FDA approves Teva, BioSante testosterone gel

Posted by Dr. Michael White, Updated on January 18th, 2018

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) and BioSante Pharmaceutical Inc. (Nasdaq: BPAX) have obtained US Food and Drug Administration (FDA) clearance for Bio-T-Gel, a testosterone replacement therapy for men. Teva will market the product for men suffering from hypogonadism (low testosterone), which can cause erectile dysfunction, infertility, osteoporosis and muscle loss, according to the Mayo Clinic.

The gel is delivered transdermally once a day. 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 and was responsible for all regulatory and marketing activities. Teva paid BioSante $1.4 million when the agreement was signed and it will pay royalties on sales.

BioSante's female sexual dysfunction treatment, LibiGel, failed in a Phase III clinical trial in December, 2011. It was the latest failed attempt to develop a female counterpart to Pfizer Inc's (NYSE: PFE; LSE: PFZ) impotence drug Viagra.

Teva's share price rose 2.4% in morning trading on the TASE today to NIS 167.70, after rising 1.3% in after-hours trading on Nasdaq to $44.10 to $44.10, recouping the loss during the trading session, giving a market cap of $38.5 billion. BioSante's share price rose 44% in after-hours trading to $1.10, giving a market cap of $115 million.

Published by Globes [online], Israel business news - http://www.globes-online.com - on February 15, 2012

? Copyright of Globes Publisher Itonut (1983) Ltd. 2012

Continued here:

FDA approves Teva, BioSante testosterone gel

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