To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Retin-A Micro Cleared by FDA for Tretinoin Acne Treatment URL: http://www.pslgroup.com/dg/1E2FE.htm Doctor's Guide February 10, 1997
REDWOOD CITY, Calif., Feb. 10, 1997 -- Advanced Polymer Systems, Inc. (Nasdaq: APOS) today announced that the U.S. Food and Drug Administration (FDA) has granted marketing clearance for Retin-A(R) Micro(TM) (tretinoin gel) microsphere, 0.1% for the treatment of acne. The new topical medication is the first ethical pharmaceutical containing Advanced Polymer's patented Microsponge delivery systems. The product has been licensed to Ortho Dermatological, a member of the Johnson & Johnson family of companies, and will be marketed by Ortho Dermatological under the trade name Retin-A Micro(TM). Ortho is a leader in the ethical dermatological market and Retin-A(R) (tretinoin) is a major product in the $500 million prescription acne market. "FDA marketing clearance of Retin-A Micro is a significant milestone for ethical pharmaceutical applications of our delivery system technology," said John J. Meakem, Jr., chairman, president, and chief executive officer of Advanced Polymer. "Our objective in developing Retin-A Micro was to improve upon a widely prescribed acne treatment and increase patient compliance by reducing the potential for skin irritation while maintaining efficacy." Marketing clearance triggers a $3 million milestone payment to Advanced Polymer from its marketing partner, Ortho Dermatological. Upon commercialization, which is anticipated in the first quarter of 1997, Advanced Polymer will also begin to receive royalties from Ortho on product sales. In comparison studies involving approximately 700 patients, Retin-A Micro had demonstrated efficacy in the treatment of acne. In patients with sensitive skin, the unique new gel was significantly less irritating than 0.1% tretinoin cream when applied to opposite facial cheeks in a double-blind study. The lower irritancy of Retin-A Micro is believed to be attributable to the design of its vehicle containing patented Microsponge systems. Advanced Polymer Systems is a leader in polymer-based delivery systems and related technologies used primarily in ethical and OTC pharmaceuticals and personal care products. Today, more than 80 commercialized products are based on the company's patented Microsponge and Polytrap(R) systems, which deliver active ingredients to the skin. New products under development include Hydrosponge(TM) systems to control more finely the delivery of active ingredients topically or internally, site-specific systems for delivering oral medications to the lower gastrointestinal tract, and bioerodible microspheres and polymers for oral or implantable drug delivery. Except for historical information, this news release contains certain forward-looking statements that involve risk and uncertainties which may cause actual results to differ materially from the statements made, including the success and timing of product development, approvals, and launches, the establishment of new corporate alliances, and other risks listed from time to time in Advanced Polymer's U.S. Securities and Exchange Commission (SEC) filings, including those described in the company's most recently filed registration statement on Form S-3. These forward-looking statements represent Advanced Polymer's judgment, as of the date of this release, and the company disclaims any intent or obligation to update these forward-looking statements. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.