AstraZeneca is paying Ironwood Pharmaceuticals $25 million up front as part of an agreement to co-develop and co-commercialize the latter’s constipation and irritable bowel syndrome (IBS) drug linaclotide in China. In May Ironwood filed a clinical trial application with the Chinese regulatory authority to enable it to start a Phase III study evaluating linaclotide in adult patients suffering from irritable bowel syndrome with constipation (IBS-C). FDA approved the guanylate cyclase-C (GC-C) agonist for the treatment of chronic idiopathic constipation and IBS-C in adults back in August.
Under terms of the latest deal, AstraZeneca will share the net profits and losses associated with linaclotide in China, with AstraZeneca taking 55% of each until a certain specified milestone is achieved, after which a 50/50 split will be established. Ironwood could be eligible for up to $125 million in additional commercial milestone payments dependent on the achievement of specified sales targets.
“China is one of the fastest-growing prescription medicines markets in the world, and linaclotide represents a valuable opportunity to meet the needs of local patients by providing an innovative new treatment option,” comments Mark Mallon, regional vp for Asia Pacific, and president, AstraZeneca China. “We are pleased to be partnering with Ironwood for linaclotide in China, which capitalizes on our leadership in the gastrointestinal sector in the emerging markets.”
In parallel with the linaclotide agreement, the two firms also inked an agreement through which Ironwood’s sales force will promote AstraZeneca’s Nexium® (esomeprazole magnesium) in the U.S. They say the arrangement will enhance AstraZeneca’s existing reach to gastroenterologists and primary care physicians, and provide Ironwood with an opportunity to increase its presence to gastrointestinal physicians in the U.S.