Novartis Division Gets European Approval for Simbrinza

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Novartis’ (NVS) ophthalmology division, Alcon, received encouraging news when Simbrinza was approved by the European Commission.

Simbrinza has been approved in Europe to decrease elevated intraocular pressure (:IOP) in adult patients with open-angle glaucoma or ocular hypertension for which monotherapy provides insufficient IOP reduction.

Alcon conducted two pivotal six month phase III studies to evaluate safety and efficacy of Simbrinza administered twice daily in patients with open-angle glaucoma or ocular hypertension who were insufficiently controlled on monotherapy or were already using multiple IOP-lowering medications. Both studies met their primary endpoints.

Alcon will launch Simbrinza in the UK in the third quarter of 2014. Thereafter, it will be launched in other European markets later in 2014 and in 2015. We note that Simbrinza was approved by the FDA in 2013.

The approval does not surprise us as the Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion to Simbrinza in May 2014.

Meanwhile, we cautiously watch Novartis' efforts to realign its portfolio in order to focus on its core portfolio of pharmaceuticals, eyecare and generics. We believe Novartis’ recent deal to acquire oncology products from GlaxoSmithKline (GSK) and the divestiture of the Vaccines business is a step in the right direction. It will broaden Novartis’ portfolio and enable it to focus better on its core capabilities besides contributing immensely to the top line.

Novartis, a large-cap pharma, currently carries a Zacks Rank #3 (Hold). Right now, Allergan (AGN) and AbbVie (ABBV) look well positioned among the large-cap pharmas. While Allergan carries a Zacks Rank #1 (Strong Buy), AbbVie is a Zacks Rank #2 (Buy) stock.

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