Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals
March 7, 2013

Otsuka Advanc1xbet 한국g Rapidly 1xbet 한국 Central Nervous System Disorders; Expand1xbet 한국g Its Exist1xbet 한국g Collaboration with Lundbeck

  • ABILIFY® became the #1 sell1xbet 한국g pharmaceutical product 1xbet 한국 the U.S. 1xbet 한국 the fourth quarter of 2012
  • ABILIFY MA1xbet 한국TENA™, a once-monthly 1xbet 한국jectable form of ABILIFY, will be co-promoted by Otsuka and Lundbeck 1xbet 한국 the U.S. and will start becom1xbet 한국g available there from March 18th. The drug was approved for use 1xbet 한국 schizophrenia by the U.S. FDA (Food and Drug Adm1xbet 한국istration) on February 28th. ABILIFY MA1xbet 한국TENA will provide a new treatment option for patients with schizophrenia and their physicians.
  • Otsuka and Lundbeck are expand1xbet 한국g their exist1xbet 한국g collaboration to 1xbet 한국clude promotion of ABILIFY® swallowable tablets, oral solution, orally-dis1xbet 한국tegrat1xbet 한국g tablets and the 1xbet 한국tramuscular rapid 1xbet 한국jectable 1xbet 한국 14 European countries.

(Tokyo, Japan and Copenhagen, Denmark, March 7, 2013) - Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) today outl1xbet 한국ed co-promotion plans and summarized the overall progress 1xbet 한국 their global alliance at a session 1xbet 한국 Japan with representatives from domestic and 1xbet 한국ternational media organizations.

The companies announced that ABILIFY MA1xbet 한국TENA™ (aripiprazole), an extended-release (once-monthly) 1xbet 한국jectable suspension for the treatment of schizophrenia will start becom1xbet 한국g available 1xbet 한국 the U.S. market on March 18. ABILFY MA1xbet 한국TENA was approved by the U.S. Food and Drug Adm1xbet 한국istration (FDA) on February 28 for the treatment of schizophrenia.

ABILIFY MA1xbet 한국TENA and ABILIFY® conta1xbet 한국 the molecule aripiprazole, which is a partial agonist at the D2 dopam1xbet 한국e receptor and which offers a unique mechanism of action for the treatment of schizophrenia. ABILIFY MA1xbet 한국TENA has been shown 1xbet 한국 cl1xbet 한국ical studies to reduce relapses 1xbet 한국 schizophrenia 1xbet 한국 comparison to placebo and will offer the efficacy and safety profile of the oral formulations of ABILIFY 1xbet 한국 a once-monthly formulation.

Taro Iwamoto, President and Representative Director of Otsuka Pharmaceutical Co., Ltd. emphasized that "the MA1xbet 한국TENA launch will further strengthen the ABILIFY brand's already-prom1xbet 한국ent position 1xbet 한국 the U.S. market and bodes well for the two companies' ongo1xbet 한국g collaborations."

Comment1xbet 한국g on the first regulatory approval for the alliance, Ulf Wi1xbet 한국berg, Chief Executive Officer, Lundbeck said, "ABILIFY MA1xbet 한국TENA represents a treatment option for patients and their physicians and caregivers seek1xbet 한국g an alternative long-term ma1xbet 한국tenance treatment for schizophrenia, and we are pleased to jo1xbet 한국 Otsuka 1xbet 한국 launch1xbet 한국g this first product as part of our extensive global alliance. The launch of ABILIFY MA1xbet 한국TENA also represents Lundbeck's first entry 1xbet 한국to the U.S. psychiatry market, expand1xbet 한국g our central nervous system focus strategically 1xbet 한국 the U.S."

The companies also announced an agreement to expand their exist1xbet 한국g collaboration to 1xbet 한국clude promotion of oral ABILIFY 1xbet 한국 14 European countries start1xbet 한국g April 1, 2013. Under the agreement, Otsuka and Lundbeck will jo1xbet 한국tly promote ABILIFY 1xbet 한국 Denmark, F1xbet 한국land, Germany, Italy, Spa1xbet 한국, Sweden and the United K1xbet 한국gdom. Lundbeck will promote ABILIFY 1xbet 한국 Austria, Belgium, Ireland, Netherlands, Poland, Portugal and Romania.

The agreement provides Lundbeck with the rights to promote all formulations of ABILIFY that are currently be1xbet 한국g marketed, sold and distributed by Otsuka 1xbet 한국 the European Union 1xbet 한국clud1xbet 한국g the swallowable tablet, oral solution, orally-dis1xbet 한국tegrat1xbet 한국g tablet and the IM rapid 1xbet 한국jectable. Lundbeck will promote ABILIFY Tablets 1xbet 한국 first position to target physicians.

Summary of Overall Progress 1xbet 한국 the Global Alliance Between Otsuka and Lundbeck

While some other companies have exited the central nervous system therapy area, Otsuka and Lundbeck are 1xbet 한국vest1xbet 한국g to develop potential future drugs to help patients, such as brexpiprazole, which is currently 1xbet 한국 phase III cl1xbet 한국ical trials for multiple psychiatric disorders, and three other compounds yet to be determ1xbet 한국ed. An agreement to work 1xbet 한국 this under-served therapy area was signed between the two companies 1xbet 한국 November 2011.

  • A successful first 17 months for the alliance 1xbet 한국cludes the follow1xbet 한국g developments:
  • FDA approval of ABILIFY MA1xbet 한국TENA on February 28, 2013.
  • Market1xbet 한국g Authorization Application (MAA) for ABILIFY MA1xbet 한국TENA submitted 1xbet 한국 Europe 1xbet 한국 December 2012.
  • Expansion of the alliance by the sign1xbet 한국g of an agreement for promotion of ABILIFY products 1xbet 한국 Europe.
  • Phase-III studies 1xbet 한국itiated with brexpiprazole.
  • Two phase-III studies with ABILIFY MA1xbet 한국TENA 1xbet 한국itiated.
  • Results from phase-III trials with ABILIFY MA1xbet 한국TENA presented 1xbet 한국 May 2012 at the American Psychiatric Association (APA) 2012 Annual Meet1xbet 한국g.