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Hormone Therapy With Innovative Delivery System Available For Prostate Cancer Eligard 7.5 mg (Leuprolide Acetate For Injectable Suspension) NEW YORK, NY -- May 28, 2002 -- Today Sanofi-Synthelabo Inc. announced the commercial availability of Eligard™ 7.5 mg (leuprolide acetate for injectable suspension), an innovative hormone therapy for the palliative treatment of advanced prostate cancer. Eligard 7.5 mg suppresses testosterone to traditional castrate levels and also meets the more stringent guidelines of the National Comprehensive Cancer Network (NCCN). The recently approved one-month formulation employs a unique drug delivery system that delivers leuprolide acetate subcutaneously. The announcement came at the conclusion of the Annual Meeting of the American Urological Association in Orlando, Fla. "Expert oncologists from NCCN's 17 member institutions have developed our Prostate Cancer Treatment Guidelines," explains Rodger Winn, M.D., chairman of the NCCN Guidelines Steering Committee. "These guidelines are updated annually and use both peer-reviewed clinical data and professional consensus. They help to ensure the efficiency of care delivery by providing medical practitioners with access to the best scientific information to guide treatment decisions." An open-label, multicenter study evaluated 120 patients with advanced prostate cancer who were treated with six monthly injections of Eligard™ 7.5 mg. Eighty-nine patients had stage C disease and 31 patients had stage D disease. This study evaluated the achievement and maintenance of serum testosterone suppression over six months of therapy. Serum testosterone was suppressed to below =50 ng/dL by Day 28 (Week 4) in 112 of 119 (94.1 percent) patients remaining in the study. The remaining seven patients all attained serum testosterone suppression by Day 42. At the conclusion of this trial (month six) all 117 patients who completed the study had testosterone levels at or below 50 ng/dL. In addition to controlling testosterone levels, another consideration when treating men with hormone therapy is the side effects. In the patient populations studied, a total of 86 hot flash/sweats adverse events were reported in 70 patients, of these, 71 events (83 percent) were mild; 14 (16 percent) were moderate; one (one percent) was severe. Eligard 7.5 mg uses the ATRIGEL® drug delivery system to provide continuous release of leuprolide acetate over a one-month treatment period. The ATRIGEL drug delivery system consists of biodegradable polymers. The ATRIGEL system is mixed with the active drug and then injected just under the skin as a viscous liquid. The liquid quickly solidifies into a solid implant, essentially a small bead of medication that slowly dissolves to release a continuous supply of leuprolide acetate for the one-month period. "Many advances have been made in the hormonal treatment of prostate cancer," said A. Oliver Sartor, M.D., director of the Stanley S. Scott Cancer Center at LSU Medical School in New Orleans, La. "In particular, Eligard 7.5 mg utilizes a new delivery system for a proven drug that has been used in prostate cancer for more than a decade. This delivery system has proven to deliver a leuprolide acetate over a 30-day period in a manner that results in a consistently very low level of testosterone thereby helping to optimally manage this difficult disease." With sales in 2001 of $6 billion and 30,000 employees in more than 100 countries, Sanofi-Synthelabo ranks among the world's top 20 pharmaceutical companies. Sanofi-Synthelabo is focused on a core group of four therapeutic areas: cardiovascular disease and thrombosis; diseases of the central nervous system; internal medicine; and oncology. Eligard 7.5 mg is marketed by Sanofi-Synthelabo Inc. under a licensing agreement with Atrix Laboratories. For full prescribing information, please call Sanofi-Synthelabo product information 800-446-6267. ATRIGEL is a registered trademark of Atrix Laboratories, Inc. Important Safety Information Eligard 7.5 mg is contraindicated in women, pediatric patients, and patients with hypersensitivity to GnRH, GnRH antagonists, or any of the components of Eligard 7.5 mg. Eligard 7.5 mg, like other LHRH agonists, causes a transient increase in serum concentrations of testosterone during the first week of treatment. Patients may experience worsening of symptoms or onset of new signs and symptoms during the first few weeks of treatment. As with all LHRH agonists, periodic monitoring if PSA and serum testosterone levels is recommended. In a clinical study (N=120), the most common systemic adverse events were hot flashes/sweats (56.7 percent), malaise and fatigue (17.5 percent), atrophy of testes (5.0 percent), dizziness (3.3 percent), and gastroenteritis/colitis (2.5 percent). Transient burning/stinging at the injection site was reported following 34.6 percent of the injections (N=716 injections). The most common other events at the injection site were pain (18.3 percent of patients), erythema (12.5 percent of patients) and mild bruising (11.7 percent of patients). The majority of injection-site adverse events were mild and brief in duration. SOURCE: Sanofi-Synthelabo Inc E-mail this page to a friend or colleague! To print, use this version