Former Valeant $VRX CEO Michael Pearson (remember him?) was willing to get past his gag reflex when it came to drug R&D and cheer on the experimental latanoprostene bunod ophthalmic solution as a blockbuster in the making. Now, more than two years after it was first submitted, the FDA has sanctioned the drug’s marketing after Valeant was finally able to get past two rejections based on the agency’s problems with its manufacturing facility in Tampa.
Picked up in the $8.7 billion buyout of Bausch + Lomb, the drug will now be sold as Vyzulta. Valeant’s shares were up a little more than 4% in pre-market trading on Friday.
The OK triggers a $17.5 million payment to Nicox — which out-licensed it to Bausch + Lomb and wound up with Valeant as a partner — and a $15 million outlay to Pfizer under its old licensing agreement.
The OK also marks good news for Aerie $AERI, which depends on the very same facility for its drug Rhopressa, now under review at the FDA.
Aerie is looking at a February 28, 2018 PDUFA date for its glaucoma drug, which is also to be made at the very same facility. Some of the shorts had bet that Valeant’s woes would be left at Aerie’s door steps, but that chance has all but disappeared now. An expert FDA panel endorsed the drug a couple of weeks ago, and there seems nothing to stop a near-term approval.
Federal inspectors have been critical of the Tampa facility in the past, citing them for a range of issues, including finding metal particulates in samples.
Score one delayed point for Pearson’s successor, Joseph Papa, who was brought in to clean up the monumental mess left by Pearson’s years-long dealmaking spree. In a statement, Papa said:
With today’s approval of Vyzulta, our customers and their patients with glaucoma now have a new treatment option that can help provide consistent and sustained IOP lowering, the only modifiable risk factor that can help slow down the progression of the disease. We expect to make this new advancement available for those who suffer with glaucoma before the end of the year.
The best place to read Endpoints News? In your inbox.
Full-text daily reports for those who discover, develop, and market drugs. Join 21,000+ biopharma pros who read Endpoints News by email every day.Free Subscription