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Verdict on Glaxo's Lovaza

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GlaxoSmithKline (GSK - Free Report) announced recently that the Court of Appeals for the Federal Circuit has issued a verdict against partner Pronova BioPharma in a patent infringement case on its marketed drug Lovaza (omega-3-acid ethyl esters).

We note that Pronova is the owner of the Lovaza patents which were licensed to Glaxo. Glaxo markets Lovaza in the U.S. and Puerto Rico for treating adults with very high triglyceride levels.

The court of appeals overturned the verdict of a lower court on two Pronova patents regarding Lovaza. The Appellate court found one of the two U.S. patents, 5,656,667, to be invalid. The other U.S. patent in question- 5,502,077- had already expired earlier in the year. We note that the patents pertain to compositions and methods of making use of omega-3 fatty acids. Following the ruling, generic companies like Teva Pharmaceutical Industries (TEVA - Free Report) can develop their generic versions of Lovaza.

We note that Glaxo was also in the news recently when it announced encouraging initial results from the phase IIIb/IV FLAMINGO study on ViiV Healthcare’s HIV drug, Tivicay (dolutegravir). The open-label, 48-week study compared the use of Tivicay with Prezista (darunavir) in combination with Norvir (ritonavir) in treatment-naïve adults suffering from HIV-1. It was found that significantly more patients in the Tivicay (90%) arm exhibited virologic suppression as compared to the Prezista (83%) arm.

We note that ViiV Healthcare, a company focused on the treatment of HIV, was established by Glaxo and Pfizer (PFE - Free Report) in 2009. After certain amendments in Oct 2012, Glaxo, Pfizer and Shionogi now own 76.5%, 13.5% and 10% of ViiV Healthcare, respectively.

We remind investors that on Aug 12, 2013, Tivicay was cleared by the U.S. Food and Drug Administration as an add-on therapy to other antiretroviral agents for the treatment of patients suffering from HIV-1, who are above 12 years and weigh at least 88 lbs (40 kg).

Glaxo, a large cap pharma company, carries a Zacks Rank #3 (Hold). We are pleased with Glaxo’s pipeline development efforts. A number of pipeline-related news is expected in the coming quarters. Given the declining sales due to generic competition, we believe Glaxo’s pipeline must deliver.

Novo Nordisk (NVO - Free Report) is favorably placed in the large cap pharma space with a Zacks Rank #2 (Buy).

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