(NVS) Novartis Presents Afinitor Data

Recently, Novartis (NVS) presented data from a late-stage study (EXIST-1) of its cancer drug Afinitor (everolimus). The randomized, placebo-controlled, double-blind, multicenter study evaluated the safety and effectiveness of the drug compared to placebo for treating patients with subependymal giant cell astrocytomas (SEGAs) coupled with tuberous sclerosis (TS). Results from the study were presented at the International tuberous sclerosis complex (TSC) Research Conference in the US.

The study revealed that treatment with Afinitor caused a 50% or more reduction in SEGA tumor size in 35% of the patients. However, no such reduction was observed in the placebo arm.

SEGA refers to a benign brain tumor associated with tuberous sclerosis. TSC, which is associated with multiple disorders such as seizures, swelling in the brain, developmental delays and skin lesions, affects approximately one or two million people across the globe.

We remind investors that Afinitor was backed for approval in the European Union in June 2011. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approval of Afinitor for the indication in the EU based on data from a mid-stage study, which showed that 9 of 27 patients experienced a SEGA tumor reduction of 50% or more at six months relative to baseline. Also 21 of 27 patients experienced a 30% or more reduction in the size of their largest SEGA tumor on being treated with Afinitor.

The drug will be marketed in the EU under the trade name of Votubia and will be the first medicine in the region for the treatment of this challenging disease, if approved. It is already marketed in the US for the disease. The drug is also approved in Switzerland, Brazil, Colombia, Canada, Guatemala, the Philippines and Korea to treat SEGA associated with TS. Novartis has filed for approval of the drug in many other countries.

Afinitor is also  marketed in the US and EU for the treatment of advanced renal cell carcinoma (kidney cancer) along with other anti-VEGF therapies like Roche’s (RHHBY) Avastin, Pfizer’s (PFE) Sutent or Onyx Pharmaceuticals’(ONXX) Nexavar. Afinitor is also being evaluated in other cancer indications as well such as diffuse large B cell lymphoma, breast cancer, gastric cancer and hepatocellular carcinoma (HCC).

Our Recommendation

Currently, we have a Neutral recommendation on Novartis. The company carries a Zacks #3 Rank (“Hold” rating) in the short run.

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