|New Treatment Designed To Correct Facial Wrinkles And Folds For Longer Than 6 Months|
Medicis (NYSE:MRX) today announced that the U.S. Food and Drug Administration (FDA) has approved Restylane(R), an injection for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds, the lines between the nose and mouth. Restylane is the first and only FDA-approved dermal filler made of a biodegradable non-animal stabilized hyaluronic acid (NASHA(TM)). Hyaluronic acid is a natural substance found in all living organisms and provides volume and fullness to the skin.
"The approval of Restylane is not only a very important milestone in the history of Medicis, but also represents a significant advance in cosmetic dermal fillers," said Jonah Shacknai, Chairman and Chief Executive Officer of Medicis. "With its proven track record for long-lasting efficacy and safety in more than one million procedures worldwide, we believe that Restylane will set a new standard for non-invasive cosmetic procedures."
Restylane is formulated as a clear gel and uses a dual mechanism of action to correct wrinkles and folds. Upon being injected beneath the skin's surface, the NASHA gel adds natural volume and lift to smooth wrinkles and folds. The NASHA gel integrates into dermal tissue then attracts and binds to water molecules to help maintain volume. Restylane is gradually degraded by the body's own mechanism and disappears without any residue. Results can be seen immediately following treatment and last six months, or even longer.
"The arrival of Restylane to the U.S. has been long-awaited by physicians and consumers alike given its worldwide safety record and reputation as the ideal solution to eliminate wrinkles and facial folds," said Rod J. Rohrich, M.D., F.A.C.S., Chairman of the Department of Plastic Surgery at the University of Texas Southwestern Medical Center and President of the American Society of Plastic Surgeons. "Restylane represents the future of cosmetic dermal fillers in that it's completely natural and biodegradable, is non-animal derived so it does not pose a risk of disease transmission, and has been shown to last longer than six months, which is better than any currently available non-permanent dermal filler."
Restylane is marketed and sold in more than 60 countries outside the United States where it has been used in more than one million procedures. Since 1996, dermatologists and plastic surgeons outside the U.S. have used it to contour and restore volume to skin and temporarily eliminate wrinkles and facial folds. Additionally, in countries other than the U.S., Restylane is also approved to enhance the appearance and fullness of lips, although the safety or efficacy of Restylane for the treatment of lips has not been established in controlled clinical studies submitted to the FDA.
Medicis anticipates shipping Restylane during the next 30 to 60 days. McKesson will serve as U.S. distributor for Restylane. Physicians wanting to place orders for Restylane should call McKesson directly at 1-877-520-0500. Restylane will be available to patients through licensed practitioners. Restylane is manufactured by Q-Med in Uppsala, Sweden.
"Restylane promises to make its mark as the non-invasive treatment of choice in the U.S. given the unique advantages it offers to both patients and physicians," added Dr. Rohrich. "For patients, Restylane is safe, its results are evident right after treatment, and there is no six week wait for allergy testing. For physicians, Restylane is readily prepared and easy to inject, requires less material to achieve desired volume than collagen and given its durability, requires fewer treatment sessions."
The 6-month randomized, multi-center double-blind study evaluated 138 patients seeking correction of bilateral nasolabial folds (smile lines). Patients received Restylane (non-animal stabilized hyaluronic acid 20 mg/mL) in one nasolabial fold and Zyplast(R) (cross-linked bovine collagen 35mg/mL, INAMED Corporation, Santa Barbara, CA) in the opposite nasolabial fold.
Clinical efficacy assessments were then conducted at two, four and six months after baseline using the Wrinkle Severity Rating Scale (WSRS)(1) and Global Aesthetic Improvement Scale (GAIS)(2). Adverse events were assessed by the treating investigator for severity and relationship to the study treatment.
The study found that Restylane showed a statistically significant difference over Zyplast with respect to the change (from pre-treatment) in WSRS score at all post-baseline timepoints (p less than 0.0001). Specifically, at six months post-baseline, Restylane was better than Zyplast in 56.9 percent of patients while Zyplast was better than Restylane in 9.5 percent of patients (p less than 0.0001). In addition, at six months, 67.2 percent of Zyplast-treated folds had returned to pre-treatment condition, compared with only 29.9 percent of Restylane-treated folds. Further, the total injection volume needed to produce an "optimal cosmetic result" was lower for Restylane (mean 1.0mL; range 0.3-2.8mL) than Zyplast (mean 1.6mL; range 0.1 - 5.0mL).
The most commonly reported adverse events were redness and swelling, which typically occurred at the injection site and were transient and mild to moderate in intensity.
About Restylane & NASHA
Restylane is the first and only dermal filler made of crystal-clear gel called NASHA (Non-Animal Stabilized Hyaluronic Acid). NASHA is developed using a unique stabilization process that results in its long duration of effect in contrast to non-stabilized hyaluronic acid, which lasts only days to weeks, at most. As opposed to other hyaluronic acid products, NASHA is not derived from animal sources. It is produced biotechnologically by natural fermentation in a sterile laboratory environment. This significantly diminishes the risk of transmitting diseases between species or of eliciting allergic reactions in patients who are sensitive to common foods, such as beef, chicken and eggs. NASHA has been extensively researched for over a decade and proven to be safe and effective. Restylane does not require any allergy or skin test prior to injection.
Medicis Aesthetics Inc., the company that is marketing and selling Restylane 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 aesthetic, dermatological, pediatric and podiatric conditions. Medicis Pharmaceutical Corporation has leading branded prescription products in a number of therapeutic categories, including acne, asthma, eczema, fungal infections, hyperpigmentation, photoaging, psoriasis, rosacea, seborrheic dermatitis and skin and skin-structure infections. The Company's products have earned wide acceptance by both physicians and patients due to their clinical effectiveness, high quality and cosmetic elegance.
Except for historical information, this press release includes "forward-looking statements" within the meaning of the 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. This includes earnings estimates, future financial performance and other matters. 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. Medicis cannot validate its assumptions of the full impact on its business of the approval of competitive generic versions of its core brands, or any future competitive product approvals that may affect its brands. Such statements are subject to a number of assumptions, risks and uncertainties, many of which are beyond the control of Medicis. Any such projections or statements include the current views of Medicis with respect to future events and financial performance. No assurances can be given, however, that these events will occur, that such results will be achieved, that Medicis will continue to have the ability to pay any dividend, or that tax rates on cash dividends will not change. Also, there are a number of important factors that could cause actual results to differ materially from those projected, including the anticipated size of the markets, the availability of product supply, the receipt of required regulatory approvals, the ability to realize anticipated synergies and benefits of the Q-Med transaction, the risks and uncertainties normally incident to the pharmaceutical industry, dependence on sales of key products, the uncertainty of future financial results and fluctuations in operating results, dependence on Medicis' strategy including the uncertainty of license payments and/or other payments due from third parties, the timing and success of new product development by Medicis or third parties, product introductions and other risks described from time to time in Medicis' SEC filings including its Annual Report on Form 10-K for the year ended June 30, 2003. There can be no assurance as to when or if any of the holders of the Notes will have the right to convert or if the Notes will be converted, and what impact the increase in the number of shares outstanding will have on its results of operations. 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.
NOTE: Full prescribing information for any Medicis product, including RESTYLANE(R), is available by contacting the Company. RESTYLANE(R) is a registered trademark of HA North American Sales AB, a subsidiary of Medicis Pharmaceutical Corporation. All other marks (or brands) and names are the property of their respective owners.
(1) The WSRS is a photograph-based outcome instrument designed specifically for quantifying facial folds. Scoring of fold is based on visual assessment of the length and apparent depth of the nasolabial fold without reference to baseline or pre-treatment appearance.
(2) The GAIS is a relative scale where the investigator grades the overall improvement in each nasolabial fold by comparing the patient's appearance at follow-up against a high magnification photograph taken prior to treatment.