LAVAL, Quebec and SOPHIA
ANTIPOLIS, France, March 20, 2017 /CNW/ -- Valeant Pharmaceuticals
International, Inc.'s (NYSE: VRX and TSX: VRX) wholly owned
subsidiary, Bausch + Lomb, and Nicox S.A. (Euronext Paris:
FR0013018124, COX) today announced that the U.S. Food and Drug
Administration (FDA) has set a PDUFA date of August 24, 2017 for its decision on the New Drug
Application (NDA) for latanoprostene bunod ophthalmic solution,
0.024%. Latanoprostene bunod is an intraocular pressure (IOP)
lowering single-agent eye drop dosed once daily, for patients with
open angle glaucoma (OAG) or ocular hypertension (OHT).
If approved, latanoprostene bunod would be the first
nitric-oxide donating prostaglandin F2α analog for ophthalmic
use.
"This is an exciting development in our journey to bring this
new treatment option to the more than 3 million1
patients in the U.S. with open angle glaucoma and ocular
hypertension, and address a significant unmet medical need," said
Joseph C. Papa, Chairman and CEO of
Valeant. "Valeant is committed to delivering therapies that make a
difference in patients' lives, and our work on latanoprostene bunod
is a strong example of that."
"If granted, the FDA's approval of latanoprostene bunod will
allow for the introduction of the first truly novel medication for
these patients in many years," said Michele
Garufi, Chairman and CEO of Nicox. "Additionally,
latanoprostene bunod would represent the first commercially
available therapy to use our proprietary nitric oxide-donating
R&D platform, which we will continue to apply in the
development of future innovative ophthalmic compounds."
Latanoprostene bunod was licensed by Nicox to Bausch + Lomb.
About Latanoprostene Bunod
Latanoprostene bunod ophthalmic solution, 0.024% is an
IOP-lowering single-agent eye drop dosed once daily for patients
with OAG or OHT. In the eye, latanoprostene bunod is metabolized to
two moieties. The first, latanoprost acid, is an F2α prostaglandin
analog, while the second, butanediol mononitrate, releases nitric
oxide, which activates the soluble guanylate
cyclase-guanosine-3',5'-monophosphate signaling pathway.
Latanoprostene bunod is believed to lower IOP by increasing outflow
of aqueous humor through both the trabecular meshwork and
uveoscleral routes.
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 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 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 Valeant
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 disorders,
eye health, neurology and branded generics. More information about
Valeant 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 over-the-counter supplements, eye care
products, 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 is available in more than 100
countries.
About Nicox
Nicox S.A. (NYSE Euronext Paris: FR0013018124, COX) is an
international ophthalmic R&D company utilizing innovative
science to maintain vision and improve ocular health. By
leveraging its proprietary expertise in nitric oxide donation and
other technologies, the Company is developing an extensive
portfolio of novel therapies that target multiple ophthalmic
conditions, including glaucoma. Nicox currently has two
products at the pre-approval stage with the U.S. Food and Drug
Administration (FDA) and a promising pipeline including
next-generation stand-alone nitric-oxide donors, with the potential
to treat a range of ophthalmic indications. Nicox is
headquartered in Sophia Antipolis, France, is listed on Euronext
Paris (Compartment B: Mid Caps; Ticker symbol: COX) and is
part of the CAC Healthcare, CAC Pharma & Bio and Next 150
indexes.
For more information on Nicox, its products or pipeline, please
visit: www.nicox.com.
Forward-looking Statements
This press release may contain forward-looking statements which
may generally be identified by the use of the words "anticipates,"
"expects," "intends," "plans," "should," "could," "would," "may,"
"will," "believes," "estimates," "potential," "target," or
"continue" and variations or similar expressions. These statements
are based upon the current expectations and beliefs of the
management of Valeant and Nicox 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 Valeant's most recent annual
or quarterly report and detailed from time to time in Valeant's
other filings with the Securities and Exchange Commission 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. These
forward-looking statements speak only as of the date hereof.
Neither Valeant nor Nicox undertakes any 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, unless required by law.
1Glaucoma Facts and Stats. (2015, May 5).Retrieved
from www.glaucoma.org/glaucoma/glaucoma-facts-and-stats.php.
Contact
Information:
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Valeant
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Nicox S.A.
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Media
Relations:
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Elif
McDonald
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Gavin
Spencer
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United
Kingdom
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514-856-3855
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Executive Vice
President Corporate Development, Nicox
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Jonathan
Birt
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877-281-6642 (toll
free)
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+33
(0)4-97-24-53-00
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+44
7860-361-746
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elif.mcdonald@valeant.com
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communications@nicox.com
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jonathan.birt@ymail.com
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Media:
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Investor
Relations:
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France
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Renée
Soto
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Europe
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NewCap
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or
Chris Kittredge/Jared Levy
Sard Verbinnen &
Co.
212-687-8080
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NewCap
Julien Perez,
Valentine Brouchot
+33 (0)1-44-71-94-94
nicox@newcap.eu
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Nicolas Merigeau
T +33 (0)1-44-71-94-98
nicox@newcap.eu
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United
States
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United
States
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Argot
Partners
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Argot
Partners
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Melissa
Forst
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Eliza
Schleifstein
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212-600-1902
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917-763-8106
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melissa@argotpartners.com
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eliza@argotpartners.com
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To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/bausch--lomb-and-nicox-announce-pdufa-date-for-novel-glaucoma-candidate-latanoprostene-bunod-300426306.html
SOURCE Valeant Pharmaceuticals International, Inc.