Date: 2012-10-23
Type of information: Development agreement
Compound: linaclotide
Company: AstraZeneca (UK) Ironwood Pharmaceuticals (China)
Therapeutic area: Gastrointestinal diseases - Digestive diseases
Type agreement: development -commercialisation - promotion
Action mechanism: peptide. Linaclotide, a first-in-class investigational drug, is an agonist of the guanylate cyclase type-C (GC-C) receptor located on the luminal surface of the intestine. In preclinical models, linaclotide reduced visceral hypersensitivity, increased fluid secretion, and accelerated intestinal transit. The effects on secretion and transit are mediated through cyclic guanosine monophosphate (cGMP), which is also believed to modulate the activity of local nerves to reduce pain. Linaclotide is an orally delivered peptide that acts locally in the gut with no measurable systemic exposure at therapeutic doses and is intended for once-daily administration. Ironwood Pharmaceuticals, Inc. and Forest Laboratories, Inc. are co-developing and, if approved, will co-promote linaclotide in the United States. Ironwood has out-licensed linaclotide to Almirall for European development and commercialisation and to Astellas Pharma Inc. for development and commercialisation in Japan, Indonesia, Korea, the Philippines, Taiwan and Thailand.
Disease: irritable bowel syndrome with constipation (IBS-C)
Details:
- AstraZeneca and Ironwood Pharmaceuticals have announced an agreement to co-develop and co-commercialise Ironwood’s linaclotide in China. In May, Ironwood filed a clinical trial application with the State Food and Drug Administration in China for a Phase III clinical trial to assess the efficacy and safety of linaclotide in adult patients suffering from irritable bowel syndrome with constipation (IBS-C).
In addition, the companies also announced their agreement that Ironwood’s sales force of approximately 160 experienced clinical sales specialists will promote AstraZeneca’s Nexium® (esomeprazole magnesium) in the US. Nexium® is a leading prescription drug currently approved to treat the symptoms of gastroesophageal reflux disease (GERD). This agreement will augment AstraZeneca’s existing interactions with gastroenterologists and primary care physicians on behalf of Nexium® and the patients who need it. It will also provide Ironwood with an opportunity to increase its presence with the key gastrointestinal physicians in the US.
Financial terms:
- Under the terms of the collaboration, AstraZeneca will make an upfront payment of $25 million to Ironwood and will share the net profits and losses associated with linaclotide in China, with AstraZeneca carrying 55 percent of each until a certain specified milestone is achieved, moving to a 50/50 split thereafter. Ironwood will also be eligible for $125 million in additional commercial milestone payments contingent on the achievement of certain sales targets.
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