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Androgel(TM) Approved In Canada ~ First Gel Testosterone Replacement Therapy Now Available ~ TORONTO, ON -- May 14, 2002 -- Solvay Pharma Inc. (Solvay) today announced the Health Canada approval, and availability, of AndroGel™ (testosterone USP) 1 % gel as a treatment for male testosterone insufficiency (low testosterone or andropause). This approval makes AndroGel™ the only gel approved by Health Canada as an effective and safe treatment for conditions associated with testosterone insufficiency in men. More than one million Canadian men have testosterone insufficiency(1), a medical condition linked to depressed mood and fatigue, reduced lean body mass and muscle strength, decreased bone density - which can lead to osteoporosis - lower interest in sex, and erectile dysfunction. "Men need to realize that the symptoms of low testosterone - fatigue, negative moods, and loss of sex drive for example - do not have to be accepted as a normal sign of aging. Testosterone insufficiency is a medical condition that can be treated," said Dr. Jack Barkin, Chief of Urology and Deputy Chief of Surgery at Humber River Regional Hospital, and Director of The Male Health Centre in Toronto. "In clinical studies, AndroGel™ has demonstrated improvements in mood, energy levels, muscle strength, bone density and sexual desire in men with testosterone insufficiency. AndroGel™ helps to bring back a man's vitality." Androgel™ Has Clear Advantages AndroGel™ is a clear, colourless, fragrance-free topical gel that men apply once daily to the shoulders, upper arms or abdomen. The gel dries rapidly, during which time the skin absorbs the testosterone. Due to the unique gel delivery system, AndroGel™ has significant advantages over other therapies currently available. With AndroGel™, normal testosterone levels are quickly restored and maintained, providing consistent symptom relief, in contrast to the more variable results achieved with pills or injections. Unlike having to contend with a number of daily pills or often painful injections that require repeated physician visits, AndroGel™ provides men with an easy-to-use treatment that can be applied once-a-day at home. With AndroGel™, men suffering from testosterone insufficiency now have a better alternative to using visible patches. Clinical data from a U.S. phase III study conducted on men with testosterone insufficiency indicated that AndroGel™ quickly raised circulating testosterone to normal levels and maintained it within the normal range. The study also found that AndroGel™ helped improve mood and relieved fatigue, while it improved bone mineral density, libido (sexual desire) and erectile function, lean body mass and muscle strength in affected men. "Testosterone insufficiency starts affecting men who are in their prime, productive years," said Dr. Laurence Downey, President and Chief Executive Officer, Solvay Pharma Inc. "Solvay Pharma is committed to the area of men's health and we are pleased to provide a therapy that can aid the approximately one million men in Canada who suffer from testosterone insufficiency." Testosterone Insufficiency Often Misunderstood And Overlooked Recent data from a survey of approximately 350 urologists, endocrinologists, general practitioners and pharmacists indicated that 46 per cent of physicians are treating andropause. Interestingly, data from the same survey indicates that only five per cent of male patients ask their physicians about treatment options for andropause. The survey was conducted under the direction of Dr. Roland R. Tremblay, D.Sc, M.D., PhD, Endocrinologist and Andrologist at Laval University Hospital, past-president of the Canadian Andropause Society, for use in future educational programs in Canada. "It is estimated that only five per cent of men with testosterone insufficiency currently receive treatment," said Dr. Tremblay. "Now that there is a new advance in the treatment of testosterone insufficiency with AndroGel™, which is effective and easy to use, we hope that men may be more motivated to speak to their physicians about this condition." Results from a national survey released today, conducted by POLLARA Inc., also revealed a lack of understanding among the Canadian public about testosterone insufficiency and its associated effects. Of those Canadians polled over the age of 35, only three per cent could name andropause as the condition associated with low testosterone levels. A further seven in 10 Canadians were unable to mention any consequences of low testosterone levels in men. The survey also showed that the majority of Canadians age 35 and older believe that the symptoms associated with low testosterone, such as fatigue and loss of sexual desire, are merely a normal part of the aging process. "However, it is important to recognize that testosterone insufficiency is a significant medical concern deserving of attention and effective treatment," said Dr. Barkin. Men And Bone Health Additionally, the POLLARA survey found that nearly 80 per cent of men and women were not aware that low testosterone levels can result in osteoporosis. However, one of the effects of testosterone insufficiency in men is the risk of osteoporosis: 50 per cent of men with low levels of testosterone have bone-mineral density below the young adult range.(2) In Canada, one-in-eight men over the age of 50 have osteoporosis, while 20 to 30 per cent of osteoporotic fractures occur in men. Elderly men account for almost 35 per cent of hip-fracture cases. Strikingly, men are also more likely to die after a hip fracture than women(3); when asked, 90 per cent of those surveyed were not aware of this statistic prior to the poll. Testosterone replacement therapy is often effective in treating these men who have low levels of testosterone. AndroGel™ has a positive effect on bone health; in a controlled clinical trial, using a 10-gram dose for 180 days, AndroGel™ produced a significant increase in bone mineral density of both the hip and spine. Androgel™ Safety Profile Safety data from clinical studies of AndroGel™ demonstrate it to be well tolerated. Androgens are contraindicated in men with carcinoma of the breast, or known or suspected carcinoma of the prostate. Elderly patients treated with androgens may be at an increased risk of developing prostatic hyperplasia and prostatic carcinoma although conclusive evidence to support this concept is lacking. AndroGel™ is not indicated for use in women and children and has not been evaluated in women and children. Women, especially pregnant women, should avoid skin contact with AndroGel™ application sites in men. Testosterone may cause fetal harm. AndroGel™ was approved in the U.S. in June 2000. For full prescription information in Canada, physicians and patients may call 1-800-268-4276. Solvay Pharma Inc. is a research-based pharmaceutical company in the therapeutic areas of gastroenterology, mental health, men's health, women's health and cardiology. Solvay Pharma Inc. is a member of the worldwide Solvay Group of chemical and pharmaceutical companies, headquartered in Brussels, Belgium. Solvay has operations in 50 countries and employs some 32,000 people. POLLARA Inc. is Canada's largest public opinion and marketing research firm. Using innovative, leading-edge research techniques, POLLARA provides a full range of research services including quantitative and qualitative research and counsel in the areas of public affairs/public policy, health care, employee satisfaction, and consumer demand and pricing models. Results from the POLLARA study are based on telephone interviews with a random sample of 920 Canadians aged 35 and older conducted between April 1 - 10, 2002. The results are accurate to within ± 3.3 percentage points 19 times out of 20. Solvay Pharma Inc. sponsored the survey. References: 1 Harman et al. Journal of Clinical Endocrinology and Metabolism 2001. Vol. 86:2, 724-31, and Statistics Canada data, 1991, CANSIM II. 2 A. Kenny et al. Endocrine Research 2000; 26 (2):153-68. 3 Osteoporosis Society of Canada, Web site: http://www.osteoporosis.ca For additional information, or to set-up an interview with a physician or patient, please contact: Cathy Metson/Laura Pagnotta Edelman Public Relations Canada Tel.: (416) 979-1120 ext. 223/224 SOURCE: Solvay Pharma Inc E-mail this page to a friend or colleague! To print, use this version