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Glaxo Initiates Phase III Study

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Genmab (GNMSF - Free Report) recently announced that its partner GlaxoSmithKline (GSK - Free Report) has initiated a phase III study (n ~ 136) on a subcutaneous formulation of their marketed drug Arzerra (ofatumumab) for an additional indication. The double blind phase III study will evaluate the safety and efficacy of Arzerra in patients suffering from pemphigus vulgaris, a rare skin related autoimmune disorder.

We note that Arzerra was approved in Oct 2009 for the treatment of patients with chronic lymphocytic leukemia (CLL), a type of blood cancer, refractory to Sanofi’s (SNY - Free Report) Campath (alemtuzumab) and Fludara (fludarabine). In the first quarter of 2013, Glaxo reported Arzerra revenues of £21 million, up 67% from the year-ago quarter.

Glaxo and Genmab are looking to expand the label of Arzerra. In May 2013, Glaxo and Genmab announced encouraging top-line data from a phase III study (n = 447) which compared the efficacy of Arzerra as an adjunct to another oncology drug at Glaxo, Leukeran (chlorambucil) in treatment-naive CLL patients versus Leukeran alone.

The study met its primary endpoint of progression free survival (PFS/the time a patient lived without worsening of their disease). Data from the study was assessed by an independent review committee. In the Arzerra + Leukeran arm of the study, median PFS of 22.4 months was observed as compared to 13.1 months in the Leukeran arm.

Glaxo carries a Zacks Rank #3 (Hold). We are pleased with Glaxo’s label expansion efforts. Moreover, Glaxo boasts of a robust pipeline. A number of pipeline-related news is expected in the coming quarters. Given the declining sales from generic competition, we believe Glaxo’s pipeline must deliver. Companies that currently look attractive include Novo Nordisk (NVO - Free Report) carrying a Zacks Rank #2 (Buy).

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