Medicis Announces FDA Approval of Its NDA for VANOS, a Patented Class I Corticosteroid for Plaque-Type Psoriasis
SCOTTSDALE, Ariz.--Feb. 14, 2005--Medicis (NYSE:MRX) today announced that the Food and Drug Administration ("FDA") has approved its New Drug Application ("NDA") for VANOS(TM), a Class I corticosteroid for the treatment of plaque-type psoriasis. VANOS(TM) is a patented corticosteroid formulation which embodies the heritage of LIDEX(R), the number six most recognized dermatology brand in North America.(1) The unique formulation of VANOS(TM) provides doctors and patients with the convenience of a new, super high potency vehicle in the form of a cream for once or twice daily application. The Class I corticosteroid market in the United States is approximately $329 million.(2) Medicis anticipates launching VANOS(TM) to dermatologists in the quarter beginning April 2005.
"We are pleased to announce the FDA's approval of VANOS(TM)," said Jonah Shacknai, Chairman and Chief Executive Officer of Medicis. "The introduction of VANOS(TM) is another example of our sophisticated research and development pipeline and our commitment to introducing at least one new product each year. VANOS(TM) provides physicians and patients with the established safety of fluocinonide and the potency of a Class I topical corticosteroid. We believe VANOS(TM), which is patent protected until 2021, enhances our therapeutic product portfolio and will be a significant addition to physicians' treatment regime."
VANOS(TM) is available by prescription in a 30-gram size (NDC #99207-525-30) and a 60-gram size (NDC #99207-525-60). The most common adverse events associated with the use of VANOS(TM) are headache and burning at the application site. VANOS(TM) is contraindicated for use by patients with a history of hypersensitivity to its components. When used as directed, VANOS(TM) is safe and efficacious for the treatment of plaque-type psoriasis. Full prescribing information for VANOS(TM) can be obtained by contacting Medicis. Consult your physician to see if VANOS(TM) is right for you.
VANOS(TM) is manufactured by Patheon, Inc. in Canada.
Medicis is the leading independent specialty pharmaceutical company in the United States focusing primarily on the treatment of dermatological and podiatric conditions and aesthetics medicine. The Company is dedicated to helping patients attain a healthy and youthful appearance and self-image. Medicis has leading branded prescription products in a number of therapeutic categories, including acne, eczema, fungal infections, 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.
The Company's products include the prescription brands RESTYLANE(R), DYNACIN(R) (minocycline HCl), LOPROX(R) (ciclopirox), OMNICEF(R) (cefdinir), PLEXION(R) (sodium sulfacetamide/sulfur), TRIAZ(R) (benzoyl peroxide), LIDEX(R) (fluocinonide) Cream, 0.05%, VANOS(TM) (fluocinonide) Cream, 0.1%, and SYNALAR(R) (fluocinolone acetonide), the over-the-counter brand ESOTERICA(R), and BUPHENYL(R) (sodium phenylbutyrate), a prescription product indicated in the treatment of Urea Cycle Disorder. For more information about Medicis, please visit the Company's website at www.medicis.com.
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. 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 or that such results will be achieved. Medicis cannot validate its assumptions of the full impact on its business of the approval of competitive generic versions of its core brands, including DYNACIN(R) Tablets and/or LOPROX(R), or any future competitive product approvals that may affect its brands. 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, the availability of product supply, the receipt of required regulatory approvals, the ability to realize anticipated synergies and benefits of the Q-Med transactions, 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, the risks of pending or future litigation, 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, 2004. There can be no assurance as to the date Medicis will launch VANOS(TM). 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 prescription product is available by contacting the Company. OMNICEF(R) is a registered trademark of Abbott Laboratories, Inc. under a license from Fujisawa Pharmaceutical Co., Ltd. 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 Medicis or its Affiliates.
References
(1) Brand Institute Inc., May 2002
(2) IMS Health, 2004
Contacts: Medicis, Scottsdale Kara Stancell, 602-808-3854