SOURCE: NICOX
SOPHIA ANTIPOLIS, FRANCE–(Marketwire – July 22, 2010) – www.nicox.com
NicOx S.A. (NYSE Euronext Paris: COX) today announced the receipt of a
Complete Response Letter from the U.S. Food and Drug Administration (FDA)
related to the New Drug Application (NDA) for naproxcinod. Naproxcinod is
being developed for the relief of the signs and symptoms of osteoarthritis.
The FDA informed NicOx that its review of the NDA is complete and that it
does not approve the naproxcinod application. The FDA has recommended
conducting one or more long-term controlled studies to assess the
cardiovascular and gastrointestinal safety of naproxcinod. Additional
studies to demonstrate a clinically meaningful therapeutic benefit
attributable to the nitric oxide donation were also recommended. No
clinical efficacy studies were requested.
NicOx plans to discuss the Complete Response Letter and potential next
steps as early as possible with the FDA.
The naproxcinod Marketing Authorization Application (MAA) submitted by
NicOx in December 2009 is currently under review by the European Medicines
Agency (EMA).
NicOx remains well funded and had cash, cash equivalents and financial
instruments of ?138.5 million at the end of March 2010. The Company
will publish its financial results for the first half of 2010 on July 30,
2010. NicOx has no long-term debt and is constantly reviewing all aspects
of its cost base to ensure careful conservation of its funds.
NicOx has a broad pipeline of nitric oxide (NO)-donating New Molecular
Entities (NMEs) targeting the therapeutic areas of inflammatory,
cardiometabolic and ophthalmological diseases. NicOx has built a network of
strong partnerships for the development of some of its promising lead
compounds, including alliances with Merck & Co., Inc., Bausch + Lomb and
Ferrer.
Risks factors which are likely to have a material effect on NicOx’s
business are 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 and commercial risk)
– Risques liés aux contraintes réglementaires et à la
lenteur des procédures d’approbation (Risks linked to regulatory
constraints and slow approval procedures)
– Manque de capacités dans les domaines de la vente et du marketing
(Lack of sales and 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
and on the reforms of the health insurance systems)
NicOx (Bloomberg: COX:FP, Reuters: NCOX.PA) is a pharmaceutical company
focused on the research, development and future commercialization of drug
candidates. NicOx is applying 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 diseases.
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 and
symptoms of osteoarthritis (OA). In July 2010, the FDA provided a Complete
Response Letter to the New Drug Application (NDA) for naproxcinod stating
that it does not approve the naproxcinod application. The naproxcinod
Marketing Authorization Application (MAA) submitted by NicOx in December
2009 is currently under review by the European Medicines Agency (EMA).
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 diseases, eye diseases and dermatological
diseases.
NicOx S.A. is headquartered in France and is listed on Euronext Paris
(Compartment B: Mid Caps).
This press release contains certain forward-looking statements. Although
the Company believes its expectations are based on reasonable assumptions,
these forward-looking statements are subject to numerous risks and
uncertainties, which could cause actual results to differ materially from
those anticipated in the forward-looking statements. For a discussion of
risks and uncertainties which could cause actual results, financial
condition, performance or achievements of NicOx S.A. to differ from those
contained in the forward-looking statements, please refer to the Risk
Factors (“Facteurs de Risque”) section of the Document de Reference filed
with the AMF, which is available on the AMF website
(http://www.amf-france.org) or on NicOx S.A.’s website
(http://www.nicox.com).
CONTACTS
NicOx
Gavin Spencer – Vice President Business Development Tel +33 (0)4 97 24 53
00 – [email protected]
Media Relations Financial Dynamics
Europe
Guillaume Granier (France) – Tel: +33 (0)1 47 03 68 10 –
[email protected]
Stéphanie Bia (France) – Tel: +33 (0)1 47 03 68 10 –
[email protected]
Jonathan Birt (UK) – Tel +44 (0)20 7269 7205 – [email protected]
United States
Robert Stanislaro – Tel +1 212 850 5657 – [email protected]
Irma Gomez-Dib – Tel +1 212 850 5761 – [email protected]
NicOx S.A.,
Les Taissounières – Bât HB4 – 1681 route des Dolines – BP313,
06906 Sophia Antipolis cedex, France. Tel. +33 (0)4 97 24 53 00 – Fax +33
(0)4 97 24 53 99
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