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NiCox still sliding as analysts predict bleak future for pain drug

World News | May 14, 2010
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Kevin Grogan

Shares in NicOx are continuing to fall this morning, after hitting record-breaking lows yesterday after advisors to the US Food and Drug Administration rejected the French biotech’s investigational pain drug naproxcinod.

The stock fell 46% yesterday after the FDA’s Arthritis Drugs and Drug Safety and Risk Management Advisory Committees voted 16 to one (with one abstention) that they did not have sufficient evidence to support the approval of naproxcinod for the relief of the signs and symptoms of osteoarthritis. The panellists want to see long-term proof that the drug, an improved version of naproxen and the first in a new class known as CINODs (COX-inhibiting nitric oxide-donators, reduces blood pressure and stomach problems and does not cause kidney damage.

Sam Fazeli, an analyst at Piper Jaffray issued a research note saying that getting this proof would need “large multiyear studies, including high-risk and vulnerable populations,” He is concerned that NiCox has not got the cash to pay for these trials and the likelihood of getting a partner for naproxcinod has diminished.

Mr Fazeli,added that “we expect the FDA to follow the panel’s opinion and, thus, have removed the US opportunity from our model.” NiCox will find out its fate from the agency by July 24 and the drug is still under review with regulators in Europe.

At 9.40 this morning (UK time), NiCox’ shares had slid again, down 8% to 2.67 euros.

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