Teva's testosterone gel nears FDA approval

Teva will market Bio-T-Gel with Biosante.

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) and BioSante Pharmaceuticals Inc. (Nasdaq: BPAX) have received a date from US Food and Drug Administration (FDA) to complete its review of the companies' testosterone gel - November 14, 2011.

Bio-T-Gel is a testosterone gel for the treatment of male hypogonadism or low testosterone levels. BioSante initially developed Bio-T-Gel and licensed it to Teva for late stage clinical development in 2004. Teva filed the New Drug Application with the FDA in January and is responsible for all Bio-T-Gel regulatory and marketing activities. BioSante received $1.4 million when the agreement was signed and will receive milestone payments and royalties upon commercialization.

, BioSante president and CEO Stephen Simes said, "We are extremely excited by Teva's NDA filing of Bio-T-Gel," said. "We are confident that Teva has the expertise and resources to capture significant market share once Bio-T-Gel is launched."

The current US market for male testosterone products is over $1.2 billion. Low testosterone affects an estimated 4-5 million men in the US. Common symptoms include reduced sex drive, decreased energy, loss of body hair or reduced shaving, and depressed mood. There is no cure for hypogonadism. It is a medical condition that usually requires ongoing treatment.

At one point Israeli shareholders owned 12-15% of Biosante's share capital. Its current share cap is $165 million.

Teva's share price rose 0.5% in early trading on Nasdaq today to $49.91, after rising 1.1% on the TASE. Biosante's share price fell 0.5% to $2.02.

Published by Globes [online], Israel business news - www.globes-online.com - on April 14, 2011

© Copyright of Globes Publisher Itonut (1983) Ltd. 2011

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