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The European Commission (EC) recently approved Swiss pharmaceutical giant Novartis’ (NVS - Analyst Report) Votubia to treat adults suffering from renal angiomyolipoma associated with tuberous sclerosis complex (TSC). The drug can now be used in patients who are at risk of complications such as tumor size or the presence of an aneurysm or multiple or bilateral tumors but at the same time who do not require immediate surgery.

Novartis’ Votubia enjoys orphan drug status in the EU for TSC. With the European approval, Votubia became the first medical treatment in this patient population in the EU. The European regulatory body’s decision did not come as a surprise, as in September this year the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had given a positive opinion on Votubia.

The favorable recommendation was based on data from a phase III study, EXIST-2, which showed that 42% of patients treated with Votubia experienced a response in angiomyolipoma compared to 0% of patients on placebo.

We note that Votubia is currently approved as Afinitor in the US for the treatment of patients suffering from renal angiomyolipoma, which is associated with TSC and not requiring immediate surgery. The drug is also approved in the US and EU for the treatment of advanced renal cell carcinoma (kidney cancer) after the failure of treatment with Pfizer Inc.’s (PFE - Analyst Report) Sutent (sunitinib) or Onyx Pharmaceuticals, Inc.’s Nexavar (sorafenib).

In July 2012, Novartis’ Afinitor gained approval both in the US and the EU for the treatment of HR+ HER2- advanced breast cancer in combination with exemestane, after the failure of treatment with Femara (letrozole) or AstraZeneca’s (AZN - Analyst Report) Arimidex (anastrozole).

Our Take

Afinitor grew 82% on a constant currency basis during the third quarter of 2012. We expect the product’s label expansion will drive sales further.

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

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