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FDA Approves Eligard 30mg (Leuprolide Acetate for Injectable Suspension), Four-Month Prostate Cancer Product

-- Approval Provides Full Market Participation

-- Third FDA Approval in Thirteen Months

-- Company Provides Information on Fourth Quarter/Year-ended 2002

FORT COLLINS, CO -- February 18, 2003 -- Atrix Laboratories, Inc. (Nasdaq: ATRX) announced today that the company has received approval from the U.S. Food and Drug Administration (FDA) for Eligard® 30mg (leuprolide acetate for injectable suspension), for the palliative treatment of advanced prostate cancer. Similar to the other Eligard products, this approval came 10 months from submission.

This approval, along with the approvals of both Eligard 7.5mg one-month and Eligard 22.5mg three-month prostate cancer products, means that the Eligard product line now has the opportunity to compete in the entire $1 billion U.S. hormone therapy market opportunity for hormone-sensitive prostate cancer. Eligard 30mg will be marketed in the U.S. by Sanofi- Synthelabo (NYSE: SNY). Sanofi-Synthelabo currently markets Eligard 7.5mg and Eligard 22.5mg in the U.S.

"A third FDA approval in 13 months clearly demonstrates the world-class skill and expertise of the Atrix team," said David R. Bethune, Atrix's chairman and chief executive officer. "Sales of the first two Eligard products are increasing month-to-month and we expect further reorders in the coming months. The approval of Eligard 30mg now enables the franchise to compete in the complete U.S. marketplace. Almost half of the total $1 billion market for prostate cancer hormone therapy consists of the four-month product. With the near-term launch of Eligard 30mg, we now have the opportunity to begin to understand the real adoption cycle for these products."

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.

Eligard 30mg, 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 Eligard 30mg should be monitored by measuring serum concentrations of testosterone and prostate specific antigen periodically.

Fourth Quarter
The company also estimates 2002 fourth quarter losses will be between $0.28 - $0.32 per share and a full year 2002 loss in the range of $0.96 - $0.99 per share.

Brian Richmond, Atrix's chief financial officer commented, "Issues impacting the fourth quarter 2002 were primarily based on timing of the Eligard launch and adoption. Also, we have increased R&D spending relating to the Atrisone™ Phase III trials and also incurred one-time expenses due to the establishment of a sales force in Germany for the direct marketing of Atridox™. We believe that these expenses are investments in the future. Comparing year-to-year financials, we continue to exhibit consistent revenue growth. For the year-ended 2002, we estimate a 70-75% increase in total revenue compared to total revenue for the year-ended 2001. Based on current trends in revenue growth, particularly with respect to Eligard, we remain on track in 2003. We project R&D spending to grow moderating within a range of $35 - $39 million, focusing the majority of our R&D budget on near-term value drivers including Atrisone and the extended-release Eligard 45mg product."

The company believes that results for 2003 will be affected by a number of factors including the approval of products, the ramp up in sales of the Eligard product line, sale of Atridox in Europe and the U.S., and specific R&D expenditures, other international and national economic trends, conditions and other factors.

About Atrix Laboratories, Inc.
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 2002/2003, company's estimates of 2002 total revenue increases and fourth-quarter/year ended loss range, the estimated R&D spending in 2002/2003; the company's expectations for Eligard and expectation that Sanofi-Synthelabo Inc. will successfully market Eligard and launch Eligard 30mg, its expectation of receiving royalties on sales of Eligard, its plan to manufacture Eligard 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, 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, 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 September 30, 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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