SOURCE: NICOX
SOPHIA ANTIPOLIS, FRANCE–(Marketwire – August 4, 2010) – www.nicox.com
NicOx S.A. (NYSE Euronext Paris: COX) today announced the decision to close
the US headquarters of NicOx Inc. with effect from August 31, 2010. The
decision follows a review of the Group’s structure and requirements after
the US Food and Drug Administration (FDA) said it could not approve its
lead drug candidate naproxcinod, which is expected to at least
significantly delay any potential US launch.
NicOx plans to discuss possible next steps as early as possible with the
FDA and to continue to pursue the European regulatory process for
naproxcinod. NicOx will also actively seek to enter into partnerships for
naproxcinod in Europe and the rest of the world as well as for other
products in its pipeline whilst also pursuing appropriate in-licensing and
M&A opportunities.
The Company had cash and cash equivalents of ?128.4 million at June
30, 2010, and no long-term debt. It also has development partnerships on
its pipeline with Bausch + Lomb, Merck & Co. Inc and Ferrer Grupo.
Michele Garufi, Chief Executive Officer of NicOx, commented: “We very much
regret having to close our operations in the US and we are grateful for the
hard work and dedication of all our employees over the past few years. They
have played a major role in raising awareness among scientists and
clinicians of naproxcinod’s potential medical and clinical value. As we
seek to work out possible next steps for naproxcinod in the US and to
pursue the approval process in Europe, it is essential that we manage our
resources in the most effective manner.”
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 U.S. Food and Drug
Administration (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).
This information is provided by HUGIN
www.nicox.com
NicOx Gavin Spencer
Vice President Business Development
Tel +33 (0)4 97 24 53 00
Email Contact
Media Relations Financial Dynamics
Europe
Guillaume Granier (France)
Tel: +33 (0)1 47 03 68 10
Email Contact
Stéphanie Bia (France)
Tel: +33 (0)1 47 03 68 10
Email Contact
Jonathan Birt (UK)
Tel +44 (0)20 7269 7205
Email Contact
United States
Robert Stanislaro
Tel +1 212 850 5657
Email Contact
Irma Gomez-Dib
Tel +1 212 850 5761
Email Contact
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