) and partner Genmab announced that a supplemental Biologics
License Application (sBLA) for their oncology drug, Arzerra, has
received Priority Review designation from the U.S. Food and Drug
Administration (FDA). The companies are looking to get the drug
approved for use in combination with an alkylator-based therapy
in treatment-naive chronic lymphocytic leukemia (CLL) patients
for whom fludarabine-based therapy is not considered suitable.
The FDA is expected to render a decision on Arzerra by Apr 17,
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The sBLA was submitted in Oct 2013 on the basis of encouraging
top-line data from a phase III study on Arzerra. The study met
its primary endpoint of progression free survival (PFS/the time a
patient lived without worsening of the disease). results showed
that median PFS in the Arzerra + Leukeran arm of the study was
22.4 months compared to 13.1 months in the Leukeran arm,
representing an improvement of 9.3 months.
Arzerra received Breakthrough Therapy designation from the FDA in
Sep 2013 for this indication.
GlaxoSmithKline and Genmab are also looking to get Arzerra
approved in combination with Leukeran for the above mentioned
indication in the EU and have submitted a variation to the
Marketing Authorisation Application for the same.
We note that Arzerra is already approved for the treatment of
patients with CLL refractory to
) Campath (alemtuzumab) and Fludara (fludarabine) since 2009.
Glaxo also announced some changes in its sales and marketing
practices worldwide. The company plans to stop paying healthcare
professionals for speaking about Glaxo's products and disease
areas at engagements and medical conferences. Glaxo expects this
policy to be in place from 2016. Additionally, by early 2015,
Glaxo plans to remove individual sales targets and roll out a new
sales force compensation program.
We note that Glaxo's promotional practices came under the scanner
when earlier this year Chinese government authorities leveled
charges of fraudulent behavior and ethical misconduct. The
investigation is ongoing; however, it is likely that a number of
Glaxo employees were engaged in fraudulent practices. Glaxo
witnessed a significant decline in sales in China (down 61%) in
the third quarter of 2013.
Glaxo carries a Zacks Rank #3 (Hold). Some better-ranked stocks
Vanda Pharmaceuticals, Inc.
Forest Laboratories Inc.
). Both hold a Zacks Rank #1 (Strong Buy).