Indevus (IDEV) 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 injection is already approved for use in Europe, where is it marketed by German drug firm Bayer. In June, Indevus had about $60 million in the bank, and was burning about $15 million a quarter. The prospect of a two-year delay for U.S. approval of the Nebido injection sent shares down 66% to a new 52-week low at that time. "We are very pleased that we can provide to FDA additional data from existing clinical trials to satisfy FDA's desire to understand the incidence of these rare oil-based reactions, without the need to conduct new clinical trials prior to resubmission or approval," said CEO Glenn Cooper in a company statement. Cooper also said that the FDA has agreed with the company's outline for a risk-mitigation plan, including a labeling description of the injection technique, allergic and oil based reactions and the commitment to conduct "a large, simple post-marketing study." Nebido is an every-three-month injectable testosterone to treat male hypogonadism, the failure to produce adequate amounts of the male reproductive hormone. Current treatments are administered via creams, gels or more frequent injections. Other companies competing in the testosterone replacement market are Repros Therapeutics ( RPRX) and Auxillium Pharmaceuticals ( AUXL).