FAIRFIELD, N.J.--(BUSINESS WIRE)--July 25, 2006--Unigene Laboratories, Inc. (OTCBB: UGNE - News) and Upsher-Smith Laboratories, Inc. have jointly filed in the U.S. District Court for the Southern District of New York a patent infringement lawsuit against Apotex Inc., a Canadian generic pharmaceutical manufacturer, and Apotex Corp., its U.S. subsidiary. The suit was brought in response to Apotex’s filing of an Abbreviated New Drug Application (ANDA) seeking approval of a nasal spray product that claims to be a generic equivalent of Fortical® calcitonin-salmon (rDNA origin) Nasal Spray, the nasal calcitonin product for the treatment of postmenopausal osteoporosis that is manufactured by Unigene and marketed by Upsher-Smith. The filing of the lawsuit automatically stays FDA approval of Apotex’s ANDA for at least 30 months, unless an adverse court decision occurs earlier. Apotex is currently the defendant in a patent infringement lawsuit involving a nasal calcitonin formulation developed and patented by Novartis.
