Nicox Receives Positive Opinion For European Orphan Drug Designation For Naproxcinod For The Treatment Of Duchenne Muscular Dystrophy

SOPHIA ANTIPOLIS CEDEX, France, Sept. 11, 2013 (GLOBE NEWSWIRE) --
Nicox S.A. (NYSE Euronext Paris: COX) today announced that it has received apositive opinion from the European Union Committee for Orphan Medicinal Products(COMP) recommending orphan drug designation for naproxcinod, a CINOD(Cyclooxygenase-Inhibiting Nitric Oxide-Donating) anti-inflammatory candidate,for the treatment of Duchenne Muscular Dystrophy (DMD). The orphan drugdesignation allows companies to benefit from a number of incentives, including a10-year market exclusivity post-approval, scientific advice and fee reductions.Final approval of the opinion on orphan designation is expected from theEuropean Commission in the coming months. Naproxcinod has shown promisingpreclinical results in models of muscular dystrophy."Naproxcinod may have the potential to address the important unmet needs of thepatients suffering from Duchenne Muscular Dystrophy, who currently have noapproved therapies available." said Michele Garufi, Chairman and CEO of Nicox."Receiving the orphan drug designation for naproxcinod in Europe will be a keymilestone for Nicox and will support our strategy of partnering the developmentof naproxcinod in this debilitating disease."Nicox is evaluating the options for developing naproxcinod through a partner asan adjuvant for the treatment of muscular dystrophy or for the treatment of thesigns and symptoms of osteoarthritis of the knee. This approach is aimed atmaximising the opportunities to progress the development of naproxcinod in oneof these indications.About naproxcinod in DMDIn  DMD, muscle damage is  caused by the inability  to synthesize the dystrophinprotein,  which is  associated with  neuronal NO-synthase.  Naproxcinod, throughboth its anti-inflammatory and NO-donating properties, may have the potential tobring  valuable  therapeutic  activity  to  the  dystrophic  muscles of Duchennepatients.In  a long-term preclinical study, naproxcinod was shown to improve skeletal andcardiac  muscle function and to reduce skeletal muscle inflammation in mdx mice.The  data was presented  at the Muscular  Dystrophy Association (MDA) ScientificConference in Washington, DC in April 2013.A  patent covering nitric oxide  releasing compounds, including naproxcinod, forthe  treatment of muscular dystrophies is pending in Europe and has been grantedin the United States in July 2013.About Duchenne Muscular Dystrophy (DMD)DMD is a chronically debilitating and life-threatening disease, characterized byrapidly progressive muscle weakness and wasting due to degeneration of skeletal,smooth  and cardiac muscles. DMD is the most common and serious form of musculardystrophy,  with the  onset of  symptoms occurring  in early  childhood (usuallybetween  three and five  years of age),  and affects about 3 in 10,000 live-bornmales.  This  condition  worsens  throughout  childhood,  with patients becomingwheelchair-bound  between the ages of seven  and thirteen. Most DMD patients dieby  the age of twenty, most frequently as a direct result of respiratory/cardiacfailure.About Orphan Drug DesignationThe  Orphan Medicinal Product  Designation is given  to products to be developedfor  the diagnosis, prevention or treatment  of life-threatening or very seriousconditions that affect not more than 5 in 10,000 persons in the European Union....................................About NicoxNicox  (Bloomberg:  COX:FP,  Reuters:  NCOX.PA)  is creating a new internationalplayer  in  the  ophthalmic  market  by  building  a  diversified  portfolio  ofinnovative  therapies  and  diagnostic  tools.  With  a  heritage of scientific,business  development and  commercial expertise,  the Nicox  team is  focused ondeveloping  and marketing novel pharmaceuticals  and diagnostic devices that canhelp  people  to  enhance  their  sight.  In  the  United  States, Nicox marketsAdenoPlus(®),  a test for the differential diagnosis of acute conjunctivitis in-                                                             licensed from RPS®.The  Company's pipeline  includes latanoprostene  bunod, a  novel drug-candidatebased  on Nicox's proprietary nitric oxide (NO)-donating R&D platform, developedin  collaboration with Bausch + Lomb for the potential treatment of glaucoma andocular 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 theCompany believes its expectations are based on reasonable assumptions, theseforward-looking statements are subject to numerous risks and uncertainties,which could cause actual results to differ materially from those anticipated inthe forward-looking statements.Risks factors which are likely to have a material effect on Nicox's business arepresented in the 4th chapter of the « Document de référence, rapport financierannuel et rapport de gestion 2012 » filed with the French Autorité des MarchésFinanciers (AMF) on March 22, 2013 and available on Nicox's website(www.nicox.com) and on the AMF's website (www.amf-france.org).................................... Nicox Contacts Nicox           Gavin Spencer | Executive Vice President Corporate Development                 Tel +33 (0)4 97 24 53 00 | communications@nicox.com Media Relations FTI Consulting Europe          Julia Phillips | D+44 (0)20 7269 7187 | M +44 (0) 7770 827 263                 Julia.Phillips@fticonsulting.com                 Stephanie Cuthbert | D +44 (0)20 3077 0458 | M +44 (0)                 7843 080947                 Stephanie.Cuthbert@fticonsulting.com                 Mo Noonan | D +44 (0)20 7269 7116 | M +44 (0)7876 444 977                 Mo.Noonan@fticonsulting.com Positive Opinion for European Orphan Drug Designation: http://hugin.info/143509/R/1728468/577240.pdf[HUG#1728468]

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