FDA, Manufacturing

Aerie boosted as Valeant’s troubled Tampa facility looks like it’s coming out of rehab

Just days after Valeant $VRX and its late-stage eye drug latanoprostene bunod were turned away by the FDA for the second time after its Bausch + Lomb manufacturing facility in Tampa failed to measure up to federal standards, the troubled biotech says it’s clearly on track to now snag a clean bill of health from inspectors.

And while Valeant still has to refile, once again, the news buoyed shares of Aerie, which relies on the facility for its supplies of Rhopressa, a glaucoma drug now under review at the FDA.

Aerie is looking at a February 28, 2018 PDUFA date for Rhopressa, and there’s been some lingering concerns — or hopes, depending whther investors were long or short on the stock — that the FDA’s uncompromising attitudes on US manufacturing standards would also trigger a CRL for their drug.
Federal inspectors have taken a dim view of the facility’s ability to resolve the problems it’s been cited for, including finding metal particulates in samples.

Joe Papa

Aerie’s stock $AERI was up about 5% in after-market trading Wednesday evening.

“Following continued close collaboration with FDA inspectors, today, the FDA confirmed that all issues related to a Current Good Manufacturing Practice inspection at the Tampa facility are being satisfactorily resolved, and VAI (Voluntary Action Indicated) status will soon be granted to the facility. We expect this to facilitate our current and upcoming regulatory submissions of products manufactured at the facility,” said Valeant CEO Joe Papa.

That would give Aerie plenty of time to get in line for an OK, if regulators green-light the drug.

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Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

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