Ironwood and Allergan Enter Agreement to Co-Promote VIBERZI for Irritable Bowel Syndrome with Diarrhea (IBS-D) in the U.S.

Ironwood Pharmaceuticals, Inc. IRWD announced today an agreement with Allergan plc for the U.S. co-promotion of VIBERZI™ (eluxadoline), Allergan's new treatment for adults suffering from irritable bowel syndrome with diarrhea (IBS-D). This arrangement is separate from and complementary to the companies' ongoing co-development and co-commercialization of LINZESS® (linaclotide) for the treatment of adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC). "This collaboration enables Ironwood and Allergan to work together to bring forward two innovative medicines demonstrated to improve the abdominal pain and bowel dysfunction that define IBS-C and IBS-D, two types of IBS that impact nearly 30 million adult Americans," said Bill Meury, executive vice president of commercial, North American brands for Allergan. "Allergan and Ironwood have an established and successful partnership co-promoting LINZESS in the U.S. market, and we have demonstrated the strength of our combined commercial teams in accessing and educating both gastroenterologists and primary care physicians." "The VIBERZI co-promotion agreement is a natural extension of Ironwood's focus on bringing innovative solutions to patients suffering from functional gastrointestinal disorders, and particularly disorders characterized by abdominal pain," said Tom McCourt, chief commercial officer of Ironwood. "We believe our promotion of VIBERZI will drive value for Ironwood and reinforce our market leadership position in this category. The co-promote requires no additional Ironwood investment and is synergistic with our existing commercial efforts for LINZESS and Cologuard®, further strengthening our commercial capabilities as we prepare to market additional gastrointestinal and primary care products." Under the terms of the agreement, Ironwood's clinical sales specialists will detail VIBERZI to the approximately 25,000 health care practitioners to whom they currently detail LINZESS and Cologuard. LINZESS will remain the first-position product for the Ironwood sales team. Ironwood's promotional efforts will be compensated based on the volume of calls delivered by Ironwood's sales force, as well as agreed upon performance metrics. Allergan will be responsible for all other costs relating to the commercialization of VIBERZI. The co-promotion will begin as soon as VIBERZI is commercially available. About VIBERZI (eluxadoline) VIBERZI (eluxadoline) is an orally active compound indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in men and women. VIBERZI has mixed opioid receptor activity, it is a mu receptor agonist, a delta receptor antagonist, and a kappa receptor agonist. Efficacy was established in two Phase III clinical studies, demonstrating significant superiority over placebo on the composite endpoint of simultaneous improvement in both abdominal pain and diarrhea at both 75 mg and 100 mg twice daily doses. The primary efficacy responder endpoint was evaluated over the duration of double-blind, placebo-controlled treatment. Response rates were compared based on patients who met the daily composite response criteria (improvement in both abdominal pain and stool consistency on the same day) for at least 50% of the days from weeks 1 to 12 (FDA endpoint) and weeks 1 to 26 (European Medicines Agency endpoint). The most common adverse events in the two Phase III clinical trials were constipation (7% and 8% for eluxadoline 75 mg and 100 mg; 2% for placebo) and nausea (8% and 7% for eluxadoline 75 mg and 100 mg; 5% for placebo). Rates of severe constipation were less than 1% in patients receiving 75 mg and 100 mg eluxadoline. Rates of discontinuation due to constipation were low for both eluxadoline and placebo (≤2%) and similar rates of constipation occurred between the active and placebo arms beyond 3 months of treatment. A total of 2,426 subjects were enrolled across the two studies. The Food and Drug Administration (FDA) has recommended that VIBERZI be classified as a controlled substance. This recommendation has been submitted to the U.S. Drug Enforcement Administration. Once VIBERZI receives final scheduling designation, the updated label will be available. For more information including full prescribing information about VIBERZI see www.actavis.com/Actavis.