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NICOX : Bausch + Lomb confirms submission of Vesneo(TM) NDA to US FDA

20:00 EDT 23 Jul 2015 | Globe Newswire

SOPHIA ANTIPOLIS, France, July 24, 2015 (GLOBE NEWSWIRE) -- Nicox S.A. (Euronext Paris: FR0000074130, COX), the international ophthalmic company, today noted the confirmation by Valeant Pharmaceuticals International, Inc's. (NYSE: VRX and TSX: VRX) wholly owned subsidiary, Bausch + Lomb,that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for VESNEO(TM) (latanoprostene bunod ophthalmic solution 0.024%), an IOP lowering single-agent eye drop dosed once daily, for patients with open angle glaucoma or ocular hypertension.

The data submitted in the NDA support VESNEO as the first nitric-oxide donating agent for ophthalmic use.

...................................

About Nicox

Nicox (Bloomberg: COX:FP, Reuters: NCOX.PA) is an international commercial-stage company focused on the ophthalmic market. With a heritage of innovative R&D, business development and marketing expertise, we are building a diversified portfolio of ophthalmic products that can help people to enhance their sight.

Nicox's advanced pipeline features two pre-NDA candidates (Vesneo(TM) for glaucoma, partnered with Bausch + Lomb / Valeant and AC-170 for allergic conjunctivitis) as well as two pre-MAA candidates (AzaSite® for bacterial conjunctivitis and BromSite(TM) for pain and inflammation after cataract surgery). The Group operates directly in six countries, including the United States. It has proprietary commercial operations in Europe's five largest markets complemented by an expanding international network of distributors.

Nicox is headquartered in France and has more than 120 staff worldwide. It is listed on Euronext Paris (Category B: Mid Caps) and is part of the CAC Healthcare, CAC Pharma & Bio and Next 150 indexes.

For more information on Nicox, its commercial products or pipeline, please visit www.nicox.com.

Upcoming events

Financial and business conferences
Sept.11 Goldman Sachs Symposium London, UK  
Sept.16-18 Kepler Cheuvreux Autumn Conference Paris, France  
Nov.5 Société Générale Healthcare Forum Paris, France  
Nov.12-13 Bryan Garnier Healthcare Conference Paris, France  
       
Scientific conferences
Sept.22-23 SOE - Congreso Socieda Espanola de Oftalmologia (Booth 139&131) Seville, Spain  
Oct.7 EVER 2015 - European Association for Vision and Eye Research Nice, France  
Nov.14-17 AAO - American Academy of Ophthalmology Las Vegas, US  
Nov.27-30 SOI National Congress Rome, Italy  

Analyst coverage

Bryan, Garnier & Co Hugo Solvet Paris, France
Stifel Max Herrmann  London, UK
Invest Securities Martial Descoutures Paris, France
Kepler Cheuvreux Alexandra Ralli Paris, France  

Contacts

Nicox Gavin Spencer | Executive Vice President Corporate Development
  Caroline Courme | Communication Manager
  Tel +33 (0)4 97 24 53 43 | communications@nicox.com
   
Media Relations  
   
United Kingdom Jonathan Birt
  Tel +44 7860 361 746 | jonathan.birt@ymail.com
   
France NewCap | Nicolas Merigeau
  Tel +33 (0)1 44 71 94 98 | nicox@newcap.fr
   
United States Argot Partners | Eliza Schleifstein
  Tel +1 (917) 763-8106 | eliza@argotpartners.com
   
Investor Relations  
   
Europe NewCap | Julien Perez | Valentine Brouchot
  Tel +33 (0)1 44 71 94 94 | nicox@newcap.fr
   
United States Argot Partners | Melissa Forst
  Tel +1 (212) 600-1902 | melissa@argotpartners.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 2014' filed with the French Autorité des Marchés Financiers (AMF) on April 10, 2015, which is available on Nicox's website ( www.nicox.com ).

Nicox S.A.
Drakkar 2 | Bât 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
www.nicox.com

Press Release: http://hugin.info/143509/R/1940826/701108.pdf

HUG#1940826

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