Healthcare Industry News: Solvay Pharmaceuticals
News Release - September 13, 2006
Unimed Pharmaceuticals, Inc. Settles AndroGel(R) Litigation with Watson Pharmaceuticals, Inc. and Paddock Laboratories/Par Pharmaceutical Companies, Inc.MARIETTA, Ga., Sept. 13 (HSMN NewsFeed) -- Unimed Pharmaceuticals, Inc., a wholly owned subsidiary of Solvay Pharmaceuticals, Inc., today announced that it has settled all pending patent litigation with Watson Pharmaceuticals, Inc. and Paddock Laboratories/Par Pharmaceutical Companies, Inc. in connection with each company's Abbreviated New Drug Application (ANDA) for a generic version of AndroGel® (testosterone gel) 1% CIII. Unimed Pharmaceuticals holds the exclusive rights in the United States to the AndroGel patent under a license with Laboratories Besins Iscovesco, the co-plaintiff in the patent litigation. AndroGel is approved by the Food and Drug Administration (FDA) in the United States for replacement therapy in men with conditions associated with a deficiency or absence of endogenous testosterone.
Under the separate settlements, a generic version of AndroGel may be marketed beginning in 2015, approximately five years prior to AndroGel patent expiry in 2020. These settlements allow Solvay Pharmaceuticals to avoid the uncertainty and cost of prolonged litigation. In turn, the company will devote its resources to growing its U.S. business and to advancing its research and development initiatives in strategic therapeutic areas, including cardio-metabolic, neuroscience and men's health.
Solvay Pharmaceuticals also has entered into separate long-term commercial agreements for AndroGel with Watson and Par in the United States, effective October 1, 2006. Solvay Pharmaceuticals will continue to support AndroGel with its own sales force.
-- Solvay Pharmaceuticals has entered into a co-promotion agreement with Watson. Watson will provide promotional support for AndroGel by detailing urologists through its U.S. sales representatives.
-- Solvay Pharmaceuticals has entered into extended-reach and back-up manufacturing agreements with Par. Under the extended-reach agreement, members of the U.S. Par sales force will supplement the Solvay Pharmaceuticals sales force and provide promotional support for AndroGel by detailing additional physicians in both new geographical regions and existing territories. Par also will serve as a manufacturer for back-up supply of AndroGel in the United States.
"AndroGel has helped hundreds of thousands of hypogonadal men by returning testosterone levels to the normal range and relieving their symptoms, but many men suffering from this condition remain undiagnosed," said Laurence Downey, MD, president and CEO of Solvay Pharmaceuticals, Inc. "Through these agreements, Solvay Pharmaceuticals is able to extend the reach of AndroGel information to more physicians and ultimately men about the diagnosis and treatment of low testosterone."
Solvay Pharmaceuticals will continue to assess additional applications for AndroGel, like the metered-dose AndroGel Pump® introduced in 2004. Solvay Pharmaceuticals also will evaluate the feasibility of expanding current FDA-approved indications, such as its proof-of-concept trial to evaluate the efficacy and safety of AndroGel in men with type 2 diabetes and low testosterone; and it will invest in next-generation products for men with low testosterone, as in its clinical development program for a low volume version of AndroGel.
About Low T
It is estimated that hypogonadism, also known as low testosterone (low T), affects up to 13 million men age 45 and older. Because symptoms of low T are subtle and often overlap with other common medical conditions, low T is frequently undiagnosed. Signs and symptoms include low sex drive, erectile dysfunction, fatigue, depressed mood, reduced muscle mass and strength, increased fat body mass and decreased bone mineral density. Men with chronic conditions, such as obesity, diabetes and hypertension, also are more likely to have low T compared to other men. Below normal levels of testosterone can be confirmed by a simple blood test. Testosterone treatment is designed to elevate a hypogonadal man's testosterone levels into the normal physiologic range and alleviate symptoms. As with any medication, patients should work with their physician to weigh treatment benefits and risks.
AndroGel is a once-daily, clear, odorless topical testosterone gel approved by the U.S. Food and Drug Administration (FDA) in 2000 for replacement therapy in men for conditions associated with a deficiency or absence of endogenous testosterone. AndroGel is the first testosterone gel to be approved by the FDA. It is also the number one prescribed form of testosterone therapy in the United States.
AndroGel is the first and only FDA-approved testosterone gel available in a non-aerosol, metered-dose pump, which is designed to deliver 1.25 grams of testosterone gel per pump depression. AndroGel also is available in 2.5 and 5 gram packets. This gives patients two convenient ways for using AndroGel and offers physicians added flexibility to dose it from the starting dose of 5g per day to 7.5g or from 7.5g to 10g per day as needed.
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. Geriatric patients treated with androgens may be at an increased risk for the development of enlarged prostate and prostate cancer. Please refer to the AndroGel prescribing information for complete safety information.
Information about AndroGel may be found online at: http://www.androgel.com .
About Solvay Pharmaceuticals, Inc.
Solvay Pharmaceuticals, Inc., of Marietta, Georgia is the U.S. subsidiary of Solvay Pharmaceuticals. For more information, visit http://www.solvaypharmaceuticals-us.com .
Solvay Pharmaceuticals is a research driven group of companies that constitute the global pharmaceutical business of the Solvay Group. The company seeks to fulfill carefully selected, unmet medical needs in the therapeutic areas of neuroscience, cardio-metabolic, influenza vaccines, gastroenterology, specialized markets and men's and women's health. Its 2005 sales were EUR 2.3 billion and it employs approximately 10,000 people worldwide. For more information, visit http://www.solvaypharmaceuticals.com .
SOLVAY is an international chemical and pharmaceutical Group with headquarters in Brussels. It employs some 30,000 people in 50 countries. In 2005 its consolidated sales amounted to EUR 8.6 billion generated by its three activity sectors: Chemicals, Plastics and Pharmaceuticals. SOLVAY (Euronext: SOLB.BE - Bloomberg: SOLB.BB - Reuters: SOLBt.BR) is listed on the Euronext stock exchange in Brussels. Details are available at http://www.solvay.com .
Source: Solvay Pharmaceuticals
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