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What's GlaxoSmithKline Doing In The E.U.?

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GlaxoSmithKline plc (ADR) (NYSE: GSK) announced that it has submitted another marketing application for Revolade in the EU. The company is looking to get the drug approved for the treatment of pediatric patients (aged 1 year and above) suffering from chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have insufficiently responded to corticosteroids or immunoglobulins.

In November last year, Glaxo had filed a marketing application in the EU for Revolade for the severe aplastic anemia indication. We note that Revolade is already approved in the U.S. under the trade name

Also towards the end of 2014, Promacta was submitted in the U.S. for the treatment of pediatric patients (aged six years and older) suffering from chronic ITP. The drug is also being developed for the treatment of myelodysplastic syndrome in phase III studies.

In 2014, Glaxo recorded Promacta sales of £231 million. Promacta is an important product at Glaxo as far as its oncology portfolio is concerned. The successful label expansion of the drug will drive sales further.

Glaxo has a licensing agreement with Ligand Pharmaceuticals (NASDAQ: LGND) for Promacta.

In a separate press release Glaxo announced positive overall survival results from the phase III COMBI-d study on the Tafinlar and Mekinist combination. The results showed that a statistically significant reduction in the risk of death was observed in patients under the Tafinlar and Mekinist combination therapy as compared to Tafinlar monotherapy in patients suffering from BRAF V600E/K mutation-positive metastatic melanoma.

We note that the study is being conducted as a post-marketing requirement for the FDA's accelerated approval for the combination in the U.S. The company intends to submit final data from the COMBI-d study to regulatory authorities in the coming months.

We are encouraged by Glaxo's progress with its oncology portfolio so far. However, the market currently has other big players like Roche (RHHBY).

Glaxo carries a Zacks Rank #3 (Hold). Allergan Inc. (NYSE: AGN) is a better-ranked stock in the health care sector carrying a Zacks Rank #2 (Buy).


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