LAVAL, Quebec and SOPHIA
ANTIPOLIS, France, Feb. 27, 2017 /PRNewswire/ -- 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 the resubmission of a New Drug
Application (NDA) to the U.S. Food and Drug Administration (FDA)
seeking approval 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).
The data submitted in the NDA support latanoprostene bunod as
the first nitric-oxide donating prostaglandin F2α analog for
ophthalmic use.
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, 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 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 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 contains forward-looking statements.
Forward-looking statements 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 and are subject to certain risks and
uncertainties that could cause actual results to differ materially
from those described in the forward-looking statements. 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. 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, unless required by law.
Contact
Information:
|
|
|
Valeant
|
Nicox S.A.
|
Media
Relations:
|
Elif
McDonald
|
Gavin
Spencer
|
United
Kingdom
|
514-856-3855
|
Executive Vice
President Corporate Development, Nicox
|
Jonathan
Birt
|
877-281-6642 (toll
free)
|
+33
(0)4-97-24-53-00
|
+44 7860 361
746
|
elif.mcdonald@valeant.com
|
communications@nicox.com
|
jonathan.birt@ymail.com
|
|
|
|
Media:
|
Investor
Relations:
|
France
|
Renée Soto
|
Europe
|
NewCap
|
or
|
NewCap
|
Nicolas
Merigeau
|
Chris Kittredge/Jared
Levy
|
Julien Perez,
Valentine Brouchot
|
T +33 (0)1 44 71 94
98
|
Sard Verbinnen &
Co.
|
+33
(0)1-44-71-94-94
|
nicox@newcap.eu
|
212-687-8080
|
nicox@newcap.eu
|
|
|
|
|
|
United
States
|
United
States
|
|
Argot
Partners
|
Argot
Partners
|
|
Melissa
Forst
|
Eliza
Schleifstein
|
|
212-600-1902
|
917-763-8106
|
|
melissa@argotpartners.com
|
eliza@argotpartners.com
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/bausch--lomb-and-nicox-resubmit-us-new-drug-application-for-novel-glaucoma-candidate-latanoprostene-bunod-300413747.html
SOURCE Valeant Pharmaceuticals International, Inc.