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NicOx SA (COX.PA) Release: Pre-Clinical Results on Naproxcinod in Models of Muscular Dystrophy Presented at Muscular Dystrophy Association Scientific Conference



4/24/2013 10:23:45 AM

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SOPHIA ANTIPOLIS, FRANCE--(Marketwired - April 23, 2013) - Nicox S.A. (EURONEXT PARIS: COX) today announced promising pre-clinical results on naproxcinod, a CINOD (Cyclooxygenase-Inhibiting Nitric Oxide-Donating) anti-inflammatory candidate, in models of muscular dystrophies. The data were presented by Nicox and the Center for Genetic Medicine Research(1), a center within the Children's Research Institute, Children's National Medical Center, in a poster session on April 22(nd) at the Muscular Dystrophy Association (MDA) Scientific Conference in Washington, DC.

The research study data were presented in a poster entitled "Long-term treatment with naproxcinod significantly improves skeletal and cardiac disease phenotype in mdx mouse model of dystrophy" (poster #175). In this study, the effects of naproxcinod were investigated on skeletal and cardiac muscle function in mdx mice. Three doses of naproxcinod (10, 21 and 41 mg/kg) were given orally to 4-week-old mdx mice (a reference model for Duchenne Muscular Dystrophy, DMD) for 9 months and compared to 0.9 mg/kg of prednisolone. The results of the study suggest that naproxcinod may have potential as a safe therapeutic option for the treatment of muscular dystrophies. Naproxcinod treatment at 10 and 21mg/kg resulted in significant improvements in hind limb grip strength as well as an approximately 25-30% decrease in inflammation in fore and hind limbs measured by in vivo optical imaging. Furthermore, there were significant improvements in heart function as evidenced by improved fraction shortening and ejection fraction, measured using echocardiography, along with improvements in systolic blood pressure. In addition, the long term detrimental effects of prednisolone typically seen in skeletal and heart function were not observed at the effective doses of naproxcinod.

Naproxcinod is a CINOD (Cyclooxygenase-Inhibiting Nitric Oxide-Donating) anti-inflammatory candidate originally developed by Nicox for the relief of the signs and symptoms of osteoarthritis. The results presented on April 22(nd) 2013 were from an exploratory research study sponsored by Nicox and conducted at the Center for Genetic Medicine Research(1). The objective was to investigate the potential for the use of naproxcinod in Duchenne Muscular Dystrophy (DMD) as there is evidence that nitric oxide can play a critical role in the functioning of skeletal muscle.

The Nicox's current strategy is to evaluate the opportunity to out-licence naproxcinod for the treatment of the signs and symptoms of osteoarthritis of the knee. Separately, the Company is also seeking specialized partners in the field of rare diseases who would be able to undertake and fund the potential development of naproxcinod in muscular dystrophy. This approach is aimed at maximising the opportunities to progress the development of naproxcinod in one of these indications.

About muscular dystrophies:

Muscular dystrophies are a group of inherited diseases that cause muscle weakness and muscle loss. These diseases are due to defects in muscle proteins, leading to structure alteration and continuous damage of fibers during contraction. DMD is the most common and serious form of muscular dystrophy, with the onset of symptoms occurring in early childhood (usually between three and five years of age) and primarily affects boys. This progressive condition worsens throughout childhood, with patients becoming wheelchair-bound between the ages of seven and thirteen. Most DMD patients die by the age of 20, most frequently as a direct result of respiratory/cardiac failure.

(1)The Center for Genetic Medicine Research (GenMed) is a center within the Children's Research Institute, at Children's National Medical Center, in Washington DC. The Center is dedicated to translational research in muscular dystrophy. Founded in 1999, GenMed serves as the Department of Integrative Systems Biology (ISB) at the George Washington University School of Medicine and Health Sciences. The muscle disease research group is among the largest worldwide, and includes drug development, pre-clinical, and clinical research groups. GenMed has 50 faculty members and about 170 staff.

About Nicox

Nicox (Bloomberg: COX:FP, Reuters: NCOX.PA) is creating a new mid-sized international player in the ophthalmic market by building a diversified portfolio of innovative therapies and diagnostic tools. With a heritage of scientific, business development and commercial expertise, the Nicox team is focused on developing and marketing novel pharmaceuticals and diagnostic devices that can help people to enhance their sight. In the United States, Nicox markets AdenoPlus™, a test for the differential diagnosis of acute conjunctivitis in-licensed from RPS®.

The Company's pipeline includes latanoprostene bunod, a novel drug-candidate based on Nicox's proprietary nitric oxide (NO)-donating R&D platform, developed in collaboration with Bausch + Lomb for the potential treatment of glaucoma and ocular hypertension. Further NO-donating compounds are under development in non-ophthalmic indications, notably through partners, including Merck (known as MSD outside the United States and Canada).

Nicox S.A. is headquartered in France and is listed on Euronext Paris (Compartment B: Small Caps). For more information please visit www.nicox.com.

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. 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 2012 » filed with the French Autorité des Marchés Financiers (AMF) on March 22, 2013 and available on Nicox's website (www.nicox.com) and on the AMF's website (www.amf-france.org).

www.nicox.com

Pre-clinical results on naproxcinod in models of muscular dystrophy pr:

http://hugin.info/143509/R/1695064/557630.pdf

This announcement is distributed by Thomson Reuters on behalf of Thomson Reuters clients. The owner of this announcement warrants that:

(i) the releases contained herein are protected by copyright and other applicable laws; and

(ii) they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: NICOX via Thomson Reuters ONE

[HUG#1695064]


Nicox Contacts

Nicox
Gavin Spencer
Executive Vice President Corporate Development
Tel +33 (0)4 97 24 53 00
Email Contact

Media Relations FTI Consulting

Europe
Jonathan Birt
D+44 (0)20 7269 7205
M +44 (0) 7515 597 858
Email Contact

Stephanie Cuthbert
D +44 (0)20 3077 0458
M +44 (0) 7843 080947
Email Contact

Nicox S.A.
Drakkar 2 | Bat D
2405 route des Dolines
CS 10313 | Sophia Antipolis
06560 Valbonne | France
T: +33 (0)4 97 24 53 00
F: +33 (0)4 97 24 53 99



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