Thursday January 24, 3:01 am Eastern Time
Press Release
SOURCE: Atrix Laboratories, Inc.
FDA Approves Atrix's Prostate Cancer Product
- To Be Marketed Under the Brand Name: Eligard(TM) 7.5 mg -
FORT COLLINS, Colo., Jan. 24 /PRNewswire-FirstCall/ -- Atrix Laboratories, Inc. (Nasdaq: ATRX - news) announced today that the company has received approval from the U.S. Food and Drug Administration (FDA) for Eligard(TM) 7.5 mg (formerly Leuprogel One-Month Depot), leuprolide acetate for subcutaneous injection for treatment of advanced prostate cancer. Atrix and Sanofi-Synthelabo Inc., Atrix's marketing partner for the Eligard product line, anticipates this new therapy will be an important addition in the fight against prostate cancer.
``The 10-month review and approval of Eligard 7.5 mg represents a major achievement in the development of the Atrix product pipeline of value drivers,'' said David R. Bethune, chairman and chief executive officer at Atrix. ``We're proud of the Eligard team. In the pharmaceutical world, a 10-month 'FDA approval' says volumes about the strength of this company. The Atrix team knows how to get it right the first time.''
Mr. Bethune continued, ``This type of treatment has become a mainstay therapy for advanced prostate cancer as evidenced by $1.2 billion in estimated annual U.S. sales. Eligard 7.5 mg will provide a new treatment option for men with advanced prostate cancer.''
According to the American Cancer Society, prostate cancer is the most common cancer, excluding skin cancers, in American men. It is estimated that during the year 2002, approximately 189,000 new cases of prostate cancer will be diagnosed in the United States and an estimated 30,200 men will die of the disease. Approximately one man in six will be diagnosed with prostate cancer during his lifetime.
Gordon Proctor, president of Sanofi-Synthelabo Inc. commented, ``The rapid approval of Eligard 7.5 mg exceeded our expectations. Sanofi-Synthelabo Inc. has been working diligently in conjunction with Atrix to bring Eligard 7.5 mg to the tens of thousands of patients who could benefit most. Our sales force will be dedicated to the success of this product.''
Last year, Atrix licensed North American marketing rights to the Eligard prostate cancer products to Sanofi-Synthelabo Inc., a subsidiary of the global healthcare company, Sanofi-Synthelabo. Under terms of the agreement, Atrix will receive royalties on sales of the Eligard products and will manufacture the products at its facility in Fort Collins, Colorado. Additionally, Atrix has licensed the European marketing rights to MediGene AG in a similar agreement. The total worldwide market for this type of therapy is estimated at $2.4 billion.
Sanofi-Synthelabo Inc. is the U.S. subsidiary of Sanofi-Synthelabo, the global healthcare company. With 2000 sales of 6 billion euros and 30,000 employees in more than 100 countries, Sanofi-Synthelabo ranks among the world's top 20 pharmaceutical companies. Currently, they have 2,000 sales representatives in the U.S. Sanofi-Synthelabo's world headquarters are located in Paris, France; U.S. headquarters are in New York.
Atrix is developing two additional Eligard products that release leuprolide acetate over a period of three and four months using Atrix's Atrigel® Depot drug delivery system. Sustained levels of leuprolide, a leutinizing hormone-releasing hormone (LHRH) agonist, 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. In September, Atrix submitted a New Drug Application (NDA) for Eligard 22.5 mg (formerly Leuprogel Three-Month Depot) to the FDA and anticipates submitting an NDA for Eligard 30 mg (formerly Leuprogel Four-Month Depot) to the FDA in the first half of 2002.
Conference call scheduled for later today:
The conference call is scheduled for today, January 24, 2002 at 10:00 am Eastern Standard Time (EST). The conference will be available by telephone at 800-451-7724; Conference ID: ATRIX. Additionally, the conference call will be simultaneously webcast over the Internet. The link for the webcast can be found at Atrix's homepage at atrixlabs.com . |
