Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) and Allergan plc
(NYSE: AGN) announced today that the companies have reached an
agreement with Sandoz Inc. (Sandoz) resolving patent litigation
brought in response to Sandoz’s abbreviated new drug application
(ANDA) seeking approval to market generic versions of LINZESS
(linaclotide) prior to the expiration of the companies’ applicable
patents. The settlement with Sandoz is the fourth patent
infringement settlement the companies have reached with respect to
LINZESS.
Pursuant to the terms of the settlement, Ironwood and Allergan
will grant Sandoz a license to market its 145 mcg and 290 mcg
generic version of LINZESS in the United States beginning February
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, the ongoing Hatch-Waxman
litigation between the companies and Sandoz regarding LINZESS
patents pending in the U.S. District Court for the District of
Delaware 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 litigation brought by the companies against
Teva Pharmaceuticals USA, Inc. and affiliates, which 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. However, the trial that was scheduled to
begin on January 7, 2020 has been postponed to enable the parties
to continue settlement negotiations.
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). In Europe, Allergan markets
linaclotide under the brand name CONSTELLA® for the treatment of
adults with moderate to severe IBS-C. Ironwood's partner Astellas
markets linaclotide under the brand name LINZESS for the treatment
of adults with IBS-C in Japan, and its partner AstraZeneca markets
linaclotide under the brand name LINZESS for the treatment of
adults with IBS-C in China (including Hong Kong and Macau).
Ironwood is partnered with Allergan for the development and
commercialization of linaclotide in all other territories
worldwide.
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (Nasdaq: IRWD) is a GI-focused
healthcare company dedicated to creating medicines that make a
difference for patients living with GI diseases. 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).
We are also advancing two late-stage, first-in-category GI
product candidates: IW-3718 is a gastric retentive formulation of a
bile acid sequestrant being developed for the potential treatment
of persistent gastroesophageal reflux disease, and MD-7246 is a
delayed-release formulation of linaclotide that is being evaluated
as an oral, intestinal, non-opioid, pain-relieving agent for
patients suffering from abdominal pain associated certain GI
diseases.
Ironwood was founded in 1998 and is headquartered in Boston,
Mass. For more information, please visit our website at
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 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 Sandoz 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 the Sandoz 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; and settlement negotiations with Teva and the
pursuit thereof. 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 patents for linaclotide may
not provide adequate protection from competition 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 ANDA filers enter the market earlier than
February 5, 2030, including due to other potential settlements; the
risk that the trial is postponed longer than expected; 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, 2019,
Allergan's Annual Report on Form 10-K for the year ended December
31, 2018 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: https://www.businesswire.com/news/home/20200106005346/en/
Lisa Brown Allergan Global Corporate Media Relations
862-289-3072
Meredith Kaya Ironwood Investor and Media Relations 617-374-5082
mkaya@ironwoodpharma.com
Fran DeSena Allergan U.S. Product Relations 201-427-8762
Manisha Narasimhan, Ph.D. Allergan Investor Relations
862-261-7162
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