Drug Development

Vernalis shares slide after FDA turn thumbs down on their latest XR cold med

Ian Garland, Vernalis

Five years ago Vernalis and Tris Pharma came up with a plan to develop a portfolio of branded cold meds, using Tris’ extended-release tech to tweak existing medications and turn them into an easier-to-use formulation. That worked on the first try, producing an FDA approval for Tuzistra XR — codeine polistirex and chlorpheniramine polistirex — in the fall of 2015. But the partners ran into a hitch today, with the FDA throwing the red flag on their second try.

According to a brief statement out this morning from Vernalis, regulators say that CCP-07 is not ready for prime time in the US. But the company provided little insight on what went wrong, or what needs to be fixed.

Their statement:

The CRL did not raise any concerns with the formulation or pharmacokinetic profile of CCP-07 but did identify outstanding items that need to be addressed prior to the resubmission and approval of the NDA.

Shares of Vernalis {LSE: VER} took a hit on the news, dropping 13%.

The idea here is a relatively modest one. Tris uses its tech and the partners execute a bioavailability study to prove to the FDA that it works like the original, just with less dosing. And they envision a set of up to six of these drugs that can be marketed to primary care groups. The third, CCP-08, is being teed up for an application now.

We have no idea, though, what regulators think about their number 2 drug, because CRLs are kept private.

“We remain committed to the approval of CCP-07 and will work closely with the FDA to resubmit the NDA as quickly as possible” said Ian Garland, CEO of Vernalis.

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Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

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