) recently suffered a setback when the US Food and Drug
Administration (FDA) issued a Complete Response Letter (CRL) to
the company regarding its New Drug Application (NDA) for its
anti-fungal candidate IDP-108 (efinaconazole).
Valeant Pharma filed the NDA for IDP-108 in the US in Jul
2012. Valeant Pharma is seeking FDA approval for IDP-108 for a
potential new treatment of onychomycosis, a fungal infection of
the fingernails and toenails, primarily in elders.
We note that Valeant Pharma obtained an exclusive license from
Kaken Pharmaceutical Co., Ltd., to commercialize IDP-108 in North
America, Central America, South America and the European
In the CRL, the FDA has raised questions relating to
Chemistry, Manufacturing and Controls (CMC) areas of the
container closure apparatus.
As the FDA did not raise questions on the efficacy or safety
profile of IDP-108, Valeant Pharma expects to address the CMC
issues soon and subsequently respond to the CRL.
Meanwhile, the stock price of Valeant Pharma surged for the
second consecutive day following the news of the company's
impending acquisition of eye-care company, Bausch + Lomb Holdings
Incorporated, for $8.7 billion in cash.
We believe the acquisition of Bausch + Lomb will significantly
strengthen Valeant Pharma's ophthalmology business.
The acquisition should also enable Valeant Pharma to penetrate
into the growing eye health market fueled by an aging patient
population, an increased rate of diabetes, and increasing demand
from the emerging markets. We note that
) is a leading player in eye care products and technologies with
operations in 75 countries through its Alcon Division.
We expect investor focus to remain on updates of the impending
Valeant Pharma currently carries a Zacks Rank #3 (Hold). Right
) appear to be well placed with a Zacks Rank #1 (Strong Buy).
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