OREANDA-NEWS. Cosmo Pharmaceuticals SpA informs that Santarus, Inc., a wholly owned subsidiary of Salix Pharmaceuticals, Ltd., and its subsidiary, Cosmo Technologies Limited (“Cosmo”), the licensor, commenced a lawsuit against generic drug maker Actavis, Inc. (“Actavis”) for Actavis’ infringement of six patents listed in the U.S. Food and Drug Administration’s (“FDA’s”) Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the “Orange Book”) as covering Uceris® and its use. The lawsuit was filed in the United States District Court for the District of Delaware.

Cosmo and Santarus filed this lawsuit in response to a notice letter, dated January 5, 2015, sent by Actavis regarding its filing with the FDA of an Abbreviated New Drug Application No. 205457 seeking approval for Actavis to manufacture and sell budesonide extended release tablets. This letter also stated that ANDA No. 205457 contained Paragraph IV certifications, under 21 U.S.C. Section 355(j) of the Federal Food, Drug, and Cosmetic Act, with respect to the six patents listed in the Orange Book on that date as covering Uceris®: U.S. Patent Nos. 7,410,651; 7,431,943; 8,293,273; 8,784,888; 8,895,064 (“the ‘064 patent”); and RE43799. These six patents are all expected to expire on June 9, 2020, with the exception of the ‘064 patent, which is expected to expire on September 7, 2031. Cosmo and Santarus remain committed to protecting their intellectual property rights, including their patent protection for Uceris®.

About Cosmo Pharmaceuticals

Cosmo is a specialty pharmaceutical company that aims to become a global leader in the field of optimized therapies for selected Gastrointestinal and topically treated Skin Disorders. The company’s proprietary clinical development pipeline specifically addresses innovative treatments for IBD, such as Ulcerative Colitis and Crohn’s Disease, and Colon Infections. In addition, the Company is developing a diagnostic for the detection of colon cancer and a medical device for polyp excision as well as a new chemical entity for the topical skin treatment. Cosmo’s MMX® products that have reached the market are Lialda®/Mezavant®/Mesavancol®, a treatment for IBD that is licensed globally to Giuliani and Shire Limited and Uceris®, the first glucocorticosteroid indicated for the induction of remission in active, mild to moderate ulcerative colitis, licensed in US to Salix and in the Rest of the World except for Japan to Ferring. Cosmo’s proprietary MMX® technology is at the core of the Company’s product pipeline and was developed from its expertise in formulating and manufacturing gastrointestinal drugs for international clients at its GMP (Good Manufacturing Practice) facilities in Lainate, Italy. The technology is designed to deliver active ingredients in a targeted manner in the colon.