PREVIEW-NicOx faces crunch time at naproxcinod U.S. panel

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.

THE LABEL

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)

http://www.reuters.com/article/idCNLDE6460GS20100507?rpc=44

Merci ; pas très encouragant :-(

encourageant ! sorry :-)

pourquoi?

on savait qu'il y aurait des avis "à charge".

de +, la phrase est tellement démagogique!

en gros "on va chez son medeçin pour l'arthrose pas pour les2 mmHg de tension en moins"


oui coco, mais c'est pour ça qu'il y a un medeçin ! il saura quoi donner a un arthrosique sous SRA par exemple.

Et qui a deja été chez le medeçin pour l'arthrose en réclamant du calebrex bien plus cher!?

Clairement il faut une phrase vague differenciatrice style "suspecptible d'avoir des effets CV moins nefastes que les autres ains notamment chez des sujets hypertendus".

Ensuite un faible remboursement "hmo tier 3" ca suffit si notice differente.

ET UN BIG PARTENAIRE: amgen, gsk, merck, ..
bonus: bnp voit une parité euro/dollar des 2011...miam! mais 1.25 maintenant c mieux pour acquisitons car il y aura une partie en cash!

"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...

qui confond encore statistique de diminution moyenne de la pression artérielle sur l"ensemble de la population, et phénomènes dangereux touchant une sous-population à risque: ce sont les hypertendus dont la tension peut augmenter de 10 mmHg - voire plus (20 à 40, cite White) - sous naproxène, qui seront la cible principale, et non ceux dont la tension varie de 1 ou 2 mm Hg...
Ceux qui n'ont pas de problème continueront à acheter leur AINS sans passer par la case "cabinet médical".
Ceux dont la tension augmente, et qui sont victimes d'oedèmes, iront consulter leur médecin qui, s'il a été prévenu du problème par les VM de NicOx ou du partenaire, saura leur prescrire le naproxcinod.

Moi qui ait des pathologies en rapport avec les deux médicaments je dois dire que jamais un rhumato ne s'est préoccupé directement de ma tension en me prescrivant un anti-inflammatoire ou équivalent, alors que la vérification que je suis sous Mopral (ref concurrence Pozen) ou équivalent est systématique.
Il faut dire qu'un médoc comme le Mobic peut détruire directement l'estomac des vieux, et selon mon gastro-entérologue (censé être une pointure) le labo qui le fabrique a menti au moment de l'AMM...les rhumatos se couvrent en prescrivant systématiquement un IPP.
Par ailleurs pour la tension je me demande si les statines ne vont pas prendre un rôle de plus en plus important, maintenant que des études indiquent que la prise d'un médicament de cette classe réduirait de 50% les risques d'accident cardiaque. Mais je ne sais pas si les statines agissent directement sur la tension artérielle.
Tout ça écrit car je sais qu'il y a des médecins ici qui peuvent corriger mes erreurs de patient lambda.

Au final c'est donc un peu casino si on veut faire un "coup" cette semaine, mais pour les LT rien de neuf.

Semaine cruciale ? Que le meilleur gagne !