SOPHIA ANTIPOLIS CEDEX, FRANCE--(Marketwire - March 13, 2012) -
NicOx, Bausch + Lomb Glaucoma Candidate BOL-303259-X Meets Primary Endpoint
Phase 2b Study
Bausch + Lomb to Pursue Global Phase 3 Development Program
13 March 2012 - Sophia Antipolis, France and Madison, NJ, USA.
Bausch + Lomb, the global eye health company, and NicOx S.A. (NYSE
(PARIS: COX) today announced positive top-line results from the phase 2b
conducted with BOL-303259-X, a novel nitric oxide-donating
alpha analog, in patients with open-angle glaucoma or ocular hypertension.
303259-X (previously NCX 116) was licensed by NicOx to Bausch + Lomb in
2010 (see NicOx and Bausch + Lomb press release dated March 3,
Bausch + Lomb will pay a $10 million milestone payment to NicOx and
initiate a global phase 3 development program for BOL-303259-X.
The phase 2b study met its primary efficacy endpoint and showed positive
on a number of secondary endpoints. The primary efficacy endpoint
reduction in mean diurnal intraocular pressure (IOP) on day 28. BOL-
consistently lowered IOP in a dose-dependent manner. Two of the four
tested showed greater IOP reduction compared with Xalatan®
0.005%, with the
differences reaching more than 1mmHg (statistical significance: p < 0.01).
"We know from several studies that every mmHg of IOP reduction is
it reduces the risk of developing glaucoma and progression of glaucoma,"
Robert N. Weinreb, M.D., Distinguished Professor and Chairman of
University of California San Diego. "A safe and well-tolerated therapy
better lower IOP compared to current prostaglandin therapies would be
by both clinicians and patients."
The most efficacious dose of BOL-303259-X also showed positive results
number of secondary endpoints, including consistently better control of IOP
24 hours on day 28 as well as a statistically significant greater
responders vs. Xalatan® 0.005%, defined as patients achieving an IOP
or less. The responder rate was 68.7% for the most efficacious dose of
303259-X, compared to 47.5% for Xalatan® 0.005% (p=0.006).
The safety of BOL-303259-X was comparable to Xalatan®. The most
event was ocular hyperemia (red eye), which occurred at a similar rate
all treatment groups.
Bausch + Lomb initiated the randomized, investigator-masked phase 2b
November 2010 to identify the most efficacious and safe dose of BOL-303259-
the reduction of IOP. The study enrolled 413 patients across 23 sites
United States and Europe. Patients were randomized to receive either BOL-
X (various concentrations) or Xalatan® 0.005% (latanoprost) once a
day in the
evening for 28 days.
"Bausch + Lomb is committed to funding and developing innovative new
to benefit physicians and the patients they serve," said Dan Wechsler,
Vice President and President, Global Pharmaceuticals, Bausch + Lomb.
303259-X adds to our growing portfolio of potential new products in eye
We are encouraged by the positive results of our phase 2b study and hope
through further research and development, BOL-303259-X will provide a
new treatment option for the millions of people around the world suffering
elevated IOP due to glaucoma or ocular hypertension."
Michele Garufi, Chairman and CEO of NicOx, said, "These positive results
the strong potential of our nitric oxide-donating platform in the
field and we look forward to continuing to collaborate with the Bausch +
team on the phase 3 development program."
NicOx and Bausch + Lomb Worldwide Licensing Agreement
In March 2010, NicOx and Bausch + Lomb signed a worldwide licensing
for BOL-303259-X for the potential treatment of glaucoma and
hypertension. Under the terms of the agreement, Bausch + Lomb made an
license payment to NicOx of $10 million. In light of these positive
Bausch + Lomb will pay an additional $10 million milestone payment to
will initiate a global phase 3 development program for BOL-303259-X.
stands to receive potential regulatory, commercialization and sales
based milestones, which could total an additional $162.5 million. NicOx
also receive tiered double-digit royalties on the sales of BOL-303259-X.
has the option to co-promote BOL-303259-X products in the United States.
Glaucoma is a group of eye diseases which can lead to the loss of
vision and eventually total blindness. Glaucoma is frequently
abnormally high pressure in the eye (intraocular pressure, IOP), due to
or malfunction of the eye's drainage system. Abnormally high IOP does not
any symptoms itself, however it can lead to optic nerve damage and vision
if left untreated. Drug therapy is used to reduce IOP and therefore
further vision loss, typically through increasing the drainage of
fluid by relaxing certain muscles in the eye. Several large trials
demonstrated that reducing IOP can prevent the progression of glaucoma in
early and late stages of the disease. A significant proportion of patients
elevated IOP require more than one medication to maintain their IOP
target levels, highlighting the need for more effective treatments.
NicOx (Bloomberg: COX:FP, Reuters: NCOX.PA) is a pharmaceutical company
on the research, development and future commercialization of drug
NicOx is applying its proprietary nitric oxide-donating R&D platform to
an internal portfolio of New Molecular Entities (NMEs) for the
treatment of inflammatory, cardio-metabolic and ophthalmological diseases.
The Company's pipeline includes several nitric oxide-donating NMEs, which
development internally and with partners, who include Merck (known
outside the United States and Canada), Bausch + Lomb and Ferrer.
NicOx S.A. is headquartered in France and is listed on Euronext
(Compartment C: Small Caps).
About Bausch + Lomb
Bausch + Lomb is one of the best-known and most respected healthcare
in the world. Its core businesses include contact lenses and lens care
ophthalmic surgical devices and instruments, and ophthalmic
Founded in 1853, the company is headquartered in Rochester, N.Y., and
more than 10,000 people worldwide. Its products are available in more than
countries. More information is available atwww.bausch.com.
This press release contains certain forward-looking statements.
Company believes its expectations are based on reasonable assumptions,
forward-looking statements are subject to numerous risks and
which could cause actual results to differ materially from those
the forward-looking statements.
Risks factors which are likely to have a material effect on NicOx's
presented in the 4th chapter of the « Document de référence,
annuel et rapport de gestion 2011 » filed with the French
Autorité des Marchés
Financiers (AMF) on February 29, 2012 and available on NicOx's
(www.nicox.com) and on the AMF's website (www.amf-france.org).
NicOx, Bausch + Lomb Glaucoma Candidate BOL 303259 X Meets Primary End:
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