European Marketing Authorization For Abilify - For Severe Manic Episodes In Bipolar I Disorder

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Main Category: Bipolar
Also Included In: Psychology / Psychiatry;  Regulatory Affairs / Drug Approvals;  Schizophrenia
Article Date: 14 Apr 2008 - 21:00 PDT

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On April 8, 2008, the European Commission made a decision to allow the drug ABILIFY® (aripiprazole) to be marketed. ABILIFY treats moderate to severe manic episodes for patients with Bipolar I Disorder and it is designed to prevent new manic episodes in patients who experience predominately manic episodes.

Before this decision, the European Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion in mid-February 2008. The CHMP made its decision using the results from eight randomized clinical trials that included over 2,400 people. The trials have shown ABILIFY to be safe, effective, and tolerable in the treatment of moderate to severe manic episodes for patients with Bipolar I Disorder. It has also demonstrated to be a safe and effective treatment to prevent a new manic episode in patients who experienced predominantly manic episodes and whose manic episodes responded to ABILIFY treatment.

In 2004, the EU approved ABILIFY for treating schizophrenia, and it is expected that ABILIFY will be launched commercially to treat Bipolar I Disorder in the EU during the second quarter of 2008.

Bipolar I Disorder usually includes one or more Manic Episodes or Mixed Episodes. Manic Episodes are period in which a person's mood is abnormally and continuously elevated, expansive, or irritable. A diagnosis required the mood disturbance to last for at least 1 week (unless the patient is hospitalized). Mixed episodes occur during a time period of at least one week in which the patient is expressing Manic Episodes and Major Depression. Manic episodes that are untreated usually sustain for three to six months and depressive episodes usually last six to 12 months unless treated.

Two companies partnered up for the development and commercialization of ABILIFY®: Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical Co., Ltd., a healthcare company founded in 1964 that discovered ABILIFY, has the following mission statement:

"Otsuka - people creating new products for better health worldwide."

Otsuka engages in the research, development, manufacturing and marketing of pharmaceutical products for the treatment of disease and consumer products related to everyday health. The Otsuka Pharmaceutical Group consists of 99 different companies with about 31,000 employees in 18 countries and regions around the world. See www.bms.com, http://www.otsuka-europe.com.

Bristol-Myers Squibb is a global company that focuses on biopharmaceutical and related health care products. Its mission is to extend and enhance human life.

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Bristol-Myers Squibb Forward-Looking Statement

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding product development. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that ABILIFY® will receive regulatory approval in the European Union or other geographies.

Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol-Myers Squibb's business, including those identified in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2006 and in our Quarterly Reports on Form 10-Q, particularly under "Item 1A. Risk Factors". Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Written by: Peter M Crosta


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