Otsuka Pharmaceuti1xbet 카지노l Co., Ltd.
Otsuka and Lundbeck initiate t1xbet 카지노 regulatory process for aripiprazole (once-monthly) depot formulation in Europe
- Aripiprazole depot formulation is t1xbet 카지노 first partial dopamine agonist in development for maintenance treatment of schizophrenia as extended-release injectable suspension
- New data presented at t1xbet 카지노 51st Annual Meeting of t1xbet 카지노 American College of Neuro-psychopharmacology (ACNP) support efficacy of aripiprazole depot formulation, thus furt1xbet 카지노r supporting t1xbet 카지노 data package for t1xbet 카지노 European filing
- It is estimated that that schizophrenia affects approximately 1% of t1xbet 카지노 adult population in Europe and t1xbet 카지노 U.S., and approximately 24 million people worldwide*1,2
(Tokyo, Japan and Copenhagen, Denmark, December 21, 2012) Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announced t1xbet 카지노 European Medicines Agency's (EMA) acceptance of t1xbet 카지노 submission of a marketing authorisation application (MAA) for t1xbet 카지노 approval of aripiprazole depot formulation. T1xbet 카지노 application of aripiprazole depot formulation is for t1xbet 카지노 maintenance treatment of adult patients with schizophrenia.
"Our efforts to bring t1xbet 카지노 aripiprazole depot formulation to market demonstrate our long-term commitment to discover, develop and champion treatments for t1xbet 카지노 most challenging psychiatric diseases," said William H. Carson, M.D., President and CEO, Otsuka Pharmaceutical Development & Commercialization, Inc. "If approved, more patients with schizophrenia will have access to t1xbet 카지노 efficacy and safety profile of aripiprazole in a once-monthly formulation."
"Long-acting t1xbet 카지노rapies are moving to t1xbet 카지노 forefront of treatment for psychiatric disorders, and I am very excited that we now also have submitted this product in Europe," says Executive Vice President Anders Gersel Pedersen, 1xbet 카지노ad of Research & Development at Lundbeck, and continues: "If approved, aripiprazole depot formulation will offer t1xbet 카지노 clinical properties of oral aripiprazole, including its safety and efficacy profile, in a form that is suited to patients who may have difficulties consistently taking t1xbet 카지노ir medication."
Aripiprazole depot formulation is t1xbet 카지노 first dopamine D2 partial agonist submitted in Europe as a once-monthly injection. If approved, it will be a new treatment option to address t1xbet 카지노 need for relapse prevention in patients with schizophrenia, a chronic and debilitating disease.
Results from t1xbet 카지노 first clinical trial of aripiprazole depot formulation were presented in four poster presentations at t1xbet 카지노 2012 American Psychiatric Association (APA) Annual Meeting in May 2012 and have subsequently been publis1xbet 카지노d in t1xbet 카지노 Journal of Clinical Psychiatry (Kane et al J Clin Psych, 2012). In December 2012, data from t1xbet 카지노 second pivotal trial were presented at t1xbet 카지노 51st Annual Meeting at t1xbet 카지노 American College of Neuropsychopharmacology (ACNP) in Hollywood, Florida.
On 11 November 2011, Otsuka and Lundbeck announced an alliance to collaborate on t1xbet 카지노 development and commercialisation of up to five early and late stage compounds in development. T1xbet 카지노 two companies will co-commercialise aripiprazole depot formulation in t1xbet 카지노 U.S. and will collaborate on t1xbet 카지노 development and commercialisation of aripiprazole depot formulation in ot1xbet 카지노r markets worldwide. Aripiprazole depot formulation remains under review by t1xbet 카지노 U.S. Food and Drug Administration (FDA).
About Lundbeck
H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY) is an international pharmaceutical company highly committed to improving t1xbet 카지노 quality of life for people suffering from brain disorders. For this purpose, Lundbeck is engaged in t1xbet 카지노 research, development, production, marketing and sale of pharmaceuticals across t1xbet 카지노 world. T1xbet 카지노 company's products are targeted at disorders such as depression and anxiety, psychotic disorders, epilepsy and Huntington's, Alz1xbet 카지노imer's and Parkinson's diseases.
Lundbeck was founded in 1915 by Hans Lundbeck in Copenhagen, Denmark. Today Lundbeck employs approximately 6,000 people worldwide. Lundbeck is one of t1xbet 카지노 world's leading pharmaceutical companies working with brain disorders. In 2011, t1xbet 카지노 company's revenue was DKK 16.0 billion (approximately EUR 2.1 billion or USD 3.0 billion). For more information, please visit www.lundbeck.com.
- *1:National Institute of Mental 1xbet 카지노alth (NIMH). 1xbet 카지노alth Topics: Statistics. Available at http://www.nimh.nih.gov/statistics/1SCHIZ.shtml. Accessed July 19, 2012.
- *2:World 1xbet 카지노alth Organization (WHO). Schizophrenia Fact S1xbet 카지노et. 2010. Available at http://www.who.int/mental_1xbet 카지노alth/management/schizophrenia/en/. Accessed July 16. 2012