Valeant's Jublia Approved in the U.S. - Analyst Blog

Positive news flowed in for Valeant Pharmaceuticals International, Inc. ( VRX ) when the FDA approved its New Drug Application (NDA) for Jublia (efinaconazole 10% topical solution) for the treatment of onychomycosis of the toenails.

The acquisition of Dow Pharmaceutical Sciences in 2008 added Jublia to Valeant's pipeline.

We remind investors that Valeant had filed the 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 had raised questions relating to Chemistry, Manufacturing and Controls (CMC) areas of the container closure apparatus.

The FDA approval was based on positive data from two pivotal studies conducted among 1,655 subjects. Jublia received approval in Canada in Oct 2013.

Valeant expects favorable managed care coverage in the U.S., with peak sales in the range of $300-$800 million.

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.

Other products from Dow Pharmaceutical Sciences acquisition for which Valeant has already received approval includes - 1% clindamycin and 5% benzoyl peroxide gel (IDP 111), Acanya and Retin-A Micro (tretinoin) Gel microsphere 0.08%.

The approval of Jublia will further broaden Valeant's already strong dermatology portfolio.

We note that Valeant has been in the news recently for its proposed acquisition of Allergan ( AGN ). However, Allergan had rejected Valeant's proposal forcing the latter to increase its offer price twice.

Valeant currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Gilead Sciences ( GILD ) and Alexion Pharmaceuticals ( ALXN ). While Gilead Sciences carry a Zacks Rank #1 (Strong Buy), Alexion Pharma is a Rank #2 (Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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