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(TM) (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(TM) 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(TM) 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 référence, rapport financier annuel et rapport de
gestion 2014 » filed with the French Autorité des Marchés
Financiers (AMF) on April 10, 2015 and available on Nicox' website
(www.nicox.com) and on the AMF's website (www.amf-france.org).
®/(TM) 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
press release http://hugin.info/143509/R/1953613/710916.pdf
HUG#1953613
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