Oral Presentation and Five Posters to be Featured
BRIDGEWATER, N.J., Oct. 8, 2018 /CNW/ -- Salix Pharmaceuticals
("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 Bausch Health Companies Inc. ("Bausch Health")
(NYSE/TSX: BHC), will present scientific data, including one podium
presentation and five posters, evaluating investigative data on the
safety and efficacy of XIFAXAN® (rifaximin) and PLENVU®
(polyethylene glycol 3350, sodium ascorbate, sodium sulfate,
ascorbic acid, sodium chloride and potassium chloride for oral
solution) at the American College of Gastroenterology (ACG) annual
meeting in Philadelphia from
Oct. 5-10, 2018.
"We look forward to presenting clinical study research elements
of our portfolio at one of the most preeminent GI conferences, such
as ACG," said Mark McKenna,
president, Salix Pharmaceuticals. "We remain committed to improving
understanding of the science and impact of GI therapies. This
commitment emerges from our mission, values and expectations — all
the factors that have made us a leading GI company for nearly 30
years."
"We believe that the new PLENVU data presented by our partner,
Salix, at ACG will be
important to help further educate physicians as they offer this
product, given the recent U.S. launch in September 2018," said Peter Martin, chief operating officer, Norgine.
"Together, we continuously strive to reinforce the benefits of
PLENVU to improve cleansing of the colon before colonoscopy."
The full schedule of research to be presented includes:
XIFAXAN (rifaximin)-Related
Presentations
- Anthony Lembo.
"Characterization of Abdominal Pain Response to Rifaximin in
Patients with Irritable Bowel Syndrome with Diarrhea (IBS-D), by
Baseline Pain Severity." Poster #P0337; Sunday, October 7, 3:30
p.m. – 7:00 p.m.; Exhibit
Halls DE (level 200)
- Brian Lacey. "Rifaximin for
Improving Abdominal Pain and Bloating Symptoms in Patients with
Irritable Bowel Syndrome with Diarrhea (IBS-D) Using Modified
Definitions of Pain Response." Poster #P1231; Monday, October 8, 10:30
a.m. – 4:15 p.m.; Exhibit
Halls DE (level 200)
- Ali Rezaie. "Lactulose Breath
Testing Predicts Response to Rifaximin for Cardinal Irritable Bowel
Syndrome With Diarrhea (IBS-D)." Poster #P2105; Tuesday, October 9, 10:30
a.m. – 4:00 p.m.; Exhibit
Halls DE (level 200)
- Steven Flamm. "Efficacy and
Safety of Rifaximin Treatment for Reducing the Risk of Overt
Hepatic Encephalopathy by Baseline Hepatic Impairment."
Wednesday, October 10, 9:00 a.m. – 9:10
a.m.; Terrace Ballroom 4 (level 400)
PLENVU®, also known as NER1006,-Related Presentations
- Neal Osborn. "Safety of 1 L
Polyethylene Glycol-Based Bowel Preparation, NER1006, for Colon
Cleansing Before Colonoscopy: A Pooled Analysis of Three Phase 3
Randomized Controlled Trials." Poster #P1249; Monday, October 8, 10:30
a.m. – 4:15 p.m.; Exhibit
Halls DE (level 200)
- Cesare Hassan. "Impact of
Cleansing Quality Using the Boston Bowel Preparation Scale on Polyp
and Adenoma Detection Rates: A Post Hoc Analysis of Three Phase 3
Randomized Trials." Poster #P1120; Monday, October 8, 10:30
a.m. – 4:15 p.m.; Exhibit
Halls DE (level 200)
Salix licensed the commercial
rights of PLENVU for the United
States and Canada from
Norgine B.V. in August 2016.
About XIFAXAN
XIFAXAN (rifaximin) 550 mg
tablets are indicated for the treatment of irritable bowel syndrome
with diarrhea (IBS-D) in adults and for the reduction in risk of
overt hepatic encephalopathy (HE) recurrence in adults.
IMPORTANT SAFETY INFORMATION
- XIFAXAN is contraindicated in patients with a hypersensitivity
to rifaximin, rifamycin antimicrobial agents, or any of the
components in XIFAXAN. Hypersensitivity reactions have included
exfoliative dermatitis, angioneurotic edema, and anaphylaxis.
- Clostridium difficile-associated diarrhea (CDAD) has
been reported with use of nearly all antibacterial agents,
including XIFAXAN, and may range in severity from mild diarrhea to
fatal colitis. If CDAD is suspected or confirmed, ongoing
antibiotic use not directed against C. difficile may need to
be discontinued.
- There is an increased systemic exposure in patients with severe
(Child-Pugh Class C) hepatic impairment. Caution should be
exercised when administering XIFAXAN to these patients.
- Caution should be exercised when concomitant use of XIFAXAN and
P-glycoprotein (P-gp) and/or OATPs inhibitors is needed.
Concomitant administration of cyclosporine, an inhibitor of P-gp
and OATPs, significantly increased the systemic exposure of
rifaximin. In patients with hepatic impairment, a potential
additive effect of reduced metabolism and concomitant P-gp
inhibitors may further increase the systemic exposure to
rifaximin.
- In clinical studies, the most common adverse reactions for
XIFAXAN in IBS-D (≥2%) were nausea (3%) and ALT increased
(2%).
- In clinical studies, the most common adverse reactions for
XIFAXAN in HE (≥10%) were peripheral edema (15%), nausea (14%),
dizziness (13%), fatigue (12%), and ascities (11%).
- INR changes have been reported in patients receiving rifaximin
and warfarin concomitantly. Monitor INR and prothrombin time. Dose
adjustment of warfarin may be required.
- XIFAXAN may cause fetal harm. Advise pregnant women of the
potential risk to a fetus.
To report SUSPECTED ADVERSE REACTIONS, contact Salix
Pharmaceuticals at 1-800-321-4576.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch, or
call 1-800-FDA-1088
Please click here for full Prescribing Information.
About PLENVU
PLENVU (polyethylene glycol 3350, sodium
ascorbate, sodium sulfate, ascorbic acid, sodium chloride and
potassium chloride for oral solution) is an osmotic laxative
indicated for cleansing of the colon in preparation for colonoscopy
in adults.
IMPORTANT SAFETY INFORMATION
- PLENVU is contraindicated in patients with gastrointestinal
(GI) obstruction, bowel perforation, gastric retention, ileus,
toxic megacolon, and hypersensitivity to any of its
ingredients.
- Advise patients to hydrate adequately before, during, and after
the use of PLENVU. It is encouraged that patients drink additional
clear liquids to help avoid cases of fluid and electrolyte
abnormalities. Fluid and electrolyte disturbances can lead to
serious adverse events including cardiac arrhythmias, seizures, and
renal impairment.
- There have been rare reports of serious arrhythmias associated
with the use of ionic osmotic laxative products for bowel
preparation. These occur predominantly in patients with underlying
cardiac risk factors and electrolyte disturbances. Consider
obtaining ECGs in patients at an increased risk of serious cardiac
arrhythmias.
- Use PLENVU with caution in patients with a history of seizures
and those at an increased risk of seizures, including patients
taking medications that lower the seizure threshold, patients
withdrawing from alcohol or benzodiazepines, or patients with
hyponatremia.
- Use PLENVU with caution in patients with renal impairment or
those taking concomitant medications that affect renal function.
Advise these patients to adequately hydrate before, during, and
after the use of PLENVU and consider performing laboratory tests in
these patients.
- Do not administer PLENVU to patients with GI obstruction or
perforation. If GI obstruction or perforation is suspected, perform
appropriate diagnostic studies prior to administering PLENVU.
- Use caution in patients with severe ulcerative colitis.
- Patients with impaired gag reflex or those prone to
regurgitation or aspiration should be observed during the
administration of PLENVU.
- Use PLENVU with caution in patients with glucose-6-phosphate
dehydrogenase (G6PD) deficiency.
- Phenylalanine can be harmful to patients with phenylketonuria
(PKU). PLENVU contains phenylalanine, a component of aspartame.
Each PLENVU treatment contains 491 mg of phenylalanine.
- PLENVU contains polyethylene glycol and may cause serious
hypersensitivity reactions including anaphylaxis, angioedema, rash,
urticaria, and pruritus. Inform patients of the signs and symptoms
of anaphylaxis and instruct them to seek immediate medical care
should signs and symptoms occur.
- In clinical trials, the most common adverse reactions (>2%
of patients taking PLENVU) were nausea, vomiting, dehydration, and
abdominal pain/discomfort. Adverse reactions were similar between
the two dosing regimens.
To report SUSPECTED ADVERSE REACTIONS, contact Salix
Pharmaceuticals at 1-800-321-4576.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch, or
call 1-800-FDA-1088
Please click here for full Prescribing Information
About Norgine
Norgine is a leading European specialist
pharmaceutical company with a direct commercial presence in all
major European markets. In 2017, Norgine's total net sales were
EUR 345 million, up 17 percent.
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. For more information, please visit
www.norgine.com
In 2012, Norgine established a complementary business Norgine
Ventures, supporting innovative healthcare companies through the
provision of debt-like financing in Europe and the US. For more information,
please visit www.norgineventures.com. NORGINE and the sail logo are
trademarks of the Norgine group of companies. PLENVU is a trademark
of the Norgine group of companies.
About Salix
Salix 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
health care providers with life-changing solutions for many chronic
and debilitating conditions. Salix
currently markets its product line to U.S. health care providers
through an expanded sales force that focuses on gastroenterology,
hepatology, pain specialists, and primary care. Salix is headquartered in Bridgewater, New Jersey.
About Bausch Health
Bausch Health Companies Inc.
(NYSE/TSX: BHC) is a global company whose mission is to improve
people's lives with our health care products. We develop,
manufacture and market a range of pharmaceutical, medical device
and over-the-counter products, primarily in the therapeutic areas
of eye health, gastroenterology and dermatology. We are delivering
on our commitments as we build an innovative company dedicated to
advancing global health. More information can be found at
www.bauschhealth.com.
Forward-looking Statements
This news 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 Bausch
Health's most recent annual or quarterly report and detailed from
time to time in Bausch Health's other filings with the Securities
and Exchange Commission and the Canadian Securities Administrators,
which factors are incorporated herein by reference. In addition,
certain material factors and assumptions have been applied in
making these forward-looking statements, including that the risks
and uncertainties outlined above will not cause actual results or
events to differ materially from those described in these
forward-looking statements. Bausch Health believes that the
material factors and assumptions reflected in these forward-looking
statements are reasonable, but 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. Bausch
Health and Salix undertake no
obligation to update any of these forward-looking statements to
reflect events or circumstances after the date of this news release
or to reflect actual outcomes, unless required by law.
The XIFAXAN product and the XIFAXAN trademark are licensed by
Alfasigma S.P.A. to Salix Pharmaceuticals or its affiliates. PLENVU
is a trademark of the Norgine group of companies.
SAL.0098.USA.18
Investor
Contact:
|
Media
Contacts:
|
Arthur
Shannon
|
Lainie
Keller
|
arthur.shannon@bauschhealth.com
|
lainie.keller@bauschhealth.com
|
(514)
856-3855
|
(908)
927-0617
|
(877) 281-6642 (toll
free)
|
|
|
Karen Paff
|
|
Karen.Paff@salix.com
|
|
(908)-927-1190
|
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