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Title: FDA Approves Abilify (Aripiprazole) Supplemental New Drug Application for Maintaining Stability in Patients With Schizophrenia

"FDA Approves Abilify (Aripiprazole) Supplemental New Drug Application for Maintaining Stability in Patients With Schizophrenia"

PRINCETON, NJ and TOKYO, JAPAN -- September 9, 2003 -- Bristol-Myers Squibb Company (NYSE: BMY) and Otsuka Pharmaceutical Co., Ltd. announced that the U.S. Food and Drug Administration (U.S. FDA) approved a Supplemental New Drug Application (sNDA) for Abilify™ (aripiprazole) for maintaining stability in patients with schizophrenia. "Because schizophrenia is a chronic illness that requires ongoing treatment, it is important for physicians, consumers and family members to have information regarding the longer-term use of medication," said Dr. Peter Weiden, Director of the Schizophrenia Research Program and Professor of Psychiatry, SUNY Downstate Medical Center. "These data demonstrate that Abilify is efficacious in the treatment of schizophrenia for up to 26 weeks. In addition, the study demonstrated there were no medically important differences between Abilify and placebo in several metabolic measures." The sNDA included results from a placebo-controlled trial involving 310 inpatients or outpatients meeting DSM-IV criteria for schizophrenia who were, by history, symptomatically stable on other antipsychotic medications for periods of 3 months or longer. These patients were discontinued from their antipsychotic medications and randomized to Abilify 15 mg/daily or placebo for up to 26 weeks of observation for relapse. In this study, patients who received Abilify 15mg/daily experienced a significantly longer time to relapse over the subsequent 26 weeks compared to those receiving placebo; the relative risk of relapse for aripiprazole-treated patients was half that of placebo-treated patients (relative risk of relapse for aripiprazole:placebo = 0.503, p < 0.001). Physicians who elect to use Abilify for extended periods should periodically re-evaluate the long-term usefulness of the drug for individual patients. In this long-term trial, there were no medically important differences in metabolic profile between patients receiving Abilify and placebo in mean change from baseline in prolactin, fasting glucose, triglyceride, high-density lipoprotein (HDL, or "good" cholesterol), low-density lipoprotein (LDL, or "bad" cholesterol) and total cholesterol measurements. Overall mean weight change in patients receiving Abilify over the course of the study was -1.3 kg (-2.86 lbs) compared to -0.9 kg (-1.98 lbs) in placebo-treated patients. When grouped by Body Mass Index (BMI), a measurement of weight compared to height, the mean weight change and percentage of patients with >/=7% increase in body weight were as follows: -- Patients with BMI <23: Placebo-treated patients had a mean weight change from baseline of -0.5 kg (-1.10 lbs) and 3.7% of patients experienced a >/=7% increase in body weight; aripiprazole-treated patients had a mean weight change from baseline of -0.5 kg (-1.10 lbs) and 6.8% of patients experienced a >/=7% increase in body weight. -- Patients with BMI 23-27: Placebo-treated patients had a mean weight change from baseline of -0.6 kg (-1.32 lbs) and 4.2% of patients experienced a >/=7% increase in body weight; aripiprazole-treated patients had a mean weight change from baseline of -1.3 kg (-2.86 lbs) and 5.1% of patients experienced a >/=7% increase in body weight. -- Patients with BMI >27: Placebo-treated patients had a mean weight change from baseline of -1.5 kg (-3.30 lbs) and 4.1% of patients experienced a >/=7% increase in body weight; aripiprazole-treated patients had a mean weight change from baseline of -2.1 kg (-4.40 lbs) and 5.7% of patients experienced a >/=7% increase in body weight. Overall weight change among Abilify-treated patients in a previously conducted 52-week trial was +1.0 kg (+2.20 lbs). When patients in this study were grouped by BMI, weight change in patients and the percentage of patients with >/=7% increase in body weight were as follows: +2.6 kg (+5.72 lbs) and 30% in patients with BMI <23; +1.4 kg (+3.08 lbs) and 19% in patients with BMI 23-27; and -1.2 kg (-2.64 lbs) and 8% in patients with BMS >27. In previously conducted short-term (4- and 6-week) placebo-controlled trials with Abilify, there was no difference in the incidence of discontinuation due to adverse events between patients treated with Abilify (7%) and placebo (9%) or incidence of extrapyramidal syndrome (6% vs. 6%). In addition, studies showed that Abilify was associated with a moderate difference in sedation (11% vs. 8% for placebo), and did not cause significant QTc interval changes. The adverse events reported in the 26-week trial were generally consistent with those reported in the short-term trials, except for a higher incidence of tremor (9% Abilify vs. 1% placebo). In this study, the majority of these cases were of mild intensity, occurred early in therapy (...49 days) and were of limited duration (...10 days). Tremor infrequently led to discontinuation (<1%) of Abilify. In addition, in a long-term (52-week) active controlled study, the incidence of tremor for Abilify was 4.0%. The most commonly reported adverse events associated with Abilify in short-term clinical trials are headache (32% vs. 25% placebo), anxiety (25% vs. 24% placebo), insomnia (24% vs. 19%), nausea (14% vs. 10% placebo), vomiting (12% vs. 7% placebo), sleepiness (11% vs. 8% placebo), lightheadedness (11% vs. 7% placebo), restlessness (10% vs. 7% placebo) and constipation (10% vs. 8% placebo). Abilify, the most recently approved treatment for schizophrenia in the United States, Mexico, Brazil, Puerto Rico, Peru, El Salvador and Australia, has been prescribed for more than 200,000 people in the United States. Abilify is available in 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets. Abilify is available by prescription only. For more information, please see full prescribing information. About Schizophrenia Schizophrenia affects more than two million Americans, and about one percent of the population worldwide. Schizophrenia interferes with a person's ability to think clearly, manage emotions, make decisions and relate to others. This illness tends to manifest itself in early adulthood and is characterized by positive symptoms, such as hallucinations, delusions, and paranoia, as well as negative symptoms, such as social withdrawal and emotional flatness. While there is no cure for schizophrenia, it is a treatable illness. SOURCE: Bristol-Myers Squibb; Otsuka Pharmaceutical Co., Ltd.

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