Bio-T-Gel Approved for Low Testosterone

Thu, 02/16/2012 - 6:25am
NEW YORK (AP) - Regulators have approved a testosterone gel from BioSante Pharmaceuticals Inc. that will be marketed by its partner Teva Pharmaceutical Industries Ltd.

The Food and Drug Administration approved Bio-T-Gel as a treatment for low testosterone levels, or male hypogonadism. Bio-T-Gel is intended to be applied to the skin once per day. Low testosterone is associated with fatigue, depression, and various sexual dysfunctions.

BioSante, of Lincolnshire, Ill., developed Bio-T-Gel and licensed it to Teva. Teva, which is based in Israel, did not say when it plans to start selling the product. BioSante will receive royalties and potentially other payments once it's on the market.

BioSante is also studying LibiGel, a testosterone gel designed to treat female sexual dysfunction, but in December it said LibiGel failed in two late-stage clinical trials. BioSante developed Elestrin, a hot flash treatment licensed to Jazz Pharmaceuticals PLC.

Teva is the world's largest maker of generic drugs, and it is expanding its branded drug business. Sales of brand-name products rose 32% in the fourth quarter after the company bought Cephalon Inc., which makes cancer drugs and the sleep disorder drug Provigil. Generic drug revenue grew 12% as Teva started selling generic versions of the cholesterol fighter Lipitor and anti-psychotic Zyprexa.

Rodman & Renshaw analyst Elemer Piros said BioSante won't get much royalty revenue from Bio-T-Gel because it's the fifth product to be approved for the condition. Other low-testosterone treatments are made by Abbott Laboratories Inc., Eli Lilly & Co., Endo Pharmaceutical Holdings Inc., and Auxilium Pharmaceuticals Inc.

Piros kept a "Market Perform" rating on shares of BioSante.

Date: February 15, 2012
Source: Associated Press


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