FORT COLLINS, Colo., Dec. 16 /PRNewswire-FirstCall/ -- Atrix Laboratories, Inc. announced today that Mayne Pharmaceutical, Atrix's licensee, has received marketing approval of Eligard(R) (leuprolide acetate for injectable suspension) one-, three- and four-month prostate cancer product in Australia from the Australian Drug Evaluation Committee.
"We continue to make great progress in making Eligard available around the world as a new choice in hormone therapy for men with advanced prostate cancer," said David R. Bethune, Atrix's chairman & chief executive officer. "Currently, Eligard is marketed in the U.S. and Argentina, with recent approvals in Canada, Germany, and now Australia. This latest approval validates Atrix's confidence in the long-term value of the Eligard product line."
Bethune continued, "With this latest approval, we are producing product in our newly expanded manufacturing facility for shipment to Mayne and anticipate launch of Eligard in Australia by second quarter of next year."
The Australian market for luteinizing hormone releasing hormone (LHRH) therapy for advanced prostate cancer is approximately $40 million. Mayne is currently expected to launch the Eligard products by second quarter of 2004 following application and approval for re-imbursement status in Australia. Eligard 7.5mg, 22.5mg and 30mg products for advanced prostate cancer are currently marketed in the U.S. by Sanofi-Synthelabo, Inc.
Sustained levels of leuprolide acetate decrease testosterone levels to suppress tumor growth in patients with hormone-responsive prostate cancer. The liquid Eligard products, using Atrix's proprietary Atrigel(R) sustained-release drug delivery technology, are injected subcutaneously with a small gauge needle, forming a solid implant in the body that slowly releases leuprolide as the implant is bioabsorbed.
Eligard products, like other hormonal treatments for prostate cancer, cause 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. Response to these products should be monitored by measuring serum concentrations of testosterone and prostate specific antigen periodically.
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. Additional information is available on the Atrix Laboratories, Inc. website at http://www.atrixlabs.com/ .
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 as a global product, the company's expectation that Mayne will launch Eligard by the second quarter of 2004, the company's expectation that Eligard will be approved for reimbursement status in Australia, the company's expectation that their marketing partners will be able to successfully market any products developed and approved, and the company's plan to manufacture the Eligard products at its facility in Fort Collins, Colorado. 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 risks associated with product demand, pricing, market acceptance, changing economic conditions, risks in product and technology development 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, 2002 and the company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2003. 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.
Eligard(R) is a registered trademark of Sanofi-Sythelabo.
Atrix Laboratories, Inc.