Bristol-Myers Squibb and Otsuka Receive European Marketing Authorisation for ABILIFY(R) in the Treatment and Prevention of Moderate to Severe Manic Episodes in Bipolar I Disorder

PARIS, and UXBRIDGE, England, April 8 /PRNewswire/ -- The European Commission has granted marketing authorisation for ABILIFY(R) (aripiprazole) in the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in patients who experienced predominantly manic episodes and whose manic episodes responded to ABILIFY treatment.(1)
The approval decision follows a positive opinion adopted on 21 February 2008 by the European Committee for Medicinal Products for Human Use. The CHMP submission is based on data from eight randomised clinical trials carried out in over 2,400 people, which have confirmed the efficacy, safety and tolerability of ABILIFY in the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in patients who experienced predominantly manic episodes and whose manic episodes responded to ABILIFY treatment.(2-9)
ABILIFY received its first EU approval for the treatment of schizophrenia in 2004.
The commercial launch of ABILIFY in Bipolar I Disorder in the countries of the European Union is expected to begin in the second quarter of 2008.
Notes to editors
Bipolar I Disorder
Bipolar I Disorder is characterised by the occurrence of one or more Manic Episodes or Mixed Episodes. A Manic Episode is defined by a distinct period during which there is an abnormally and persistently elevated, expansive, or irritable mood. The mood disturbance must last for at least 1 week (unless hospitalisation is required). A Mixed episode is characterised by a period of time (lasting at least 1 week) in which the criteria are met both for a Manic Episode and a Major Depressive episode.(10) Untreated manic episodes generally last three to six months and depressive episodes generally last six to 12 months without treatment.(11)
About Bristol-Myers Squibb and Otsuka Pharmaceutical Co. Ltd
Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. are collaborative partners in the development and commercialisation of ABILIFY(R). ABILIFY was discovered by Otsuka Pharmaceutical Co., Ltd. Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a healthcare company with the mission statement: "Otsuka - people creating new products for better health worldwide." Otsuka researches, develops, manufactures and markets innovative, original products, focusing its core businesses on pharmaceutical products for the treatment of disease and consumer products for the maintenance of everyday health. The Otsuka Pharmaceutical Group comprises 99 companies and employs approximately 31,000 people in 18 countries and regions worldwide.
Bristol-Myers Squibb is a global biopharmaceutical and related health care products company whose mission is to extend and enhance human life.
About ABILIFY(R) (aripiprazole) in schizophrenia
ABILIFY(R) (aripiprazole) is manufactured in 5 mg, 10 mg, 15 mg and 30 mg tablets, 10 mg and 15 mg orodispersible tablets and 1 mg / ml oral solution.
ABILIFY is currently indicated for the treatment of schizophrenia; the current recommended dosing for ABILIFY in schizophrenia is a once-daily dose. The recommended starting dose is 10mg or 15mg, with a maintenance dose of 15mg.
About ABILIFY(R) (aripiprazole) in Bipolar I Disorder
Manic episodes:
The recommended starting dose for ABILIFY is 15 mg administered on a once-a-day schedule without regard to meals as monotherapy or combination therapy (see SmPC section 5.1). Some patients may benefit from a higher dose. The maximum daily dose should not exceed 30 mg.
Recurrence prevention of manic episodes in Bipolar I Disorder:
For preventing recurrence of manic episodes in patients who have been receiving ABILIFY, continue therapy at the same dose. Adjustments of daily dosage, including dose reduction should be considered on the basis of clinical status.
The Marketing Authorisation Application for ABILIFY in Europe is supported by 8 Phase III clinical studies.
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(R) 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.
References
1. ABILIFY(R) SUMMARY OF PRODUCT CHARACTERISTICS
2. Keck P, Marcus R, Tourkodimitris S et al. A placebo-controlled, double-blind study of the efficacy and safety of aripiprazole in patients with acute bipolar mania. Am J Psychiatry. 2003; 160: 1651-1658.
3. Keck P, Calabrese J, McQuade R et al. A randomized, double-blind, placebo-controlled 26-week trial of aripiprazole in recently manic patients with bipolar I disorder. J Clin Psychiatry. 2006; 67: 626-637.
4. Keck P, Calabrese J, McQuade R et al. Aripiprazole monotherapy for maintenance therapy in Bipolar I Disorder: a 100-week double-blind study versus placebo. J Clin Psychiatry. 2007; 68: 1480-1491.
5. Sachs G, Sanchez R, Marcus R et al. Aripiprazole in the treatment of acute manic or mixed episodes in patients with bipolar I disorder: a 3-week placebo-controlled study. J Psychopharmacology. 2006; 20: 536-546
6. Vieta E, T'joen C, McQuade R et al. Efficacy of adjunctive aripiprazole to either valproate or lithium in bipolar mania patients partially nonresponsive to valproate/lithium monotherapy: a placebo-controlled study. Am J Psychiatry. Published online 1 April 2008. http://ajp.psychiatryonline.org/.
7. Keck P.E, Sanchez R, Torbeyns A et al. Aripiprazole monotherapy in the treatment of acute bipolar I mania: a randomized, placebo- and lithium-controlled study (CN138-135). Poster presented at APA 160th Annual Meeting, San Diego, U.S., 19-27 May 2007.
8. Dillenschneider A, Sanchez R, McQuade R.D, Torbeyns A. Aripiprazole monotherapy in acute bipolar I mania: a randomized, placebo- and haloperidol-controlled study (CN138-162). Poster presented at WEBP, Strasbourg, France, 13-15 December, 2007.
9. Vieta E, Bourin M, Sanchez R et al. Effectiveness of aripiprazole v. haloperidol in acute bipolar mania. Brit J of Psychiatry. 2005; 187: 235-242
10. American Psychiatric Association 2000. (DSM-IV-TR) Diagnostic and statistical manual of mental disorders, 4th edition, text revision. Washington, DC: American Psychiatric Press, Inc. p320-323, 328-330, 333, 350-351.
11. Royal College of Psychiatrists. Bipolar Disorder (Manic Depression). http://www.rcpsych.ac.uk/mentalhealthinformation/mentalhealthproblems/bipolarmanicdepression/bipolardisorder.aspx Date accessed 11 January 2007.
Contact: Carmel Hogan, Bristol-Myers Squibb Company, Mobile: +33-6-74-10-76-58, carmel.hogan@bms.com; Alison Ross, Otsuka Pharmaceutical Europe Ltd, Mobile: +44(0)7768-337-128, aross@otsuka-europe.com.
Contact: Carmel Hogan, Bristol-Myers Squibb Company, Mobile: +33-6-74-10-76-58, carmel.hogan@bms.com; Alison Ross, Otsuka Pharmaceutical Europe Ltd, Mobile: +44(0)7768-337-128, aross@otsuka-europe.com.