Salix Will Maintain Market Exclusivity for XIFAXAN®
(rifaximin) 200 mg and 550 mg Tablets Until
20281
LAVAL, QC, Sept. 22, 2020 /CNW/ -- Bausch Health
Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company")
along with its gastroenterology business, Salix Pharmaceuticals
("Salix"), which is one of the largest specialty pharmaceutical
companies in the world committed to the prevention and treatment of
gastrointestinal diseases, together with Salix's licensor Alfasigma
SpA (collectively the "Salix Parties"), have agreed to resolve
outstanding intellectual property disputes with Sun Pharmaceutical
Industries Ltd. ("Sun") regarding XIFAXAN® (rifaximin) 200 mg and
550 mg tablets. The Salix Parties will grant Sun a non-exclusive
license effective Jan. 1, 2028 to its
intellectual property relating to XIFAXAN 200 mg and 550 mg tablets
in the United States.
In April 2019, Bausch Health filed
a lawsuit against Sun following receipt of a Notice of Paragraph IV
Certification relating to XIFXAN 200 mg tablets. Additionally,
Bausch Health received a Notice of Paragraph IV Certification from
Sun relating to XIFAXAN 550 mg tablets on Aug. 10, 2020.
"Resolving these matters with Sun is another testament to the
strength of the XIFAXAN intellectual property," said Joseph C. Papa, chairman and CEO, Bausch Health. "We will continue to defend our
intellectual property protecting XIFAXAN, and we will continue to
invest in the research and development of new indications and
formulations for rifaximin that can potentially benefit more
patients."
"Alfasigma is satisfied with the resolution," said Pier Vincenzo
Colli, CEO of Alfasigma. "In the interest of patients and
customers, our company is committed to using any efforts to protect
its intellectual property covering XIFAXAN."
Sun acknowledges the validity of the licensed patents with
respect to the two XIFAXAN products. Final patent expiry on XIFAXAN
200 mg and 550 mg tablets are July and October 2029, respectively.
Under the terms of the agreement, beginning Jan. 1, 20281 (or earlier under
certain circumstances), Sun will have the right to market
royalty-free generic versions of XIFAXAN 200 mg and 550 mg
tablets, should it receive approval from the U.S. Food and Drug
Administration (FDA) on its Abbreviated New Drug Application.
Litigation between the parties related to XIFAXAN will be
dismissed, and all intellectual Property protecting XIFAXAN remains
intact. Bausch Health and Alfasigma remain confident in the
strength of the XIFAXAN patents, and they will continue to
vigorously defend their intellectual property. XIFAXAN 200 mg and
550 mg tablets are collectively protected by 26 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.
Bausch Health agreed to resolve outstanding intellectual
property litigation with Actavis Laboratories FL, Inc. ("Actavis")
and Sandoz Inc. ("Sandoz") regarding XIFAXAN 550 mg tablets In
September 2018 and in May 2020, respectively. Under the terms of the
agreements, the Salix Parties will grant Actavis and Sandoz
non-exclusive licenses effective Jan. 1,
20282 to the Salix Parties' intellectual property
relating to XIFAXAN 550 mg tablets in the
United States.
About Alfasigma
Alfasigma, one of the leading
Italian pharmaceutical companies, is present in over 90 countries,
through distributors and subsidiaries and has a workforce of around
3,000 people, R&D laboratories, and 5 production plants. In
Italy, Alfasigma is a leader in
the market for prescription products where, in addition to the
strong focus on gastrointestinal, it is present in many primary
care therapeutic areas. Alfasigma also produces and markets
self-medication products, nutraceuticals and food supplements. More
information is available at the Alfasigma website at:
http://www.alfasigma.com/en.
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,"
"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, the risks and uncertainties discussed in Bausch
Health's most recent annual report on Form 10-K and detailed from
time to time in Bausch Health's other filings with the U.S.
Securities and Exchange Commission and the Canadian Securities
Administrators, which factors are incorporated herein by reference.
They also include, but are not limited to, risks and uncertainties
caused by or relating to the evolving COVID-19 pandemic, and the
fear of that pandemic and its potential effects, the severity,
duration and future impact of which are highly uncertain and cannot
be predicted, and which may have a material adverse impact on
Bausch Health, including but not limited to its project development
timelines, and costs (which may increase). 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.
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Sun will be able to
begin marketing the medicine earlier if another generic rifaximin
product is granted approval and starts selling or distributing such
generic rifaximin product before Jan. 1, 2028. On Feb. 17, 2020,
the Salix Parties received a Notice of Paragraph IV Certification
from Norwich Pharmaceuticals, Inc. relating to XIFAXAN tablets, 550
mg; and filed suit against Norwich on March 26, 2020, which remains
pending.
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Actavis and Sandoz
will be able to begin marketing the medicine earlier if another
generic rifaximin product is granted approval and starts selling or
distributing such generic rifaximin product before Jan. 1,
2028.
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Investor
Contact:
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Media
Contact:
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Arthur
Shannon
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Lainie
Keller
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arthur.shannon@bauschhealth.com
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lainie.keller@bauschhealth.com
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(514)
856-3855
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(908)
927-1198
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(877) 281-6642 (toll
free)
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SOURCE Bausch Health Companies Inc.