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Glaxo's Label Expansion Plans Marred as Arzerra Disappoints

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GlaxoSmithKline (GSK - Free Report) and partner Genmab announced disappointing top-line data on their oncology drug, Arzerra. The phase III study (OMB114242) compared Arzerra versus physicians’ choice in patients suffering from bulky fludarabine-refractory chronic lymphocytic leukemia (CLL).

The OMB114242 study failed to meet the primary endpoint. Statistically significant difference in progression free survival was not observed between patients receiving Arzerra and patients receiving therapies of physicians’ choice.

The OMB114242 study was conducted by Glaxo to fulfill requirements set by the European Commission for the conditional approval of Arzerra for the treatment of patients with CLL refractory to Campath (alemtuzumab) and Fludara (fludarabine). Earlier this year, the FDA approved Arzerra in combination with another Glaxo drug, Leukeran (chlorambucil), in treatment-naive CLL patients for whom fludarabine-based therapy is not suitable.

Glaxo reported Arzerra revenues of approximately £16 million in the first quarter of 2014. After the disappointing OMB114242 study data, Glaxo and Genmab are unlikely to submit a marketing application for Arzerra for the bulky fludarabine-refractory CLL indication.

Update on HIV Portfolio

Meanwhile, Glaxo received some positive news on its HIV portfolio. ViiV Healthcare announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a favorable opinion on Triumeq (a combination of Tivicay, abacavir and lamivudine) for the treatment of HIV infection in adults and adolescents  aged 12 years and older and weighing at least 40kg. The European Commission is expected to render a final decision in the third quarter of 2014.

Glaxo currently holds a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Allergan (AGN - Free Report) , Regeneron Pharmaceuticals, Inc. (REGN - Free Report) and Affymax, Inc. . While Regeneron carries a Zacks Rank #1 (Strong Buy), Allergan and Affymax hold a Zacks Rank #2 (Buy).

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