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Positive CHMP Opinions for Novartis

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Novartis’ (NVS - Free Report) global eye care division, Alcon, recently received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for Jetrea (ocriplasmin). Jetrea is under review in the EU for the treatment of vitreomacular traction (VMT) including instances where the macular hole diameter is less than or equal to 400 microns.

The CHMP’s opinion was based on data submitted from two pivotal phase III studies which showed that Jetrea successfully resolved VMT and macular hole compared to placebo.

Belgian biopharmaceutical company ThromboGenics had granted Novartis the rights to commercialize Jetrea outside the US. In Oct 2012, Novartis’ Jetrea was approved for the treatment of patients with symptomatic vitreomacular adhesion (VMA) in the US, where it was launched earlier this year.

Novartis estimates that 250,000 to 300,000 patients in Europe suffer from visual distortion, decreased visual acuity and central blindness. This represents significant commercial potential for Jetrea, which should be able to capture a share of the European market considering the limited treatment options available for VMT. With the CHMP in favor of approving Jetrea, we expect EU approval for the candidate shortly.

Meanwhile, Novartis received a positive opinion from the CHMP for another of its candidates, llaris (canakinumab, ACZ885). Ilaris is under review in the EU for the treatment of patients with acute gouty arthritis and suffering from frequent attacks, and whose symptoms were not managed with current treatment options. A final decision on Ilaris should be out shortly.

Novartis carries a Zacks Rank #3 (Hold). Other pharmaceutical companies performing well are Salix Pharmaceuticals Ltd. and Valeant Pharmaceuticals International, Inc. (VRX - Free Report) , both of which carry a Zacks Rank #1 (Strong Buy). Additionally, BioCryst Pharmaceuticals, Inc. (BCRX - Free Report) is also performing well and carries a Zacks Rank #2 (Buy).

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