SOPHIA ANTIPOLIS, FRANCE -- 12/02/08 --
www.nicox.com
NicOx S.A. (NYSE Euronext Paris: COX) today announced it has signed an
agreement with DSM for the commercial manufacture and supply of naproxcinod
drug substance (or API, active pharmaceutical ingredient). Naproxcinod is
NicOx' lead investigational product and the first compound in the
Cyclooxygenase-Inhibiting Nitric Oxide-Donating (CINOD) class of
anti-inflammatory agents, which recently achieved positive results in the
third pivotal phase 3 study in osteoarthritis patients.
Under the terms of the agreement, DSM will supply naproxcinod API for
commercial purposes from its fine chemicals production site in Linz,
Austria. DSM is one of the world's leading independent suppliers to the
pharmaceutical industry, with some 40% of today's top-selling medicines in
the world containing ingredients developed and produced by DSM. This
follows the signature of an agreement with Capsugel in September 2008 for
the commercial manufacture of naproxcinod oral capsules, which is widely
recognized as the world leader in capsule manufacturing.
Staffan Stroemberg, Vice President of Technical Development and Operations
at NicOx, commented: "The latest positive results observed in the 111 and
303 studies support our confidence in naproxcinod's blockbuster potential.
We are therefore very pleased to have signed these contracts with global
leaders in high capacity API and capsule production. We project these
agreements should cover the high sales forecasts for the initial years of
naproxcinod's commercialization that have been suggested by our market
research."
The agreement with DSM aims to secure commercial supplies of an appropriate
scale to support the successful launch of naproxcinod. As per the
agreement, NicOx envisages the first deliveries of significant quantities
of commercial material being made from the fourth quarter of 2009 onwards.
Following this agreement with DSM and the importance of cost control in the
current economic environment, NicOx has ended its present API supply
agreement with Archimica. At the point of termination, Archimica had met
all contract milestones and was in full compliance with the other terms of
the contract.
Luca Mantovani, President & Business Unit Director at DSM Pharma Chemicals,
declared: "We are happy to consolidate our relationship with NicOx through
this agreement. Naproxcinod is an exciting compound and being part of its
pre-launch and future commercialization plans is an interesting opportunity
for DSM."
On November 24, NicOx announced that the third pivotal phase 3 study for
naproxcinod in osteoarthritis of the hip had met all three co-primary
efficacy endpoints. Following the positive results from the 301 and 302
studies in osteoarthritis of the knee, 303 represents the third pivotal
phase 3 study for naproxcinod to achieve p < 0.001 on all three co-primary
efficacy endpoints. In addition, naproxcinod 750 mg bid showed the same
gastrointestinal (GI) adverse event rate and a similar blood pressure
profile to placebo in the 303 study.
This followed the announcement of positive results from a 118 patient
Ambulatory Blood Pressure Monitoring (ABPM) trial (the 111 study) on
November 4, where naproxcinod showed a statistically significant reduction
in systolic blood pressure of 3.8 mmHg (p < > = 0.011) compared to naproxen
over the whole study period. The filing of a New Drug Application (NDA) for
naproxcinod with the U.S. Food and Drug Administration (FDA) is projected
for mid-2009.
DSM - the Life Sciences and Materials Sciences Company
Royal DSM N.V. creates innovative products and services in Life Sciences
and Materials Sciences that contribute to the quality of life. DSM's
products and services are used globally in a wide range of markets and
applications, supporting a healthier, more sustainable and more enjoyable
way of life. End markets include human and animal nutrition and health,
personal care, pharmaceuticals, automotive, coatings and paint, electrics
and electronics, life protection and housing. DSM has annual sales of
almost EUR 8.8 billion and employs some 23,000 people worldwide. The
company is headquartered in the Netherlands, with locations on five
continents. DSM is listed on the NYSE Euronext Amsterdam. More information:
www.dsm.com.
NicOx (Bloomberg: COX:FP, Reuters: NCOX.PA) is a product-driven
biopharmaceutical company dedicated to the development and future
commercialization of investigational drugs for unmet medical needs. NicOx
is applying its proprietary nitric oxide-donating technology to develop an
internal portfolio of New Chemical Entities (NCEs) in the therapeutic areas
of inflammatory and cardio-metabolic disease.
Resources are focused on the development and pre-commercialization
activities for naproxcinod, a proprietary NCE and the first compound in the
Cyclooxygenase-Inhibiting Nitric Oxide-Donating (CINOD) class of
anti-inflammatory agents for the treatment of the signs and symptoms of
osteoarthritis. Naproxcinod has completed three pivotal phase 3 studies
with positive results and the submission of a New Drug Application (NDA) to
the US Food and Drug Administration (FDA) is projected for mid-2009.
Beyond naproxcinod, NicOx has a pipeline containing multiple nitric
oxide-donating NCEs, which are in development internally and with partners,
including Pfizer Inc and Merck & Co., Inc., for the treatment of prevalent
and underserved diseases, such as atherosclerosis, hypertension, widespread
eye diseases and Chronic Obstructive Pulmonary Disease (COPD).
NicOx S.A. is headquartered in France and is listed on the NYSE 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: http://www.nicox.com
NicOx: Karl Hanks
Director of Investor Relations and Corporate Communication
Tel +33 (0)4 97 24 53 42 - hanks@nicox.com
Media in the United States - FD
Robert Stanislaro - Tel +1 212 850 5657 - robert.stanislaro@fd.com
Irma Gomez-Dib - Tel +1 212 850 5761 - irma.gomez-dib@fd.com
Media in Europe - Citigate Dewe Rogerson
David Dible - Tel +44 (0)207 282 2949 - david.dible@citigatedr.co.uk
Nina Enegren - Tel +44 (0)207 282 1050 - nina.enegren@citigatedr.co.uk
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
This information is provided by HUGIN
