FDA APPROVES ATRIX'S PROSTATE CANCER PRODUCT.Atrix Laboratories, Inc. (Nasdaq: ATRX ATRX Alpha-Thalassemia/Mental Retardation Syndrome, Nondeletion Type, X-Linked ), Fort Collins, Colo., has received approval from the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. for Eligard(TM) 7.5 mg (formerly Leuprogel One-Month Depot), leuprolide acetate leu·pro·lide acetate n. A synthetic polypeptide analog of naturally occurring gonadotropin-releasing hormone used in the treatment of advanced prostate cancer. for subcutaneous injection for treatment of advanced prostate cancer prostate cancer, cancer originating in the prostate gland. Prostate cancer is the leading malignancy in men in the United States and is second only to lung cancer as a cause of cancer death in men. . Atrix and Sanofi-Synthelabo Inc., Atrix's marketing partner for the Eligard product line, anticipates this new therapy will be an important addition in the fight against prostate cancer. "The 10-month review and approval of Eligard 7.5 mg represents a major achievement in the development of the Atrix product pipeline of value drivers," said David R. Bethune, chairman and chief executive officer at Atrix. "We're proud of the Eligard team. In the pharmaceutical world, a 10-month 'FDA approval' says volumes about the strength of this company. The Atrix team knows how to get it right the first time." Bethune continued, "This type of treatment has become a mainstay therapy for advanced prostate cancer as evidenced by $1.2 billion in estimated annual U.S. sales. Eligard 7.5 mg will provide a new treatment option for men with advanced prostate cancer." According to the American Cancer Society American Cancer Society, n.pr established in 1913, this national volunteer-based health organization is committed to the elimination of cancer through prevention and treatment and to diminishing cancer suffering through advocacy, scholarship, research, , prostate cancer is the most common cancer, excluding skin cancers, in American men. It is estimated that during the year 2002, approximately 189,000 new cases of prostate cancer will be diagnosed in the United States and an estimated 30,200 men will die of the disease. Approximately one man in six will be diagnosed with prostate cancer during his lifetime. Gordon Proctor, president of Sanofi-Synthelabo Inc. commented, "The rapid approval of Eligard 7.5 mg exceeded our expectations. Sanofi-Synthelabo Inc. has been working diligently in conjunction with Atrix to bring Eligard 7.5 mg to the tens of thousands of patients who could benefit most. Our sales force will be dedicated to the success of this product." Last year, Atrix licensed North American North American named after North America. North American blastomycosis see North American blastomycosis. North American cattle tick see boophilusannulatus. marketing rights to the Eligard prostate cancer products to Sanofi-Synthelabo Inc., a subsidiary of the global healthcare company, Sanofi-Synthelabo. Under terms of the agreement, Atrix will receive royalties on sales of the Eligard products and will manufacture the products at its facility in Fort Collins, Colorado The City of Fort Collins, a home rule municipality situated on the Cache la Poudre River along the Colorado Front Range, is the county seat and most populous city in Larimer County, Colorado. . Additionally, Atrix has licensed the European marketing rights to MediGene AG in a similar agreement. The total worldwide market for this type of therapy is estimated at $2.4 billion. Sanofi-Synthelabo Inc. is the U.S. subsidiary of Sanofi-Synthelabo, the global healthcare company. With 2000 sales of 6 billion euros and 30,000 employees in more than 100 countries, Sanofi-Synthelabo ranks among the world's top 20 pharmaceutical companies. Currently, they have 2,000 sales representatives in the U.S. Sanofi-Synthelabo's world headquarters are located in Paris, France; U.S. headquarters are in New York New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of . Atrix is developing two additional Eligard products that release leuprolide acetate over a period of three and four months using Atrix's Atrigel(R) Depot drug delivery system. Sustained levels of leuprolide, a leutinizing hormone-releasing hormone (LHRH LHRH abbr. luteinizing hormone-releasing hormone LHRH Luteinizing hormone-releasing hormone, GnRH, gonadotropin-releasing hormone, LRH, LRF Endocrinology A decapeptide synthesized by hypothalamic neurons which ) agonist agonist /ag·o·nist/ (ag´ah-nist) 1. one involved in a struggle or competition. 2. agonistic muscle. 3. , decreases testosterone levels to suppress tumor growth in patients with hormone-responsive prostate cancer. The liquid Eligard products are injected subcutaneously with a small gauge needle, forming a solid implant in the body that slowly releases leuprolide as the implant is bioabsorbed. In September, Atrix submitted a New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) for Eligard 22.5 mg (formerly Leuprogel Three-Month Depot) to the FDA and anticipates submitting an NDA for Eligard 30 mg (formerly Leuprogel Four-Month Depot) to the FDA in the first half of 2002. About Atrix Laboratories, Inc. Atrix Laboratories, Inc. is an emerging specialty pharmaceutical company focused on advanced drug delivery. With five unique patented technologies, Atrix is currently developing a diverse portfolio of proprietary products, including oncology, pain management, and dermatology products. The company also partners with large pharmaceutical and biotechnology companies to apply its proprietary technologies to new chemical entities or to extend the patent life of existing products. For more information, visit http://www.atrixlabs.com or call 970-482-5868. |
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