Perrigo Company (Nasdaq: PRGO; TASE) today announced that together with its partner Cobrek Pharmaceuticals, Inc. final approval has been received from the U.S. Food and Drug Administration to manufacture and market Clindamycin Phosphate Foam 1%, a generic version of Evoclin® Foam 1% of Stiefel. As the ANDA was first to file with a Paragraph IV certification against Evoclin®, 180 days of generic exclusivity was granted by the U.S. Food and Drug Administration. Perrigo commenced shipping of the product immediately following Food and Drug Administration approval on March 31, 2010. In addition, Perrigo and Cobrek have reached an agreement to settle the underlying Hatch Waxman litigation brought by Stiefel Laboratories, a GSK Company. In accordance with the terms of the settlement Perrigo and Cobrek could continue to ship product until April 2, 2010. In addition, Perrigo can recommence shipments of the product on or after October 1, 2010. The agreement with Stiefel includes payments from Perrigo to Stiefel of license fees as well as royalties.
Evoclin® (clindamycin phosphate) Foam 1% is a topical antibiotic indicated for topical application in the treatment of acne vulgaris, and had sales of approximately $44 million for the 12 months ended February 2010, as measured by Wolters Kluwer Health.
Perrigo's Chairman and CEO Joseph C. Papa concluded, "This launch reflects our continuing investment in new products. It is an example of the excellent partnership we have with Cobrek for developing foam products which is a key product category for our Rx business. Perrigo will manufacture, sell and market Clindamycin exclusively in the U.S. As always, Perrigo is committed to making quality healthcare more affordable for our customers and drive value for our shareholders."
New modular strategy reduces piperidine synthesis steps for pharmaceuticals