FDA Approves Oral Solution Formulation of Abilify® (Aripiprazole) for Schizophrenia

Bristol-Myers Squibb Company (NYSE: BMY) and Otsuka Pharmaceutical Co, Ltd today announced that the companies received
approval from the US Food and Drug Administration (FDA) for an oral solution formulation of Abilify® (aripiprazole). Abilify
Oral Solution will provide an important new option for adult patients who are unable to swallow or have difficulty swallowing
tablets, providing a greater measure of flexibility in addressing individual patient needs. The oral solution formulation
will be available in pharmacies in February 2005.


Abilify is indicated for the treatment of schizophrenia and acute manic and mixed episodes associated with bipolar disorder.
Abilify is the first and only dopamine partial agonist.i Since its introduction in 2002, Abilify has been prescribed to more
than 700,000 patients.ii


"The FDA approval of this new oral formulation of Abilify underscores Bristol-Myers Squibb's and Otsuka's ongoing commitment
to addressing the special needs of patients," said Anthony Hooper, president, U.S. Pharmaceuticals, Bristol-Myers Squibb
Company. "We are pleased to provide another effective treatment option, helping physicians manage patients for whom the oral
tablet may not be appropriate."


"We are very proud to have discovered Abilify, a unique pharmacological agent that represents our strong focus on
pharmaceutical innovation," said Tatsuo Higuchi, president and representative director, Otsuka Pharmaceutical Co., Ltd. "It
is very encouraging that this medication is now approved in two formulations to allow greater flexibility in supporting the
management of patients requiring different options."


About Abilify


Abilify® (aripiprazole) was approved by the FDA in 2002 for the treatment of schizophrenia. The efficacy and tolerability of
Abilify in schizophrenia was established by short-term and longer-term placebo-controlled trials. In September 2004, Abilify
was approved for the treatment of acute bipolar mania, including manic and mixed episodes associated with bipolar disorder.
Since its approval, more than 2.9 million prescriptions have been written in the United States.iii


Abilify is available by prescription only. Patients should talk to their health care provider for more information. To learn
more about Abilify and for full product information, please visit ABILIFY.


Important Safety Information


As with all antipsychotic medications, 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).















Hyperglycemia, including some serious cases ranging from ketoacidosis, hyperosmolar coma, or death, has been reported in
patients treated with atypical antipsychotics. Abilify was not included in epidemiologic studies suggesting this risk;
therefore the risk of hyperglycemia with Abilify is not known. However, there have been few reports of hyperglycemia in
patients treated with Abilify. Patients 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. Seizures occurred in 0.3 percent of bipolar patients treated with Abilify in
placebo-controlled trials.


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 anticholinergic
medications, or be subject to dehydration.


As antipsychotics have been associated with esophageal dysmotility, Abilify® (aripiprazole) should be used cautiously in
patients at risk for aspiration pneumonia.


As the possibility of a suicide attempt is inherent in psychotic illnesses and bipolar disorder, close supervision of
high-risk patients should accompany drug therapy.


While taking Abilify, patients should not:


-- Drink alcohol

-- Breastfeed an infant


Patients on Abilify should notify their physician:


-- If they become pregnant or intend to become pregnant

-- Of all medications they are taking


Commonly observed adverse events reported with Abilify in three-week bipolar mania-trials at a greater than or equal to 5
percent incidence for Abilify and at a rate at least twice the rate of placebo include, respectively, akathisia (15 percent
vs 4 percent), constipation (13 percent vs 6 percent), and accidental injury (6 percent vs 3 percent).


Treatment-emergent adverse events reported with Abilify in short-term trials at an incidence greater than or equal to 10
percent and greater than placebo, respectively, include headache (31 percent vs 26 percent), agitation (25 percent vs 24
percent), anxiety (20 percent vs 17 percent), insomnia (20 percent vs 15 percent), nausea (16 percent vs 12 percent),
dyspepsia (15 percent vs 13 percent), somnolence (12 percent vs 8 percent), akathisia (12 percent vs 5 percent),
lightheadedness (11 percent vs 8 percent), vomiting (11 percent vs 6 percent), and constipation (11 percent vs 7 percent).



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 percent for Abilify vs 1 percent for placebo. In this study the majority of the cases of tremor were of mild
intensity (9/13 mild and 4/13 moderate), occurred early in therapy (9/13 less than or equal to 49 days), and were of limited
duration (9/13 less than or equal to 10 days). Tremor infrequently led to discontinuation (less than 1 percent) of Abilify.
In addition, in a long-term (52-week), active-controlled study, the incidence of tremor for Abilify was 4 percent.


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
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 health
care company with the mission statement: "Otsuka -- people creating new products for better health worldwide." Otsuka
researches, develops, manufactures and markets innovative products, focusing its core businesses on pharmaceutical products
for the treatment of disease and consumer products for the promotion of everyday health. The Otsuka Pharmaceutical Group
includes 73 companies around the world, employs 23,000 people, and has total annual revenues of $4.4 billion.


Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and
enhance human life.



Full Abilify
Prescribing Information


Visit Otsuka Pharmaceutical Co., Ltd. at otsuka.co.jp


For more information, contact: David Rosen, Bristol-Myers Squibb, 609-252-5675, david.m.rosenbms; Debra Kaufmann, Otsuka
America Pharmaceutical, Inc.,240-683-3568, debrakotsuka; or Hideki Shirai, Otsuka Pharmaceutical Co., Ltd.,
81-3-3292-0021, siraihotsuka.jp


i 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.


ii Kikuchi T, Tottori K, Uwahodo Y, et al. 7-{4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butyloxy}-3,4-dihydro-2
(1H)-quinolinone (OPC-14597), a new putative antipsychotic drug with both presynaptic dopamine autoreceptor agonistic
activity and postsynaptic D2 receptor antagonistic activity. J Pharmacol Exp Ther. 1995;274:329-336.


iii IMS Weekly NPA Plus, Verispan longitudinal database as of November 26, 2004.


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