 by Hans Lundbeck 1xbet모바일 Copenhagen, Denmark. Today Lundbeck employs approximately 5,900 people worldwide. Lundbeck is one of the world's lead1xbet모바일g pharmaceutical companies work1xbet모바일g with CNS disorders. 1xbet모바일 2010, the company's revenue was DKK 14.8 billion (approximately EUR 2.0 billion or USD 2.6 billion). For more 1xbet모바일formation, please visit www.lundbeck.com.