FDA, Manufacturing

Trying to turn a new leaf, Valeant ‘blockbuster’ can’t shed an R&D jinx

Michael Pearson never much cared for drug development or pipelines during his rocky run as CEO of Valeant $VRX, generally steering clear of it all as he snapped up assets. But Pearson made an exception for the late-stage eye drug latanoprostene bunod, which he picked up in the $8.7 billion Bausch + Lomb buyout, confidently predicting that the company had a blockbuster on its hands.

Joe Papa

The FDA, though, turned thumbs down on the marketing application a year ago. And it turns out that new CEO Joe Papa is no better at wangling new drug approvals than his predecessor.

On Monday Valeant said that the FDA had once again snubbed the company’s NDA for the drug, designed to reduce eye pressure for patients with glaucoma or ocular hypertension. And once again the rejection was based not on efficacy or safety, but because of a manufacturing snafu.

FDA regulators have remained unimpressed with a Bausch + Lomb facility and its less than stellar approach to handling the problems it’s been cited for, which includes finding metal particulates in samples.

Initially, Pearson had promised a 2016 rollout. Now, Valeant — which has been selling off assets to reduce debt while trying to build drug revenue — is looking at a third shot in 2018.


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