Valeant Pharmaceuticals says the situation is looking up at that Bausch + Lomb plant where manufacturing issues have twice undermined the drugmaker’s chance for approval of its new eye drug, and may have put at risk an NDA for a contract client.
The Canada-based drugmaker reported today that the FDA has confirmed it intends to tag the plant with a Voluntary Action Indicated (VAI) inspection classification, which means that during their last inspection reviewers found mostly issues of a technical nature but none of regulatory significance. Its shares rose about 4% on the news.
"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 status will soon be granted to the facility,” CEO Joseph Papa said in a statement today. “We expect this to facilitate our current and upcoming regulatory submissions of products manufactured at the facility."
The update comes a week after the FDA for the second time issued Valeant a complete response letter for its glaucoma drug candidate for relieving eye pressure. The first CRL came a year ago following an inspection that turned up a host of issues at the plant.
The facility also makes a product for Irvine, California-based biotech Aerie Pharmaceuticals, whose approval process for its own eye drug candidate, Rhopressa, has been delayed by problems with the Tampa plant
Last fall Aerie had to withdraw its NDA for the eye drug, saying its Tampa-based CMO would not have a manufacturing line ready for an FDA preinspection by year-end. It then had to postpone again in December when the CMO said the line would not be up and running until late February. This all followed Valeant’s announcements of FDA concerns at the plant.
On the same day that Valeant reported receiving its second complete response letter, Aerie sad it had been notified that its contractor, which it has identified as Valeant, about the CRL tied to issues at the Tampa plant. Aerie said after discussions, it believed its own February 2018 PDUFA date for Rhopressa would be unaffected by the any issues at the facility. It shares rose about 5% on the news.
In the future, Airie expects to have control of its own manufacturing for Rhopressa. In January, the biotech announced it was investing $25 million in a new manufacturing facility in Athlone, Ireland, which it hoped would be ready for commercial production by 2020.