Glaxo's Promacta Holds Promise - Analyst Blog


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Updates related to pipeline and label expansion efforts are eagerly awaited by investors in the biotech/pharma space as these play a crucial role in their investment decisions. These updates provide an insight into the commercial potential of a drug/candidate.

Last week, GlaxoSmithKline ( GSK ) announced encouraging results from the phase III PETIT2 study on Promacta. The study evaluated the efficacy, safety and tolerability of Promacta in pediatrics with previously treated chronic immune (idiopathic) thrombocytopenic purpura (cITP) as compared to placebo.

Results from the study revealed that patients under Promacta treatment showed a statistically significant improvement in platelet count compared to those under placebo. This was also the primary endpoint of the study. Results from the study were presented at the European Haematology Association Annual Congress.

Glaxo also mentioned that the efficacy results in the phase III study were consistent throughout other age cohorts. Moreover, the safety profile of the drug was also similar to the established profile of Promacta. Glaxo intends to file regulatory applications for Promacta for the above indication later in the year.

Glaxo has a licensing agreement with Ligand Pharmaceuticals Incorporated ( LGND ) for Promacta. Ligand receives royalties on the sales of the drug.

We note that Promacta is currently approved for the treatment of thrombocytopenia (low blood platelet count) in patients with cITP. The drug is also approved for the treatment of thrombocytopenia in patients with chronic hepatitis C virus (HCV) infection. Promacta is marketed in Europe and other countries across the world under the trade name Revolade.

The companies are looking to get Promacta approved in other indications as well. In Feb 2014, Glaxo and Ligand submitted a supplemental New Drug Application (sNDA) for Promacta in the U.S. for the treatment of cytopenias (reduction in blood cells) in patients suffering from severe aplastic anemia (SAA), who have not responded sufficiently to immunosuppressive therapy. Promacta enjoys breakthrough therapy designation in the U.S. for the SAA indication.

Glaxo has progressed well with Promacta. Further label expansion of the drug should drive growth. Promacta sales grew 19% year over year in the first quarter of 2014.

Glaxo carries a Zacks Rank #3 (Hold). Right now, stocks like Allergan ( AGN ) and Gilead Sciences ( GILD ) look better placed in the healthcare space. Both Allergan and Gilead carry a Zacks Rank #1 (Strong Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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