SOPHIA ANTIPOLIS, FRANCE -- 05/13/08 --
May 13, 2008. Sophia Antipolis,
France.
www.nicox.com
NicOx S.A. (Eurolist: COX) today announced that Merck & Co., Inc. has
initiated the first in a series of planned clinical studies, in mild to
moderate hypertensive patients, under the companies' collaborative
agreement to develop new nitric oxide-donating antihypertensive agents
using NicOx' proprietary technology. Three drug candidates have now been
selected from the companies' joint research program, of which two have
completed initial dose ranging studies in healthy volunteers under the
exploratory clinical study paradigm with encouraging results.
Merck plans to conduct a number of clinical studies in hypertensive
patients involving single and multiple ascending dosing, prior to the
selection of a compound to be advanced into phase 2. The most advanced
candidate is now being evaluated in the first of these studies, which is a
single ascending dose trial in mild to moderate hypertensive patients. The
main objectives of this study are to assess the efficacy, safety,
tolerability and pharmacokinetics of single ascending doses of this
candidate. Subsequent studies will assess multiple ascending doses.
"The initiation of this series of clinical studies in hypertensive patients
is a very important step towards delivering a new treatment paradigm for
hypertension, where the medical need remains significant," commented
Jacques Djian MD., NicOx' Cardiometabolic Area Leader. "We believe these
drug candidates have considerable potential as improved antihypertensive
agents based on their nitric oxide-donating properties and we hope they
will deliver a major advance in antihypertensive treatment for patients
worldwide."
In July 2007, NicOx announced the initiation of the first in a series of
studies in healthy volunteers for the selected candidates (see press
release of July, 16th 2007). Merck is responsible for funding and
performing the development of these compounds going forward.
To date, NicOx has received EUR 19.2 million from Merck under this
agreement. NicOx also stands to receive potential additional milestone
payments of EUR 269 million and industry standard royalties on the sales of
products which result from the agreement. Furthermore, NicOx has the option
to co-promote resulting products, on a fee-for-detail basis, to specialist
physicians in the United States and certain major European countries.
"We are delighted that less than one year after the first drug candidate
entered human testing, we now have three drug candidates identified and
that the first of these has started patient dosing," said Michele Garufi,
Chairman and CEO of NicOx. "We look forward to continued rapid progress in
our collaboration with Merck and to the future introduction of a new
anti-hypertensive class on the market."
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 NCEs in the therapeutic areas of inflammatory and
cardio-metabolic disease.
Resources are focused on the development of naproxcinod, a proprietary NCE
and the first compound in the Cyclooxygenase Inhibiting Nitric
Oxide-Donating (CINOD) class of anti-inflammatory agents, which is in phase
3 clinical studies for the treatment of the signs and symptoms of
osteoarthritis, with final phase 3 results anticipated in 2008.
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, glaucoma
and Chronic Obstructive Pulmonary Disease (COPD).
NicOx S.A. is headquartered in France and is listed on the Euronext Paris
Stock Exchange (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
Communications - Tel +33 (0)4 97 24 53 42 - hanks@nicox.com
Investors in the United States - Burns McClellan: Lisa Burns -
lburns@burnsmc.com
Juliane Snowden - Tel +1 212 213 0006 - jsnowden@burnsmc.com
Media in the United States - FD: Jonathan Birt - Tel +1 212 850 56 34 -
jbirt@fd-us.com
Media in Europe - Citigate Dewe Rogerson: David Dible - Tel +44 (0)207 282
2949 - david.dible@citigatedr.co.uk
Sylvie Berrebi - Tel +44 (0)207 282 1050 - sylvie.berrebi@cititgatedr.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
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