Bristol upbeat on Vanlev
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May 10, 2000: 10:56 a.m. ET
Drug maker says it's on track to refile application for blood pressure treatment
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BALTIMORE (CNNfn) - Bristol-Myers Squibb Co. still believes its proposed blood pressure treatment Vanlev has the potential to be a "blockbuster product," and intends to resubmit data on the medication to U.S. regulators early next year, a company official said Wednesday.
Bristol-Myers pulled its application for the hypertension drug, which was considered one of its most promising new treatments, last month after the U.S. Food and Drug Administration raised concerns about severe facial swelling and other serious side effects in a small number of patients taking the medicine in clinical trials. That news triggered a more than 20 percent drop in the company's share price in one day, a plunge that continues to weigh down the stock.
Bristol-Myers (BMY: Research, Estimates) executive vice president Don Hayden told investors and industry analysts Wednesday that the company is progressing with efforts to gather additional clinical data and plans to resubmit its application to the FDA in early 2001.
"We believe Vanlev is a blockbuster product with significant potential in hypertension ... and everyone in the organization is committed to generating the data to make that potential a reality," he said at a Deutsche Banc Alex. Brown health care conference in Baltimore.
In the pharmaceutical industry, a blockbuster drug is considered to be a product that achieves annual sales of at least $1 billion at its peak.
Hayden said the company also is continuing its discussions with European regulators about the drug's approval, and those talks remain "on track."
Shares of New York-based Bristol-Myers slipped 3/4 to 52-7/8 in Wednesday morning trading. The stock is down from a 52-week high of 79-1/4, but is trading above its 12-month low of 42-7/16.
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Bristol-Myers
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