SCOTTSDALE, Ariz., May 8, 2006 (PRIMEZONE) -- Medicis (NYSE:MRX) today announced that the U.S. Food and Drug Administration ("FDA") has approved its New Drug Application ("NDA") for SOLODYN(TM) (minocycline HCl, USP) Extended Release Tablets. SOLODYN(TM) is the only oral minocycline approved for once daily dosage in the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. SOLODYN(TM) is also the only approved minocycline in extended release tablet form. SOLODYN(TM) is lipid soluble, and its mode of action occurs in the skin and sebum. SOLODYN(TM) is not bioequivalent to any other minocycline products, and is in no way interchangeable with other forms of minocycline.
The dosing and administration for SOLODYN(TM) is unique, and redefines minocycline therapy for acne. Based on extensive multi-year clinical trials conducted by Medicis in which over 1,000 patients participated, the recommended dosage for SOLODYN(TM) is 1 mg/kg daily. In Medicis sponsored studies, higher doses of minocycline were tested against SOLODYN(TM), and did not show additional therapeutic benefits in the treatment of inflammatory lesions of acne. These higher doses, consistent with traditional minocycline use, may actually be associated with more acute vestibular side effects. (See Note 1)
There were more than 7.5 million acne patient visits to physicians in 2005. Greater than 5 million prescriptions were written by dermatologists for minocycline, doxycycline and/or tetracycline, totaling approximately $435 million in branded and generic retail dollars. Less than 20 percent of the 5 million prescriptions were written for branded products. (See Note 2)
SOLODYN(TM) is patented until 2018 by U.S. Patent No. 5,908,838, which covers SOLODYN(TM)'s unique dissolution rate. Other patents covering SOLODYN(TM)'s dosing, pharmacokinetics, and carrier composition are pending. The Company continues to seek additional patent protection for its products.
"We are excited to announce FDA approval of SOLODYN(TM)," said Jonah Shacknai, Chairman and Chief Executive Officer of Medicis. "Having the only oral patented minocycline extended release tablet for acne with once daily dosage is indicative of the innovation of our product pipeline. We believe SOLODYN(TM)'s unique, weight-based dosing will transform the way doctors prescribe minocycline, and improve the overall safety of oral antibiotic use in acne. With this highly specialized dosing method and safety profile, we believe SOLODYN(TM) will be a leader in the oral antibiotic market for acne, where U.S. dermatologists prescribe minocycline more frequently than any other molecule." (See Note 3)
SOLODYN(TM) is available by prescription in the following extended release tablet dosages: 45 mg (NDC No. 99207-460-10 and NDC No. 99207-460-11), 90 mg (NDC No. 99207-461-10 and NDC No. 99207-461-11), and 135 mg (NDC No. 99207-462-10 and NDC No. 99207-462-11). When used as directed, SOLODYN(TM) is safe and effective for the treatment of only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. The most commonly reported side effects associated with the use of SOLODYN(TM) were headache, fatigue, dizziness, and pruritus. Central nervous system side effects including light-headedness, dizziness, or vertigo, have been reported with minocycline therapy, but were not significant in SOLODYN(TM) clinical investigations. In rare cases, photosensitivity has been reported. Should not be used during pregnancy nor by individuals of either gender who are attempting to conceive a child while on therapy; concurrent use of tetracyclines with oral contraceptives may render oral contraceptives less effective. SOLODYN(TM) is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines. Safety beyond 12 weeks of use has not been established. Full prescribing information for SOLODYN(TM) can be obtained by contacting Medicis. For more information about SOLODYN(TM), visit www.solodyn.com.
The Company expects product supply to be available for shipping to wholesalers within the quarter, and anticipates promotion and sample distribution of SOLODYN(TM) to physicians shortly thereafter.
SOLODYN(TM) currently is manufactured by AAIPharma Inc. in Wilmington, NC.
About Medicis
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), SOLODYN(TM) (minocycline HCl, USP) Extended Release Tablets, TRIAZ(R) (benzoyl peroxide), LIDEX(R) (fluocinonide) Cream, 0.05%, VANOS(TM) (fluocinonide) Cream, 0.1%, and SYNALAR(R) (fluocinolone acetonide), 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 www.medicis.com.
Forward-Looking Statements
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 Medicis' future prospects and product development pipeline and the safety, efficacy and market acceptance of SOLODYN(TM). 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 and other documents we file with the Securities and Exchange Commission. At the time of this press release, 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 recent approval of a generic LOPROX(R) Cream and LOPROX(R) TS, or a substitutable DYNACIN(R) Tablet form, and any future competitive product approvals that may affect the Company's brands. 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, as was the case with AAIPharma relating to the research and development of SOLODYN(TM). 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 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, 2005, 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 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
Note 1: MP-0104-01, "A Randomized, Double-Blind, Placebo-Controlled Phase II Dose Ranging Study of an Oral Extended Release Formulation of Minocycline as Primary Therapy for Acne Vulgaris in Participants 12-30 Years of Age."
Note 2: IMS Health, 2005
Note 3: IMS Health, 2005