Allergan to Present New Data at the World Congress of Gastroenterology at ACG 2017

DUBLIN, Oct. 16, 2017 /PRNewswire/ -- Allergan plc (NYSE: AGN) today announced that new data from its gastroenterology portfolio will be featured at the World Congress of Gastroenterology (WCOG), American College of Gastroenterology (ACG), from October 13?18, 2017 in Orlando, Florida.

"Through our innovation and Open Science research and development model, our dedication to collaborations allows Allergan to continue to be on the cutting-edge in the field of gastroenterology," said David Nicholson, Ph.D., Chief Research and Development Officer, Allergan. "Our presentations at WCOG cover our two effective treatment options for Irritable Bowel Syndrome with Diarrhea (IBS-D), Irritable Bowel Syndrome with Constipation (IBS-C), and Chronic Idiopathic Constipation (CIC).We are excited to share these results with the gastroenterology community and continue to work with them to realize the full potential of our medicines."

A key presentation will include the radar plots used to display disparate global effects of eluxadoline in a large group of patients who typically experience a broad range of symptoms associated with Irritable Bowel Syndrome with Diarrhea (IBS-D) (Poster #P2029).

Three abstracts will also be presented about linaclotide:

• Poster #P2020: Safety and tolerability of linaclotide for the treatment of CIC and IBS-C: A pooled analysis of Phase 3-3b placebo-controlled trials in North America;
• Poster #P1149: Effect of linaclotide DR1, a delayed-release formulation of linaclotide, in IBS-C patients: Analysis of symptom improvement using responder radar plots;
• Poster #P301: Impact of Stool Consistency on Bowel Movement Satisfaction in IBS-C or CIC Patients Treated with Linaclotide or Other Medications: Results from the CONTOR Study.

About VIBERZI^® (Eluxadoline)

Eluxadoline is marketed by Allergan in the United States as VIBERZI^® (eluxadoline) CIV. VIBERZI^® is a twice daily, oral medication used to treat adults with irritable bowel syndrome with diarrhea (IBS-D). VIBERZI^® has mixed opioid receptor modulator activity; it is a mu- and kappa-opioid receptor agonist and a delta-opioid receptor antagonist. VIBERZI^® is thought to decrease visceral hypersensitivity and control GI motility, based on nonclinical studies. VIBERZI^® is indicated for the treatment of IBS-D in adult men and women. Please also see full Prescribing Information: https://www.allergan.com/assets/pdf/viberzi_pi.

IMPORTANT SAFETY INFORMATION

Contraindications 

VIBERZI is contraindicated in patients:

• Without a gallbladder.
• With known or suspected biliary duct obstruction, or sphincter of Oddi disease or dysfunction; a history of pancreatitis; or structural diseases of the pancreas.
• With alcoholism, alcohol abuse, alcohol addiction, or who drink more than 3 alcoholic beverages per day.
• With severe hepatic impairment.
• With a history of chronic or severe constipation or sequelae from constipation, or known or suspected mechanical gastrointestinal obstruction.

Warnings and Precautions 

Pancreatitis:

• Pancreatitis, with or without sphincter of Oddi spasm, has been reported in patients taking either the 75 mg or 100 mg dosage of VIBERZI, including serious cases resulting in hospitalization, primarily in patients without a gallbladder. Fatal cases have also been reported in patients without a gallbladder. VIBERZI is contraindicated in patients without a gallbladder. Most of the reported cases of serious pancreatitis occurred within a week of starting treatment with VIBERZI and some patients developed symptoms after one to two doses.
• In patients with a gallbladder, evaluate a patient's alcohol intake prior to starting VIBERZI. Instruct patients to avoid chronic or acute excessive alcohol use while taking VIBERZI. Monitor for new or worsening abdominal pain that may radiate to the back or shoulder, with or without nausea and vomiting. Instruct patients to immediately stop VIBERZI and seek medical attention if they experience symptoms suggestive of pancreatitis such as acute abdominal or epigastric pain radiating to the back or shoulder associated with elevations of pancreatic enzymes with or without nausea and vomiting.

Sphincter of Oddi Spasm:

• There is a risk of sphincter of Oddi spasm, resulting in pancreatitis or hepatic enzyme elevation associated with acute abdominal pain (eg, biliary-type pain) in patients taking VIBERZI. Serious adverse reactions of sphincter of Oddi spasm with or without pancreatitis resulting in hospitalization have been reported, primarily in patients without a gallbladder. Cases of serious sphincter of Oddi spasm occurred within a week of starting treatment with VIBERZI and some patients developed symptoms after one to two doses.
• Instruct patients to immediately stop VIBERZI and seek medical attention if they experience symptoms suggestive of sphincter of Oddi spasm such as acute worsening of abdominal pain that may radiate to the back or shoulder with or without nausea or vomiting, associated with elevations of pancreatic enzymes or liver transaminases. Do not restart VIBERZI in patients who developed biliary duct obstruction while taking VIBERZI.

Adverse Reactions

• The most commonly reported adverse reactions (incidence >5% and greater than placebo) were constipation, nausea, and abdominal pain.
• >5% and greater than placebo) were constipation, nausea, and abdominal pain.

About LINZESS^® (Linaclotide)

LINZESS^® (linaclotide) is indicated in adults for the treatment of both irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC). Please see full Prescribing Information: http://www.allergan.com/assets/pdf/linzess_pi. Linaclotide is a guanylate cyclase?C (GC?C) agonist. Linaclotide binds to the GC-C receptor locally, within the intestinal epithelium, and is thought to work in two ways, based on nonclinical studies. Activation of GC-C results in increased intestinal fluid secretion and accelerated transit, as well as a decrease in the activity of pain-sensing nerves in the intestine. The clinical relevance of the effect on pain fibers, which is based on nonclinical studies, has not been established. Linaclotide is marketed by Allergan plc and Ironwood Pharmaceuticals in the United States as LINZESS^®, with greater than 1.5 million unique patients in the United States having filled more than 8 million prescriptions since launch, per QuintilesIMS. 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.

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.

Contraindications

• 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

Pediatric Risk:

• 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:

• 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%).

About Allergan plc

Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical company and a leader in a new industry model ? Growth Pharma. 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 with 65+ mid-to-late stage pipeline programs currently in development.

Allergan's success is powered by our more than 18,000 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.

Forward-Looking Statement

Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan's current perspective on existing trends and information as of the date of this release. Actual results may differ materially from Allergan's current expectations depending upon a number of factors affecting Allergan's business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Annual Report on Form 10-K for the year ended December 31, 2016 and Allergan's Quarterly Report on Form 10-Q for the period ended June 30, 2017. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.

CONTACTS: Allergan:
Investors:
Daphne Karydas
(862) 261-8006

Media:
Mark Marmur
(862) 261-7558

Tara Schuh
(201) 427-8888

SOURCE Allergan plc