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FDA Approves Ziana(TM) (Clindamycin Phosphate 1.2% and Tretinoin 0.025%) Gel for Acne

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

SCOTTSDALE, AZ, and PETALUMA, CA -- November 8, 2006 -- Medicis and Dow Pharmaceutical Sciences, Inc. 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.

REFERENCE:
IMS Health, National Prescription Audit, MAT 9/2006


SOURCE: Medicis Pharmaceutical Corporation

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