FORT COLLINS, Colo., Sept. 1 /PRNewswire-FirstCall/ -- Atrix Laboratories, Inc. announced today that on August 31, 2004, together with co-development partner Fujisawa Healthcare, Inc., they submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ACZONE(TM) Gel 5%(dapsone topical gel), formerly called Atrisone(TM), for the treatment of acne vulgaris.
"We are excited about the submission of this NDA for ACZONE," said David R. Bethune, Atrix's chairman and chief executive officer. "We are proud of the extraordinary hard work, commitment, and dedication of the ACZONE development team, made up of representatives from both Atrix and Fujisawa. The submission of this NDA illustrates the ability of the team to put together complex NDAs and meet the timelines associated with this challenging task."
ACZONE uses Atrix's proprietary Solvent Microparticle (SMP(TM)) delivery system to deliver dapsone, a water-insoluble compound with anti-inflammatory and anti-microbial properties. Dapsone currently is only commercially available for other indications as an oral tablet for systemic delivery due to the compound's water insolubility. Atrix's SMP system allows localized delivery of this drug. The North American market for topical acne products is over $800 million.
Fujisawa Healthcare, Inc., the North American subsidiary of Fujisawa Pharmaceutical Co., Ltd., in a co-development agreement, has licensed the marketing rights to ACZONE for the treatment of acne vulgaris and has provided significant support for the development of the product and submission of the NDA.
Hideo Fukumoto, chairman and chief executive officer of Fujisawa Healthcare, Inc., said, "We are excited about this important milestone, and the prospect of adding ACZONE to our dermatology portfolio."
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, 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/.
Fujisawa Healthcare, Inc., headquartered in Deerfield, Illinois, develops, manufactures and markets proprietary pharmaceutical products in the United States and abroad. Fujisawa Healthcare, Inc. is a subsidiary of Fujisawa Pharmaceutical Co., Ltd., based in Osaka, Japan. Fujisawa Pharmaceutical Co., Ltd., founded in 1894, is a leading pharmaceutical manufacturer and is actively developing its international operations in North America, Europe and Asia. Additional information on Fujisawa Healthcare, Inc. and its products can be found on the company's web site at http://www.fujisawa.com/. On April 1, 2005, Astellas Pharma, Inc. will be created with the merger of Fujisawa Pharmaceutical Co., Ltd. and Yamanouchi Pharmaceutical Co, Ltd., subject to relevant regulatory clearances.
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 belief that there is significant interest in a topical acne product, the company's expectation that the FDA will accept the NDA and that the product will eventually be approved. 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, market acceptance, 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, 2003 and the company's Quarterly Report on Form 10-Q for the quarter ended June 30, 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.