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FROM THE ARCHIVES: September 4, 2002
Bristol-Myers, Otsuka Near Schizophrenia Drug ApprovalBy GEETA ANAND
Bristol-Myers Squibb Co. and Otsuka Pharmaceutical Co. said they received conditional approval from regulators for their schizophrenia medication, aripiprazole, and hope to bring the drug to market later this year. The conditional approval was viewed as something of a disappointment. But Carl Seiden, pharmaceutical analyst at J.P. Morgan Chase & Co., said it has become common for the Food and Drug Administration to issue conditional approvals of drugs to meet legal deadlines for ruling on applications. Conditional approval delays final clearance until outstanding issues can be resolved. Bristol-Myers wouldn't say what issues remained to be resolved. But Mr. Seiden said he was heartened the company continued to predict it would win FDA approval to market the drug this year. The New York company, struggling with patent expirations on important drugs at a time when it has few drugs to replace them, is pinning a lot on the prospects for aripiprazole. The drug, to be marketed as Abilify, was discovered by scientists at Otsuka, a Japanese drug company, and is being developed by Otsuka and Bristol-Myers. Unlike most competing drugs, it binds with the brain's tiny receptors for the chemical dopamine without fully blocking them, as most other drugs do. In doing so, the drug seems to moderate dopamine levels, which are out of whack in the brains of people with schizophrenia. Bristol-Myers stock, which had risen nearly 10% during August based on anticipation of FDA approval, fell 95 cents to $24 in New York Stock Exchange 4 p.m. composite trading Tuesday. About two million Americans suffer from schizophrenia, a frequently progressive disease that causes hallucinations and delusions. Drugs to treat the disease have been blockbusters. The biggest sellers are Zyprexa, from Eli Lilly & Co., and Risperdal, from Johnson & Johnson. Together, the two drugs had sales of more than $3 billion for the past year. Mr. Seiden estimated aripiprazole's sales could reach $1.2 billion for 2006. Write to Geeta Anand at geeta.anand@wsj.com6
Updated September 4, 2002
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