Indevus Pharmaceuticals ended last week on the upbeat news that it had struck a licensing deal for one of its experimental therapies and worked out an advantageous arrangement with the FDA on another drug up for approval. The news sent the company's shares up 86 percent.
Teva signed on to develop the stuttering drug pagoclone in a deal which is worth up to $92.5 million for Indevus in milestone payments. Under certain circumstances the deal can be structured for a 50/50 royalty split.
On another front, Indevus announced that the FDA gave it a green light to submit additional data for the testosterone replacement therapy Nebido rather than mount a new trial for the therapy. The agency's concerns are centered on adverse reactions at the injection site. Indevus can now resubmit its applications in the first quarter of next year rather than face a lengthy delay for a new trial. An approval could come in the fourth quarter of 2009.
- check out the Indevus release [1] regarding the licensing deal
- read the Indevus release [2] regarding the FDA agreement
Related Articles:
Indevus shares plunge on approval delay [3]
Indevus trumpets positive results of Nebido study [4](June 2007)
Links:
[1] http://www.fiercebiotech.com/press-releases/indevus-announces-agreement-teva-develop-pagoclone-treatment-stuttering
[2] http://www.fiercebiotech.com/press-releases/indevus-and-fda-agree-path-forward-nebido-r
[3] http://www.fiercebiotech.com/story/indevus-shares-plunge-on-approval-delay/2008-06-04
[4] http://www.fiercebiotech.com/story/indevus-trumpets-positive-results-of-nebido-study/2007-06-07