SOPHIA ANTIPOLIS, FRANCE -- 05/05/09 --
www.nicox.com
NicOx S.A. (NYSE Euronext Paris: COX) today announced that four scientific
posters on PF‑03187207 for glaucoma were presented yesterday by NicOx
and Pfizer at the Association for Research in Vision and Ophthalmology
(ARVO) Annual Meeting in Fort Lauderdale, Florida. PF‑03187207 is a
nitric oxide-donating prostaglandin F2-alpha analog, which completed two
phase 2 studies in the United States and Japan during 2008, in patients
with primary open angle glaucoma and ocular hypertension.
The results of the US phase 2 study were presented in a poster entitled
"Efficacy and Safety of PF‑03187207, A Novel Nitric Oxide Donating
Prostaglandin F2-Alpha Analogue, vs. Latanoprost in Hypertensive Eyes"
(poster number 2481/A156). This study randomized 176 patients and evaluated
five different concentrations of PF‑03187207 compared to Xalatan®
(latanoprost) 0.005%. Xalatan® is a proprietary Pfizer product and the
highest selling drug for glaucoma, with approximately $1.7 billion of
franchise sales in 2008.
Evening administration of the highest dose of PF-03187207 consistently
lowered diurnal intraocular pressure (IOP) to a greater degree than evening
dosing of Xalatan® 0.005% at days 7, 14, 21 and 28. On the primary
endpoint, evening administration of the highest dose of PF‑03187207
showed a numerical improvement over Xalatan® 0.005% of 12% in reducing
diurnal IOP after 28 days, compared to baseline. Adverse event rates were
similar across the treatment groups. No patients reported serious adverse
events after exposure to the study drugs and no patients discontinued due
to adverse events.
Two preclinical posters are also being presented during this meeting,
showing that PF-03187207 brought about superior IOP lowering compared to
Xalatan® 0.005% in different animal models:
"Ocular Hypotensive Activity of PF-03187207, a Nitric Oxide Donating
Prostaglandin Analog, in Preclinical Models" (poster number 1471/A361)
"Dose-Response Profile of PF-03187207 (PF-207) and Peak IOP Lowering
Response Following Single Topical Administration to FP Receptor Knockout
Mice vs. Wild Type Mice" (poster number 4064/A226)
One poster on a meta-analysis of clinical data for PF‑03187207 and
several currently used glaucoma treatments was also presented yesterday:
"A Model-Based Dose-Response Meta-Analysis of Single Agent Intraocular
Pressure (IOP) Therapies Used to Evaluate Efficacy of a Potential New
Therapy (PF-03187207) in Glaucoma Patients" (poster number 2479/A154)
Pfizer is currently in active discussions with NicOx regarding the
worldwide rights to this compound. PF-03187207 is covered by the companies'
August 2004 agreement.
Maarten Beekman, Vice-President of Clinical Development & Medical Affairs
at NicOx, commented: "The ARVO congress is the leading research conference
in ophthalmology and it represents a very good opportunity for the joint
Pfizer-NicOx team to share these interesting results. We believe
PF‑03187207 has a clear therapeutic potential which deserves to be
developed, due to the potential of nitric oxide donation to enhance
intraocular pressure lowering. "
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 a Cyclooxygenase-
Inhibiting Nitric Oxide-Donating (CINOD) anti-inflammatory agent 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 and
widespread eye diseases and respiratory conditions.
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
This information is provided by HUGIN
NicOx:
Karl Hanks
Director of Investor Relations and Corporate Communication
Tel +33 (0)4 97 24 53 42
Email Contact
Media in the United States - FD
Robert Stanislaro
Tel +1 212 850 5657
Email Contact
Irma Gomez-Dib
Tel +1 212 850 5761
Email Contact
Media in Europe - Citigate Dewe Rogerson
David Dible
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NicOx S.A.,
Les Taissounières - Bât HB4 - 1681 route des Dolines - BP313, 06906 Sophia
Antipolis cedex, France.
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