Medicis Announces FDA Approval of DYNACIN -minocycline HCl- Tablets
SCOTTSDALE, Ariz.--April 16, 2003--Medicis (NYSE:MRX) today announced the approval of an Abbreviated New Drug Application ("ANDA") by the Food and Drug Administration ("FDA") to market its new DYNACIN(R) Tablets (minocycline HCl). Minocycline is the most frequently prescribed drug by U.S. dermatologists and DYNACIN(R) is the number one prescribed brand of minocycline in the specialty of dermatology. Par Pharmaceutical, a wholly owned subsidiary of Pharmaceutical Resources, Inc. (NYSE:PRX) will manufacture new DYNACIN(R) Tablets for Medicis pursuant to an exclusive manufacturing and supply agreement. Financial terms of the agreement were undisclosed.
DYNACIN(R) Tablets is a prescription product and will be available in 50 mg., 75 mg. and 100 mg. dosages. DYNACIN(R) Tablets formulation is the most recent innovation to the DYNACIN(R) family of products. DYNACIN(R) Tablets is the only prescription minocycline tablet approved in the United States for the adjunctive treatment of severe acne.
In addition to being the only minocycline tablet on the market, new DYNACIN(R) Tablets are small, easy-to-swallow, coated tablets suitable for patients who experience difficulty swallowing larger-sized capsules. Additionally, DYNACIN(R) Tablets incorporates the same dye-free formulation as the capsules to avoid potential allergic reactions in patients with sensitivities to dye additives.
"We are pleased to announce approval of DYNACIN(R) Tablets, the only prescription minocycline tablet indicated for the adjunctive treatment of severe acne," said Jonah Shacknai, chairman and chief executive officer of Medicis. "Approval of this new dosage form of DYNACIN(R) has the potential to enhance the brand's already significant success. The new, smaller-sized, coated DYNACIN(R) Tablets are expected to offer a high degree of patient compliance by providing an easier to swallow form of the most widely prescribed brand of minocycline in dermatology."
The Company's previously provided fiscal year 2003 guidance remains unchanged. Medicis anticipates promoting the new DYNACIN(R) Tablets as an alternative to DYNACIN(R) Capsules. The Company expects product supply to be available during the fourth quarter fiscal 2003 ending June 30, 2003, for shipping to wholesalers and anticipates promotion and sample distribution of DYNACIN(R) Tablets to physicians soon thereafter.
Medicis has not provided guidance for fiscal year 2004. The Company normally provides such guidance for the upcoming fiscal year approximately one month prior to its commencement. The Company provided guidance for fiscal year 2003 in June 2002.
At the time of this disclosure, Medicis believes these objectives are attainable based upon information currently available to the Company. The Company's business is subject to all risk factors outlined in the Company's most recent annual report on Form 10-K, its Form S-3 registration statement and other filed documents with the Securities and Exchange Commission. At the time of this release, the Company cannot, among other things, assess the forthcoming results of the Company's 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, or 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. There can be no certainty which periods these potential payments could be made, nor if any payments such as these will be made at all. The above estimated future guidance does not include the potential payments associated with any such transactions, except for two payments associated with the Dow transaction previously announced.
Medicis is the leading independent specialty pharmaceutical company in the United States focusing primarily on the treatment of dermatological, pediatric and podiatric conditions. Medicis has leading 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.
The Company's products include the prescription brands DYNACIN(R) (minocycline HCl), LOPROX(R) (ciclopirox), LUSTRA(R) (hydroquinone), LUSTRA-AF(R) (hydroquinone) with sunscreen, ALUSTRA(R) (hydroquinone) with retinol, OMNICEF(R) (cefdinir), ORAPRED(R) (prednisolone sodium phosphate), PLEXION(R) Cleanser (sodium sulfacetamide/sulfur), PLEXION TS(R) (sodium sulfacetamide/sulfur), PLEXION SCT(R) (sodium sulfacetamide/sulfur), TRIAZ(R) (benzoyl peroxide), LIDEX(R) (fluocinonide), 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. The Company cannot validate its assumptions of the full impact on its business of the approval of competitive generic versions of the Company's core brands, or any future competitive product approvals that may affect the Company's 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 or that such results will be achieved and 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 of DYNACIN(R) Tablets, the receipt of required regulatory approvals, the ability to realize anticipated synergies and benefits of the Q-Med and the Ascent 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 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, 2002. In addition, Medicis recently sold $400 million of 2.5% Contingent Convertible Notes Due 2032. There can be no assurance as to when or if any of the Notes will be converted, and what impact the increase in the number of shares outstanding will have on our 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, including DYNACIN(R) Tablets, is available by contacting the Company. All market share claims contained in this press release are based upon data provided by Verispan SPA, January 2003 and/or First Data Bank, March 2003. OMNICEF(R) is a registered trademark of Abbott Laboratories, Inc. under a license from Fujisawa Pharmaceutical Co., Ltd. All other marks (or brands) and names are the property of Medicis or its Affiliates.
NOTE TO EDITORS: A photograph of DYNACIN(R) Tablets is available by contacting the Company.
Contact: Medicis, Scottsdale
Libby Ivy, 602/808-3854