NICOX : Bausch + Lomb Initiates Phase 3 Program for Glaucoma Drug Candidate Licensed from Nicox

 NICOX : Bausch + Lomb Initiates Phase 3 Program for Glaucoma Drug Candidate
                             Licensed from Nicox

Bausch + Lomb Initiates Phase 3 Program for Glaucoma Drug Candidate Licensed
from Nicox


January 29th, 2013.

Sophia Antipolis, France and Madison, NJ, USA.

Bausch + Lomb, the  global eye health company,  and Nicox S.A. (NYSE  Euronext 
Paris: COX)  today announced  that  Bausch+Lomb has  initiated its  Phase  3 
clinical program of latanoprostene bunod (previously known as BOL-303259-X and
NCX116) for  the reduction  of intraocular  pressure (IOP)  in patients  with 
glaucoma  or   ocular  hypertension.   Latanoprostene   bunod  is   a   nitric 
oxide-donating  prostaglandin   F2-alpha   analog   licensed   by   Nicox   to 

This pivotal Phase  3 program includes  two separate randomized,  multicentre, 
double-masked, parallel-group clinical studies, APOLLO and LUNAR, designed  to 
compare the  efficacy and  safety of  latanoprostene bunod  administered  once 
daily (QD)  with  timolol  maleate  0.5% administered  twice  daily  (BID)  in 
lowering IOP in patients with open-angle glaucoma or ocular hypertension.  The 
primary endpoint  of both  studies, which  will include  a combined  total  of 
approximately 800 patients, is the reduction in mean IOP measured at specified
time points during three months of treatment. The Phase 3 studies are  pivotal 
forU.S. registration  and will  be  conducted in  North America  and  Europe. 
Additional   information    about    the    studies   can    be    found    at

"There is a need for more  effective, safer and better tolerated therapies  to 
lower IOP,"said Robert N.  Weinreb, M.D.,chairman & distinguished  professor 
of Ophthalmology,University of California San Diego anddirector, Shiley  Eye 
Center and Hamilton Glaucoma Center. "The Phase 2b results  forlatanoprostene 
bunod were  promising,so it  is excitingthatthis  potential new  therapyis 
nowin pivotal trials."

Bausch + Lomb's decision  to proceed with a  pivotal Phase 3 program  followed 
positive results with latanoprostene bunod in a Phase 2b trial in 413 patients
with elevated IOP due to glaucoma  and ocular hypertension. This study  showed 
that latanoprostene bunod consistently lowered IOP in a dose-dependent manner.
All four  doses tested  in the  Phase 2b  trial showed  greater IOP  reduction 
compared with Xalatan® 0.005%, with the differences for two of the four  doses 
reaching more than 1mmHg (statistical significance: p<0.01).

"Bausch + Lomb believes that latanoprostene bunod has the potential to  become 
an important new treatment option for  people suffering from elevated IOP  due 
to glaucoma and ocular  hypertension," said Cal  Roberts, M.D. executive  vice 
president and  chief medical  officer,  Bausch +  Lomb.  "We look  forward  to 
completing this pivotal research program, and hope to develop an effective new
treatment option to benefit physicians and the patients they serve."

"Latanoprostene bunod is a nitric oxide-donating compound which was discovered
in our Research Laboratories in Milan and is the first Nicox program  licensed 
to a partner to enter into Phase 3," said Michele Garufi, chairman and CEO  of 
Nicox."We are pleased with Bausch + Lomb's commitment to pursuing this program
in  an  area  of  significant  therapeutic  need.  Thewhole  Nicox  team   has 
contributed to this important milestone which underlines the potential of  our 
research platform in the ophthalmic field."

Nicox and Bausch + Lomb Worldwide Licensing Agreement

In March 2010, Bausch + Lomb signed a worldwide licensing agreement with Nicox
for latanoprostene bunod, and made an initial license payment of $10  million. 
In light of  the positive results  of the  Phase 2b study  completed in  2011, 
Bausch + Lomb made an additional  $10 million milestone payment in April  2012 
following their  decision  to  pursue further  development  of  latanoprostene 
bunod. If  certain  regulatory,  commercialization and  sales  milestones  for 
latanoprostene bunod  are met,  Nicox stands  to receive  from Bausch  +  Lomb 
additional potential payments  which, over time,  could total $162.5  million. 
Nicox will  also  receive  tiered  double-digit  royalties  on  the  sales  of 
latanoprostene bunod  and has  the option  to co-promote  the product  in  the 
United States.

About Glaucoma

Glaucoma is a group of eye diseases  which can lead to the loss of  peripheral 
vision and  eventually  total  blindness. Glaucoma  is  frequently  linked  to 
abnormally high  pressure  in the  eye  (intraocular pressure,  IOP),  due  to 
blockage or malfunction of the eye's drainage system. Abnormally high IOP does
not cause any symptoms itself, however it  can lead to optic nerve damage  and 
vision loss  if  left  untreated. Drug  therapy  is  used to  reduce  IOP  and 
therefore prevent  further  vision  loss,  typically  through  increasing  the 
drainage of intraocular fluid by relaxing certain muscles in the eye.  Several 
large trials have demonstrated that  reducing IOP can prevent the  progression 
of glaucoma  in both  early and  late  stages of  the disease.  A  significant 
proportion of patients with elevated IOP  require more than one medication  to 
maintain their  IOP  within target  levels,  highlighting the  need  for  more 
effective treatments.


About Bausch + Lomb

Bausch + Lomb is one of the best-known and most respected healthcare companies
in the  world.  Its core  businesses  include  contact lenses  and  lens  care 
products,  ophthalmic  surgical  devices   and  instruments,  and   ophthalmic 
pharmaceuticals. Founded in 1853, the  company is headquartered in  Rochester, 
NY, and employs roughly 11,000 people worldwide. Its products are available in
more than 100 countries. More information is available at

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(TM), 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) and Ferrer.

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


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  2011 » filed with the French  Autorité 
des Marchés Financiers  (AMF) on February  29, 2012 and  available on  Nicox's 
website ( and on the AMF's website


Nicox Contacts
Nicox           Gavin Spencer|Executive Vice President Corporate Development
                Tel +33 (0)4 97 24 53 00 |
Media Relations FTI Consulting
Europe          Jonathan Birt | D+44 (0)20 7269 7205 | M +44 (0) 7515 597 858
                Stephanie Cuthbert | D +44 (0)20 3077 0458 |M +44 (0) 7843
United States   Robert Stanislaro | D +1 (212) 850 5657 | M +1 (917) 968 9795
                Irma Gomez-Dib | D +1 (212) 850 5761 | M +1 (415) 706 9155
Bausch + Lomb
US              Teresa Gatto Panas |Director Global Pharmaceutical
                Tel +1(973) 360-6382 ·
Europe          GeorginaPinnington|Manager, Communications
                Tel +44 (0)20 8781 5709 ·

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

Bausch + Lomb - Nicox: Phase 3 Program Initiation


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Source: NICOX via Thomson Reuters ONE
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