FORT COLLINS, Colo., June 1 /PRNewswire-FirstCall/ -- Atrix Laboratories, Inc. announced today that Tecnofarma International Ltd., Atrix's Latin America licensee, received marketing authorization from the Mexican regulatory authorities for the company's one- and three-month prostate cancer products. Eligard 7.5mg (leuprolide acetate for injectable suspension) one-month prostate cancer product was launched in May. Eligard(R) 7.5mg and 22.5mg (leuprolide acetate for injectable suspension) are indicated for the palliative treatment of hormone sensitive advanced prostate cancer.
"We estimated the private market in Mexico to be approximately $4 million. However, regardless of the size of the market, it is our goal to make Eligard a global product and give access to this new treatment option for prostate cancer patients around the world," said Michael R. Duncan, Atrix's vice president and general manager.
Additionally, Tecnofarma has submitted for marketing authorizations in Peru, Venezuela, Bolivia, Chile and in other countries of the region. Tecnofarma currently markets Eligard in Argentina. The estimated total market for hormone therapies like Eligard is approximately $3.3 million.
In 2002, Tecnofarma entered into a supply agreement for Eligard in Latin America including Mexico. Atrix will manufacture the products in its Fort Collins, Colorado facility. Tecnofarma is a privately held company that develops, manufactures, and markets a wide range of pharmaceutical products. The company has a sales force of over 1,200 sales representatives covering 16 countries throughout Latin America and focuses on several therapeutic areas including oncology and urology.
Leuprolide acetate is a lutenizing 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.
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 unique sustained release and topical 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 estimates of the LHRH markets in Mexico, the company's expectation that Tecnofarma will be able to achieve marketing approvals in Peru, Venezuela, Bolivia, and Chile and successfully market the products, and the stated goal to make Eligard a global product. 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, the company's expectation to manufacture the product in its facility in Fort Collins, Colorado, market acceptance, changing economic conditions, political instability, 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, 2003 and the company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2004. All forward-looking statements in this press release are made as of the date hereof, based on information available to the company as of the date hereof, and the company assumes no obligation to update or revise any of its forward-looking statements even if experience or future changes show that the indicated results or events will not be realized.
Atrix Laboratories, Inc.