Naproxcinod could become the leader !
Datamonitor s'attend à une décision positive de la FDA et voit le napro devenir le leader en 2014 quand le brevet du célébrex tombera . Datamonitor estime que le naproxcinod a réussi à se différencier en fonction de son profil de tension artérielle et l'ajout d'importants avantages cliniques par rapport aux anti-inflammatoires non stéroïdiens (AINS).ils prévoient la 1ere mise sur le marché pour le Q3 2010 . ils trouvent " inquiétant " que NicOx n'ai pas encore son partenaire . bonne journée à tous !
NicOx: FDA approval a stepcloser for naproxcinod, but marketing partner remains elusive
Mon. September 28, 2009; Posted: 01:08 PM
Sep 28, 2009 (Datamonitor via COMTEX) NicOx has filed a New Drug Application for osteoarthritis treatment naproxcinod to the FDA. While Datamonitor expects a positive decision, the success of the drug will hinge on NicOx obtaining a marketing partner, as the company currently has inadequate resources to commercialize naproxcinod on its own in the competitive and highly genericized US osteoarthritis market.
NicOx has submitted an NDA to the FDA for its lead compound naproxcinod, for the relief of the signs and symptoms associated with osteoarthritis (OA). The NDA filing, which comes later than forecast by Datamonitor, is supported by data from three pivotal Phase III clinical studies conducted in the US, Canada and Europe, which recruited more than 2,700 patients with OA of the knee and hip.
Naproxcinod, is the first in a new class of anti-inflammatory agents known as cyclooxygenase-inhibiting nitric oxide donators (CINODs). Clinical studies of knee and hip OA found the drug to be safe, efficacious and well tolerated. Datamonitor believes that naproxcinod has successfully differentiated itself based on its blood pressure profile, adding significant clinical advantages over current non-steroidal anti-inflammatory drugs (NSAIDs).
In 2007, Datamonitor valued the OA market at nearly $4 billion in the seven major markets, with the NSAID class generating almost a quarter of these sales. However, although naproxcinod will launch into a lucrative market, it is mature and highly genericized. In addition, the drug will have to compete with Pfizer's Celebrex (celecoxib), which remains the leading COX-2 brand for OA.
Should the FDA grant naproxcinod's approval, Datamonitor estimates a US launch for Q3 2010. Its success will hinge on whether NicOx can secure an experienced marketing partner prior to launching the drug in the US. Assuming this positive outcome, Datamonitor forecasts sales worth $0.5 billion in the US and 5EU by 2013. Moreover, in light of Celebrex's 2014 patent expiry, naproxcinod could become the leading OA brand.
Time remains of the essence for NicOx, as the company does not have adequate resources to go it alone in such a competitive market. The fact that no marketing partners have yet to sign a deal with NicOx represents a worrying sign for the product.
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