AstraZeneca and Ironwood Pharmaceuticals, Inc. announced an agreement to develop and commercialize Ironwood’s linaclotide constipation drug in China. Linaclotide was approved by the US Food and Drug Administration, in August. AstraZeneca is aggressively seeking ways to fill its drug pipeline as blockbuster products go off patent.
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 drug in adult patients suffering from irritable bowel syndrome with constipation. The condition is characterized by symptoms of abdominal pain and constipation, is a chronic and widespread disorder with few treatments in China.
AstraZeneca and Ironwood are jointly responsible for strategic oversight of the development and commercialization of linaclotide in China. AstraZeneca will have primary responsibility for the local operations in that nation.
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. The arrangement would move 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.
In addition, the companies also announced their agreement calling for Ironwood’s sales force of 160 l sales specialists to promote AstraZeneca’s Nexium heartburn drug in the U.S.
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.
“A large percentage of adult patients who have IBS‐C or who have chronic idiopathic constipation, may also suffer from gastroesophageal reflux disease,” said Thomas McCourt, senior vice president, marketing and sales at Ironwood. “This agreement provides our experienced clinical sales specialists with the opportunity to bring two different and effective therapies to physicians for managing their patients who have these prevalent and troublesome gastrointestinal disorders.”
Linaclotide is taken in capsule form once daily and according to Ironwood aids in frequency of bowel movements and decreases activity in nerves that can cause pain.
Ironwood is based near Boston. AstraZeneca is headquartered in London and has administrative and manufacturing operations in northern Delaware.
