October 3, 2013 / 3:21 PM / in 4 years

Valeant gets drug, contact-lens approvals, shares rise

Oct 3 (Reuters) - Canadian drugmaker Valeant Pharmaceuticals Inc won regulatory approval on Thursday for a topical nail fungus drug in Canada and clearance for a new contact lens in the United States, pushing its shares up nearly 2 percent.

Health Canada approved Valeant’s Jublia, a topical solution that uses the drug efinaconazole to treat onychomycosis, a nail infection caused by fungi.

Other approved topical treatments have limited effectiveness, and oral treatments are limited by interactions with other drugs and safety concerns, Valeant said.

Jublia is the first new approved topical treatment for the infection in more than a decade, it said.

Valeant also said the U.S. Food and Drug Administration (FDA) had cleared Bausch + Lomb’s latest frequent replacement contact lens.

Both approvals are positive developments for Valeant, which agreed in May to acquire Bausch + Lomb, said Morningstar analyst David Krempa.

“If efinaconazole gets U.S. approval, that would be a bigger deal since the U.S. market is about 10 times Canada,” he said.

The FDA denied approval for the drug in May, raising questions about manufacturing and controls related to the drug’s container. Valeant said it was working on a response.

Onychomycosis causes nails to deform, discolor, thicken, become brittle and split and separate from the nail bed.

Valeant shares rose 1.9 percent in both Toronto and New York, touching a record high C$117.28 in Toronto. The stock had the single biggest positive influence on the Toronto Stock Exchange’s benchmark TSX Composite Index in early trading.

The Quebec-based company, which has grown rapidly through acquisitions, is up 94 percent in Toronto so far in 2013. (Reporting by Rod Nickel in Winnipeg, Manitoba; Editing by Peter Galloway)

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