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| |  FDA Approves Eligard 22.5mg (Leuprolide Acetate for Injectable Suspension), Three-Month Prostate Cancer Product - Atrix's Second NDA Approved This Year - FORT COLLINS, CO -- July 25, 2002 -- Atrix Laboratories, Inc. announced that the company has received approval from the U.S. Food and Drug Administration (FDA) for Eligard™ 22.5mg (leuprolide acetate for injectable suspension), for the palliative treatment of advanced prostate cancer. Approval of the Eligard 22.5mg (three-month sustained release product), comes following a less than ten-month approval process for the New Drug Application (NDA) and is the second Eligard product to be approved in 2002. Eligard 7.5mg (leuprolide acetate for injectable suspension), a once-a-month sustained release product, was approved in late January 2002 after a ten-month review by FDA. Atrix's marketing partner, Sanofi-Synthelabo Inc. will market both products in the U.S. Eligard 7.5mg was officially launched at the American Urological Association meeting. "To receive FDA approval of a second NDA in less than ten-months is a major achievement for Atrix," said David R. Bethune, Atrix's chairman and chief executive officer. "Rapid approval of the one-month and three-month Eligard products has created the largest revenue opportunity that Atrix has ever had. I congratulate the Atrix team for this great accomplishment." A standard treatment regimen for advanced prostate cancer often includes a urologist starting a patient on one-month luteinizing hormone releasing hormone (LHRH) therapy and then moving to a longer release product if the patient responds to therapy. According to the National Cancer Institute, a majority of advanced prostate cancer patients will receive LHRH therapy, like Eligard, during the course of their treatment regimen. The American Cancer Society estimates that prostate cancer is the most common cancer, excluding skin cancers, in American men. 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. "Atrix has succeeded again, achieving approval for a second Eligard product," said Gordon Proctor, president of Sanofi-Synthelabo Inc. "Now the ball is in our court to take this franchise and make it a sales success. We are prepared for the challenge." Proctor continued, "Sanofi-Synthelabo is assembling a specialized urology sales force dedicated to the marketing and distribution of all dosage strengths of Eligard. Our plans are to focus our efforts on the over 5,000 practicing urologists in the United States by the end of the year." Last year, Atrix licensed North American marketing rights to Eligard 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. 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. Sustained levels of leuprolide 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. About Sanofi-Synthelabo, Inc. About Atrix Laboratories, Inc. This press release contains statements that qualify as "forward-looking statements" under the Private Securities Litigation Reform Act of 1995, including statements about the following topics: the company's expectations for Eligard; its estimate of the U.S. and total worldwide market for this type of therapy; the company's expectation of Sanofi-Synthelabo Inc. to successfully market Eligard; its expectation of receiving royalties on sales of Eligard and its plan to manufacture Eligard at its facility in Fort Collins, Colorado; and its plans to develop two additional Eligard products over the next several months. The company is subject to certain risk factors that may cause actual results to differ materially from anticipated results. Those risks include, but are not limited to, the following: risks associated with product demand, pricing, market acceptance of its current and proposed products, changing economic conditions, risks in product and technology development, the risk that the FDA may not approve an NDA for Eligard 30 mg or the unique dosage form and competition from other products and treatments. For additional information about risk factors, please see the reports filed by the company with the SEC, including the company's Annual Report on Form 10-K for the year ended December 31, 2001 and the company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2002. The statements in this press release are made as of today, based on information currently known to management, and the company disclaims any duty to update such statements.
SOURCE: Atrix Laboratories, Inc.
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