AP News

BioSante rises after ending LibiGel safety study


LINCOLNSHIRE, Ill. (AP) — Shares of BioSante Pharmaceuticals Inc. rose 10 percent Tuesday afternoon after the drug developer said a safety study of its female sexual dysfunction drug LibiGel did not reveal links to heart attack or breast cancer.

The company also said that it is planning two new trials of the drug, which has failed in two late-stage trials.

BioSante said it is ending the safety trial because a review of the data did not reveal any general or specific safety concerns. The company said patients who were treated with LibiGel were less likely to suffer cardiovascular problems like heart attacks, and they were diagnosed with breast cancer at a rate that was similar to the general population based on their ages.

The study was designed to show that LibiGel, which is a topical testosterone gel, does not increase the risk of breast cancer and problems like heart attack. A decade ago, a large government study in postmenopausal women found that hormone replacement therapy was linked to increased risk of heart disease and breast cancer.

BioSante said the Food and Drug Administration asked it to report data from a study where patients used LibiGel for 12 months on average, and it said the subjects in the trial used the product for 24.5 months on average. The company ended the trial after a safety review by an independent monitoring committee.

In the clinical trials LibiGel failed, the treatment increased the number of days on which the women experienced a "satisfying sexual event" and increased their sexual desire, but did not work significantly better than a placebo.

BioSante said it will ask the FDA to approve the design of its two new studies in the first quarter of 2013.

Shares of Lincolnshire, Ill., company rose 15 cents, or 10 percent, to $1.63 in afternoon trading. The stock had lost about half its value this year.


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