Allergan plc and Ironwood Pharmaceuticals, Inc. have announced that Allergan has acquired rights to Constella (linaclotide) in the European Union, Switzerland, Turkey and the Commonwealth of Independent States from Almirall, S.A. and has also reacquired rights to Linzess (linaclotide) in Mexico from Almirall.
Companies stated that under the terms of the agreement, Allergan acquired an exclusive license for Constella in these countries. The license agreement includes the development and commercialization of Constella for the treatment of irritable bowel syndrome with constipation (IBS-C), chronic idiopathic constipation (CIC) and other gastrointestinal (GI) conditions. Constella is currently approved by the European Commission for the symptomatic treatment of moderate-to-severe IBS-C in adults.
“The acquisition of rights for Constella in these international markets is the next step towards our goal of becoming an even stronger partner for physicians globally seeking innovative therapies for their patients suffering from gastrointestinal disorders,” said Paul Navarre, EVP and President of International Brands at Allergan.
“This agreement allows us to add Constella to our existing GI portfolio in select countries internationally and paves the way for future GI treatments in our own pipeline.”
“Constella is the only prescription product approved for IBS-C patients in Europe, providing them with a treatment option that can improve symptoms such as abdominal pain, bloating and constipation which are associated with this disorder,” said Tom McCourt, Chief Commercial Officer of Ironwood.
“With Allergan’s strong global commercial presence, including experience in Europe commercializing both specialty and primary care brands, we look forward to their efforts to bring Constella to adult IBS-C patients internationally.”
Companies remarked that Linaclotide was approved in 2012 by the European Commission and, until assumed by Allergan under the announced transaction, was marketed in a number of European countries under the brand name Constella through a license agreement between Ironwood and Almirall. Linaclotide was approved in 2014 in Mexico as a treatment for adults suffering from IBS-C or CIC under the brand name Linzess and was marketed by Almirall through a sublicense from Allergan. Allergan and Ironwood co-develop and co-commercialize linaclotide under the brand name Linzess in the U.S. and Allergan is commercializing linaclotide in Canada under the brand name Constella.
Allergan About Linaclotide
Linaclotide is a guanylate cyclase-C receptor agonist (GCCA) with visceral analgesic and secretory activities. Linaclotide is a 14-amino acid synthetic peptide structurally related to the endogenous guanylin peptide family. Both linaclotide and its active metabolite bind to the guanylate cyclase-C receptor, on the luminal surface of the intestinal epithelium. Through its action at GC-C, linaclotide has been shown to reduce visceral pain and increase GI transit in animal models and increase colonic transit in humans. Activation of GC-C results in an increase in concentrations of cyclic guanosine monophosphate (cGMP), both extracellularly and intracellularly. Extracellular cGMP decreases pain-fiber activity, resulting in reduced visceral pain in animal models. Intracellular cGMP causes secretion of chloride and bicarbonate into the intestinal lumen, through activation of the cystic fibrosis transmembrane conductance regulator (CFTR), which results in increased intestinal fluid and accelerated transit. Linaclotide was discovered by scientists at Ironwood.