Indevus to announce results of Sanctura XR phase 3 test next month

By Jennifer Lanning Drey

Eugene, Ore., May 8 - Indevus Pharmaceuticals Inc. said results from two phase 3 trials of Sanctura XR are among findings from five phase 2 or phase 3 studies that the company will announce over the next 12 months.

"We're about to enter one of the most active periods in the history of the company," said Glenn L. Cooper, M.D., chairman, president and chief executive officer of Indevus, during the company's earnings conference call.

Among the most anticipated forthcoming test results are those for Sanctura XR, a product being tested for treatment overactive bladder.

Indevus expects to announce the outcome of the first trial by the end of June and conclusions from the second trial about a month later. The company has enrolled 1,200 participants and, assuming successful results, Indevus Pharmaceuticals said it could have a New Drug Application filed by the end of the year and launch Sanctura XR before the close of 2007.

But before releasing the data from Sanctura XR trials, Indevus plans to announce the results of its phase 2 research on the use of pagoclone, a selective non-sedating GABA-A receptor partial agonist, as treatment for stuttering in June.

The company has also filed a new patent application to cover the use of pagoclone as treatment for premature ejaculation and is looking to start a trial on that usage of it sometime in the summer. Once commenced, the study will take about six months.

At the same time, the company is working to get Nebido, a testosterone preparation that can be used a treatment for male hypogonadism and has already launched in Europe but not domestically, on the market in the United States as soon as possible. The company began the pharmacokinetic trial, requested by the Food and Drug Administration, at the end of March, and intends to have data from it in about a year.

The company said Monday it anticipates experiencing a quarterly loss in the mid-teens of millions of dollars through the next several quarters while it works on its late-stage pipeline products.

Indevus reported consolidated net loss of $11.2 million or 24 cents per share on revenues of $14.4 million for the quarter ended March 31, its second fiscal quarter. This compares to revenues of $9.3 million and a consolidated net loss of $9.7 million or 21 cents per share for the same quarter of 2005. As of March 31, 2006, the company had consolidated cash, cash equivalents and marketable securities totaling $68.4 million.

Indevus is a Lexington, Mass.-based biopharmaceutical company engaged in the acquisition, development and commercialization of products targeting medical specialty areas including urology, gynecology and men's health.

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