Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) and Allergan
plc (NYSE: AGN) announced today that the companies have
reached an agreement with wholly-owned subsidiaries of Sun
Pharmaceutical Industries Ltd. (Sun Pharma, including its
subsidiaries and/or associate companies), resolving patent
litigation brought in response to Sun Pharma’s abbreviated new drug
application (ANDA) seeking approval to market a generic version of
LINZESS (linaclotide) prior to the expiration of the companies’
applicable patents.
Pursuant to the terms of the settlement, Ironwood and Allergan
will grant the wholly-owned subsidiaries of Sun Pharma a license to
market a generic version of LINZESS in the United States beginning
on February 1, 2031 (subject to U.S. FDA approval), unless certain
limited circumstances, customary for settlement agreements of this
nature, occur. As a result of the settlement, all Hatch-Waxman
litigation between the companies and Sun Pharma regarding LINZESS
patents will be dismissed. Additional details regarding the
settlement were not disclosed.
“Ironwood and Allergan have established LINZESS as the branded
prescription market leader in the IBS-C and CIC category,” said Tom
McCourt, Chief Commercial Officer, Ironwood. “We are pleased to
have resolved this patent litigation with Sun Pharma, as we believe
it confirms the strength of our LINZESS intellectual property.
Allergan and Ironwood are committed to continuing to grow the
LINZESS franchise for many years to come.”
As required by law, the companies will submit the settlement
agreement to the U.S. Federal Trade Commission and the U.S.
Department of Justice for review.
Patent infringement litigations brought by the companies against
other parties who have submitted ANDAs to the U.S. FDA seeking
approval to market generic versions of LINZESS remain pending in
the U.S. District Court for the District of Delaware, where the
earliest scheduled trial date is June 17, 2019.
About Linaclotide
Linaclotide is a guanylate cyclase‐C (GC‐C) agonist that binds
to the GC-C receptor locally, within the intestinal epithelium.
Linaclotide is marketed by Ironwood and Allergan plc in the United
States as LINZESS® and is indicated for the treatment of adults
with irritable bowel syndrome with constipation (IBS-C) or chronic
idiopathic constipation (CIC), with greater than 1.5 million unique
patients in the United States having filled more than 9 million
linaclotide prescriptions since launch, according to QuintilesIMS.
In Europe, Allergan markets linaclotide under the brand name
CONSTELLA® for the treatment of adults with moderate to severe
IBS-C. In Japan, Ironwood's partner Astellas markets linaclotide
under the brand name LINZESS for the treatment of adults with
IBS-C. Ironwood also has partnered with AstraZeneca for development
and commercialization of linaclotide in China, Hong Kong and Macau,
and with Allergan for development and commercialization of
linaclotide in all other territories worldwide.
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (NASDAQ: IRWD) is a commercial
biotechnology company focused on creating medicines that make a
difference for patients, building value for our fellow
shareholders, and empowering our passionate team. We are
commercializing two innovative primary care products: linaclotide,
the U.S. branded prescription market leader for adults with
irritable bowel syndrome with constipation (IBS-C) or chronic
idiopathic constipation (CIC), and lesinurad, which is approved to
be taken with a xanthine oxidase inhibitor (XOI), or as a
fixed-dose combination with allopurinol, for the treatment of
hyperuricemia associated with gout. We are also advancing a
pipeline of innovative product candidates in areas of significant
unmet need, including uncontrolled gastroesophageal reflux disease,
diabetic nephropathy, heart failure with preserved ejection
fraction, achalasia and sickle cell disease. Ironwood was founded
in 1998 and is headquartered in Cambridge, Mass. For more
information, please visit www.ironwoodpharma.com or
www.twitter.com/ironwoodpharma; information that may be important
to investors will be routinely posted in both these locations.
About Allergan plc
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a
bold, global pharmaceutical company and a leader in a new industry
model – Growth Pharma. Allergan is focused on developing,
manufacturing and commercializing branded pharmaceutical, device,
biologic, surgical and regenerative medicine products for patients
around the world.
Allergan markets a portfolio of leading brands and best-in-class
products for the central nervous system, eye care, medical
aesthetics and dermatology, gastroenterology, women's health,
urology and anti-infective therapeutic categories.
Allergan is an industry leader in Open Science, a model of
research and development, which defines our approach to identifying
and developing game-changing ideas and innovation for better
patient care. With this approach, Allergan has built one of the
broadest development pipelines in the pharmaceutical industry with
55+ mid-to-late stage pipeline programs currently in
development.
Allergan's success is powered by our more than 18,000 global
colleagues' commitment to being Bold for Life. Together, we build
bridges, power ideas, act fast and drive results for our customers
and patients around the world by always doing what is right.
With commercial operations in approximately 100 countries,
Allergan is committed to working with physicians, healthcare
providers and patients to deliver innovative and meaningful
treatments that help people around the world live longer, healthier
lives every day.
For more information, visit Allergan's website at
www.Allergan.com.
LINZESS® and CONSTELLA® are trademarks of Ironwood
Pharmaceuticals, Inc. Any other trademarks referred to in this
press release are the property of their respective owners. All
rights reserved.
Forward-Looking Statement
This press release contains forward-looking statements.
Investors are cautioned not to place undue reliance on these
forward-looking statements, including statements about the
resolution of patent litigation with Sun Pharma and all related
settlement terms, including the date of generic entry and the
potential for earlier generic entry under certain limited
circumstances; the dismissal of all Sun Pharma Hatch-Waxman
litigation regarding LINZESS; the submission of the settlement
agreement to the U.S. Federal Trade Commission and the U.S.
Department of Justice for review; the coverage, strength and extent
of the intellectual property covering LINZESS; and our commitment
to grow the linaclotide franchise in the future. Each
forward‐looking statement is subject to risks and uncertainties
that could cause actual results to differ materially from those
expressed or implied in such statement. Applicable risks and
uncertainties include those related to decisions by regulatory and
judicial authorities; competition and future business decisions
made by us, as well as our competitors or potential competitors;
the risk that we may never get sufficient patent protection for
linaclotide or that we are not able to successfully protect such
patents; the risk that we lose, or settle on less favorable terms,
other linaclotide ANDA litigation, or that other ANDA filers enter
the market earlier than February 1, 2031, as well as any other
potential settlements; developments in the intellectual property
landscape; and the risks listed under the heading "Risk Factors"
and elsewhere in Ironwood's Quarterly Report on Form 10-Q for the
quarter ended September 30, 2017, Allergan's Annual
Report on Form 10-K for the year ended December 31,
2016 and in the subsequent SEC filings of each
company. These forward-looking statements (except as otherwise
noted) speak only as of the date of this press release, and
Ironwood and Allergan undertake no obligation to update
these forward-looking statements.
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version on businesswire.com: http://www.businesswire.com/news/home/20180116005684/en/
Allergan Global Corporate Media RelationsMark Marmur,
862-261-7558orAllergan US Product RelationsFran DeSena,
201-427-8762orAllergan Investor RelationsDaphne Karydas,
862-261-7558orIronwood Investor and Media RelationsMeredith Kaya,
617-374-5082mkaya@ironwoodpharma.com
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