CAMBRIDGE, Mass. & DUBLIN--(BUSINESS WIRE)--
Pharmaceuticals, Inc. (NASDAQ: IRWD) and Allergan
plc (NYSE: AGN) announced today that the companies have reached an
agreement with Aurobindo Pharma Ltd., resolving patent litigation
brought in response to Aurobindo 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. The settlement with Aurobindo is the second patent
infringement settlement the companies have reached with respect to
Pursuant to the terms of the settlement, Ironwood and Allergan will
grant Aurobindo Pharma a license to market a generic version of LINZESS
in the United States beginning on August 5, 2030 (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 ongoing Hatch-Waxman litigation between the companies
and Aurobindo Pharma regarding LINZESS patents will be dismissed.
Additional details regarding the settlement were not disclosed.
"LINZESS is the leading branded treatment prescribed in the U.S. for
adult sufferers of irritable bowel syndrome with constipation or chronic
idiopathic constipation, with more than 10 million prescriptions
filled," said Bill Meury, Executive Vice President and Chief Commercial
Officer, Allergan. "We are pleased to have resolved the patent
litigation with Aurobindo Pharma. Allergan and Ironwood continue to
invest in the LINZESS franchise and to be confident in the product's
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 2 million unique patients in the United States
having filled approximately 10 million linaclotide prescriptions since
launch, according to IQVIA. 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 leader. 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.
Allergan's success is powered by our 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.
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 Aurobindo 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
Aurobindo 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 confidence in the product's market leadership and strength of its
growth trajectory. 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
August 5, 2030, 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 Annual Report on Form
10-K for the year ended December 31, 2017, Allergan's Annual Report on
Form 10-K for the year ended December 31, 2017 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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Allergan Global Corporate Media Relations
Amy Rose, 862-289-3072
U.S. 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.
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