Atrix Laboratories, Inc. announced that Mayne Pharmaceutical, Atrix's licensee, has received marketing approval of Eligard (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 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.