NicOx Shutters HQ After Approval Fail - Pharmaceutical Executive

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NicOx Shutters HQ After Approval Fail



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NicOx will be closing its US headquarters in the wake of FDA’s decision not to approve naproxcinod, the most important drug in the French firm’s pipeline nitric oxide-donating new molecular entities.

“We very much regret having to close our operations in the US and we are grateful for the hard work and dedication of all our employees over the past few years,” stated Michele Garufi, CEO of NicOx, in a release. “They have played a major role in raising awareness among scientists and clinicians of naproxcinod’s potential medical and clinical value. As we seek to work out possible next steps for naproxcinod in the US and to pursue the approval process in Europe, it is essential that we manage our resources in the most effective manner.”

FDA issued a complete response letter to NicOx in late July denying approval of the osteoarthritis treatment and demanding more long-term clinical studies to determine cardiovascular and gastrointestinal side effects. The treatment did meet FDA’s efficacy criteria, however, according to NicOx. An FDA advisory panel recommended that regulators deny approval in May, causing NicOx’s stock to crash. The stock dropped even further on July 22 when FDA made its response public.

The company stated that it would meet with FDA to determine what it needs to do to get the treatment back on track. Few, however, thought that the company would pack its bags and leave the US altogether.

According to Bloomberg, stocks “plunged 60 cents, or 21 percent, to 2.24 Euros,” which appears to have led to the decision to close the New Jersey branch. Analysts question whether the company has the financial means to conduct another large-scale study.

“What was supposed to be the most important day in the company's history ended in what we can only describe as a debacle," Rodolphe Besserve, an analyst at Societe Generale, told Reuters before suggesting that NicOx should contemplate shelving the drug for now.

Naproxcinod is still up for approval in Europe.

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