Tuesday, February 01, 2005

IN BRIEF: SOLVAY PHARMACEUTICALS INC.

Solvay Pharmaceuticals Inc. and Icos Corp. entered into a co-promotion agreement that will last until at least 2006 for AndroGel (testosterone gel) 1% CIII. Icos said it will provide promotional support for the topical gel, which is approved by the Food and Drug Administration as a replacement therapy for men with conditions associated with absent or low testosterone levels. Icos will receive a service fee per physician detail, along with other fees based on specified sales goals. Solvay will continue to use its own sales force to support AndroGel.

Tuesday, November 2, 2004

IN BRIEF: PAR PHARMACEUTICAL COS. INC.

Par Pharmaceutical Cos. Inc. said its partner Paddock Laboratories received tentative approval from the Food and Drug Administration to market testosterone gel 1%, the generic equivalent to Unimed Pharmaceuticals Inc.'s AndroGel, which is indicated for replacement therapy in men who have conditions associated with a deficiency of endogenous testosterone. The product has annual U.S. sales of approximately $300 million, according to Par.

Friday, July 2, 2004

ZONAGEN RELEASES POSITIVE RESULTS FROM STUDY OF TESTOSTERONE DEFICIENCY TREATMENT ANDROXAL

Shares of Zonagen Inc. rose 77.3 percent, or $1.98 per share, after the company released positive results from a study of its investigational drug Androxal in hypogonadal men.

The trial involved 70 hypogonadal men with testosterone levels of less than 300 nanograms per deciliter. Solvay Pharmaceuticals Inc. and Unimed Pharmaceuticals Inc.'s AndroGel (testosterone gel) 1% CIII, a pharmaceutical brand name cream designed to treat testosterone deficiency, was used as a positive control in the study.

Patients were randomized into six different treatment arms, three of which consisted of varying doses of Androxal. The remaining treatment arms consisted of groups for both high and low doses of Androgel and a placebo group.

Patients in the low-, mid- and high-dose groups of Androxal treatment achieved mean increases in testosterone levels of 169 ng/dL, 247 ng/dL and 294 ng/dL, respectively. In addition, seven of 10 men in the low-dose group, 10 of 11 in the mid-dose group and 10 of 10 in the high-dose group of Androxal treatment experienced a restoration of normal testosterone levels. There were no statistically significant changes within the placebo group.

Data comparing the Androxal and AndroGel groups are currently being analyzed. Full results of the study will be presented at the International Congress of Endocrinology beginning Aug. 31 in Lisbon, Portugal, and the American Society for Reproductive Medicine meeting scheduled to begin Oct. 16 in Philadelphia.

Zonagen shares closed at $4.54 in heavy trading on the Nasdaq.