Medicis and Dow Pharmaceutical Sciences Announce FDA Approval of Ziana Gel
First and Only Combination Product of Clindamycin and Tretinoin Approved for Acne
SCOTTSDALE, Ariz. and PETALUMA, Calif., November 7, 2006 -- Medicis and Dow Pharmaceutical Sciences, Inc. ("Dow Pharmaceutical Sciences") today announced that the U.S. Food and Drug Administration ("FDA") 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.
Ziana 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 Gel.
"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."
"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 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 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 Gel can be obtained at www.medicis.com.
Ziana Gel currently is manufactured for Medicis by Contract Pharmaceuticals Limited Niagara in Buffalo, NY.
Source: Medicis
References
Note: IMS Health, National Prescription Audit, MAT 9/2006
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