FDA Grants Marketing Clearance For New Formulation
REDWOOD CITY, Calif., October 30, 2000 – Advanced Polymer Systems, Inc. (Nasdaq: APOS) announced today that the U.S. Food and Drug Administration (FDA) has granted marketing clearance for a new Microsponge® formulation of 5-fluorouracil (5-FU), a treatment for actinic keratoses.
This unique formulation of 5-fluorouracil, which utilizes Advanced Polymer's patented Microsponge system, has demonstrated efficacy in achieving clearance of actinic keratoses in Phase III clinical studies involving 384 patients. Actinic keratoses are pre-cancerous skin lesions, usually resulting from cumulative sun exposure. The product will be marketed by Dermik Laboratories, an Aventis company, in the U.S. initially. Upon commercialization, which is anticipated in the first quarter of 2001, Advanced Polymer will begin to receive royalties from Dermik on product sales. The new Drug Application (NDA) was filed by Dermik in the fourth quarter of 1999.
“Through initial use in Retin-A® Micro™ for the treatment of acne, and now in 5-FU, we have demonstrated the use of the Microsponge system in delivering highly effective therapeutic treatments for serious skin conditions,“ said Michael P.J. O'Connell, president and chief executive officer of Advanced Polymer Systems, Inc.
The patented Microsponge system consists of porous polymeric microspheres that are loaded with the active ingredient such as 5-FU. The particles are dispersed in a cream and hold the active until applied to the skin. This permits the design of unique therapeutic formulations. The safety of the Microsponge systems has been well-established and they are used in several over-the-counter drug and skin care products besides the two prescription products, Retin-A Micro and the new 5-FU product.
“Our research and development efforts are moving toward establishing new pharmaceutical collaborations and developing additional product applications with partners for our new oral and bioerodible polymer delivery systems for use in broader pharmaceutical markets,” said O'Connell.
About Actinic Keratoses
Approximately 15 percent of actinic keratoses develop into squamous cell carcinoma. Based on current demographics in the United States, the incidence of actinic keratoses is expected to increase. Older individuals are more likely than younger ones to have actinic keratoses, because cumulative sun exposure increases with age. A survey of older Americans found keratoses in more than half of all men and more than a third of women aged 65 to 74 who had a high degree of lifetime sun exposure. Some experts believe the majority of people who live to the age of 80 have the disease.
About Advanced Polymer Systems, Inc.
Advanced Polymer Systems, is a leader in polymer-based delivery systems and related technologies with a broad proprietary and intellectual property platform. The Company is committed to the identification, development and commercialization of proprietary polymer-based systems for the pharmaceutical industry. Working in collaboration with academic researchers, corporate partners and licensees, the Company is developing and providing specialized proprietary delivery systems for use in an increasing number of ethical pharmaceutical applications. The company recently sold its cosmeceutical division to R.P. Scherer Corporation in a strategic refocus.
Except for historical information, this news release contains certain forward-looking statements that involve risks and uncertainties, including among others, uncertainty associated with timely development, approval, launch and acceptance of new products, establishment of new corporate alliances and progress in research and development programs. Other risks and uncertainties associated with the Company's business and prospects are identified in the Company's filings with the Securities and Exchange Commission. The Company does not undertake to revise these forward-looking statements to reflect events or circumstances occurring in the future.
1. Retin-A® MicroTM is marketed by Ortho Dermatological.