Healthcare Industry News: fluocinolone acetonide
News Release - May 21, 2007
Medicis Begins Shipping PERLANE to PhysiciansNewest Member of the Worldwide Market Leading RESTYLANE Family of Hyaluronic Acid Dermal Filler Products is Now Available to U.S. Physicians
SCOTTSDALE, Ariz., May 21, 2007 (Healthcare Sales & Marketing Network) -- Medicis (NYSE:MRX ) today announced that it has begun shipment of PERLANE(R) to physicians. PERLANE(R), the newest member of the RESTYLANE(R) family of hyaluronic acid dermal filler products, was approved by the U.S. Food and Drug Administration (``FDA'') on May 2, 2007 for implantation into the deep dermis to superficial subcutis for the correction of moderate to severe facial folds and wrinkles, such as nasolabial folds.
``We are pleased to be shipping PERLANE(R) so soon after its FDA approval,'' said Jonah Shacknai, Chairman and Chief Executive Officer of Medicis. ``From the worldwide market leading RESTYLANE(R) family of hyaluronic acid dermal fillers, PERLANE(R) provides larger gel particles that offer volume and lifting power for facial wrinkle and fold correction in deep layers of the skin, all with a favorable patient safety profile and patented technology. Initial pre-orders from U.S. physicians have indicated a strong and encouraging demand for PERLANE(R), and we look forward to its important role in the aesthetics marketplace.''
Like RESTYLANE(R), PERLANE(R) 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(R) and PERLANE(R) is that the hyaluronic acid gel particles in PERLANE(R) are larger than those found in RESTYLANE(R). PERLANE(R) 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(R) and PERLANE(R) are hydrophilic molecules, attracting and binding to water molecules as they degrade, helping to maintain volume augmentation for about six months. The minimal cross-linking in RESTYLANE(R) and PERLANE(R) distinguishes them from other hyaluronic acid dermal fillers.
McKesson is the U.S. distributor for PERLANE(R). Physicians wanting to place orders for PERLANE(R) should call McKesson directly at 1-877-520-0500. For more information about PERLANE(R) or RESTYLANE(R), please contact Medicis Aesthetics Customer Service at 1-866-222-1480.
The RESTYLANE(R) family of products, including RESTYLANE(R), PERLANE(R), RESTYLANE FINE LINES(TM) and SUBQ(TM), is marketed and sold in more than 70 countries outside the United States, where the products have been used in over seven million procedures. RESTYLANE FINE LINES(TM) and SUBQ(TM) 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(R) products to contour and restore volume to skin and temporarily eliminate facial wrinkles and facial folds. PERLANE(R) 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 AB, 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(R), PERLANE(R) and RESTYLANE FINE LINES(TM). In July of 2004, Medicis acquired the rights for another product from Q-Med AB called SUBQ(TM). RESTYLANE(R) was approved by the FDA for use in the U.S. in December 2003, and subsequently launched in January 2004. RESTYLANE(R), PERLANE(R), RESTYLANE FINE LINES(TM) and RESTYLANE SUBQ(TM) have been approved for use in Canada. In accordance with the agreement between Medicis and Q-Med AB, Medicis has paid Q-Med AB approximately $29.1 million as a result of the FDA approval of PERLANE(R).
PERLANE(R) 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(R) should only be administered under the supervision of a licensed practitioner. For complete product and safety information about PERLANE(R) and RESTYLANE(R), please visit http://www.medicis.com.
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), OMNICEF(R) (cefdinir), PLEXION(R) (sodium sulfacetamide/sulfur), SOLODYN(R) (minocycline HCl, USP) Extended Release Tablets, TRIAZ(R) (benzoyl peroxide), LIDEX(R) (fluocinonide) Cream, 0.05%, VANOS(TM) (fluocinonide) Cream, 0.1%, SYNALAR(R) (fluocinolone acetonide), and ZIANA(TM) (clindamycin phosphate 1.2% and tretinoin 0.025%) Gel, BUPHENYL(R) (sodium phenylbutyrate) and AMMONUL(R) (sodium phenylacetate/sodium benzoate), 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 http://www.medicis.com.
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, including the successful launches of PERLANE(R) and ZIANA(TM) 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(R) and it is subject to all of the risks associated with the Company's other products. At the time of this press release, the Company cannot, among other things, assess the likelihood, timing or forthcoming results of R&D projects, the risks associated with the FDA approval process and 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 primary brands, and any future competitive product approvals that may affect the Company's brands, including the RESTYLANE(R) franchise. 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(R) 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(R) and PERLANE(R) are trademarks of HA North American Sales AB, a subsidiary of Medicis Pharmaceutical Corporation. All other marks are the property of Medicis or its Affiliates.
Source: Medicis Pharmaceutical
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