Perrigo Company has announced that it has purchased the ANDA forclindamycin phosphate (1 and benzoyl peroxide (5%) gel from KVPharmaceutical for $14 million in cash at closing and a $2 million milestonepayment upon the completion of a successful technical transfer. This productis the AB-rated equivalent to Stiefel Laboratories' (a subsidiary of GlaxoSmithKline) Duac gel, indicated for the topical treatment of inflammatoryacne vulgaris. Annual sales for the brand were approximately $165 millionaccording to Wolters Kluwer data.
KV Pharmaceutical was the first to file its ANDA for clindamycin phosphate(1 and benzoyl peroxide (5%) gel containing a Paragraph IV Certificationwith the U.S. Food & Drug Administration. After KV Pharmaceutical notifiedStiefel Laboratories, the patent owner and New Drug Application holder forDuac gel of their filing, Stiefel filed suit in May 2009 in the United StatesDistrict Court for the District of Delaware, alleging patent infringementagainst KV Pharmaceutical. Perrigo has assumed responsibility for thislitigation. Subsequent to the acquisition, Perrigo will immediately beginworking on the transfer of production to a Perrigo site with the intention toamend the ANDA accordingly.
Perrigo's Chairman and CEO Joseph C. Papa concluded, "This acquisition isanother example of Perrigo's commitment to make the investments to build ourproduct portfolio and deliver quality affordable healthcare products, as wellas solidify our leadership position in the generic topical space."