CAMBRIDGE, Mass. & DUBLIN--(BUSINESS WIRE)--
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
"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
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.
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
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.
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
View source version on businesswire.com: http://www.businesswire.com/news/home/20180116005684/en/
Allergan Global Corporate Media Relations
Mark Marmur, 862-261-7558
US Product Relations
Fran DeSena, 201-427-8762
Daphne Karydas, 862-261-7558
Investor and Media Relations
Meredith Kaya, 617-374-5082
Source: Ironwood Pharmaceuticals, Inc.
News Provided by Acquire Media