eligard

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

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

Interim Phase III clinical data presented at the Tenth Annual CaP CURE ScientificRetreat suggested Eligard 45mg suppresses testosterone to low levels with minimalbreakthroughs, a situation where testosterone levels rise above the castratethreshold of 50 ng/dL.

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

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

Eligard, like other hormonal treatments for prostate cancer, causes a transientincrease in serum concentrations of testosterone during the first week of treatment eligard. Patients may experience worsening of symptoms or onset of new signs and symptomsduring the first few weeks of treatment eligard. Response to these products should bemonitored by measuring serum concentrations of testosterone and prostate specificantigen periodically.

Atrix Laboratories, Inc eligard. is an emerging specialty pharmaceutical company focusedon advanced drug delivery eligard. With unique extended release and topical technologies,Atrix is currently developing a diverse portfolio of proprietary products, includingoncology and dermatology products eligard. The company also partners with large pharmaceuticaland biotechnology companies to apply its proprietary technologies to new chemicalentities or to extend the patent life of existing products eligard. Additional informationis available on the Atrix Laboratories, Inc eligard. website at www.atrixlabs.com.

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