Bristol-Myers says women's facial hair cream cleared

NEW YORK (Reuters) -- Bristol-Myers Squibb Co. said on Monday that U.S. regulators have given it approval to sell the first prescription medicine for inhibiting the growth of unwanted facial hair in women, a twice-daily cream called Vaniqa.

The New York drugmaker, which is developing the cream in partnership with Gillette Co., said Vaniqa was approved last week by the U.S. Food and Drug Administration and would be available by prescription in September.

Vaniqa, which is dabbed on in the morning and evening, inhibits an enzyme that hair follicles need to grow but takes about two months to start showing results. Within six months, up to 60 percent of the patients who used it in clinical trials reported a favorable difference compared with those given a placebo cream, Bristol-Myers said.

Bristol-Myers, best known for cancer and diabetes drugs, said an estimated 41 million American women have unwanted facial hair and a large number deal with it by regularly plucking, shaving, waxing or using depilatory products that chemically melt away growth.

"Many women have facial hair that annoys them and it's usually on the chin or upper lip, the sideburns or the neck," said Marty Sawaya, a University of Miami adjunct professor and Bristol-Myers consultant who helped supervise the Vaniqa trials.

"Those are the regions where women in our trials tended to treat themselves with the Vaniqa cream, and with good results," Sawaya said, adding that about 5 percent of users reported mild side effects such as stinging or irritation to skin.

Although Bristol-Myers will use its own sales force to promote the cream among doctors, it and Boston-based personal care products maker Gillette will otherwise co-promote the drug. They will share profits, but exactly how has not been disclosed, said Bristol-Myers spokeswoman Bonnie Jacobs.

Some analysts have previously predicted that the cream, which has not been tested in men, could achieve annual sales of $200 million or more.

Copyright 2000 Reuters. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

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