Healthcare Industry News: S.A.
News Release - May 13, 2010
NicOx provides update on FDA Advisory Committee Meeting for naproxcinod
SOPHIA ANTIPOLIS, FRANCE, May 13 --(HSMN NewsFeed)-- NicOx S.A. (NYSE Euronext Paris: COX) announced today that the Joint Advisory Committees of the U.S. Food and Drug Administration (FDA), including the Arthritis DrugS.A.visory Committee and the Drug Safety and Risk Management Advisory Committee, voted by 16 to 1 with 1 abstention that they did not have sufficient evidence at this time to support the approval of naproxcinod for the relief of the signS.A.d symptoms of osteoarthritis.Chair Dr Kathleen O'Neil MD, Associate Professor of Pediatrics, University of Oklahoma College of Medicine, Division of Rheumatology, summarized the findings of the Advisory Committee meeting, saying there was enthuS.A.m for the potential of naproxcinod but more data was required from additional safety studies.
The FDA Arthritis DrugS.A.visory Committee and Drug Safety and Risk Management Committee based their recommendation on a review of data from the naproxcinod clinical development program, which included 35 clinical studies involving more than 6,500 subjects. The New Drug Application (NDA) file contains data from three large pivotal phase 3 studies, all of which met their co-primary efficacy endpoints.
The FDA is not bound by the recommendations of the Advisory Committee but may take their advice into consideration when evaluating the NDA for naproxcinod. The FDA is expected to make a decision on whether to approve naproxcinod by July 24, 2010.
NicOx submitted a Marketing Authorization Application (MAA) for naproxcinod to the European MedicineS.A.ency (EMA) in December 2009.
Conference calls on ThurS.A. May 13
NicOx will hold a conference call in French on ThurS.A. May 13 at 3:00 pm CET (9:00 am EST - 2:00 pm UK) and another one in English at 4:00 pm CET (10:00 am EST - 3:00 pm UK) to discuss the outcome of the Advisory Committee meeting. Details of these conference callS.A.e available on the Company's website www.nicox.com.
About naproxcinod
Naproxcinod is NicOx's lead investigational compound and the first in a new class of anti-inflammatory agents known as CINODs (Cyclooxygenase- Inhibiting Nitric Oxide Donators). The NDA file is supported by data from a large program of 35 clinical trials that involved more than 6,500 subjects. The program evaluated the efficacy of naproxcinod in relieving signS.A.d symptoms of osteoarthritis, as well as its safety, with particular care given to its effect on blood pressure.
In September 2009, NicOx submitted an NDA for naproxcinod, seeking approval for the relief of the signS.A.d symptoms of osteoarthritis, which waS.A.cepted for filing by the FDA in November 2009. Based on the Prescription Drug User Fee Act (PDUFA), the FDA has set an action date of July 24, 2010. In December 2009, NicOx submitted a Marketing Authorization Application (MAA) to the European MedicineS.A.ency (EMA), which was validated in January 2010.
About osteoarthritis
Osteoarthritis (OA), the most common type of arthritis, iS.A.widespread degenerative diS.A.e which affects the jointS.A.d causes moderate to severe chronic pain. OA mainly occurs in the weight-bearing joints of the hipS.A.d kneeS.A.d iS.A.sociated with the breakdown of cartilage, a material which covers the ends of bones in normal joints. OA is most commonly seen in older people, especially women, and its exact cause is unknown, although heredity factors, previous joint damage and obesity appear to play a role. According to a Datamonitor estimate published in December 2009, OA is estimated to have afflicted over 81 million people in 2009 in the seven major markets (US, Japan, France, Germany, Italy, S.A.n and the UK), including approximately 29 million in the United S.A.eS.A.one. Symptomatic treatments commonly used by OA patients include traditional non-steroidal anti-inflammatory drugs (NSAIDs) and COX-2 inhibitors.
Risks factors which are likely to have a material effect on NicOx's businesS.A.e presented in the 4th chapter of the " Document de référence, rapport financier annuel et rapport de gestion 2009 " filed with the French Autorité des Marchés Financiers (AMF) on March 5, 2010 and available on NicOx's website (www.nicox.com) and on the AMF's website (www.amf-france.org).
The Company notably draws the investors' attention to the following risk factors:
- Risques liés à la dépendance de la Société à l'égard du naproxcinod (Risks related to the Company's dependence on the success of its lead product naproxcinod)
- Risques commerciaux et développements cliniques (Clinical developmentS.A.d commercial risk)
- Risques liéS.A.x contraintes réglementaires et à la lenteur des procédures d'approbation (Risks linked to regulatory constraintS.A.d slow approval procedures)
- Manque de capacités dans les domaines de la vente et du marketing (Lack of saleS.A.d marketing capabilities)
- Incertitude relative aux prix des médicaments et aux régimes de remboursement, ainsi qu'en matière de réforme des régimes d'assurance maladie (Uncertainty on drug pricing and reimbursement policieS.A.d on the reforms of the health insurance systems)
NicOx (Bloomberg: COX:FP, Reuters: NCOX.PA) iS.A.pharmaceutical company focused on the reS.A.ch, development and future commercialization of drug candidates. NicOx iS.A.plying its proprietary nitric oxide-donating R&D platform to develop an internal portfolio of New Molecular Entities (NME) for the potential treatment of inflammatory, cardio-metabolic and ophthalmological diS.A.es.
NicOx's lead investigational compound is naproxcinod, an NME and a first- in-class CINOD (Cyclooxygenase-Inhibiting Nitric Oxide-Donating) anti- inflammatory drug candidate developed for the relief of the signS.A.d symptoms of osteoarthritis (OA), which is currently under review by regulatory authorities, following the submission and filing of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) to the European MedicineS.A.ency (EMA). The FDA has set an action date of July 24, 2010, under the Prescription Drug User Fee Act (PDUFA). The FDA and the EMA are evaluating the data submitted. NicOx does not wish to make any claims in regard to naproxcinod's safety or efficacy prior to its potential approvals.
In addition to naproxcinod, NicOx's pipeline includes several nitric oxide- donating NMEs, which are in development internally and with partners, including Merck & Co., Inc. and Bausch + Lomb, for the treatment of hypertension, cardiometabolic diS.A.es, widespread eye diS.A.eS.A.d dermatological diS.A.es.
NicOx S.A. is headquartered in France and is listed on Euronext Paris (Compartment B: Mid Caps).
This press release contains certain forward-looking S.A.ements. Although the Company believes its expectationS.A.e based on reasonable assumptions, these forward-looking S.A.ementS.A.e subject to numerous riskS.A.d uncertainties, which could cause actual results to differ materially from those anticipated in the forward-looking S.A.ements.
For a discussion of riskS.A.d uncertainties which could cause actual results, financial condition, performance or achievements of NicOx S.A. to differ from those contained in the forward-looking S.A.ements, please refer to the Risk Factors ("Facteurs de Risque") section of the Document de Reference filed with the AMF, which iS.A.ailable on the AMF website (http://www.amf-france.org) or on NicOx S.A.'s website (http://www.nicox.com).
CONTACTS: www.nicox.com NicOx: Gavin Spencer Vice President Business Development Tel +33 (0)4 97 24 53 00 - communications@nicox.com
Source: NICOX
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