Indevus shares double on deals with FDA, Teva

Indevus' stock surged $1.78, more than doubling to close at $3.51. The Lexington, Mass.-based company's stock has traded between $1.19 and $8.22 over the past 52 weeks.

Shares of Israel-based Teva, which makes both generic and branded drugs, rose 31 cents to $46.03.

The FDA had rejected approval for Nebido, aimed at treating a male hormonal disorder, but in June said it could be approved if safety issues were addressed. The company now has a plans to resubmit a database and has agreed to an education plan to minimize the risk of oil-based reactions prompting respiratory problems with the drug. The FDA agreed on the conditions, and the company said it could be in a position to launch the drug by the end of 2009.

Meanwhile, under the licensing deal for Pagoclone with Teva, Indevus said it could see up to $92.5 million in milestone payments and reimbursements, with an additional $50 million in U.S. based sales threshold milestones.

Indevus will conduct a Phase IIb, or midstage, clinical trial on the drug involving about 300 patients, funded by Teva. That study is expected to start in the first quarter of 2009.

If that study is successful, the companies will evenly split future development and marketing costs in the U.S. and split future profits. Teva will be solely responsible for development and sales outside of the U.S.

There are currently no approved drugs anywhere in the world for patients with stuttering, Indevus said.

"Pagoclone has tremendous potential to become a highly significant commercial product, as well as to provide a groundbreaking therapy to the nearly 3 million Americans and millions of patients around the world who are afflicted with this condition," Dr. Glenn L. Cooper, Indevus' chairman and chief executive, said in a statement.