An FDA Rejection Prompts NicOx To Shutter US HQ

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closedIn a dramatic move, a drugmaker that hoped to become a “fully integrated specialty pharmaceutical company,” complete with its own sales force targeting doctors in the US and R&D program, is now shuttering its US headquarters after the FDA last month rejected a key drug.

NicOX, which is based in France, later this month will close its US headquarters in Warren, New Jersey, where 22 people are employed. The move follows a complete response letter received two weeks ago from the FDA concerning its naproxcinod med for osteoarthritis. The agency requested additional trials (see here).

In a statement, NicOx ceo Michele Garufi says “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.” The move comes three years after NicOx, which intends to pursue a partnership for its drug and seek European approval, heralded the opening of the New Jersey office as an important new chapter.

For those keeping tabs, the decision is yet another blow to New Jersey, which has long prided itself on being the nation’s medicine chest, but has suffered the loss of tens of thousands of pharma jobs in recent years thanks to mergers, downsizing and - as in NicOx’s case - setbacks with products.

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  1. The free radical theory of disease was flawed at best. Lots of wasted time and money by this company, and now the workers pay the ultimate price.

    http://www.telegraph.co.uk/news/uknews/1455339/Scientists-challenge-free-radical-theory-of-disease.html

  2. There were other proposed uses of nitric oxide beyond antiinfective use, certainly in 2004-6. The data were good but the difficulty of harnessing the gas made any pharmaceutical production complicated.

    Hard to be too hard on NicOX though. Didn’t they ink a deal with Pfizer a couple of years ago. Presumably some of that found its way to the (22 person) bonus pool.

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