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March 7, 2013

Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals

Otsuka Advancing Rapidly in Central Nervous System Disorders; Expanding Its Existing Collaboration with Lundbeck

  • ABILIFY® became the #1 selling pharmaceutical product in the U.S. in the fourth quarter of 2012
  • ABILIFY MAINTENA™, a once-monthly injectable form of ABILIFY, will be co-promoted by Otsuka and Lundbeck in the U.S. and will start becoming available there from March 18th. The drug was approved for use in schizophrenia by the U.S. FDA (Food and Drug Administration) on February 28th. ABILIFY MAINTENA will provide a new treatment option for patients with schizophrenia and their physicians.
  • Otsuka and Lundbeck are expanding their existing collaboration to include promotion of ABILIFY® swallowable tablets, oral solution, orally-disintegrating tablets and the intramuscular rapid injectable in 14 European countries.

(Tokyo, Japan and Copenhagen, Denmark, March 7, 2013) - Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) today outlined co-promotion plans and summarized the overall progress in their global alliance at a session in Japan with representatives from domestic and international media organizations.

The companies announced that ABILIFY MAINTENA™ (aripiprazole), an extended-release (once-monthly) injectable suspension for the treatment of schizophrenia will start becoming available in the U.S. market on March 18. ABILFY MAINTENA was approved by the U.S. Food and Drug Administration (FDA) on February 28 for the treatment of schizophrenia.

ABILIFY MAINTENA and ABILIFY® contain the molecule aripiprazole, which is a partial agonist at the D2 dopamine receptor and which offers a unique mechanism of action for the treatment of schizophrenia. ABILIFY MAINTENA has been shown in clinical studies to reduce relapses in schizophrenia in comparison to placebo and will offer the efficacy and safety profile of the oral formulations of ABILIFY in a once-monthly formulation.

Taro Iwamoto, President and Representative Director of Otsuka Pharmaceutical Co., Ltd. emphasized that "the MAINTENA launch will further strengthen the ABILIFY brand's already-prominent position in the U.S. market and bodes well for the two companies' ongoing collaborations."

Commenting on the first regulatory approval for the alliance, Ulf Wiinberg, Chief Executive Officer, Lundbeck said, "ABILIFY MAINTENA represents a treatment option for patients and their physicians and caregivers seeking an alternative long-term maintenance treatment for schizophrenia, and we are pleased to join Otsuka in launching this first product as part of our extensive global alliance. The launch of ABILIFY MAINTENA also represents Lundbeck's first entry into the U.S. psychiatry market, expanding our central nervous system focus strategically in the U.S."

The companies also announced an agreement to expand their existing collaboration to include promotion of oral ABILIFY in 14 European countries starting April 1, 2013. Under the agreement, Otsuka and Lundbeck will jointly promote ABILIFY in Denmark, Finland, Germany, Italy, Spain, Sweden and the United Kingdom. Lundbeck will promote ABILIFY in Austria, Belgium, Ireland, Netherlands, Poland, Portugal and Romania.

The agreement provides Lundbeck with the rights to promote all formulations of ABILIFY that are currently being marketed, sold and distributed by Otsuka in the European Union including the swallowable tablet, oral solution, orally-disintegrating tablet and the IM rapid injectable. Lundbeck will promote ABILIFY Tablets in first position to target physicians.

Summary of Overall Progress in the Global Alliance Between Otsuka and Lundbeck

While some other companies have exited the central nervous system therapy area, Otsuka and Lundbeck are investing to develop potential future drugs to help patients, such as brexpiprazole, which is currently in phase III clinical trials for multiple psychiatric disorders, and three other compounds yet to be determined. An agreement to work in this under-served therapy area was signed between the two companies in November 2011.

  • A successful first 17 months for the alliance includes the following developments:
  • FDA approval of ABILIFY MAINTENA on February 28, 2013.
  • Marketing Authorization Application (MAA) for ABILIFY MAINTENA submitted in Europe in December 2012.
  • Expansion of the alliance by the signing of an agreement for promotion of ABILIFY products in Europe.
  • Phase-III studies initiated with brexpiprazole.
  • Two phase-III studies with ABILIFY MAINTENA initiated.
  • Results from phase-III trials with ABILIFY MAINTENA presented in May 2012 at the American Psychiatric Association (APA) 2012 Annual Meeting.

Information in this news release was current as of the original release date.

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