For a second time, the FDA has turned its back on Valeant Pharmaceuticals' NDA for a new eye drug because of manufacturing issues at a Bausch + Lomb plant.
The drugmaker reported on Tuesday that it had gotten a second CRL for latanoprostene bunod ophthalmic solution, 0.024%, an eye drop that relieves pressure in the eyes of patients with open angle glaucoma or ocular hypertension.
It said the FDA did not raise any efficacy or safety issues, focusing only on cGMP issues at the plant in Tampa, Florida, which the agency cited last year in a Form 483. The company said it intends to work with the FDA to figure out its next step.
The current complete response letter is pretty much the same as the one the company got a year ago. The FDA’s concerns about the company's manufacturing stem from a three-week inspection of the Florida plant in February 2016 which resulted in the Form 483. While there were only four observations, the FDA had serious reservations about the plant’s laissez faire approach to investigating out-of-spec issues, saying employees failed to get at the root of problems that included finding metal particulate in samples.
Valeant had pledged to fix the issues and announced the new PDUFA date in March, indicating that it believed the plant was now in order or would be by the August date. Clearly, the FDA sees it otherwise.
Before all of the plant problems emerged, Valeant had said it believed the new drug had the potential to reach $1 billion in annual sales, so the CRL is a big disappointment for the company and its leader, Joseph Papa. The CEO is trying to dig the company out from under a slag pile of debt and legal troubles accumulated during the tenure of his predecessor.
The CRL news came just ahead of Valeant's second-quarter earnings announcement, in which it reported a loss of $38 million, or 11 cents per share, compared with a loss of $302 million, or 88 cents, in the same quarter a year ago. Excluding items, the Canadian company earned $1.05 per share, which Reuters reported was soundly ahead of the average analyst estimate of 94 cents.
Revenue was down 7.7% to $2.23 billion and the company adjusted its revenue projection for 2017 to $8.7 billion to $8.9 billion, down from its earlier forecast of $8.9 billion to $9.1 billion. It said it expects to be ahead of schedule in achieving a $5 billion reduction in debt by selling off assets.