- Valeant on Thursday said the Food and Drug Administration had rejected its application for approval of an eye drug, setting back the company's high hopes for the treatment.
- The FDA issued the complete response letter to Valeant after an inspection found deficiencies tied to its manufacturing process for production of the drug, an eye drop designed to treat glaucoma and ocular hypertension.
- Valeant stock fell by about 4% in morning trading Friday, although the drugmaker took pains to clarify that the FDA's letter did not identify any efficacy or safety concerns with the drug, nor ask for any new clinical trials to be completed.
Valeant picked up the drug (known as Vesneo or latanoprostene bunod ophthalmic solution, 0.024%) when it acquired Bausch + Lomb in 2013. Bausch + Lomb, in turn, licensed the drug from the French company Nicox, and took over Phase 3 development.
While the FDA's letter apparently did not flag any issues with the drug itself, the rejection is a setback for, or at least a deferral of, Valeant's blockbuster hopes. When Valeant announced Vesneo had met its primary endpoint in Phase 3 trials in late 2014, it pegged peak U.S. sales at more than $500 million and peak global revenues topping $1 billion.
That potential revenue is still shimmering on the horizon, but may stand on shakier ground. "The concerns raised by the FDA pertain to a Current Good Manufacturing Practice (CGMP) inspection at Bausch + Lomb's manufacturing facility in Tampa, Florida where some deficiencies were identified by the FDA," Valeant said in a statement.
With a $30 billion debt looming over the drugmaker, in addition to continued fallout from the tumultuous first half of the year, Valeant can hardly afford more bad news.
The company did score two notable wins last week, however. The FDA approved its oral form of Relistor for the treatment of opioid induced constipation in adults with chronic non-cancer pain. A injectable form of Relistor had previously been approved in 2008.
Valeant plans to begin selling the new oral formulation sometime in the third quarter.
Perhaps more encouragingly, Valeant also secured the support of a key advisory panel for its psoriasis drug brodalumab, albeit with recommendations for a broader warning label and strict risk management plan due to a potential risk of suicide.
Valeant bet $100 million upfront on brodalumab last year, buying global rights from AstraZeneca, except in Japan and some Asian countries. AstraZeneca has clawed back some of those rights, handing a license in Europe to LEO Pharma instead.
But brodalumab still represents a significant investment for Valeant, one it hopes will help it continue to turn around its fortunes.