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Atrix Reports Positive Phase III Results for Leuprogel(TM) Three-Month Depot Prostate Cancer Product.

FORT COLLINS, Colo., July 10 /PRNewswire/ --

Atrix Laboratories, Inc. (Nasdaq: ATRX) today announced results from its Phase III study of Leuprogel(TM) Three-Month Depot, 22.5 mg, leuprolide acetate for subcutaneous depot injection, for the treatment of advanced prostate cancer. Atrix will submit its second New Drug Application (NDA) later this year for marketing approval of the Leuprogel Three-Month Depot product to the U.S. Food and Drug Administration (FDA). The Phase III data for 117 patients enrolled in the Leuprogel Three-Month Depot study showed 100% suppression of serum testosterone to very low levels. In addition to achieving low mean testosterone levels, mean PSA levels were also decreased to low single-digit levels in the study and no serious treatment-related adverse events were recorded over the course of treatment with Leuprogel Three-Month Depot.

"The results of this study exceeded our expectations," said Dr. Steve Garrett, vice president of clinical development. "At the end of the study, 100% of the patients were suppressed below the generally accepted testosterone level of 50 ng/dL and 94% of the patients had steady-state testosterone levels below the more stringent National Comprehensive Cancer Network (NCCN) recommendations."

Breakthrough occurred in less than 1% of the total patients receiving Leuprogel. One patient in the Leuprogel Three-Month Phase III study was reported to have testosterone breakthrough, however the patient's testosterone level was below the FDA suppression level following the second injection resulting in 100% of patients achieving and maintaining testosterone suppression in this study.

"I am pleased that we are demonstrating a high sense of urgency in moving the Leuprogel products toward U.S. marketing," said David R. Bethune, chairman and chief executive officer. "Last February, we filed an Investigational New Drug Application (INDA) to move Leuprogel Three-Month Depot into humans. Just a year and a half later, we are now preparing the NDA for this product, the second NDA in one year for this company. The Atrix team knows the importance of speed to market."

Atrix is in late-stage development of three Leuprogel products for one-, three- and four-month sustained release of leuprolide acetate using Atrix's Atrigel(R) depot drug delivery system. The goal of this therapy is to reduce testosterone in the body to inhibit the growth of hormone-responsive advanced prostate cancer. The liquid Leuprogel 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.

In March, Atrix filed an NDA for the Leuprogel One-Month Depot 7.5 mg product and this application is under active review at the FDA. Earlier this year, Atrix licensed the U.S. and Canadian marketing rights for the Leuprogel products to Sanofi-Synthelabo in a $60 million agreement. Similarly in April, Atrix signed a licensing agreement with MediGene AG for the European marketing rights for the products.


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. Atrix has strategic alliances with several pharmaceutical companies including recent collaborations with Pfizer, Elan Corporation Plc, Sanofi-Synthelabo, MediGene and the Novartis company -- Geneva Pharmaceuticals, to use its drug delivery technologies and expertise in the development of new products. Additional information is available on the Atrix Laboratories, Inc. Web site at

Statements contained in this press release, which are not historical facts, are forward-looking statements, as the term is defined in the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to risks and uncertainties which can cause actual results to differ materially from those currently anticipated, due to a number of factors, which include, but are not limited to, product demand, pricing, market acceptance, changing economic conditions, risks in product and technology development, the effect of the company's accounting policies and other risk factors discussed in documents filed by the company with the Securities and Exchange Commission from time to time.

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Publication:PR Newswire
Date:Jul 10, 2001
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