Valeant's Jublia Approved in Canada

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Valeant Pharmaceuticals International, Inc. (VRX) has been receiving good news in the last few days.

Last week, Valeant received positive news when the U.S. Food and Drug Administration (:FDA) issued marketing clearance for Bausch + Lomb's newest frequent replacement silicone hydrogel contact lenses.

Valeant acquired Bausch + Lomb in Aug 2013 to strengthen its ophthalmology business, which was a miniscule portion of Valeant’s overall portfolio.

Meanwhile, Valeant continues to develop its dermatology portfolio as well. Valeant received approval for its topical triazole antifungal solution Jublia (efinaconazole) in Canada.

Jublia has been approved for the treatment of mild-to-moderate onychomycosis, a fungal nail infection.

The approval was based on positive data from two pivotal studies conducted among 1,655 subjects.

We note that Valeant obtained an exclusive license from Kaken Pharmaceutical Co., Ltd. to commercialize Jublia  in North America, Central America, South America and the European Union.

However, the approval is still pending in the U.S. Valeant filed the New Drug Application (:NDA) for Jublia in the U.S. in Jul 2012. In May 2013, the FDA issued a Complete Response Letter (CRL) to the company regarding its NDA. In the CRL, the FDA has raised questions relating to Chemistry, Manufacturing and Controls (CMC) areas of the container closure apparatus.

Valeant expects to address the issues raised by the FDA and launch the product in 2014 in the U.S. as well.

Valeant currently carries a Zacks Rank #3 (Hold). Right now, Actelion Ltd. (ALIOF), Jazz Pharmaceuticals (JAZZ), and Cempra, Inc. (CEMP), and look attractive. While Actelion carry a Zacks Rank #1 (Strong Buy), Jazz Pharma and Cempra carry a Zacks Rank #2 (Buy).

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