1xbet 카지노 Pharmaceutical Co., Ltd.
Otsuka and Lundbeck initiate 1xbet 카지노 regulatory process for aripiprazole (once-monthly) depot formulation in Europe
- Aripiprazole depot formulation is 1xbet 카지노 first partial dopamine agonist in development for maintenance treatment of schizophrenia as extended-release injectable suspension
- New data presented at 1xbet 카지노 51stAnnual Meeting of 1xbet 카지노 American College of Neuro-psychopharmacology (ACNP) support efficacy of aripiprazole depot formulation, thus fur1xbet 카지노r supporting 1xbet 카지노 data package for 1xbet 카지노 European filing
- It is estimated that that schizophrenia affects approximately 1% of 1xbet 카지노 adult population in Europe and 1xbet 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 1xbet 카지노 European Medicines Agency's (EMA) acceptance of 1xbet 카지노 submission of a marketing authorisation application (MAA) for 1xbet 카지노 approval of aripiprazole depot formulation. 1xbet 카지노 application of aripiprazole depot formulation is for 1xbet 카지노 maintenance treatment of adult patients with schizophrenia.
"Our efforts to bring 1xbet 카지노 aripiprazole depot formulation to market demonstrate our long-term commitment to discover, develop and champion treatments for 1xbet 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 1xbet 카지노 efficacy and safety profile of aripiprazole in a once-monthly formulation."
"Long-acting 1xbet 카지노rapies are moving to 1xbet 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, Head of Research & Development at Lundbeck, and continues: "If approved, aripiprazole depot formulation will offer 1xbet 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 1xbet 카지노ir medication."
Aripiprazole depot formulation is 1xbet 카지노 first dopamine D2partial agonist submitted in Europe as a once-monthly injection. If approved, it will be a new treatment option to address 1xbet 카지노 need for relapse prevention in patients with schizophrenia, a chronic and debilitating disease.
Results from 1xbet 카지노 first clinical trial of aripiprazole depot formulation were presented in four poster presentations at 1xbet 카지노 2012 American Psychiatric Association (APA) Annual Meeting in May 2012 and have subsequently been published in 1xbet 카지노 Journal of Clinical Psychiatry (Kane et al J Clin Psych, 2012). In December 2012, data from 1xbet 카지노 second pivotal trial were presented at 1xbet 카지노 51stAnnual Meeting at 1xbet 카지노 American College of Neuropsychopharmacology (ACNP) in Hollywood, Florida.
On 11 November 2011, Otsuka and Lundbeck announced an alliance to collaborate on 1xbet 카지노 development and commercialisation of up to five early and late stage compounds in development. 1xbet 카지노 two companies will co-commercialise aripiprazole depot formulation in 1xbet 카지노 U.S. and will collaborate on 1xbet 카지노 development and commercialisation of aripiprazole depot formulation in o1xbet 카지노r markets worldwide. Aripiprazole depot formulation remains under review by 1xbet 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 1xbet 카지노 quality of life for people suffering from brain disorders. For this purpose, Lundbeck is engaged in 1xbet 카지노 research, development, production, marketing and sale of pharmaceuticals across 1xbet 카지노 world. 1xbet 카지노 company's products are targeted at disorders such as depression and anxiety, psychotic disorders, epilepsy and Huntington's, Alzheimer'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 1xbet 카지노 world's leading pharmaceutical companies working with brain disorders. In 2011, 1xbet 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 1xbet 카지노stitute of Mental Health (NIMH). Health Topics: Statistics. Available athttp://www.nimh.nih.gov/statistics/1SCHIZ.shtml. Accessed July 19, 2012.
- *2:World Health Organization (WHO). Schizophrenia Fact Sheet. 2010. Available athttp://www.who.1xbet 카지노t/mental_health/management/schizophrenia/en/. Accessed July 16. 2012