FDA Approves Perlane
Medicis Announces FDA Approval of Perlane
SCOTTSDALE, Ariz., May 2, 2007 (PRIME NEWSWIRE) -- Medicis (NYSE:MRX) today announced that the U.S. Food and Drug Administration ("FDA") has approved the dermal filler Perlane for implantation into the deep dermis to superficial subcutis for the correction of moderate to severe facial folds and wrinkles, such as nasolabial folds. Perlane is the newest member of the Restylane family of products and, like Restylane, Perlane is comprised of biotechnologically engineered, non-immunogenic, stabilized hyaluronic acid gel particles, and has patent protection until at least 2017. The primary difference between Restylane and Perlane is that the hyaluronic acid gel particles in Perlane are larger than those found in Restylane. Perlane is intended to be implanted into the deep dermis to superficial layer of the subcutis to add volume to restore surface contour in facial wrinkles and folds. The three-dimensional gel particles in Restylane and Perlane are hydrophilic molecules, attracting and binding to water molecules as they degrade, helping to maintain volume augmentation for about six months. Also distinct from other hyaluronic acid dermal fillers, Restylane and Perlane are minimally cross-linked, making them similar to the natural hyaluronic acid found in the body.
"We are pleased to announce FDA's approval of another product from the worldwide market leading Restylane family," said Jonah Shacknai, Chairman and Chief Executive Officer of Medicis. "With Perlane's approval, physicians now have a new treatment option for their patients which is designed specifically to fill areas in the skin from the deep dermis to the superficial layer of the subcutis. Perlane's larger gel particles offer enhanced volume and lifting power, ideal for wrinkle and fold correction in deeper layers of the skin. Like Restylane, Perlane also has a favorable patient safety profile. As we move forward with our aesthetic product pipeline, we anticipate being able to offer physicians and patients the gamut of high quality aesthetic products for their treatment options."
Medicis anticipates shipping Perlane during the next 30 days. McKesson will serve as U.S. distributor for Perlane. Physicians wanting to place orders for Perlane should call McKesson directly at 1-877-520-0500.
The Restylane family of products, including Restylane, Perlane, Restylane Fine Lines and SubQ, are marketed and sold in more than 70 countries outside the United States, where they have been used in over seven million procedures. Restylane Fine Lines and SubQ have not been approved by the FDA for use in the U.S. Since 1996, dermatologists and plastic surgeons outside the U.S. have used Restylane products to contour and restore volume to skin and temporarily eliminate wrinkles and facial folds. Perlane has been used safely by dermatologists and plastic surgeons since 2000 outside the U.S.
In March of 2003, Medicis acquired all outstanding shares of HA North American Sales AB from a subsidiary of Q-Med, a Swedish biotechnology/medical device company. HA North American Sales AB holds a license for the exclusive U.S. and Canadian rights to market, distribute and commercialize the dermal filler product lines known as Restylane, Perlane and Restylane Fine Lines. In July of 2004, Medicis acquired the rights for another product from Q-Med called SubQ. Restylane was approved by the FDA for use in the U.S. in December 2003, and subsequently launched in January 2004. Restylane, Perlane, Restylane Fine Lines and SubQ have been approved for use in Canada. In accordance with the agreement between Medicis and Q-Med, Medicis has agreed to pay Q-Med approximately $29.1 million upon FDA approval of Perlane.
Perlane is a class III restricted medical device indicated for implantation into the deep dermis to superficial subcutis for the correction of moderate to severe facial folds and wrinkles, such as nasolabial folds. Perlane should only be administered under the supervision of a licensed practitioner. For complete product and safety information about Perlane and Restylane, please visit www.medicis.com.
Medicis Aesthetics Inc., the company that currently 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 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 (hyaluronic acid), Perlane (hyaluronic acid), Dynacin (minocycline HCl), Loprox (ciclopirox), Omnicef (cefdinir), Plexion (sodium sulfacetamide/sulfur), Solodyn (minocycline HCl, USP) Extended Release Tablets, Triaz (benzoyl peroxide), Lidex (fluocinonide) Cream, 0.05%, Vanos (fluocinonide) Cream, 0.1%, Synalar (fluocinolone acetonide), and Ziana (clindamycin phosphate 1.2% and tretinoin 0.025%) Gel, Buphenyl (sodium phenylbutyrate) and Ammonul (sodium phenylacetate/sodium benzoate), prescription products indicated in the treatment of Urea Cycle Disorder, and the over-the-counter brand Esoterica. For more information about Medicis, please visit the Company's website at www.medicis.com.
This press release contains "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, including the successful launches of Perlane and Ziana Gel. 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. The Company's business is subject to all risk factors outlined in the Company's most recent annual report on Form 10-K for the year ended December 31, 2006, and other documents we file with the Securities and Exchange Commission. The Company cannot predict the market acceptance of Perlane and it is subject to all of the risks associated with the Company's other products. In addition, the Company cannot, among other things, assess the likelihood, timing or forthcoming results of research and development projects and the risks associated with the FDA approval process, risks associated with significant competition within the Company's industry, nor can the Company validate its assumptions of the full impact on its business of the approval of competitive generic versions of the Company's core brands, in particular, the approval of a generic Loprox Cream and Loprox TS, or a substitutable Dynacin Tablet form, and any future competitive product approvals that may affect the Company's brands, including Perlane. Additionally, Medicis may acquire and/or license products or technologies from third parties to enter into new strategic markets. The Company periodically makes up-front, non-refundable payments to third parties for research and development work which has been completed and periodically makes additional non-refundable payments for the achievement of various milestones. There can be no certainty in which periods these potential payments could be made, nor if any payments such as these will be made at all. Any estimated future guidance does not include among other things the potential payments associated with any such transactions. Also, there are a number of additional important factors that could cause actual results to differ materially from those projected, including the anticipated size of the markets for Medicis' products, the availability of product supply and the receipt of required regulatory approvals, the risks and uncertainties normally incident to the pharmaceutical and medical device industries including product liability claims, the introduction of federal and/or state regulations relating to the Company's business, 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, competitive product introductions, the risks of pending and future litigation or government investigations and other risks described from time to time in Medicis' SEC filings including its Annual Report on Form 10-K for the year ended December 31, 2006, 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. Omnicef is a trademark of Fujisawa Pharmaceutical Co. Ltd. and is used under a license from Abbott Laboratories, Inc. On April 1, 2005, Fujisawa Pharmaceutical Co. Ltd. merged with Yamanouchi Pharmaceutical Co. Ltd., creating Astelles Pharma, Inc. Restylane and Perlane are registered trademarks of HA North American Sales AB, a subsidiary of Medicis Pharmaceutical Corporation. All other marks (or brands) and names are the property of Medicis or its Affiliates.
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CONTACT: Medicis - Kara Stancell (602) 808-3854
Posted: May 2007