) 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
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
Regeneron Pharmaceuticals, Inc.
). While Regeneron carries a Zacks Rank #1 (Strong Buy), Allergan
and Affymax hold a Zacks Rank #2 (Buy).
Want the latest recommendations from Zacks Investment Research?
Today, you can download 7 Best Stocks for the Next 30 Days.
Click to get this free report
REGENERON PHARM (REGN): Free Stock Analysis
ALLERGAN INC (AGN): Free Stock Analysis Report
GLAXOSMITHKLINE (GSK): Free Stock Analysis
To read this article on Zacks.com click here.