PREVIEW-NicOx faces crunch time at naproxcinod U.S. panel
* U.S. panel meeting on May 12, FDA decision due by July 23
* Blood pressure mention is key for arthritis pain drug
* U.S. partner only seen emerging after U.S. label decision
By Caroline Jacobs and Noelle Mennella
PARIS, May 7 (Reuters) - NicOx (NCOX.PA) faces a crunch week as U.S. experts meet to consider if its first medicine should be cleared for sale as an arthritis pain drug and, crucially, whether its blood-pressure benefits set it apart from rivals.
Shares in the French biotech firm are up by half since mid-February on hopes for naproxcinod -- but there are still plenty of uncertainties and analysts see scope for a further gain or loss of around 50 percent after the panel vote.
While many analysts expect approval, commercial success -- and NicOx's hopes for a lucrative partnering deal -- hinge on whether the drug's benign blood-pressure profile, which may help prevent heart problems, is recognised by regulators.
Even then, some do not share NicOx's view that naproxcinod is a potential $1 billion-a-year seller.
"From a commercial perspective, when patients go to see a doctor to get their arthritis treated, generally they are not going to worry about a one or two millimetre mercury increase in their blood pressure but are interested in reducing the inflammation," said Andy Smith, head of the Axa Framlington biotech fund which has 55 million pounds under management.
"Naproxcinod virtually leads to the same pain reduction as generic naproxen, which sells for a few pennies a tablet. So NicOx has been spending all this money and time to develop this drug when there's one already there," he said.
That will make it a tough sell at times of healthcare spending cuts, Smith believes.
Naproxcinod is an improved version of naproxen, a old non-steroidal anti-inflammatory drug that can increase blood pressure and cause stomach problems. The new drug is a nitric oxide-releasing version designed to get round these problems.
A Food and Drug Administration panel will meet on May 12 to advise on naproxcinod, which NicOx last year filed for approval as a drug to relieve the signs and symptoms of osteoarthritis, a painful chronic disease of the joint cartilage and bone.
The Food and Drug Administration's final decision is due by July 23, when the details of the drug's label will become clear, possibly after further negotiations with FDA officials, according to Piper Jaffray analyst Sam Fazeli.
"A partner will not sign before it knows the details ... of the label, that is, not before the FDA's approval," Natixis Securities analyst Sebastian Malafosse said.
If the label sets out naproxcinod's benign effect on blood pressure, he sees peak sales of 1.3 billion euros ($1.7 billion) in 2017. Otherwise, it could be 400 million to 500 million.
For NicOx, it has been a long journey. The company, based in the south of France, has regularly expressed confidence it will find a new partner for naproxcinod after AstraZeneca (AZN.L) abandoned it in 2003, when it failed to meet the mid-stage trial goal of reducing the risk of ulcers.
But the deal that Chief Executive Michele Garufi -- a bullish Italian chemist who co-founded NicOx in 1996 -- had hoped to do by the summer of 2009 never arrived.
NicOx confirmed in its quarterly results on Friday that it wanted a partnership agreement with a pharmaceutical company to sell naproxcinod to primary care doctors in the United States, while retaining co-promotion rights for specialist prescribers.
COMPETITION FROM EX-PARTNER
Another challenge comes from the fact NicOx will face a branded competitor by the time it gets to market in 2011.
Former partner AstraZeneca and U.S. biotech Pozen (POZN.O) recently won marketing approval for Vimovo, a naproxen-based drug that cuts the risk of developing stomach ulcers.
"The choice will come down to which feature has a more meaningful impact on the patient's daily living and what doctors consider to be more relevant: lower blood pressure or decreased occurrence of gastric ulcers," Bryan Garnier analyst Annie Cheng said, seeing naproxcinod sales of 750 million euros by 2014.
There is also a competitor in Pfizer's (PFE.N) Celebrex, a so-called COX-2 drug that remains on the market following the withdrawal of Merck & Co's (MRK.N) Vioxx in 2004.
NicOx has conducted multiple naproxcinod clinical trials involving more than 4,000 patients.
(Editing by Ben Hirschler)