Meda, through its wholly owned US subsidiary, Meda Pharmaceuticals Inc., has entered into a settlement agreement with Cobalt Pharmaceuticals Inc. that resolves the US patent litigation between the companies regarding Cobalt's proposed generic version of Astelin.
Astelin (azelastine hydrochloride nasal spray) is used for treatment of allergic and non-allergic rhinitis. The product is protected in the US by a patent that expires on 1 November 2010, with paediatric exclusivity extending until 1 May 2011.
The settlement agreement resolves the patent infringement action filed by Meda after Cobalt's submission of an ANDA (Abbreviated New Drug Applications) to the US FDA (Food & Drug Administration) for a generic version of Astelin in July 2007. Under the settlement agreement, Cobalt admits infringement of Meda's patent. The settlement agreement allows Cobalt to launch a generic version of Astelin, under a license from Meda, on 28 August 2010 at the earliest. In such case, Cobalt will pay 32.5 per cent of their net sales of this product to Meda until 1 February 2011.
"With this settlement agreement, Meda has no further patent litigations pending in the US for Astelin", said Anders Lönner, CEO Meda. In compliance with US law, the settlement agreement will be submitted to the US Federal Trade Commission and Department of Justice and is subject to their review.
Meda AB (publ) is an international specialty pharma company that concentrates on marketing and market-adapted product development. Acquisitions and long-term partnerships are fundamental factors that drive the company's strategy. Meda is represented by its own organisations in 26 countries and has more than 1 500 employees within marketing and sales.