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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.
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.
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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Allergan Global Corporate Media Relations
Ironwood Investor and Media Relations
Allergan U.S. Product Relations
Manisha Narasimhan, Ph.D.
Allergan Investor Relations