Date: 2015-10-27
Type of information: Product acquisition
Compound: Constella® (linaclotide)
Company: Allergan (Ireland) Almirall (Spain)
Therapeutic area: Digestive diseases - Gastrointestinal diseases - Inflammatory diseases
Type agreement: product acquisition
Action mechanism:
- peptide. Linaclotide is a guanylate cyclase-C receptor agonist (GCCA) with visceral analgesic and secretory activities. This 14-amino acid synthetic peptide is 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.
Ironwood has out-licensed linaclotide to Almirall for European development and commercialisation and to Astellas Pharma for development and commercialisation in Japan, Indonesia, Korea, the Philippines, Taiwan and Thailand. Constella® is currently approved by the European Commission for the symptomatic treatment of moderate-to-severe IBS-C in adults.
Disease: Irritable Bowel Syndrome with Constipation (IBS-C)
Details:
- • On October 27, 2015, Allergan announced that the company has acquired rights to Constella® (linaclotide) in the European Union , Switzerland , Turkey and the Commonwealth of Independent States from Almirall, and has also reacquired rights to Linzess® (linaclotide) in Mexico from Almirall . 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.
- 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® .
Financial terms:
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Is general: Yes
