GlaxoSmithKline (GSK) 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, 2014.
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 Sanofi’s (SNY) 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 include Vanda Pharmaceuticals, Inc. (VNDA) and Forest Laboratories Inc. (FRX). Both hold a Zacks Rank #1 (Strong Buy).
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