Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. Announce Availability of 2 mg ABILIFY(R) (aripiprazole) Tablet and Nonrefrigerated Oral Solution Newly Available Options Equip Physicians with Increased Flexibility when

Customizing Treatment to Address Specific Needs of Adults with Schizophrenia

or Bipolar I Disorder



    PRINCETON, N.J. and TOKYO, Feb. 7 /PRNewswire-FirstCall/ -- Bristol-Myers
 Squibb Company (NYSE:   BMY) and Otsuka Pharmaceutical Co., Ltd. today announced
 two newly available options of ABILIFY(R) (aripiprazole) -- a 2 mg tablet
 strength and a nonrefrigerated oral solution (1 mg/mL).  The ABILIFY 2 mg
 tablet equips physicians with an additional dosage strength to help them
 titrate patients to an effective dose.  The nonrefrigerated oral solution
 formulation allows greater convenience for adults who are unable to swallow or
 have difficulty swallowing tablets.
     ABILIFY is indicated for the treatment of schizophrenia, acute manic and
 mixed episodes associated with Bipolar I Disorder, and for maintaining
 efficacy in adults with Bipolar I Disorder with a recent manic or mixed
 episode who had been stabilized and then maintained for at least six weeks.(i)
 ABILIFY is the first and only available dopamine partial agonist.(ii)
     "The availability of the ABILIFY 2 mg tablet is important for physicians
 because it allows us to better meet the specific dosing needs of adults with
 schizophrenia or Bipolar I Disorder," said John Zajecka, M.D., Director,
 Treatment Research Center, and Associate Professor of Psychiatry, Rush
 University Medical Center.  "The nonrefrigerated oral solution gives
 physicians another choice when prescribing ABILIFY, which allows for more
 convenience and flexibility for adult patients."
 
     About ABILIFY
     ABILIFY is indicated for the treatment of schizophrenia including
 maintaining stability in adults who had been symptomatically stable on other
 antipsychotic medications for periods of three months or longer and observed
 for relapse during a period of up to 26 weeks.  ABILIFY is also indicated for
 the treatment of acute manic and mixed episodes associated with Bipolar I
 Disorder, and for maintaining efficacy in adults with Bipolar I Disorder with
 a recent manic or mixed episode who had been stabilized and then maintained
 for at least six weeks.  Physicians who elect to use ABILIFY for extended
 periods should periodically re-evaluate the long-term usefulness of the drug
 for the individual.  Since its initial approval in 2002, nearly six million
 prescriptions have been written in the United States.(iii)
     ABILIFY is available by prescription only.  ABILIFY tablets are available
 in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths.  The effective dose
 range is 10-30 mg/day for schizophrenia patients, and 15 or 30 mg/day for
 Bipolar I Disorder patients.  In addition to administration as a tablet,
 ABILIFY is available in a 1 mg/mL nonrefrigerated oral solution.
     It is important to talk to a healthcare provider for more information
 about ABILIFY.  To learn more about ABILIFY and for FULL PRESCRIBING
 INFORMATION, including Boxed WARNING, please visit http://www.abilify.com .
 
     IMPORTANT SAFETY INFORMATION for ABILIFY:
     Increased Mortality in Elderly Patients With Dementia-Related Psychosis:
     Elderly patients with dementia-related psychosis treated with atypical
 antipsychotic drugs are at an increased risk of death compared to placebo.
 Although the causes of death were varied, most of the deaths appeared to be
 either cardiovascular or infectious in nature.  ABILIFY is not approved for
 the treatment of patients with dementia-related psychosis (see Boxed WARNING).
     ABILIFY is contraindicated in patients with a known hypersensitivity to
 the product.
     As with all antipsychotic medications, including ABILIFY, a rare condition
 referred to as neuroleptic malignant syndrome (NMS) has been reported.  As
 with all antipsychotic medications, prescribing should be consistent with the
 need to minimize the risk of tardive dyskinesia (TD).
     Cerebrovascular adverse events (e.g., stroke, transient ischemic attack),
 including fatalities, have been reported at an increased incidence in clinical
 trials of elderly patients with dementia-related psychosis treated with
 ABILIFY, including a significant dose response relationship in a fixed-dose
 trial.  ABILIFY is not approved for the treatment of patients with
 dementia-related psychosis.
     Hyperglycemia, including some serious cases ranging from ketoacidosis,
 hyperosmolar coma, or death, has been reported in patients treated with
 atypical antipsychotics.  Patients on ABILIFY should be appropriately tested
 before and monitored during treatment.
     ABILIFY may be associated with orthostatic hypotension and should be used
 with caution in patients with known cardiovascular disease, cerebrovascular
 disease, or conditions which would predispose them to hypotension.
     As with other antipsychotic drugs, ABILIFY should be used with caution in
 patients with a history of seizures or with conditions that lower the seizure
 threshold.
     Like other antipsychotics, ABILIFY may have the potential to impair
 judgment, thinking, or motor skills.  Patients should not drive or operate
 hazardous machinery until they are certain ABILIFY does not affect them
 adversely.
     Disruption of the body's ability to reduce core body temperature has been
 attributed to antipsychotics.  Appropriate care is advised for patients who
 may exercise strenuously, be exposed to extreme heat, receive concomitant
 medication with anticholinergic activity, or be subject to dehydration.
     As antipsychotics have been associated with esophageal dysmotility and
 aspiration, ABILIFY should be used cautiously in patients at risk for
 aspiration pneumonia.
     As the possibility of a suicide attempt is inherent in psychotic illness
 and bipolar disorder, close supervision of high-risk patients should accompany
 drug therapy.
     Prescriptions for ABILIFY should be written for the smallest quantity
 consistent with good patient management to reduce the risk of overdose.
     Physicians should determine if a patient is pregnant or intends to become
 pregnant while taking ABILIFY.  Patients should be advised not to breast-feed
 while taking ABILIFY.
     Patients should be advised to avoid alcohol while taking ABILIFY.
     Both CYP3A4 and CYP2D6 are responsible for ABILIFY metabolism.  Agents
 that induce CYP3A4 (e.g., carbamazepine) could cause an increase in ABILIFY
 clearance and lower blood levels.  Inhibitors of CYP3A4 (e.g., ketoconazole)
 or CYP2D6 (e.g., quinidine, fluoxetine, or paroxetine) can inhibit ABILIFY
 elimination and cause increased blood levels.
     Commonly observed adverse events reported with ABILIFY in 3-week bipolar
 mania trials at a greater than or equal to 5% incidence for ABILIFY and at a
 rate at least twice the rate of placebo include, respectively, akathisia (15%
 vs. 4%), constipation (13% vs. 6%), and accidental injury (6% vs. 3%).
     Treatment-emergent adverse events reported with ABILIFY in short-term
 trials at an incidence greater than or equal to 10% and greater than placebo,
 respectively, include headache (31% vs. 26%), agitation (25% vs. 24%), anxiety
 (20% vs. 17%), insomnia (20% vs. 15%), nausea (16% vs. 12%), dyspepsia (15%
 vs. 13%), somnolence (12% vs. 8%), akathisia (12% vs. 5%), lightheadedness
 (11% vs. 8%), vomiting (11% vs. 6%), and constipation (11% vs. 7%).
 
     The adverse events reported in a 26-week, double-blind schizophrenia trial
 comparing ABILIFY and placebo were generally consistent with those reported in
 the short-term, placebo-controlled schizophrenia trials, except for a higher
 incidence of tremor: 9% for ABILIFY vs. 1% for placebo.
 
     INDICATIONS: ABILIFY is indicated for the treatment of:
     -- Schizophrenia, including maintaining stability in patients who had been
        symptomatically stable on other antipsychotic medications for periods
        of 3 months or longer and observed for relapse during a period of up to
        26 weeks*
     -- Acute manic and mixed episodes associated with Bipolar I Disorder
     -- Maintaining efficacy in patients with Bipolar I Disorder with a recent
        manic or mixed episode who had been stabilized and then maintained for
        at least 6 weeks*
     * Physicians who elect to use ABILIFY for extended periods should
       periodically re-evaluate the long-term usefulness of the drug for the
       individual patient.
 
     ABILIFY is taken once daily with or without food.
     Please see accompanying FULL PRESCRIBING INFORMATION including Boxed
 WARNING for ABILIFY.
 
     About Bristol-Myers Squibb and Otsuka Pharmaceutical Co., Ltd.
     Bristol-Myers Squibb and Otsuka Pharmaceutical Co., Ltd. are collaborative
 partners in the development and commercialization of aripiprazole in the
 United States and major European countries.
     Aripiprazole 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 81 companies and employs
 approximately 26,000 people in 16 countries and regions worldwide.  Otsuka and
 its consolidated subsidiaries earned US $6.2 billion in annual revenues in
 fiscal 2004.
     Bristol-Myers Squibb is a global pharmaceutical and related health care
 products company whose mission is to extend and enhance human life.
 
         For more information and FULL PRESCRIBING INFORMATION, visit:
                             http://www.abilify.com
               Visit Bristol-Myers Squibb at: http://www.bms.com
       Visit Otsuka Pharmaceutical Co., Ltd. at: http://www.otsuka.co.jp
 
     (i).   ABILIFY Product Labeling, pg. 2.
     (ii).  Burris KD, Molski TF, Xu C, et al. Aripiprazole, a novel
            antipsychotic, is a high-affinity partial agonist at human dopamine
            D2 receptors. J Pharmacol Exp Ther. 2002;302:381-389.
     (iii). Auditrac IMS Weekly NPA Plus; Month ending September 2005.
 
 

SOURCE Bristol-Myers Squibb Company
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