GlaxoSmithKline confirms Pronova BioPharma reaches agreement with Apotex regarding Lovaza™ US patent litigation

Issued: London UK

• Litigation continues between Pronova BioPharma and two other generic challengers

GlaxoSmithKline (GSK), which has the marketing rights for Lovaza (omega-3-acid ethyl esters) in the US and Puerto Rico, confirmed today that Pronova BioPharma Norge AS, which owns the patents for Lovaza, has entered into an agreement with Apotex Corp. and Apotex Inc. (collectively “Apotex”), to settle their patent litigation in the United States related to Lovaza.

The settlement grants Apotex a license to enter the US market with a generic version of Lovaza in the first quarter of 2015, or earlier depending on certain circumstances. Other terms of the settlement are confidential. 

Pronova BioPharma is currently still involved in lawsuits with Teva Pharmaceuticals USA, Inc., and Par Pharmaceutical, Inc., regarding its patents relating to Lovaza.

In 2010, GSK reported Lovaza turnover of £530 million ($822 million).  All GSK sales of Lovaza were generated in the US and Puerto Rico. 

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information please visit www.gsk.com

Cautionary statement regarding forward-looking statements Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2010.