Medicis Announces FDA Approval of PMA Supplement for RESTYLANE

SCOTTSDALE, Ariz., Oct 10, 2008 (GlobeNewswire via COMTEX) -- MRX | Quote | Chart | News | PowerRating -- Medicis (NYSE:MRX) today announced the U.S. Food and Drug Administration (FDA) has approved its premarket approval application (PMA) supplement, based on clinical data which highlights RESTYLANE(R)'s duration effect up to 18 months in 97% of patients with repeated treatment. The RESTYLANE(R) package insert will be amended to include the study results. The Company anticipates using this information in its promotional activities.

About the Study

This randomized, evaluator-blinded, multi-center study enrolled 75 patients to study the safety and effectiveness of two different retreatment schedules, including duration of correction. Following a bilateral (split-face) design, each patient had both nasolabial folds corrected with RESTYLANE(R). One side of the face was randomly selected to be corrected with RESTYLANE(R) and then re-treated at 4.5 months; the opposite side was re-treated at 9 months. Patients were evaluated using the Wrinkle Severity Rating Scale (WSRS), a five-point scale to measure visual severity of wrinkles where five is the most severe rating (extreme). Patients enrolled in the study had an initial WSRS rating of three (moderate) or four (severe).

Study Results

RESTYLANE(R)'s effective correction of nasolabial folds persisted for up to 18 months post initial treatment, regardless of retreatment schedule. A vast majority of patients (97%) had at least one grade improvement on the WSRS at 18 months when retreated at 4.5 months. The study showed no significant difference between 4.5-month and 9-month retreatment schedules for effectiveness and safety assessment. Adverse events were primarily swelling (24%) and bruising (19%); none were serious.

The study was conducted by Rhoda S. Narins, MD, Steven H. Dayan, MD, FAS, and Frederic S. Brandt, MD.

Important Safety Considerations of RESTYLANE(R)

RESTYLANE(R) restores volume and fullness to the skin to correct moderate to severe facial wrinkles and folds, such as the lines from your nose to the corners of your mouth (nasolabial folds). After your treatment, you might have some swelling, redness, pain, bruising, and tenderness. This will normally last less than seven days. Although rare, red or swollen small bumps may occur. If you have had facial cold sores before, an injection can cause another outbreak. In rare circumstances, the doctor may inject into a blood vessel, which can damage the skin. To avoid bruising and bleeding, you should not use RESTYLANE(R) if you have recently used drugs that thin your blood or prevent clotting. If you are pregnant, breastfeeding, or under 18, you should not use RESTYLANE(R).

RESTYLANE(R) should not be used by people with previous bad allergies, particularly to certain microorganisms known as gram positive bacteria; by people with previous bad allergies to drugs that have required in-hospital treatment; or by people with bleeding disorders. RESTYLANE(R) should not be injected anywhere except the skin or just under the skin.

The use of RESTYLANE(R) at the site of skin sores, pimples, rashes, hives, cysts, or infection should be postponed until healing is complete. Use of RESTYLANE(R) in these instances could delay healing or make your skin problems worse.

RESTYLANE(R) is available only through a licensed practitioner. For complete product and safety information, visit www.RestylaneUSA.com.

About Medicis

Medicis Aesthetics Inc., the company that currently is marketing and selling RESTYLANE(R) and PERLANE(R) in the U.S., is a wholly owned subsidiary of Medicis Pharmaceutical Corporation, a leading independent specialty pharmaceutical company in the United States focusing primarily on the treatment of dermatological and aesthetic conditions. Medicis Pharmaceutical Corporation has leading branded prescription products in a number of therapeutic and aesthetic categories. The Company's products have earned wide acceptance by both physicians and patients due to their clinical effectiveness, high quality and cosmetic elegance.

The Company's products include the prescription brands RESTYLANE(R) (hyaluronic acid), PERLANE(R) (hyaluronic acid), DYNACIN(R) (minocycline HCl), LOPROX(R) (ciclopirox), PLEXION(R) (sodium sulfacetamide 10% and sulfur 5%), SOLODYN(R) (minocycline HCl, USP) Extended Release Tablets, TRIAZ(R) (benzoyl peroxide), LIDEX(R) (fluocinonide) Cream 0.05%, VANOS(R) (fluocinonide) Cream 0.1%, and ZIANA(R) (clindamycin phosphate 1.2% and tretinoin 0.025%) Gel, BUPHENYL(R) (sodium phenylbutyrate) Tablets and Powder and AMMONUL(R) (sodium phenylacetate and sodium benzoate) Injection 10%/10%, prescription products indicated in the treatment of Urea Cycle Disorder, and the over-the-counter brand ESOTERICA(R). For more information about Medicis, please visit the Company's website at www.medicis.com.

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act. All statements included in this press release that address activities, events or developments that Medicis expects, believes or anticipates will or may occur in the future are forward-looking statements. These statements are based on certain assumptions made by Medicis based on its experience and perception of historical trends, current conditions, expected future developments and other factors it believes are appropriate in the circumstances. No assurances can be given, however, that these activities, events or developments will occur or that such results will be achieved. Such statements are subject to a number of assumptions, risks and uncertainties, many of which are beyond the control of Medicis. Several of these risks are outlined in the Company's most recent annual report on Form 10-K for the year ended December 31, 2007, and other documents we file with the Securities and Exchange Commission. Forward-looking statements represent the judgment of Medicis' management as of the date of this release, and Medicis disclaims any intent or obligation to update any forward-looking statements contained herein, which speak as of the date hereof.

NOTE: Full prescribing information for any Medicis prescription product is available by contacting the Company. RESTYLANE(R) and PERLANE(R) are registered trademarks of HA North American Sales AB. All other marks are the property of Medicis or its Affiliates.

This news release was distributed by GlobeNewswire, www.globenewswire.com

SOURCE: Medicis Pharmaceutical Corporation

Medicis Kara Stancell (480) 291-5854

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