CHMP Positive on Novartis' Votubia

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Switzerland-based pharmaceutical company, Novartis AG (NVS) recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (:EMA) gave a positive opinion on Votubia (everolimus) for the treatment of patients suffering from renal angiomyolipoma, associated with tuberous sclerosis complex (:TSC).

On approval, the drug can be used in patients who are at risk of complications such as tumor size or in the presence of 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. EU approval would make Votubia the first non-surgical treatment alternative for patients diagnosed with kidney tumors associated with TSC.

According to data from National Institute of Neurological Disorders and Stroke, kidney tumors, or renal angiomyolipomas, are found to affect up to 80% of patients with TSC and the increase in tumor size can be life-threatening.

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 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.

Votubia is also approved as Afinitor 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) Sutent (sunitinib) or Onyx Pharmaceuticals, Inc.’s (ONXX) 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) Arimidex (anastrozole).

We note that Novartis recorded Afinitor sales of $175 million in the second quarter of 2012.

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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