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 
SOPHIA ANTIPOLIS, FRANCE and MADISON, NJ -- (Marketwire) -- 01/29/13
--  
Bausch + Lomb Initiates Phase 3 Program for Glaucoma Drug Candidate
Licensed
from Nicox 
Bausch  + Lomb,  the global  eye health  company, and  Nicox S.A.
(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 NCX 116)  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
Bausch + Lomb. 
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 for U.S. registration
and  will be
conducted in North America and Europe. Additional information
about
the studies can be found at www.clinicaltrials.gov. 
"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  and director, Shiley Eye Center  and Hamilton  Glaucoma
Center.  "The Phase 2b results for latanoprostene
bunod  were 
promising, so  it  is  exciting that this  potential new therapy is
now in 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(R) 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. The whole 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 www.bausch.com. 
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(R). 
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
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
reference, rapport financier annuel  et rapport de gestion 2011 >>
filed  with the French Autorite des Marches Financiers   (AMF)   on 
February  29, 2012 and  available  on  Nicox's
website
(www.nicox.com) and on the AMF's website www.amf-france.org). 
................................... 
Bausch + Lomb - Nicox: Phase 3 Program Initiation: 
http://hugin.info/143509/R/1673716/544910.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#1673716] 
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
Jonathan Birt
D +44 (0)20 7269 7205
M +44 (0)7515 597 858
Jonathan.Birt@fticonsulting.com 
Stephanie Cuthbert
D +44 (0)20 3077 0458
M +44 (0)7843 080947
Stephanie.Cuthbert@fticonsulting.com 
United States
Robert Stanislaro
D +1 (212) 850 5657
M +1 (917)968 9795
Robert.Stanislaro@fticonsulting.com 
Irma Gomez-Dib
D +1 (212) 850 5761
M +1 (415)706 9155
Irma.Gomez-Dib@fticonsulting.com 
Bausch + Lomb Contacts 
US
Teresa Gatto Panas
Director Global Pharmaceutical Communications
Tel +1(973) 360-6382
teresa.panas@bausch.com 
Europe
Georgina Pinnington
Manager, Communications
Tel +44 (0)20 8781 5709
georgina.pinnington@bausch.com 
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 
www.nicox.com
 
 
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