Retin-A
Micro Cleared by FDA for Tretinoin Acne Treatment
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.
