PDUFA: July 21 2016
This one is an eye drop designed to treat, or more specifically reduce, intraocular pressure (IOP) in patients with glaucoma. IOP is symptom of glaucoma, and while in itself it is symptomless (for the most part) it can damage the optic nerve over a period of time and eventually lead to blindness or severe vision loss. Vesneo is a liquid formulation of latanoprostene bunod, which is a nitric oxide-donating prostaglandin F2-alpha analog. We don’t really need to go into too much detail on the translation of this jargon, as it doesn’t make for light reading, but it works to decrease IOP. Scientists aren’t 100% sure why this is the case, but they believe its linked to aqueous humor outflow, or the flow of the fluid inside the eye beneath the sclara. In glaucoma patients, for some reason the aqueous humor doesn’t drain well, and the build up causes pressure. Latanoprostene bunod increases the drainage, or at least that’s the hypothesis.
The data on this one was also pretty good. It derived from a Phase III called LUNAR and another called APOLLO, which saw altogether 840 patients tested. The drug went up against an already approved treatment called Timoptic. The primary endpoint in both trials was the mean reduction in IOP at various time points over three months of treatment. In both of the studies, Valeant’s drug translated to a mean reduction in IOP of 7.5 mmHg to 9.1 mmHg between week two and week twelve, coming in as statistically superior to Timoptic in both instances. Safety data didn’t really cause any issues, outside the normal irritation, redness etc.
The estimated market for this drug, if it had picked up approval, would have depended on the labeling to a certain degree. For this reason, analyst predictions were pretty widespread across the estimates. The general consensus, however, was that the company would be able to pick up a lower threshold of $500 million, and at the high end, it could be a blockbuster ($1 billion plus) product
The outcome and response
Unfortunately for Valeant, the FDA issued a complete response letter (CRL) saying that it could not approve the drug at that time. Markets sold off on Valeant as a result, and the company pretty much returned the gains it made on the back of the Relistor approval to the market.
The reason for the CRL is not yet known, but we do know it relates to the manufacturing element of the NDA, rather than the drug itself. This is good and bad. It’s good, because it means that the drug is deemed safe and effective by the agency. It’s bad, because rectifying manufacturing deficiencies can be expensive and time consuming. The only specifics we have right now are that the problem is rooted in a Bausch + Lomb facility. Valeant is going to sit down with the agency over the coming weeks and see if it can get a quick resolution.
Earlier this year, Opko Health Inc. (NASDAQ:OPK) had the same issue with its hyperparathyroidism vitamin D deficiency drug Rayaldee, and it was solved in a matter of weeks. That may not be the case with Valeant and Vesneo, but the drug will eventually be approved in any case. Valeant is low enough and the biotech sector trending enough at this point to warrant a cautious buy for Valeant as a minor hold in a biotech portfolio. The tumult with the company appears to finally be receding and the stock looks to have finally bottomed.
Note: This article is written by David Rich and was originally published at Market Exclusive.