PDUFA date is July 21,
2016
LAVAL, Quebec and SOPHIA
ANTIPOLIS, France, Sept. 22, 2015 /CNW/ -- Valeant
Pharmaceuticals International, Inc.'s (NYSE: VRX and TSX: VRX)
wholly owned subsidiary, Bausch + Lomb, and Nicox S.A. (NYSE
Euronext Paris: COX) today announced that the U.S. Food and Drug
Administration (FDA) has accepted for review its New Drug
Application (NDA) for VESNEO™ (latanoprostene bunod
ophthalmic solution 0.024%), an intraocular pressure (IOP) lowering
single-agent eye drop dosed once daily, for patients with open
angle glaucoma or ocular hypertension. If approved, VESNEO
will be the first nitric oxide donating prostaglandin receptor
agonist available for the above indication.
Upon instillation in the eye, latanoprostene bunod is rapidly
metabolized to two actives: latanoprost acid, a prostaglandin
analog, and nitric oxide. Nitric oxide is an important
physiological signaling molecule, which plays a key role in IOP
regulation in healthy eyes. VESNEO is thought to increase
aqueous humor outflow by acting on both the uveoscleral
(non-conventional) pathway via latanoprost acid, and trabecular
meshwork and Schlemm's canal (conventional pathway) via nitric
oxide signaling.
VESNEO was licensed by Nicox to Bausch + Lomb.
"The acceptance for review of the VESNEO NDA by
the FDA marks an important milestone in our effort to bring a new
treatment to patients with open angle glaucoma and ocular
hypertension," stated J. Michael
Pearson, chairman and chief executive officer of Valeant.
"It is also another illustration of how Valeant's robust pipeline
continues to be filled by a commitment to innovation driven by
significant R&D programs and partnerships focused on the needs
of medical professionals and their patients around the world."
"If granted, the FDA's approval of VESNEO will clear the
way for the first truly novel IOP-lowering medication in years,"
said Michele Garufi, chairman and
CEO of Nicox. "Open angle glaucoma and ocular hypertension
represent significant unmet medical needs. The clinical advancement
of VESNEO is particularly gratifying as it validates the
therapeutic and commercial potential of our proprietary nitric
oxide-donating R&D platform, which we will continue to leverage
in the development of additional innovative ophthalmic
compounds."
The FDA has set an action date of July
21, 2016 to complete its review, as per the Prescription
Drug User Fee Act (PDUFA).
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
usually does not cause any symptoms itself, however it can lead to
optic nerve damage and vision loss over time if left untreated.
Drug therapy is used to reduce IOP and therefore prevent further
vision loss, typically through either reducing aqueous humor
production or by increasing the drainage of intraocular fluid.
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 Valeant Pharmaceuticals International, Inc.
Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX) is a
multinational specialty pharmaceutical company that develops,
manufactures and markets a broad range of pharmaceutical products
primarily in the areas of dermatology, gastrointestinal disease,
eye health, neurology and branded generics. More information
about Valeant Pharmaceuticals International, Inc. can be found at
www.valeant.com.
About Bausch + Lomb
Bausch + Lomb, a Valeant
Pharmaceuticals International, Inc. company, is a leading global
eye health organization that is solely focused on protecting,
enhancing, and restoring people's eyesight. Our core businesses
include ophthalmic pharmaceuticals, contact lenses, lens care
products, ophthalmic surgical devices and instruments. We
develop, manufacture and market one of the most comprehensive
product portfolios in our industry, which are available in more
than 100 countries.
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, Nicox is building a
diversified portfolio of ophthalmic products that can help people
enhance their sight.
Nicox's advanced pipeline features VESNEO™ for the lowering of
intra-ocular pressure (IOP) in patients with open angle glaucoma or
ocular hypertension, and for which a New Drug Application (NDA) was
recently submitted to the FDA by the Company's licensee Valeant.
Our pipeline also features AC-170, a pre-NDA candidate for the
treatment of ocular itching associated with allergic
conjunctivitis, as well as two pre-MAA candidates in Europe: AzaSite® for bacterial
conjunctivitis and BromSite™ for pain and inflammation after
cataract surgery. Beyond these late-stage candidates, Nicox is
developing a pipeline of ophthalmology-focused candidates which
utilize its proprietary nitric oxide (NO)-donating research
platform. 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 130 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.
Valeant Forward-looking Statements
This press release
may contain forward-looking statements, including, but not limited
to, statements regarding expected regulatory filings,
commercialization plans, product potential, future investment in
R&D programs and the related benefits and effects of such
programs. Forward-looking statements may be identified by the use
of the words "anticipates," "expects," "intends," "plans,"
"should," "could," "would," "may," "will," "believes," "estimates,"
"potential," or "continue" and variations or similar expressions.
These statements are based upon the current expectations and
beliefs of management and are subject to certain risks and
uncertainties that could cause actual results to differ materially
from those described in the forward-looking statements. These risks
and uncertainties include, but are not limited to, risks and
uncertainties discussed in the company's most recent annual or
quarterly report filed with the Securities and Exchange Commission
("SEC") and other risks and uncertainties detailed from time to
time in the Company's filings with the SEC and the Canadian
Securities Administrators, which factors are incorporated herein by
reference. Readers are cautioned not to place undue reliance on any
of these forward-looking statements. Valeant undertakes no
obligation to update any of these forward-looking statements to
reflect events or circumstances after the date of this press
release or to reflect actual outcomes.
Nicox Forward-looking Statement
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 2014 >> filed with the
French Autorite des Marches Financiers (AMF) on April 10, 2015 and available on Nicox' website
(www.nicox.com) and on the AMF's website
(www.amf-france.org).
®/™ are trademarks of Bausch & Lomb
Incorporated and its affiliates.
© 2015 Bausch
& Lomb Incorporated.
Contacts:
Valeant Pharmaceuticals International, Inc.
Investors:
Laurie Little
SVP, Investor Relations
(949) 461-6002 or laurie.little@valeant.com
Financial Media:
Renee E. Soto/Meghan Gavigan
Sard Verbinnen &
Co.
212-687-8080or rsoto@sardverb.com
Kristy Marks
Public Relations Product Manager, Bausch + Lomb
(585) 338-8095 or kristy.marks@bausch.com
Nicox S.A.
Gavin Spencer Executive Vice President Corporate Development,
Nicox
+33 (0)4 97 24 53 00 or communications@nicox.com
Media Relations in the United
States
Argot Partners, Eliza
Schleifstein
(917)-763-8106 or eliza@argotpartners.com
Media Relations in the United
Kingdom
Jonathan Birt
+44 7860 361 746 or jonathan.birt@ymail.com
Media Relations in France
NewCap, Nicolas Merigeau
+33 (0)1 44 71 94 98 or nicox@newcap.fr
Investor Relations in the United
States
Argot Partners, Melissa Forst
(212)-600-1902 or melissa@argotpartners.com
Investor Relations in Europe
NewCap, Julien Perez and Valentine
Brouchot
+33 (0)1 44 71 94 94 or nicox@newcap.fr
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SOURCE Valeant Pharmaceuticals International, Inc.