SOURCE: NICOX
SOPHIA ANTIPOLIS, FRANCE–(Marketwire – September 15, 2010) – Partners to exploit new approach
to the delivery of nitric oxide
NicOx S.A. (NYSE Euronext Paris: COX) today announced that it has agreed
with its partner Merck, known as MSD outside the United States and Canada,
to expand the scope of their worldwide license agreement, originally
executed in 2006. This decision follows the discovery of a new approach to
nitric oxide (NO) donation during the course of the joint research program.
This approach may be used to develop new classes of NO-donating new
molecular entities (NMEs), designed to offer a different mechanism for
controlling the delivery of NO while retaining the potential therapeutic
benefits. Additional information will not be disclosed for reasons of
commercial confidentiality.
The clinical program evaluating several NO-donating antihypertensive
candidates from the original agreement in healthy volunteers and mild to
moderate hypertensive patients has now been completed and none of the
compounds tested will be further advanced in development.
NicOx has developed a world-leading position in the therapeutic application
of NO-donating compounds. NO is an endogenous cell-signaling molecule of
basic importance in physiology and there is significant evidence that
certain diseases are related to a deficiency in the production of nitric
oxide. This new approach with Merck continues to build on the concept of a
slow release of NO with a sustained pharmacological effect at tissue level.
Under the revised agreement, Merck has the right to develop NMEs using this
new approach in certain cardiovascular indications. NicOx will have the
right to develop product candidates in other indications. NicOx and Merck
will pay development milestones and royalties to the other partner on
products emerging from their respective research programs. NicOx and Merck
have agreed that no further announcements on the compounds developed by
Merck under the collaboration are anticipated unless and until a drug-
candidate advances into phase 2 clinical studies.
Ennio Ongini, Vice President Research at NicOx, commented: “The research
collaboration with Merck has been very fruitful, and it is as a result of
the excellent scientific interaction that this new approach to NO donation
was discovered. Novel molecules using this approach offer an exciting new
alternative route to exploit the biological properties of NO which can
potentially be used in a wide range of therapeutic areas.”
Under the revised agreement, each company will be responsible for funding
their own research and development costs. NicOx and Merck do not have the
option to co-promote any NMEs from the other partner resulting from this
expanded license.
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 select
cardiovascular indications, 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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