Companies Announce Resolution of Outstanding
Arbitration
BRIDGEWATER, N.J., Oct. 29, 2018 /CNW/ -- Salix Pharmaceuticals,
Inc. ("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. (NYSE/TSX: BHC) ("Bausch Health"), announced
it has entered into an amendment to its existing license agreement
with Alfasigma S.p.A. ("Alfasigma") to initiate a late-stage
clinical program to study an investigational formulation of
rifaximin in patients with postoperative Crohn's disease, an area
of unmet medical need. Additionally, the companies have agreed to
resolve the outstanding arbitration regarding another development
project for a formulation of rifaximin.
According to the Crohn's & Colitis Foundation, more than
750,000 Americans have Crohn's disease, and of those, up to 75
percent will eventually require surgery. Surgery in Crohn's disease
is not curative, and postoperative recurrence frequently
occurs.1
"Today, there are no approved treatments in the United States for the prevention of
postoperative Crohn's disease recurrence. Based on existing
clinical data, we believe rifaximin may be a potential treatment
solution to help postoperative patients manage their Crohn's
disease," said Mark McKenna,
president of Salix Pharmaceuticals. "The amended agreement with
Alfasigma allows us to start working together on a clinical
research program that could lead to a new option in the treatment
paradigm for postoperative Crohn's disease patients."
The new formulation of rifaximin, called Extended Intestinal
Release (EIR), will be used in the late-stage clinical research
program. In 2012, a European clinical Phase 2 study in 402 patients
with moderately active Crohn's disease was performed to assess the
efficacy and safety of multiple doses of rifaximin-EIR. The Phase 2
trial demonstrated that administration of rifaximin-EIR twice daily
for 12 weeks induced remission with few adverse events in patients
with moderately active Crohn's disease.2
"I am very happy regarding this agreement with Salix as it
re-energizes our long-term partnership, one that has played a
critical role in the success of XIFAXAN® (rifaximin) in
the United States," commented
Anton Giorgio Failla, executive
director of Corporate Development, Alfasigma. "We look forward to
dedicating our efforts to develop a new generation of rifaximin
that may improve patients' lives and address a significant unmet
medical need."
Resolution of the Arbitration
The companies have
agreed to resolve the outstanding arbitration regarding performance
under an Amended and Restated License Agreement between Alfasigma
and Salix concerning another development project for a new
formulation of rifaximin. As a result of the resolution, all claims
related to the arbitration will be released.
About XIFAXAN
XIFAXAN® (rifaximin) 550 mg
tablets are indicated for the reduction in risk of overt hepatic
encephalopathy (HE) recurrence in adults and for the treatment of
irritable bowel syndrome with diarrhea (IBS-D) 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 (Pgp) 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 were: o HE (≥10%): Peripheral edema (15%), nausea (14%),
dizziness (13%), fatigue (12%), and ascites(11%) o IBS-D (≥2%):
Nausea (3%), ALT increased (2%).
- 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 Alfasigma
Alfasigma, is
an Italy-based integrated multinational pharmaceutical company
with 2017 revenues in excess of €1 billion and 2,800 employees
globally. Outside of its core Italian market, Alfasigma has 16
subsidiaries in Europe, Asia, North and Central
America and Africa, and has authorised distributors in
more than 70 countries. More than 44% of Alfasigma turnover comes
from internally developed proprietary products, one of which is
XIFAXAN.
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.
References
- Crohn's & Colitis Foundation (2014) The Facts About
Inflammatory Bowel Diseases.
http://www.crohnscolitisfoundation.org/assets/pdfs/updatedibdfactbook.pdf.
Accessed October 24, 2018.
- Gastroenterology (2011) Rifaximin-Extended Intestinal Release
Induces Remission in Patients With Moderately Active Crohn's
Disease.
https://www.gastrojournal.org/article/S0016-5085(11)01628-3/fulltext
Accessed October 24, 2018.
XIF.0196.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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SOURCE Bausch Health Companies Inc.