Indevus up on Nebido plans

Indevus (NASDAQ:IDEV) was up $1.78 (103%) to $3.51 on Friday after announcing it reached an agreement with FDA about the additional data and risk management strategy sufficient for a complete response to a June approvable letter for Nebido testosterone depot to treat male hypogonadism. The company now plans to submit a response in 1Q09 that will be based on data from U.S. clinical trials and European post-marketing studies. Indevus said in June that it would have taken 18 months to submit the follow-up data from ongoing U.S. and European studies to satisfy FDA's concerns, which were primarily related to short-term respiratory symptoms immediately following injections of the long-acting testosterone (See BioCentury Extra, Wednesday, June 04, 2008).

The company and the agency also agreed on a plan that will fit the new Risk Evaluation and Mitigation Strategy (REMS) guidelines. The plan includes an education plan to minimize the risks associated with use of testosterone undecanoate intramuscular injection, as well as a post-marketing safety study in about 10,000 patients. Indevus received U.S. rights to Nebido from Schering Pharma, now part of Bayer (Xetra:BAY). ...