) recently announced that its partner
) 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.
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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
) 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
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
) carrying a Zacks Rank #2 (Buy).