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
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
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
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.
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 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 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 (www.nicox.com) and on the AMF's website www.amf-france.org).
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Bausch + Lomb - Nicox: Phase 3 Program Initiation
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