Indevus Soars on Improved FDA Timeline

Indevus (IDEV Quote) shares surged early Friday after the specialty pharmaceutical firm announced it had reached an agreement with regulators and would resubmit sooner than expected its application for its testosterone replacement therapy.

Shares of the Lexington, Mass.-based company were rising $1.39, or 80%, to $3.12 in recent trading.

Indevus said in June that the Food and Drug Administration would withhold approval and would require additional safety data on Nebido, a long-acting injectable testosterone.

Executives said a new clinical trial could be necessary to collect that safety data, estimating that it wouldn't be able to resubmit its application for at least 18 months. On Friday, the company said it now expects to use existing data and resubmit its application in the first quarter of 2009.

Given an estimated six-month FDA review time, assuming approval, Indevus said it will be in a position to launch the injection in the fourth quarter of 2009.

Indevus will fork over a database with safety information from more than 14,000 injections in more than 2,600 patients from existing trials in the U.S. as well as post-marketing studies in Europe. The FDA, according to the company, has said this database will suffice to determine the incidence of serious post-injection oil based reactions.

The FDA's safety concerns related to a short-term adverse reaction to the injection that can cause patients to cough or suffer shortness of breath, according to the company. It was seen in one of 500 patients enrolled in the Indevus clinical trials.