FDA manufacturing concerns hold up Valeant drug launch

Valeant Pharmaceuticals this month agreed to delay the launch of efinaconazole, a drug for treating a nail fungal condition, until after an arbitration hearing in September with Anacor Pharmaceuticals. But today Valeant ($VRX) said it has another factor affecting the launch. The FDA has sidelined its new drug application (NDA) over concerns tied to manufacturing.

At the same time that Valeant was outlining an $8.7 billion deal to buy Bausch + Lomb, the Canadian drugmaker said it had received a completed response letter (CRL) from the FDA about its drug application for efinaconazole, its topical treatment for onychomycosis. Its release was short on details, saying only that the FDA had problems with "Chemistry, Manufacturing and Controls (CMC) related areas of the container closure apparatus." Because it is CMC concerns and not efficacy or safety issues, Valeant said it believed it could get them worked out pretty quickly.

Valeant last year found itself entangled in a breach of contract issue over the drug. California-based Anacor said it was seeking $215 million in an action over an agreement it had with Dow Pharmaceutical Sciences (DPS) for development services that Dow had done for Anacor for its own drug for treating onychomycosis. Valeant bought DPS in 2009. Valeant has said it will "vigorously" defend against the claim.

Manufacturing problems have cropped up a number of times recently in regards to NDAs. This month, the FDA told Gilead Sciences ($GILD) it needed to fix quality testing issues before it would consider approval of the standalone use of elvitegravir and cobicistat, two of the four drugs in Stribild, its four-drug HIV treatment approved last year. Separately, GlaxoSmithKline ($GSK) broke off a partnership with Impax Laboratories ($IPXL) because plant problems have held up approval of an extended-release version of a drug for Parkinson's disease.

- here's the release
- and the earlier arbitration release

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