Wednesday, October 1, 2008

Indevus moves hormone suppressing implant to Phase 3 trials

By Mass High Tech Staff

Lexington-based Indevus Pharmaceuticals Inc. has begun Phase 3 clinical trials of the company’s octreotide implant, used to treat acromegaly, a chronic disorder marked by excessive growth hormone production. The trials will determine the implant’s safety, tolerability and efficacy in suppressing the growth hormone.

The clinical trials will randomly test 140 patients through 34 clinical sites in six countries throughout Europe and the U.S., Indevus officials said.

Acromegaly tends to occur in middle-aged people, with eventual untreated symptoms of enlarged bones, muscles, cartilage, organs and other tissues. Indevus’ octreotide implant releases the synthetic peptide, octreotide, into a patient’s arm to provide six months’ worth of growth hormone suppression, the company reports.

In August, Indevus (Nasdaq:IDEV) closed on a $105 million private placement, with notes that are secured by royalty payments derived from its overactive bladder drugs Sanctura and Sanctura XR. The financing came at a critical time for Indevus. In June, the company’s stock dropped more than 60 percent after the U.S. Food and Drug Administration requested additional safety data on the firm’s testosterone drug Nebido, delaying a ruling on the product’s approval by at least two years, company officials said.

Indevus reported a 2007 net loss of $103.8 million on revenue of $66.1 million. The company employs 251 workers.