Positive news flowed in for
Valeant Pharmaceuticals International, Inc.
) 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
). 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
). While Gilead Sciences carry a Zacks Rank #1 (Strong Buy),
Alexion Pharma is a Rank #2 (Buy).
Want the latest recommendations from Zacks Investment Research?
Today, you can download 7 Best Stocks for the Next 30 Days.
Click to get this free report
VALEANT PHARMA (VRX): Free Stock Analysis
ALEXION PHARMA (ALXN): Free Stock Analysis
ALLERGAN INC (AGN): Free Stock Analysis Report
GILEAD SCIENCES (GILD): Free Stock Analysis
To read this article on Zacks.com click here.