– Settlement with Teva represents final outstanding LINZESS patent litigation –
– The earliest licensed entry of any generic linaclotide 145 mcg or 290 mcg in the U.S. is March 2029 –
Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) and Allergan plc (NYSE: AGN) announced today that the companies have reached an agreement with Teva Pharmaceuticals, USA (Teva) resolving patent litigation brought in response to Teva’s abbreviated new drug application (ANDA) seeking approval to market generic versions of 145 mcg and 290 mcg LINZESS (linaclotide) prior to the expiration of the companies’ applicable patents. This settlement with Teva is the last of the remaining defendants in this patent infringement litigation with respect to LINZESS. This settlement does not grant any license to Teva with regard to its 72 mcg generic version of LINZESS.
Pursuant to the terms of the settlement, Ironwood and Allergan will grant Teva a license to market its 145 mcg and 290 mcg generic version of LINZESS in the United States beginning March 31, 2029 (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 Teva regarding LINZESS patents pending in the U.S. District Court for the District of Delaware was dismissed. Additional details regarding the settlement were not disclosed.
"This latest ANDA settlement with Teva reinforces our belief in the strength of the LINZESS intellectual property, having preserved the majority of LINZESS patent coverage for the 145 mcg and 290 mcg dosage forms," stated Mark Mallon, Chief Executive Officer of Ironwood Pharmaceuticals. "LINZESS is an important treatment option for the millions of Americans living with IBS-C or CIC and we look forward to working with our partner to continue 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 for review.
Previously, upon the parties’ request, the District of Delaware dismissed without prejudice the pending patent infringement litigations relating only to Teva’s 72 mcg generic version of LINZESS. Ironwood and Allergan had asserted patents against Teva’s 72 mcg ANDA, the last of which expires in 2026, subject to possible pediatric extension. Prior to this dismissal, Teva stipulated to infringement of certain claims of those patents. Ironwood and Allergan are also pursuing additional patent applications covering formulations related to the LINZESS 72 mcg dosage strength.
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.
LINZESS Important Safety Information
INDICATIONS AND USAGE
LINZESS (linaclotide) is indicated in adults for the treatment of both irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC).
IMPORTANT SAFETY INFORMATION
WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS
LINZESS is contraindicated in patients less than 6 years of age. In nonclinical studies in neonatal mice, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths due to dehydration. Use of LINZESS should be avoided in patients 6 years to less than 18 years of age. The safety and effectiveness of LINZESS have not been established in patients less than 18 years of age.
- LINZESS is contraindicated in patients less than 6 years of age due to the risk of serious dehydration.
- LINZESS is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.
Warnings and Precautions
- LINZESS is contraindicated in patients less than 6 years of age. The safety and effectiveness of LINZESS in patients less than 18 years of age have not been established. In neonatal mice, linaclotide increased fluid secretion as a consequence of GC-C agonism resulting in mortality within the first 24 hours due to dehydration. Due to increased intestinal expression of GC-C, patients less than 6 years of age may be more likely than patients 6 years of age and older to develop severe diarrhea and its potentially serious consequences.
- Use of LINZESS should be avoided in pediatric patients 6 years to less than 18 years of age. Although there were no deaths in older juvenile mice, given the deaths in young juvenile mice and the lack of clinical safety and efficacy data in pediatric patients, use of LINZESS should be avoided in pediatric patients 6 years to less than 18 years of age.
- Diarrhea was the most common adverse reaction in LINZESS-treated patients in the pooled IBS-C and CIC double-blind placebo-controlled trials. The incidence of diarrhea was similar in the IBS-C and CIC populations. Severe diarrhea was reported in 2% of 145 mcg and 290 mcg LINZESS-treated patients, and in <1% of 72 mcg LINZESS-treated CIC patients. If severe diarrhea occurs, dosing should be suspended and the patient rehydrated.
Common Adverse Reactions (incidence ≥2% and greater than placebo)
- In IBS-C clinical trials: diarrhea (20% vs 3% placebo), abdominal pain (7% vs 5%), flatulence (4% vs 2%), headache (4% vs 3%), viral gastroenteritis (3% vs 1%) and abdominal distension (2% vs 1%).
- In CIC trials of a 145 mcg dose: diarrhea (16% vs 5% placebo), abdominal pain (7% vs 6%), flatulence (6% vs 5%), upper respiratory tract infection (5% vs 4%), sinusitis (3% vs 2%) and abdominal distension (3% vs 2%). In a CIC trial of a 72 mcg dose: diarrhea (19% vs 7% placebo) and abdominal distension (2% vs <1%).
Please see full Prescribing Information including Boxed Warning: http://www.allergan.com/assets/pdf/linzess_pi
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 Teva and all related settlement terms, including the date of generic entry and the potential for earlier generic entry under certain limited circumstances; the strength of the LINZESS intellectual property; the preservation of the majority of LINZESS patent coverage for the 145 mcg and 290 mcg dosage forms; the market for LINZESS and our growth of the LINZESS franchise and the timing and duration thereof; the expected period of patent exclusivity, durability and life of the linaclotide patent portfolio, including possible exclusivities or pediatric or other extensions; our pursuit of additional patent applications covering formulations relating to the LINZESS 72 mcg dosage strength; 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 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 may never get additional patent protection for linaclotide, including with respect to the LINZESS 72 mcg dosage strength, and ANDA filers enter the market as early as 2026; the risk that additional ANDAs with respect to LINZESS are filed or that competitors otherwise seek to market a generic linaclotide or other competitive product before the expiration of the applicable patents; the risk that we are party to other linaclotide ANDA litigation; the risk that we lose, or settle on less favorable terms, other linaclotide ANDA litigation, or that ANDA filers enter the market earlier than March 31, 2029, including due to 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, 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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