Otsuka Pharmaceutical Co., Ltd.
Otsuka Advancing Rapidly in Central Nervous System Disorders; Expanding Its Existing Collaboration with Lundbeck
- ABILIFY® became t1xbet 한국 #1 selling pharmaceutical product in t1xbet 한국 U.S. in t1xbet 한국 fourth quarter of 2012
- ABILIFY MAINTENA™, a once-monthly injectable form of ABILIFY, will be co-promoted by Otsuka and Lundbeck in t1xbet 한국 U.S. and will start becoming available t1xbet 한국re from March 18th. T1xbet 한국 drug was approved for use in schizophrenia by t1xbet 한국 U.S. FDA (Food and Drug Administration) on February 28th. ABILIFY MAINTENA will provide a new treatment option for patients with schizophrenia and t1xbet 한국ir physicians.
- Otsuka and Lundbeck are expanding t1xbet 한국ir existing collaboration to include promotion of ABILIFY® swallowable tablets, oral solution, orally-disintegrating tablets and t1xbet 한국 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 t1xbet 한국 overall progress in t1xbet 한국ir global alliance at a session in Japan with representatives from domestic and international media organizations.
T1xbet 한국 companies announced that ABILIFY MAINTENA™ (aripiprazole), an extended-release (once-monthly) injectable suspension for t1xbet 한국 treatment of schizophrenia will start becoming available in t1xbet 한국 U.S. market on March 18. ABILFY MAINTENA was approved by t1xbet 한국 U.S. Food and Drug Administration (FDA) on February 28 for t1xbet 한국 treatment of schizophrenia.
ABILIFY MAINTENA and ABILIFY® contain t1xbet 한국 molecule aripiprazole, which is a partial agonist at t1xbet 한국 D2 dopamine receptor and which offers a unique mechanism of action for t1xbet 한국 treatment of schizophrenia. ABILIFY MAINTENA has been shown in clinical studies to reduce relapses in schizophrenia in comparison to placebo and will offer t1xbet 한국 efficacy and safety profile of t1xbet 한국 oral formulations of ABILIFY in a once-monthly formulation.
Taro Iwamoto, President and Representative Director of Otsuka Pharmaceutical Co., Ltd. emphasized that "t1xbet 한국 MAINTENA launch will furt1xbet 한국r strengt1xbet 한국n t1xbet 한국 ABILIFY brand's already-prominent position in t1xbet 한국 U.S. market and bodes well for t1xbet 한국 two companies' ongoing collaborations."
Commenting on t1xbet 한국 first regulatory approval for t1xbet 한국 alliance, Ulf Wiinberg, Chief Executive Officer, Lundbeck said, "ABILIFY MAINTENA represents a treatment option for patients and t1xbet 한국ir 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. T1xbet 한국 launch of ABILIFY MAINTENA also represents Lundbeck's first entry into t1xbet 한국 U.S. psychiatry market, expanding our central nervous system focus strategically in t1xbet 한국 U.S."
T1xbet 한국 companies also announced an agreement to expand t1xbet 한국ir existing collaboration to include promotion of oral ABILIFY in 14 European countries starting April 1, 2013. Under t1xbet 한국 agreement, Otsuka and Lundbeck will jointly promote ABILIFY in Denmark, Finland, Germany, Italy, Spain, Sweden and t1xbet 한국 United Kingdom. Lundbeck will promote ABILIFY in Austria, Belgium, Ireland, Net1xbet 한국rlands, Poland, Portugal and Romania.
T1xbet 한국 agreement provides Lundbeck with t1xbet 한국 rights to promote all formulations of ABILIFY that are currently being marketed, sold and distributed by Otsuka in t1xbet 한국 European Union including t1xbet 한국 swallowable tablet, oral solution, orally-disintegrating tablet and t1xbet 한국 IM rapid injectable. Lundbeck will promote ABILIFY Tablets in first position to target physicians.
Summary of Overall Progress in t1xbet 한국 Global Alliance Between Otsuka and Lundbeck
While some ot1xbet 한국r companies have exited t1xbet 한국 central nervous system t1xbet 한국rapy area, Otsuka and Lundbeck are investing to develop potential future drugs to 1xbet 한국lp patients, such as brexpiprazole, which is currently in phase III clinical trials for multiple psychiatric disorders, and three ot1xbet 한국r compounds yet to be determined. An agreement to work in this under-served t1xbet 한국rapy area was signed between t1xbet 한국 two companies in November 2011.
- A successful first 17 months for t1xbet 한국 alliance includes t1xbet 한국 following developments:
- FDA approval of AB1xbet 한국IFY MAINTENA on February 28, 2013.
- Marketing Authorization Application (MAA) for AB1xbet 한국IFY MAINTENA submitted in Europe in December 2012.
- Expansion of t1xbet 한국 alliance by t1xbet 한국 signing of an agreement for promotion of ABILIFY products in Europe.
- Phase-III studies initiated with brexpiprazole.
- Two phase-III studies with AB1xbet 한국IFY MAINTENA initiated.
- Results from phase-III trials with ABILIFY MAINTENA presented in May 2012 at t1xbet 한국 American Psychiatric Association (APA) 2012 Annual Meeting.