BRIDGEWATER, N.J., Feb. 9, 2018 /CNW/ -- Salix Pharmaceuticals,
Ltd. ("Salix"), one of the largest specialty pharmaceutical
companies in the world committed to the prevention and treatment of
gastrointestinal diseases and a wholly owned subsidiary of Valeant
Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX), and
its partner Norgine B.V. ("Norgine") have received notice that the
U.S. Food and Drug Administration (FDA) has extended the PDUFA
action date for its review of the New Drug Application for PLENVU®*
(NER1006) by three months to May 13,
2018. The PDUFA action date has been extended to allow the
FDA more time to review additional data that was recently provided
at its request.
PLENVU® was licensed by Salix from Norgine in August 2016 for introduction to the U.S. market.
Salix and Norgine will continue to work closely with the FDA to
support the review of PLENVU®, a next-generation bowel cleansing
preparation for colonoscopies.
About PLENVU® (NER1006)
PLENVU® (NER1006) is an investigational, novel, low-volume
(1L) polyethylene glycol based bowel preparation that has been
developed to provide whole bowel cleansing, with an additional
focus on the ascending colon. This low-volume solution is developed
not only to support improved patient acceptability and compliance,
but also to contribute to effectiveness of colonoscopy procedures
at detecting colon cancer by optimized bowel surveillance, through
effective bowel cleansing.
About Norgine
Norgine is a leading European specialist pharmaceutical company
with a direct commercial presence in all major European markets. In
2016, Norgine's total revenue was EUR 368
million. Norgine employs over 1,000 people across its
commercial, development and manufacturing operations and manages
all aspects of product development, production, marketing, sale and
supply. Norgine specialises in gastroenterology, hepatology, cancer
and supportive care. Norgine is headquartered in the Netherlands. Norgine owns a R&D site
in Hengoed, Wales and two
manufacturing sites in Hengoed, Wales and Dreux, France. For more information, please
visit www.norgine.com.
About Salix
Salix Pharmaceuticals is one of the largest specialty
pharmaceutical companies in the world committed to the prevention
and treatment of gastrointestinal diseases. For almost 30 years,
Salix has licensed, developed, and marketed innovative products to
improve patients' lives and arm healthcare providers with
life-changing solutions for many chronic and debilitating
conditions. Salix currently markets its product line to U.S.
healthcare providers through an expanded sales force that focuses
on gastroenterology, hepatology, pain specialists, and primary
care. Salix is headquartered in Bridgewater, New Jersey.
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 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 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. 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.
*Provisionally approved name
PLV.0016.USA.18
Investor
Contact:
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Media
Contacts:
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Arthur
Shannon
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Lainie
Keller
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arthur.shannon@valeant.com
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lainie.keller@valeant.com
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514-856-3855
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908-927-1190
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|
|
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Karen Paff
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Karen.Paff@salix.com
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908-927-1190
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SOURCE Salix Pharmaceuticals, Ltd.