Valeant begins long comeback trail with FDA approval

pharmafile | November 6, 2017 | News story | Sales and Marketing Valeant, Vyzulta, biotech, drugs, pharma, pharmaceutical 

Valeant has had precious little to be happy about over the last few years, it’s bounced from one piece of bad news to another; however, it has managed a rare piece of good news after the FDA finally gave the green light for its glaucoma drug, Vyzulta.

The approval comes after the drug had already received two rejections, though not for reasons regarding the drug’s efficacy. Twice the FDA raised concerns about the manufacturing facility in Tampa, Florida – in particular, citing the finding of metal particulates in samples.

However, after two CRLs, it seems that Valeant was able to clear up the issues and the treatment is now free to enter the market.

The drug had been picked up alongside Valeant’s acquisition of Bausch + Lomb for $8.7 billion and had been touted as a potential by former CEO, Michael Pearson.

The decision to bring in Bausch + Lomb had previously been questioned, after sluggish sales, and there was a suggestion that Valeant was looking to divest the unit in order to pay down its debt. However, it looks like the deal could be one of the few made by Pearson to actually pay off.

The company desperately needs it to, after an acquisition spree saddled the company with $30 billion in debt that current CEO, Joseph Papa, is tasked with managing.

“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,” said Joseph C. Papa, chairman and CEO, Valeant. “We expect to make this new advancement available for those who suffer with glaucoma before the end of the year.”

The treatment was licensed from Nicox and, as a result of the approval, the company will be due a payment of $17.5 million. A figure that will be reduced to $2.5 million immediately, after it is pays a $15 million due to Pfizer under a previous licensing agreement.

Ben Hargreaves

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