Oslo, 30 March 2011: Pronova BioPharma announced today that it has entered into an agreement with Apotex Corp. and Apotex Inc. (collectively "Apotex") to settle patent litigation regarding Apotex's proposed generic version of Lovaza(TM) (omega-3-acid ethyl esters) yesterday.
The settlement grants Apotex a license to enter the US market with a generic version of Lovaza(TM) in the first quarter of 2015, or earlier depending on certain circumstances.
The US District Court of Delaware will enter the Stipulation of Dismissal without Prejudice and the corresponding patent litigation will be dismissed. Other terms of the settlement are confidential.
Pronova BioPharma is currently still involved in lawsuits with Teva Pharmaceuticals USA, Inc. ("Teva") and Par Pharmaceutical, Inc. ("Par"), regarding infringement of the company's patents relating to Lovaza(TM).
Omacor®/Lovaza(TM) is the first commercialised product developed from Pronova BioPharma's active pharmaceutical ingredient (API). It is also the first and only EU and U.S. FDA-approved Omega 3-derived prescription drug. Blockbuster status was achieved in the fourth quarter of 2009 as the global end-user sales were USD 1 063 million. Pronova BioPharma estimates that more than one million patients are currently on a prescription for one of the branded products containing its API.
About Pronova BioPharma
Pronova BioPharma is a global leader in research, development and manufacture of lipid therapies derived from nature
The group's first commercialised product is branded in a number of countries throughout Europe, Asia and in the USA. End-user sales are growing rapidly in all international markets and the reached annual run rate at 31 December 2010 was USD 1 260 million, according to IMS Health.
The product is the first and only EU- and FDA-approved Omega 3-derived prescription drug.
Marketing and distribution of Pronova BioPharma's key product is currently licensed to both local and global pharmaceutical companies.
Pronova BioPharma's headquarters are located at Lysaker in Norway, while production takes place in manufacturing facilities at Sandefjord in Norway and in Kalundborg, Denmark. The company's shares are listed on Oslo Børs with the ticker code PRON.