(Updates with closing stock price in second paragraph.)
Dec. 15 (Bloomberg) -- BioSante Pharmaceuticals Inc. fell the most in a dozen years after its experimental gel intended to boost women’s libido failed to work in two large studies.
BioSante dropped 77 percent to 48 cents at 4:09 p.m. New York time, the biggest decline since September 1999.
Women treated with the product, LibiGel, didn’t have more frequent sexual encounters or experience them more days of the week than those on placebo in either study, the Lincolnshire, Illinois-based company said yesterday in a statement. They also didn’t have a significantly greater increase in sexual desire. Testosterone levels were higher in women using LibiGel.
“The magnitude of the miss on the efficacy data is what is surprising everybody,” said Graig Suvannavejh, an analyst at Jefferies & Co. in New York, by phone yesterday. “People had a view the bigger concern might have been safety, and efficacy was a layup of sorts. The big question isn’t what happens with LibiGel going forward, but what’s next for the company.”
Women using LibiGel did have an increase in sexual desire and satisfying sexual events, though the placebo group had a similar, unexpected benefit, BioSante Chief Executive Officer Stephen M. Simes said in a conference call after the results were announced. The company will continue to analyze the studies and look for other products to license and develop, he said.
“We are an operating pharmaceutical company with other products in our pipeline,” Simes said. “We are in the enviable position of having a strong cash balance at a time when there are excellent products that might be available for development that might lack appropriate funding.”
BioSante previously planned to seek U.S. Food and Drug Administration approval of the treatment next year and hoped to start sales in 2013, Simes said in a July interview.
BioSante has another trial involving 3,656 women still under way. While it was designed primarily to ensure the drug was safe for the heart and didn’t increase the risk of cancer, BioSante could use interim results analyzed a year after the last woman in the study started treatment as part of a U.S. marketing application, the company said.
BioSante’s setback is the most recent failure among drugmakers seeking to boost women’s sexual drive.
Boehringer Ingelheim GmbH abandoned development of its female desire pill flibanserin last year after U.S. regulators said it wasn’t proven safe and effective. Pfizer Inc. stopped testing Viagra, its blockbuster male impotence pill, for women in 2004. Procter & Gamble Co. failed to win marketing approval of a testosterone patch the same year.
--with reporting by Elizabeth Lopatto in New York. Editors: Andrew Pollack, Bruce Rule
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