In the wake of having its pain product naproxcinod rejected by regulators in the USA, NicOx has announced that it is to close its headquarters across the pond at the end of August.
The decision to pull down the shutters at its Warren, New Jersey base follows a review of the French biotech’s “structure and requirements” after the FDA voted that month to reject naproxcinod for the relief of the signs and symptoms of osteoarthritis. The agency recommended conducting “one or more” long-term controlled studies to assess the cardiovascular and gastrointestinal safety of the drug, an improved version of naproxen and part of a new class of treatments known as CINODs (COX-inhibiting nitric oxide-donators).
The FDA’s stance will “at least significantly delay any potential US launch”, NicOx said, and chief executive Michele Garufi commented that “we very much regret having to close our operations in the USA and we are grateful for the hard work and dedication of all our employees over the past few years”. He added that “they have played a major role in raising awareness among scientists and clinicians of naproxcinod's potential medical and clinical value” but “as we seek to work out possible next steps for naproxcinod in the USA and to pursue the approval process in Europe, it is essential that we manage our resources in the most effective manner”.
The New Jersey office was opened in November 2007 and at the time NicOx said that opening the base reflected its desire to move from being a pure R&D organisation into a fully-integrated commercial company.