Updated from 10:47 a.m. EDTIndevus (IDEV) shares surged early Friday on a positive regulatory update on one product and a new partnership deal for another.The specialty pharmaceutical firm has reached with the Food and Drug Administration and will now resubmit its application for its testosterone replacement therapy Nebido sooner than expected. Separately, Indevus said it signed an agreement with Teva Pharmaceutical ( TEVA) for its pagoclone for the treatment of stuttering. Shares of the Lexington, Mass.-based company were rising $1.50, or 86.7%, to $3.23 in recent midday trading. Indevus said in June that the FDA 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). On Friday, Indevus also announced a research and development deal with Teva Pharmaceutical ( TEVA) for its midstage product for the treatment of stuttering. Under the terms of the agreement, Indevus will be reimbursed for expenses for a phase IIb study expected to begin enrollment in the first quarter of 2009. If the trial is successful, Indevus and Teva will split costs and profits in half in the U.S. thereafter. Outside of the U.S., Teva will be responsible for all future development and commercialization paying Indevus milestones and royalties on net sales. Indevus said that it could receive up to $92.5 million in development milestones and reimbursement, including the expenses for the phase IIb study. Under certain circumstances, both companies can convert the 50/50 deal to a royalty structure, in which case Teva will be responsible for all development expenses, paying Indevus milestones and royalties.