Sucampo Extends Global Rights To Takeda For Amitiza, Constipation Treatment
By Cyndi Root
Sucampo Pharmaceuticals has extended further Amitiza (lubiprostone) development and marketing rights to Takeda. Sucampo announced the licensing agreement in a press release, stating that, in addition to the rights that Takeda currently holds in the U.S. and Canada, Takeda now has exclusive rights to the chloride channel activator in all global markets, except Japan and the People's Republic of China. Peter Greenleaf, CEO of Sucampo, said, "We are confident that with the combination of their extensive experience with Amitiza and proven global infrastructure, that Takeda will build the brand in new global markets as they have done in the U.S., where Amitiza continues to grow steadily."
Sucampo, Takeda Agreement
The agreement between Sucampo and Takeda calls for Takeda to conduct development activities and fund the efforts entirely, except for $6 million, which Sucampo will supply initially. Takeda will become the marketing authorization holder of record and be responsible for regulatory activities and costs. Takeda will make an upfront payment of $14 million to Sucampo and confer an additional $35 million in milestone payments. Sucampo will supply Takeda the product at an agreed-upon supply price.
Amitiza
Amitiza (lubiprostone) is a locally-acting chloride channel activator. The Food and Drug Administration (FDA) first approved it in 2006 and it is currently approved for chronic idiopathic constipation (CIC) in adults, opioid-induced constipation (OIC) in adults with chronic, non-cancer pain, and irritable bowel syndrome with constipation (IBS-C) in women 18 years of age and older.
About Sucampo Pharmaceuticals
Sucampo Pharmaceuticals is headquartered in Bethesda, MD and has operations in Japan, Switzerland, and the United Kingdom. Sucampo markets two products, Amitiza and Rescula (a treatment to lower intraocular pressure), licensed from R-Tech Ueno. On October 10, 2014, Sucampo announced the resolution of patent litigation related to Amitiza. Sucampo, R-Tech Ueno, and Takeda settled with Anchen Pharmaceuticals and Par Pharmaceutical, granting Par a non-exclusive license to market Par’s generic version of lubiprostone in the U.S. beginning January 1, 2021, and requiring a split of the sales proceeds with Sucampo. All the entities have agreed to dismiss the patent litigation filed in the United States District Court for the District of Delaware, meaning that the action is final and the parties may not file the same or similar claim.