Nicox : Vif rebond, la notice comme enjeu pour le naproxcinod

Nicox : Vif rebond, la notice comme enjeu pour le naproxcinod
Lundi 10 mai 2010 à 11:03

(Tradingsat.com) - Emporté par la débâcle du marché parisien la semaine dernière, NicOx rebondit lundi (8,1% à 7,34 euros) à deux jours de la réunion d'experts mandaté par la FDA pour se pencher sur l'avenir de son candidat médicament phare, l'anti-inflammatoire naproxcinod. L'avis de ces experts n'est que consultatif, mais la FDA se conforme souvent à leur avis.

Pour PiperJaffray, « les chances d'une approbation du naproxcinod sont raisonnablement bonnes ». Le broker rappelle cependant que c'est la notice du médicament qui déterminera le potentiel du médicament, le prix auquel Nicox pourra le vendre, et son éventuel futur remboursement.

« Nous continuons à penser que la question clé pour le naproxcinod n'est pas simplement de savoir s'il sera approuvé ou non mais si la notice finale reflètera les effets plus réduits du produit sur la pression artérielle par rapport au générique naproxène », explique ainsi PiperJaffray, qui est "Neutre" sur NicOx, avec un objectif de cours de 7,5 euros.

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FDA Panel Decision Alert: NicOx


(RTTNews) - The bench to bedside journey of drugs is no easy task. Some fail to complete the journey while many make it to the finish line only after undergoing numerous obstacles. The drug stocks awaiting FDA decisions are highly speculative since they could be make-or-break events, particularly for emerging biotech companies.

French pharmaceutical company Nicox S.A. (NIXCF.PK) faces a review of its investigational arthritis drug Naproxcinod by an advisory panel for the U.S. Food and Drug Administration on May 12. The regulatory agency is scheduled to announce its final decision by July 23.

NicOx submitted its New Drug Application for Naproxcinod last September, seeking approval for the relief of signs and symptoms of osteoarthritis. The New Drug Application was supported by data from three large pivotal phase III studies, all of which met their co-primary efficacy endpoints. The phase III program also specifically assessed Naproxcinod’s blood pressure profile. According to NicOx, the data from the clinical studies for Naproxcinod show that it is effective, safe and well tolerated.

Naproxcinod is the first investigational drug in the new Cyclooxygenase-Inhibiting Nitric Oxide-Donator, or CINOD, class of anti-inflammatory agents.

In 1998, NicOx and AstraZeneca plc (AZN) signed a development and license agreement under which, AstraZeneca was granted an exclusive worldwide license to develop, manufacture and sell products containing certain COX-Inhibiting Nitric Oxide Donators designed for the treatment of pain and inflammation. However, this agreement was terminated in September 2003, after a compound belonging to the COX-Inhibiting Nitric Oxide Donators class selected for development failed in a mid-stage trial.

Last week, NicOx said it will seek to enter into a partnership agreement with a pharmaceutical company for the promotion and marketing of Naproxcinod to primary care physicians in the U.S, while retaining co-promotion rights for specialist prescribers.

COX-2 inhibitors and traditional non-steroidal anti-inflammatory drugs, or NSAIDs, such as Naproxen and Ibuprofen, are widely used as symptomatic treatments for osteoarthritis. However, NSAIDs like Naproxen have been linked to increased blood pressure, which is a particular concern in the osteoarthritis population where about 50% of patients are estimated to be hypertensive.

Naproxcinod is also under review in Europe. Given the product profile, some analysts have estimated Naproxcinod sales potential at $1 billion annually.

If approved, Naproxcinod will have to compete with NSAIDs, such as Naproxen, which are available in generic versions, Pfizer Inc.’s (PFE) branded drug Celebrex and the newly approved Vimovo manufactured by Pozen Inc. (POZN) and AstraZeneca.

Will Naproxcinod impress the FDA advisory panel? Stay tuned…

For comments and feedback: contact editorial@rttnews.com

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NiCox braces itself for naproxcinod meeting in the USA
10 May 2010
NicOx has posted a rise in revenues for the first quarter but all eyes are now on a meeting this week which will decide whether the French biotechnology group’s anti-inflammatory naproxcinod is deemed approvable in the USA.

Figures-wise, revenues reached 7.4 million euros compared to 400,000 euros for the corresponding period of 2009. The leap is due to a licence payment received from Bausch & Lomb for the investigational glaucoma drug NCX 116, a nitric oxide-donating prostaglandin analogue.

Operating expenses were 16.2 million euros in the first quarter of 2010, up 18.2%, due principally to the regulatory submissions for naproxcinod in the USA and in Europe and to “investment expenses” in the supply chain for the drug which has been filed for osteoarthritis. Losses for the period were 7.2 million euros, down 55.5%, and at the end of the quarter, NiCox had cash and equivalents of 138.5 million euros.

The US Food and Drug Administration’s Arthritis Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee are meeting on May 12 to discuss the New Drug Application for naproxcinod. Expectation is high about the treatment, the first in a new class of drugs known as CINODs (COX-inhibiting nitric oxide-donators) and if the FDA’s panellists recommend it, NiCox will hope to sign up a partner and start the process of turning naproxcinod into a blockbuster.

Naproxcinod is an improved version of naproxen, a non-steroidal anti-inflammatory drug that can increase blood pressure and cause stomach problems. Data has shown that the NiCox drug can reduce these problems but some analysts fear that in terms of pain reduction, the levels are similar to naproxen, which is available generically and is very cheap.

NiCox is confident, however, and chief financial officer Eric Castaldi says “we are increasingly investing in the activities of our commercial affairs team in Warren, New Jersey" ahead of a possible launch.

By Kevin Grogan