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Glaxo's Votrient Gets European Nod

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GlaxoSmithKline (GSK - Free Report) recently announced that its oncology drug, Votrient (pazopanib), has received approval from the European Commission. Votrient was approved for use in advanced soft tissue sarcoma patients, who have received prior chemotherapy or have progressed within a year after neo adjuvant treatment. We note that approval was only for certain subtypes of advanced soft tissue sarcoma.

In April 2012, Glaxo had received approval from the US Food and Drug Administration (FDA) for the use of Votrient in advanced soft tissue sarcoma patients, who have received prior chemotherapy. Approval was granted on the basis of positive data from a pivotal phase III study of Votrient.

The PALETTE (PAzopanib ExpLorEd in SofT-Tissue Sarcoma) study was conducted in patients with advanced soft tissue sarcomas, whose disease had progressed despite treatment with chemotherapy. Patients with gastrointestinal stromal tumours (GIST) and adipocytic sarcomas were not included in this study.

The study data demonstrated that median progression free survival among patients receiving Votrient was 4.6 months compared to 1.5 months among those receiving placebo. However, overall survival was not statistically significant, with median overall survival for patients receiving Votrient and placebo being 11.9 months and 10.4 months, respectively.

Votrient is marketed worldwide for the treatment of patients with advanced renal cell carcinoma (RCC). It enjoys an 18% share of total prescriptions in the advanced renal cell carcinoma market in the US. Glaxo reported that Votrient sales are rapidly growing in the US, benefiting from the launch of the new indication. Glaxo is also evaluating Votrient as a treatment for ovarian cancer.

Our Recommendation

We currently have an Underperform recommendation on Glaxo. The stock carries a Zacks #4 Rank (Sell rating) in the short run.

A major part of Glaxo's revenues will be exposed to generic competition as multiple drugs are scheduled to lose exclusivity in the next few years. We expect the company's top line and gross margins to remain under pressure in the coming quarters. The US health care reform and EU pricing pressure will continue to affect sales.

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