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Medicis and Dow Pharmaceutical Sciences Announce FDA Approval of Ziana (Clindamycin Phosphate 1.2% and Tretinoin 0.025%) Gel
The First and Only Combination Product of Clindamycin and Tretinoin Approved for Acne.
Medicis (NYSE:MRX) and Dow Pharmaceutical Sciences, Inc. ("Dow Pharmaceutical Sciences") today announced that the U.S. Food and Drug Administration has approved ZIANA™ (clindamycin phosphate 1.2% and tretinoin 0.025%) Gel. ZIANA™ 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™ Gel is also the first and only approved acne product to combine an antibiotic and a retinoid. ZIANA™ Gel contains clindamycin phosphate 1.2% and tretinoin 0.025%, formulated as a cosmetically elegant topical gel. ZIANA™ 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™ Gel to physicians shortly thereafter.
"We are pleased to announce FDA's approval of ZIANA™ 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™ 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™ Gel provides a synergistic efficacy greater than either a clindamycin or retinoid used alone. ZIANA™ Gel also brings the convenience of once-a-day dosing."
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.
ZIANA™ 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™ 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™ Gel clinical trials were nasopharyngitis, pharyngolaryngeal pain, dry skin, cough and sinusitis. ZIANA™ 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.