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Eligard - Atrix Submits New Drug Application to FDA for First of Its Kind Six-Month Prostate Cancer Product

FORT COLLINS, Colo., February 23, 2004 -- Atrix Laboratories, Inc. announced today that the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Eligard 45mg (leuprolide acetate for injectable suspension), a novel six-month sustained release product for hormone-sensitive advanced prostate cancer.

"We believe there will be significant interest by urologists in our six-month injectable hormone treatment for palliative treatment of advanced prostate cancer. This is the first NDA to be submitted to the FDA for a six-month LHRH product," said David R. Bethune, Atrix's chairman and chief executive officer.

Interim Phase III clinical data presented at the Tenth Annual CaP CURE Scientific Retreat suggested Eligard 45mg suppresses testosterone to low levels with minimal breakthroughs, a situation where testosterone levels rise above the castrate threshold of 50 ng/dL.

Leuprolide acetate is a luteinizing hormone releasing hormone (LHRH) agonist. Sustained levels of leuprolide acetate decrease testosterone levels to suppress tumor growth in patients with hormone-responsive advanced prostate cancer. The liquid Eligard product, using Atrix's proprietary Atrigel(R) sustained-release drug delivery technology, is injected subcutaneously with a small gauge needle, forming a solid implant in the body that slowly releases leuprolide as the implant is bioabsorbed.

Sanofi-Synthelabo Inc. is currently marketing one-month, three-month and four-month extended release Eligard products (Eligard 7.5mg, 22.5mg and 30mg) in the U.S indicated for the palliative treatment of advance prostate cancer. Following approval, Sanofi-Synthelabo will also market the six-month product.

Eligard, like other hormonal treatments for prostate cancer, 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. 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 unique extended release and topical technologies, Atrix is currently developing a diverse portfolio of proprietary products, including oncology 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.

Eligard is a registered trademark of Sanofi-Synthelabo Inc.

Posted: February 2004

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