CAMBRIDGE, Mass. & DUBLIN--(BUSINESS WIRE)--Jan. 2, 2019--
Ironwood
Pharmaceuticals, Inc. (NASDAQ: IRWD) and Allergan
plc (NYSE: AGN) announced today that the companies have reached an
agreement with Mylan Pharmaceuticals, Inc. (NASDAQ: MYL) resolving
patent litigations brought in response to Mylan’s abbreviated new drug
applications (ANDAs) seeking approval to market generic versions of
LINZESS (linaclotide) prior to the expiration of the companies’
applicable patents. The settlement with Mylan is the third patent
infringement settlement the companies have reached with respect to
LINZESS.
Pursuant to the terms of the settlement, Ironwood and Allergan will
grant Mylan a license to market its generic version of LINZESS 145 mcg
and 290 mcg in the United States beginning February 5, 2030, and its
generic version of LINZESS 72 mcg in the United States beginning August
5, 2030 (both 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
litigations between the companies and Mylan regarding LINZESS patents
pending in the U.S. District Court for the Northern District of West
Virginia will be dismissed. Additional details regarding the settlement
were not disclosed.
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 Allergan and Ironwood 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 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 discovered, developed and are commercializing
linaclotide, the U.S. branded prescription market leader for adults with
irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic
constipation (CIC). Our pipeline priorities for linaclotide include a
Phase IIIb trial evaluating its efficacy and safety on multiple
abdominal symptoms, including abdominal bloating, pain, and discomfort
in adult patients with IBS-C, as well as research into a formulation of
linaclotide designed to relieve pain across all IBS subtypes.
We are also advancing a pipeline of innovative product candidates in
areas of significant unmet need, including persistent gastroesophageal
reflux disease, diabetic nephropathy, heart failure with preserved
ejection fraction 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 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.
Forward-Looking Statements
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 Mylan 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 Mylan Hatch-Waxman
litigation regarding LINZESS; and the submission of the settlement
agreement to the U.S. Federal Trade Commission and the U.S. Department
of Justice for review. 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 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
Quarterly Report on Form 10-Q for the quarter ended September 30, 2018,
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190102005558/en/
Source: Ironwood Pharmaceuticals, Inc.
Amy Rose
Allergan Global Corporate Media Relations
862-289-3072
Fran DeSena
Allergan U.S. Product Relations
201-427-8762
Manisha Narasimhan, Ph.D.
Allergan Investor Relations
862-261-7162
Meredith Kaya
Ironwood Investor and Media Relations
617-374-5082
mkaya@ironwoodpharma.com