Valeant says FDA to reclassify troubled Tampa plant
- Valeant Pharmaceuticals International, Inc. could soon see some relief from manufacturing-related delays at its Tampa, Florida facility, announcing Thursday it anticipates the Food and Drug Administration will confirm that issues with the site are being satisfactorily resolved.
- "We expect this to facilitate our current and upcoming regulatory submissions of products manufactured at the facility," said Valeant CEO Joseph Papa. Chief among those products is the drugmaker's eye drug latanoprostene bunod, which has been rejected twice due to manufacturing issues at the Tampa facility.
- Shares in the Canadian drugmaker rose nearly 3% in value in Thursday trading. The news also boosted shares in Aerie Pharmaceuticals Inc, which relies on Valeant's plant to manufacture its own eye drug candidate, Rhopressa.
While Valeant's larger problems are well-documented — from high indebtedness to patent expiries and continued government scrutiny — the company's struggle to clear up manufacturing violations at its Bausch + Lomb facility in Tampa have been a nagging headache.
Under former CEO Michael Pearson, Valeant projected big things for its drug for intraocular pressure, latanoprostene bunod. Early forecasts once pegged peak U.S. sales for the drug at more than $500 million. But those hopes have since been tempered by two regulatory rejections and new leadership that no longer touts the drug's blockbuster potential.
Earlier this year, the company believed it had effectively resolved the issues at the Tampa site, predicting an August approval for the eye drug. A fresh complete response letter from the FDA injected new uncertainty into the drug's path forward.
Now, however, Valeant believes it is coming to an understanding with the agency that will allow regulatory submissions to progress with more certainty.
According to Wednesday's statement, the FDA confirmed it would issue a Voluntary Action Initiated (VAI) inspection classification for the site. A VAI classification indicates that FDA inspectors have observed objectionable concerns at a facility, but that the problems do not meet the threshold of regulatory significance.
Valeant noted it had secured approval earlier this week of an application to use the facility for release testing of drug substance used in Alaway (ketotifen fumarate ophthalmic solution).
A VAI classification would also be good news for Aerie, potentially clearing the way for a February approval of its eye drug Rhopressa (netarsudil ophthalmic solution, 0.02%). Compliance issues at Valeant's facility, which Aerie contracts to manufacture Rhopressa, led the biotech to pull its New Drug Application last October.
"We currently believe it is probable that open issues will be resolved prior to the February 28, 2018 PDUFA date for Rhopressa," Aerie said in an August 10 statement. That forecast now appears to stand more of a chance of coming true.
- Valeant Pharmaceuticals International, Inc. Press release
- BioPharma Dive Manufacturing issues threaten delay for Aerie eye drug
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