Medicis announced the approval of an Abbreviated New Drug Application (ANDA) by the Food and Drug Administration (FDA) to market its new Dynacin Tablets (minocycline HCl). Minocycline is the most frequently prescribed drug by U.S. dermatologists and Dynacin is the number one prescribed brand of minocycline in the specialty of dermatology. Par Pharmaceutical, a wholly owned subsidiary of Pharmaceutical Resources Inc will manufacture new Dynacin Tablets for Medicis pursuant to an exclusive manufacturing and supply agreement. Financial terms of the agreement were undisclosed.
Dynacin Tablets is a prescription product and will be available in 50 mg., 75 mg. and 100 mg. dosages. Dynacin Tablets formulation is the most recent innovation to the Dynacin family of products. Dynacin 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 Tablets are small, easy-to-swallow, coated tablets suitable for patients who experience difficulty swallowing larger-sized capsules. Additionally, Dynacin 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 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 has the potential to enhance the brand's already significant success. The new, smaller-sized, coated Dynacin 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 Tablets as an alternative to Dynacin 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 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.