- Valeant expects a decision from the Food and Drug Administration on approval of its experimental eye drug by late August, nearly a year after a manufacturing-related problem at one of its facilities led to an initial rejection, the company reported earlier this week.
- Announcement of the target action date suggests the good manufacturing practice (GMP) issue flagged by the regulator at the Tampa, Fla., facility last July has been successfully resolved.
- The Canadian drugmaker's CEO Joseph Papa has been trying to engineer a recovery for the struggling company, which is still plagued by the effects of a disastrous 2016. Asset sales and refinancing have pushed off a reckoning with the company's $30 billion debt burden, but growth prospects remain uninspiring.
Valeant's gloomy outlook means a smooth regulatory review for new products is even more essential.
On that front, the company has had some luck so far this year. In February, the FDA approved its anti-inflammatory drug Siliq (brodalumab) for treatment of plaque-psoriasis. But the drug will carry a black box warning for increased risk of suicidal ideation, and a strict risk management program could limit uptake (not to mention strong competition from existing drugs and new treatments from Novartis and Eli Lilly).
Approval for Valeant's experimental eye drug, known as latanoprostene bunod, could give the company's Bausch & Lomb business a new source of revenue amid looming patent expiries that are expected to knock $60 million off the unit's topline revenue.
Latanoprostene bunod, an eye drop treatment, is designed to lower intraocular pressure for patients with open angle glaucoma or ocular hypertension. In 2014, under then-CEO Michael Pearson, Valeant optimistically predicted peak U.S. sales of the drug at over $500 million.
On a February call, Papa said Valeant believes the Tampa facility's manufacturing quality process is now on track, with the past issues "remediated."
Dreams of a top-seller aside, a successful launch would give Valeant a leg up on the 5% to 7% growth it predicted for the Bausch & Lomb unit in 2017.
But that expected growth is overshadowed by the forecasted 6% to 8% drop in revenues Valeant set out as guidance this year. And, on top of that, longtime Valeant backer and board member William Ackman reportedly sold off his sizable stake in the company earlier this month, putting further pressure on the stock price.
Moving forward with latanoprostene bunod is positive momentum for a company still struggling to gather itself, but approval — if forthcoming — would only be a small step in a long uphill climb.