LAVAL, Quebec, Oct. 31, 2019 /CNW/ -- Bausch Health Companies
Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company") and its
gastroenterology business, Salix Pharmaceuticals, ("Salix"), one of
the largest specialty pharmaceutical companies in the world
committed to the prevention and treatment of gastrointestinal
diseases, announced that the U.S. Patent and Trademark Office has
issued an additional patent covering the use of XIFAXAN®
(rifaximin) 550 mg tablets to treat symptoms of Irritable
Bowel Syndrome (IBS). The patent issued is United States Patent No.
10,456,384, entitled "Methods for Treating Irritable Bowel Syndrome
(IBS)." Final expiry of the new patent covering IBS is in
February 2029.
"We have always been confident in the strength of the XIFAXAN
patents, and the addition of this new patent specific to the
treatment of IBS further strengthens our XIFAXAN intellectual
property," said Joseph C. Papa,
chairman and CEO, Bausch Health. "We
will continue to vigorously defend our intellectual property."
XIFAXAN is now protected by 23 patents covering the composition
of matter and the use of XIFAXAN listed in the FDA's Approved Drug
Products with Therapeutic Equivalence Evaluations, or the Orange
Book.
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 Salix
Salix Pharmaceuticals is one of the
largest specialty pharmaceutical companies in the world committed
to the prevention and treatment of gastrointestinal diseases. For
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, N.J.
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
Company's most recent annual or quarterly report and detailed from
time to time in the Company'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. The Company 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 undertakes 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.
Investor
Contact:
|
Media
Contact:
|
Arthur
Shannon
|
Lainie
Keller
|
arthur.shannon@bauschhealth.com
|
lainie.keller@bauschhealth.com
|
(514)
856-3855
|
(908)
927-1198
|
(877) 281-6642 (toll
free)
|
|
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SOURCE Bausch Health Companies Inc.