Wednesday, June 4, 2008

FDA delays clearance of Indevus testosterone drug

By Mass High Tech Staff

Indevus Pharmaceuticals Inc. expects the U.S. Food and Drug Administration to request additional safety data on the firm’s testosterone drug Nebido, delaying a ruling on the product’s approval by two years, company officials said.

The announcement Wednesday caused Lexington-based Indevus’ (Nasdaq: IDEV) common stock price to drop by more than 60 percent.

The firm expects the FDA to request more safety information due to the agency’s concern about a side effect of Nebido injections that causes patients to cough, experience shortness of breath and in rare cases become dizzy. Company officials said they expect to file again for approval of Nebido in 18 months, after which it anticipates a six-month review by the FDA.

Indevus initially filed for FDA approval of Nebido in August 2007 and expects the agency to formally rule on that application by June 27, 2008, according to the company.

The company licensed U.S. rights to Nebido from Bayer Schering Pharma AG of Germany in July 2005. The drug is intended to treat male hypogonadism, a condition that causes a decrease in hormone and sperm production.

Indevus, which markets such products as Sanctura for overactive bladder syndrome, reported a 2007 net loss of $103.8 million on revenue of $66.1 million. The company employs 251 workers.