Indevus Pharmaceuticals, a Lexington, MA, maker of specialty drugs, says it has launched a Phase 3 clinical trial of an implant designed to provide long-term treatment of patients with acromegaly, a rare and potentially life-threatening condition caused by the overproduction of growth hormone. The company (NASDAQ:IDEV) plans to use its patented “hydron polymer technology” in the implant to outlast Sandostatin LAR injections, the leading current treatment for acromegaly marketed by Switzerland’s Novartis (NYSE:NVS)—pitting the local biotech firm against a global drug giant.
The Indevus implant is inserted under the skin of a patient’s arm at their doctor’s office and is designed to release octreotide—which is a synthetic peptide designed to replicate the growth-hormone-suppressing properties of a natural hormone—for six months. (Indevus already markets to two treatments—Vantas for advanced prostate cancer and Supprelin for early onset of puberty—that use the same polymer technology to allow for this kind of extended release of the drug.) Sandostatin injections also deliver the octreotide peptide, but must be repeated every month.
In the randomized Phase 3 trial, Indevus plans to recruit 140 patients in the U.S. and Europe to, treat them with either octreotide implants or Sandostatin injections, and compare how well the two treatments suppress growth hormone and insulin-like growth factor. Depending on the results of the trial, Indevus says it may be able to launch the implant by early 2011.
It’s unclear what impact the octreotide implant would have on Novartis, which has managed to stave off competition from generic alternatives to Sandostatin, which had 2007 sales of $1.027 billion out of a market of $1.2 billion for such drugs. “This product represents a large commercial opportunity for the company,” says Glenn Cooper, CEO of Indevus, in a statement. He notes that the company plans to begin a Phase 2 trial of the octreotide implant to treat carcinoid syndrome, which is caused when carcinoid tumors secrete such natural chemicals as serotonin into the bloodstream, in early 2009.
Breaking into a well-trodden market with a longer-acting version of an existing drug has brought mixed results for some biotechs. For example, Cambridge, MA-based Alkermes (NASDAQ:ALKS) has seen slow sales of Vivitrol, a once-per-month injection based on generic drug naltrexone to treat alcohol dependence, which is about 10 times as expensive as generic naltrexone and difficult to get reimbursed by health insurers.