MARIETTA, Ga. - (January 9, 2003) - Unimed Pharmaceuticals, Inc., a wholly owned subsidiary of Solvay Pharmaceuticals, Inc., today announced that the United States Patent and Trademark Office has granted a composition of matter patent for Unimed's product AndroGel® 1% (testosterone gel) CIII.
The patent, entitled "Pharmaceutical composition and method for treating hypogonadism," was issued on January 7, 2003 as U.S. Patent No. 6,503,894 and covers AndroGel® pharmaceutical composition, as well as a method of administering the composition and a unit dose containing the composition.
"We are very pleased to add this new patent to our portfolio," said Harold H. Shlevin, Ph.D., president and CEO of Solvay Pharmaceuticals, Inc. and Chairman of the Board at Unimed. "The patent is recognition of the novel gel forumulation of AndroGel®. This convenient delivery method is helping thousands of men suffering from low testosterone."
The patent is jointly owned by Unimed Pharmaceuticals, Inc. and Laboratories Besins Iscovesco. Unimed holds the exclusive rights in the United States to the patent under a license with Besins.
AndroGel® is a once-daily, clear, topical testosterone gel approved by the U.S. Food and Drug Administration for the treatment of conditions associated with hypogonadism, or low testosterone, in men. AndroGel® is available in 2.5g and 5g sachets. The FDA estimates that four to five million American men suffer from low testosterone, which is linked with conditions such as diminished interest in sex, erectile dysfunction (ED), reduced lean body mass, decreased bone density, depression and fatigue. Androgens are contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate. AndroGel® is not indicated for use in women, has not been evaluated in women, and must not be used in women.
Unimed Pharmaceuticals, Inc. a wholly owned, independently operated subsidiary of Solvay Pharmaceuticals, Inc., focuses on drugs with multiple indications in the therapeutic areas of men's health (urology and endocrinology), and certain infectious diseases.
Solvay Pharmaceuticals, Inc. of Marietta, Georgia, is a research-based pharmaceuticals company, active in the therapeutic areas of cardiology, gastroenterology, mental health and women's health. It is a member of the worldwide Solvay S.A. chemical and pharmaceutical group, headquartered in Brussels, Belgium.
