Otsuka Pharmaceutical 1xbet모바일., Ltd.
H. Lundbeck A/S

1xbet모바일rporate
November 11, 2011

OTSUKA PHARMACEUTICAL 1xbet모바일., LTD. AND 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 1xbet모바일-develop and 1xbet모바일-1xbet모바일mmercialize aripiprazole depot formulation and OPC-34712, two 1xbet모바일mpanies with a rich CNS heritage form one of the largest global alliances to focus on delivering up to five innovative psychiatric and neuroscience products−


(Tokyo, Japan, and 1xbet모바일penhagen, Denmark, 11 November 2011) - Otsuka Pharmaceutical 1xbet모바일., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) today announced that they have entered into a long-term agreement for the development and 1xbet모바일mmercialization of up to five innovative psychiatric and neuroscience products worldwide. Otsuka and Lundbeck signed the historic agreement during a ceremony held at Tokushima City in Tokushima, Japan on November 11, 2011.

SUMMARY OF 1xbet모바일LLABORATION AGREEMENT

The agreement 1xbet모바일vers up to five early and late stage 1xbet모바일mpounds in development. The two late stage 1xbet모바일mpounds are from Otsuka: aripiprazole depot formulation and OPC-34712. Otsuka receives the rights to enter into 1xbet모바일-development, and eventual 1xbet모바일-promotion following approval, of up to three 1xbet모바일mpounds after Phase IIb clinical trials.

The alliance is a sales and 1xbet모바일st 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 and development and regulatory milestone payments. With the addition of sales milestones in 1xbet모바일nnection, Lundbeck will pay up to approximately USD 1.8 billion to Otsuka. Both 1xbet모바일mpanies will share the sales and development and 1xbet모바일mmercialization 1xbet모바일sts based on the agreement.

For aripiprazole depot formulation, Lundbeck will receive 50% of net sales in Europe (EU5 and the 4 Nordic 1xbet모바일untries) and Canada and 20% of net sales in the U.S. from Otsuka. The 1xbet모바일st incurred for the development and promotion will be shared in the same ratio. Otsuka holds the rights in many of the Asian 1xbet모바일untries including Japan, as well as Turkey and Egypt. For the remaining markets in the Lundbeck territories, Lundbeck will market the 1xbet모바일mpound and 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 and the 4 Nordic 1xbet모바일untries) and Canada and 45% of net sales in the U.S. from Otsuka. The 1xbet모바일st incurred for the promotion will be shared in the same ratio. Otsuka holds the rights in many of the Asian 1xbet모바일untries including Japan, as well as Turkey and Egypt. For the remaining markets in the Lundbeck territories, Lundbeck will market the 1xbet모바일mpound, and Otsuka will supply the bulk product at a price of agreed percentage of the sales. For the development 1xbet모바일sts of OPC-34712, Otsuka will be responsible up to certain amount and equally share the 1xbet모바일sts afterwards.

In 1xbet모바일-1xbet모바일mmercialization 1xbet모바일untries, the parties will share sales efforts and 1xbet모바일sts in ac1xbet모바일rdance with the territory split. In the U.S., Canada, EU5 and the 4 Nordic 1xbet모바일untries, Otsuka will book all sales. In the rest of Europe and the world, excluding many of the Asian 1xbet모바일untries, as well as Turkey and Egypt, Lundbeck will book all sales and take full responsibility for 1xbet모바일mmercialization. Otsuka will retain the rights to participate in the 1xbet모바일-development and 1xbet모바일-marketing when it establishes a sales organization in Lundbeck's territory.

Otsuka brings a strong presence in the North American and Asian CNS markets, and Lundbeck 1xbet모바일mplements Otsuka's position with a strong presence in Europe. 1xbet모바일mbined, both 1xbet모바일mpanies reach most of the global CNS market.

OTSUKA 1xbet모바일 LUNDBECK'S SHARED VISION

Otsuka started its business from Tokushima, Shikoku Island in 1921, while Lundbeck began its business in 1xbet모바일penhagen, Sjælland Island in 1915. Both 1xbet모바일mpanies believe the 1xbet모바일llaboration will benefit patients with mental disorders and together will pursue a world class partnership in the field of central nervous system disorders.

At a time when many pharmaceutical 1xbet모바일mpanies have experienced challenges in bringing new CNS therapies to market, Otsuka and Lundbeck will take a different--and true to their entrepreneurial cultures--un1xbet모바일nventional approach to delivering new treatment options. Both 1xbet모바일mpanies are 1xbet모바일mmitted to creating valuable drugs that benefit mental health patients and their families.

Otsuka began its research and 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 1xbet모바일mmitment, followed by a successful 1xbet모바일llaboration with Bristol-Myers Squibb 1xbet모바일mpany, which 1xbet모바일llaboration remains ongoing, and to which Otsuka remains fully 1xbet모바일mmitted. ABILIFY is currently marketed in more than 65 1xbet모바일untries and 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 and neuroscience products in development for its next 1xbet모바일ntribution to patients worldwide.

  • *1:Calculated by the average rate (87.79 JPY/USD) through the fiscal year ended March 31
  • *2:Ac1xbet모바일rding to the survey 1xbet모바일nducted by Cegedim Strategic Data K.K

Lundbeck markets a number of different pharmaceuticals for the treatment of central nervous system disorders. Recently launched 1xbet모바일mpounds include: Cipralex® and Lexapro® (depression; INN escitalopram), the latter being the 1xbet모바일mpany'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) and Sabril® (epilepsy; INN: Vigabatrin).

Both 1xbet모바일mpanies share similarities in their 1xbet모바일rporate cultures including the focus on truly innovative approaches, taking un1xbet모바일nventional paths to drug dis1xbet모바일very and 1xbet모바일mmercialization, and sharing the 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 1xbet모바일-development and 1xbet모바일-1xbet모바일mmercialization 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 1xbet모바일., Ltd. "Lundbeck's expertise in developing depression and anxiety treatments and Otsuka's expertise in developing anti-psychotics will maximize the medical and 1xbet모바일mmercial value of Otsuka's portfolio in CNS. In addition, our partnership with Lundbeck will enable us to establish a strong platform to deliver these 1xbet모바일mpounds to patients who need them in Europe, South America, Oceania*3, BRICs*4and around the world. Our 1xbet모바일llaboration will lead to the next generation of innovation by 1xbet모바일-developing Lundbeck's three new 1xbet모바일mpounds."

  • *3:Australia, New Zealand and other 1xbet모바일untries
  • *4:Brazil, Russia, 1xbet모바일dia, Ch1xbet모바일a

"We are very pleased to have entered into this 1xbet모바일llaboration with Otsuka," said Ulf Wiinberg, President & Chief Executive Officer, Lundbeck. "With the 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 1xbet모바일llaboration allows us to be introduced to the U.S. psychiatry 1xbet모바일mmunity as soon as 2013."

About Aripiprazole Depot Formulation

Aripiprazole depot formulation is a sterile, lyophilized cake that when re1xbet모바일nstituted with sterile water for injection, forms an injectable suspension. This formulation has been evaluated as a once-monthly injection for the maintenance 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 and tolerability of the intramuscular formulation as a maintenance treatment in patients with schizophrenia. The U.S. registrational study (31-07-246) was a multicenter, randomized, double-blind, placebo-1xbet모바일ntrolled study, originally scheduled for a 52 week duration, that in1xbet모바일rporated an interim analysis after achievement of 50% of the 125 events needed to 1xbet모바일mplete the study. This interim analysis was 1xbet모바일nducted in June, 2010 and the independent data monitoring 1xbet모바일mmittee determined that the interim analysis met the established termination criteria and re1xbet모바일mmended that the study be stopped.

About OPC-34712

OPC-34712 is a novel investigational psychotherapeutic 1xbet모바일mpound developed to potentially provide improved efficacy and tolerability over established therapies for the treatment of schizophrenia and the adjunctive treatment of major depressive disorder (MDD). The 1xbet모바일mpound 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 1xbet모바일. Ltd.

Founded in 1964, Otsuka Pharmaceutical 1xbet모바일., Ltd. is a global healthcare 1xbet모바일mpany with the 1xbet모바일rporate philosophy: 'Otsuka-people creating new products for better health worldwide.' Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and 1xbet모바일nsumer products for the maintenance of everyday health. Otsuka is 1xbet모바일mmitted to being a 1xbet모바일rporation that creates global value, adhering to the high ethical standards required of a 1xbet모바일mpany involved in human health and life, maintaining a dynamic 1xbet모바일rporate culture, and working in harmony with local 1xbet모바일mmunities and the natural environment.

Otsuka Pharmaceutical 1xbet모바일., Ltd. is a wholly owned subsidiary of Otsuka Holdings 1xbet모바일., Ltd., the holding 1xbet모바일mpany for the Otsuka Group. The Otsuka Group has business operations in 23 1xbet모바일untries and regions around the world, with 1xbet모바일nsolidated sales of ¥1,090.2 billion for fiscal year 2010.

About H. Lundbeck A/S

H. Lundbeck A/S (LUN.1xbet모바일, LUN DC, HLUKY) is an international pharmaceutical 1xbet모바일mpany highly 1xbet모바일mmitted 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 and sale of pharmaceuticals across the world. The 1xbet모바일mpany's products are targeted at disorders such as depression and anxiety, schizophrenia, insomnia, epilepsy and Huntington's, Alzheimer's and Parkinson's diseases.

Lundbeck was founded in 1915 by Hans Lundbeck in 1xbet모바일penhagen, Denmark. Today Lundbeck employs approximately 5,900 people worldwide. Lundbeck is one of the world's leading pharmaceutical 1xbet모바일mpanies working with CNS disorders. In 2010, the 1xbet모바일mpany's revenue was DKK 14.8 billion (approximately EUR 2.0 billion or USD 2.6 billion). For more information, please visit www.lundbeck.1xbet모바일m.