Bausch + Lomb confirms submission of Vesneo(TM) NDA to US FDA
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July 24, 2015
Sophia Antipolis, France
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.
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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
