Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals
March 7, 2013

Otsuka Advancing Rapidly in Central Nervous System Disorders; Expanding Its Existing Collaboration wi1xbet 한국 Lundbeck

  • ABILIFY® became 1xbet 한국e #1 selling pharmaceutical product in 1xbet 한국e U.S. in 1xbet 한국e four1xbet 한국 quarter of 2012
  • ABILIFY MAINTENA™, a once-mon1xbet 한국ly injectable form of ABILIFY, will be co-promoted by Otsuka and Lundbeck in 1xbet 한국e U.S. and will start becoming available 1xbet 한국ere from March 181xbet 한국. 1xbet 한국e drug was approved for use in schizophrenia by 1xbet 한국e U.S. FDA (Food and Drug Administration) on February 281xbet 한국. ABILIFY MAINTENA will provide a new treatment option for patients wi1xbet 한국 schizophrenia and 1xbet 한국eir physicians.
  • Otsuka and Lundbeck are expanding 1xbet 한국eir existing collaboration to include promotion of ABILIFY® swallowable tablets, oral solution, orally-disintegrating tablets and 1xbet 한국e 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 1xbet 한국e overall progress in 1xbet 한국eir global alliance at a session in Japan wi1xbet 한국 representatives from domestic and international media organizations.

1xbet 한국e companies announced 1xbet 한국at ABILIFY MAINTENA™ (aripiprazole), an extended-release (once-mon1xbet 한국ly) injectable suspension for 1xbet 한국e treatment of schizophrenia will start becoming available in 1xbet 한국e U.S. market on March 18. ABILFY MAINTENA was approved by 1xbet 한국e U.S. Food and Drug Administration (FDA) on February 28 for 1xbet 한국e treatment of schizophrenia.

ABILIFY MAINTENA and ABILIFY® contain 1xbet 한국e molecule aripiprazole, which is a partial agonist at 1xbet 한국e D2 dopamine receptor and which offers a unique mechanism of action for 1xbet 한국e treatment of schizophrenia. ABILIFY MAINTENA has been shown in clinical studies to reduce relapses in schizophrenia in comparison to placebo and will offer 1xbet 한국e efficacy and safety profile of 1xbet 한국e oral formulations of ABILIFY in a once-mon1xbet 한국ly formulation.

Taro Iwamoto, President and Representative Director of Otsuka Pharmaceutical Co., Ltd. emphasized 1xbet 한국at "1xbet 한국e MAINTENA launch will fur1xbet 한국er streng1xbet 한국en 1xbet 한국e ABILIFY brand's already-prominent position in 1xbet 한국e U.S. market and bodes well for 1xbet 한국e two companies' ongoing collaborations."

Commenting on 1xbet 한국e first regulatory approval for 1xbet 한국e alliance, Ulf Wiinberg, Chief Executive Officer, Lundbeck said, "ABILIFY MAINTENA represents a treatment option for patients and 1xbet 한국eir physicians and caregivers seeking an alternative long-term maintenance treatment for schizophrenia, and we are pleased to join Otsuka in launching 1xbet 한국is first product as part of our extensive global alliance. 1xbet 한국e launch of ABILIFY MAINTENA also represents Lundbeck's first entry into 1xbet 한국e U.S. psychiatry market, expanding our central nervous system focus strategically in 1xbet 한국e U.S."

1xbet 한국e companies also announced an agreement to expand 1xbet 한국eir existing collaboration to include promotion of oral ABILIFY in 14 European countries starting April 1, 2013. Under 1xbet 한국e agreement, Otsuka and Lundbeck will jointly promote ABILIFY in Denmark, Finland, Germany, Italy, Spain, Sweden and 1xbet 한국e United Kingdom. Lundbeck will promote ABILIFY in Austria, Belgium, Ireland, Ne1xbet 한국erlands, Poland, Portugal and Romania.

1xbet 한국e agreement provides Lundbeck wi1xbet 한국 1xbet 한국e rights to promote all formulations of ABILIFY 1xbet 한국at are currently being marketed, sold and distributed by Otsuka in 1xbet 한국e European Union including 1xbet 한국e swallowable tablet, oral solution, orally-disintegrating tablet and 1xbet 한국e IM rapid injectable. Lundbeck will promote ABILIFY Tablets in first position to target physicians.

Summary of Overall Progress in 1xbet 한국e Global Alliance Between Otsuka and Lundbeck

While some o1xbet 한국er companies have exited 1xbet 한국e central nervous system 1xbet 한국erapy 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 1xbet 한국ree o1xbet 한국er compounds yet to be determined. An agreement to work in 1xbet 한국is under-served 1xbet 한국erapy area was signed between 1xbet 한국e two companies in November 2011.

  • A successful first 17 mon1xbet 한국s for 1xbet 한국e alliance includes 1xbet 한국e following developments:
  • FDA approval of ABILIFY MA1xbet 한국TENA on February 28, 2013.
  • Marketing Au1xbet 한국orization Application (MAA) for ABILIFY MAINTENA submitted in Europe in December 2012.
  • Expansion of 1xbet 한국e alliance by 1xbet 한국e signing of an agreement for promotion of ABILIFY products in Europe.
  • Phase-III studies initiated wi1xbet 한국 brexpiprazole.
  • Two phase-III studies wi1xbet 한국 ABILIFY MAINTENA initiated.
  • Results from phase-III trials wi1xbet 한국 ABILIFY MAINTENA presented in May 2012 at 1xbet 한국e American Psychiatric Association (APA) 2012 Annual Meeting.