) recently presented positive data on its oncology drug, Votrient
(pazopanib) from a pivotal phase III study. The phase III study
COMPARZ (COMParing the efficacy, sAfety and toleRability of
paZopanib vs. sunitinib) evaluated the use of Votrient versus
) Sutent (sunitinib) in patients with advanced renal cell
The open-label, head-to-head, randomized study enrolled 1,110
patients. Votrient was found to be non-inferior compared to Sutent
in terms of progression free survival (PFS). Median PFS was 8.4
months and 9.5 months in the Votrient and Sutent arms,
respectively. Votrient demonstrated an objective response rate
(ORR) of 31%, while ORR was 25% in the Sutent arm.
Votrient is currently marketed worldwide for the treatment of
patients with advanced renal cell carcinoma. On April 26, 2012, the
FDA approved Votrient for the treatment of patients with advanced
soft tissue sarcoma who have received prior chemotherapy. On August
7, 2012, Votrient received approval from the European Commission
for use in advanced soft tissue sarcoma patients, who have received
prior chemotherapy or have progressed within a year after neo
In the second quarter of 2012, Glaxo reported that Votrient sales
increased 77% to £39 million. In the US, Votrient sales went up
67%, benefiting from the label expansion.
We currently have a Neutral recommendation on Glaxo. The stock
carries a Zacks #3 Rank (Hold rating) in the short run.
Several products in Glaxo's portfolio including Valtrex, Arixtra,
Evoclin, Lamictal, Imitrex, Requip, Combivir and Epivir are facing
declining sales due to intense generic competition. We expect the
company's top line and gross margins to remain under pressure in
the coming quarters. The EU pricing pressure will continue to
Glaxo is looking towards deals and acquisitions to drive growth.
The company is focusing on increasing the rights on its partnered
products and promising pipeline candidates, so that it stands to
benefit more from their success.
Glaxo's acquisition of Cellzome and Human Genome Sciences and
increasing investment in
) indicate its efforts to expand the pipeline.
Apart from this, Glaxo continues to make progress with its
cost-cutting initiative, which should help reduce the impact of
increasing generic competition over the next few years and help
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