Perrigo purchases KV Pharmaceutical's ANDA for clindamycin phosphate and benzoyl peroxide gel

Sep 21 2009

Perrigo Company (Nasdaq: PRGO;TASE) today announced that it has purchased the ANDA for clindamycin phosphate (1%) and benzoyl peroxide (5%) gel from KV Pharmaceutical for $14 million in cash at closing and a $2 million milestone payment upon the completion of a successful technical transfer. This product is the AB-rated equivalent to Stiefel Laboratories' (a subsidiary of Glaxo SmithKline) Duac(R) gel, indicated for the topical treatment of inflammatory acne vulgaris. Annual sales for the brand were approximately $165 million according 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 Certification with the U.S. Food & Drug Administration. After KV Pharmaceutical notified Stiefel Laboratories, the patent owner and New Drug Application holder for Duac(R) gel of their filing, Stiefel filed suit in May 2009 in the United States District Court for the District of Delaware, alleging patent infringement against KV Pharmaceutical. Perrigo has assumed responsibility for this litigation. Subsequent to the acquisition, Perrigo will immediately begin working on the transfer of production to a Perrigo site with the intention to amend the ANDA accordingly.

Perrigo's Chairman and CEO Joseph C. Papa concluded, "This acquisition is another example of Perrigo's commitment to make the investments to build our product portfolio and deliver quality affordable healthcare products, as well as solidify our leadership position in the generic topical space."