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Bristol -Myers Squibb Company and Otsuka Pharmaceutical Co. Ltd

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 (ots/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/mentalh
ealthproblems/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:

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.

Plus de actualités: Bristol -Myers Squibb Company and Otsuka Pharmaceutical Co. Ltd
Plus de actualités: Bristol -Myers Squibb Company and Otsuka Pharmaceutical Co. Ltd