Meda, through its wholly owned U.S. subsidiary, Meda Pharmaceuticals Inc., has entered into a settlement agreement with Apotex that resolves the U.S. patent litigation between the companies regarding Apotex’s proposed generic versions of Astelin® and Optivar®. Astelin® (azelastine hydrochloride nasal spray) is used for treatment of allergic and non-allergic rhinitis and Optivar® (azelastine hydrochloride ophthalmic solution) is used for treatment of allergic conjunctivitis. These products are protected in the U.S. by a patent that expires on 1 November 2010, with pediatric exclusivity extending until May 1, 2011. The settlement agreement resolves patent infringement actions filed by Meda after Apotex’s submission of ANDAs (Abbreviated New Drug Applications) to the FDA for generic versions of Astelin® and Optivar® in 2006 and 2007, respectively. Under the settlement agreement, Apotex admits infringement of Meda’s patent. Given the settlement agreement, the parties will jointly request that scheduled trials regarding Apotex’s proposed generic version of Astelin® in May 2008 and proposed generic version of Optivar® in February 2009 be adjourned and the actions closed. The settlement agreement allows Apotex to launch a generic version of Astelin®, under a license from Meda, on 1 March 2010. In such case, Apotex will pay 32.5% of their net sales of this product to Meda until 1 February 2011. The agreement also allows Apotex to launch a generic version of Optivar®, under license from Meda, on December 1, 2009, without further payments to Meda. “This settlement agreement brings clarity to Meda’s intellectual property rights on the U.S. patent for Astelin® and Optivar®,” said Anders Lonner, CEO Meda. In compliance with U.S. law, the settlement agreement will be submitted to the U.S. Federal Trade Commission and Department of Justice and is subject to their review.
