Medicis and Dow Pharmaceutical Sciences Announce FDA Approval of Ziana (Clindamycin Phosphate 1.2% and Tretinoin 0.025%) Gel

First and Only Combination Product of Clindamycin and Tretinoin Approved for Acne


SCOTTSDALE, Ariz. and PETALUMA, Calif., Nov. 7, 2006 (PRIMEZONE) -- Medicis (NYSE:MRX) and Dow Pharmaceutical Sciences, Inc. ("Dow Pharmaceutical Sciences") today announced that the U.S. Food and Drug Administration ("FDA") has approved ZIANA(TM) (clindamycin phosphate 1.2% and tretinoin 0.025%) Gel. ZIANA(TM) Gel is the first and only combination of clindamycin and tretinoin approved for once daily use for the topical treatment of acne vulgaris in patients 12 years or older. ZIANA(TM) Gel is also the first and only approved acne product to combine an antibiotic and a retinoid. ZIANA(TM) Gel contains clindamycin phosphate 1.2% and tretinoin 0.025%, formulated as a cosmetically elegant topical gel. ZIANA(TM) Gel has an alcohol-free, aqueous base. Medicis expects product supply to be available for shipping to wholesalers in the fourth quarter of 2006, and anticipates promotion and sample distribution of ZIANA(TM) Gel to physicians shortly thereafter.

ZIANA(TM) Gel is protected by U.S. Patent No. 6,387,383, both a composition of matter and a method patent, which expires in 2020. Additionally, U.S. Patent No. 5,721,275, a composition of matter patent, has been placed before the U.S. Patent and Trademark Office to be reissued. Each of these patents covers aspects of the unique vehicle which are used to deliver the active ingredients in ZIANA(TM) Gel.

"We are pleased to announce FDA's approval of ZIANA(TM) Gel," said Jonah Shacknai, Chairman and Chief Executive Officer of Medicis. "Our collaboration with Dow Pharmaceutical Sciences has resulted in the first and only product of its kind. We believe ZIANA(TM) Gel achieves the balance of tolerance and efficacy in this acne category. Armed with strong intellectual property protection, the unique combination of two traditionally separate drugs with different modes of action in ZIANA(TM) Gel provides a synergistic efficacy greater than either a clindamycin or retinoid used alone. ZIANA(TM) Gel also brings the convenience of once-a-day dosing."

"We are proud of this successful collaboration with Medicis, and our track record in conceptualizing, patenting and obtaining regulatory clearance for innovative dermatological products such as ZIANA(TM) Gel," said Dr. Bhaskar Chaudhuri, President and Chief Executive Officer of Dow Pharmaceutical Sciences. "This unique combination product could simplify the treatment regimen for many acne patients who struggle with this difficult to treat condition."

In the past year, nearly 17 million prescriptions were written by physicians for topical acne products, totaling approximately $1.4 billion in branded and generic dollars. Dermatologists wrote approximately 50 percent of these topical acne prescriptions, totaling approximately $800 million of the branded and generic dollars. Clindamycin and retinoids accounted for eight million of the total 17 million prescriptions written for topical acne products, with dermatologists writing over half of these clindamycin and retinoid prescriptions. The total weighted average wholesale cost of branded and generic dollars for the clindamycin and retinoid prescriptions in all specialties was over $680 million, and over $390 million in dermatology alone (see Note).

ZIANA(TM) Gel is available by prescription in a 30 gram tube (NDC No. 99207-300-30) and a 60 gram tube (NDC No. 99207-300-60). When used as directed, ZIANA(TM) Gel is safe and effective for the topical treatment of acne vulgaris in patients 12 years or older. The most common adverse events reported during several ZIANA(TM) Gel clinical trials were nasopharyngitis, pharyngolaryngeal pain, dry skin, cough and sinusitis. ZIANA(TM) Gel is contraindicated in persons who have regional enteritis, ulcerative colitis, or a history of antibiotic-associated colitis. Exposure to sunlight, including sunlamps, should be avoided during use. Full safety and prescribing information for ZIANA(TM) Gel can be obtained at www.medicis.com.

ZIANA(TM) Gel currently is manufactured for Medicis by Contract Pharmaceuticals Limited Niagara in Buffalo, NY.

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 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), 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%, 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 www.medicis.com.

About Dow Pharmaceutical Sciences

Dow Pharmaceutical Sciences, Inc. is a privately held company that specializes in the development of topical drug products for pharmaceutical and biotechnology clients. Dow Pharmaceutical Sciences provides a full range of product development services including formulation and regulatory consulting, formulation optimization utilizing state-of-the-art in vitro permeation models, full analytical support, cGMP clinical manufacturing and clinical labeling. Dow Pharmaceutical Sciences conducts dermatology studies at clinical sites in California, and in Europe through its Bioskin Division, a full service dermatology CRO. Dow Pharmaceutical Sciences also supports all aspects of regulatory and clinical planning and development, including FDA meeting support, regulatory document preparation, and electronic IND and NDA submissions. For more information, visit www.Dowpharm.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 the successful launch of 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/T for the transition year ended December 31, 2005, 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. 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/T for the transition 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: IMS Health, National Prescription Audit, MAT 9/2006



            

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