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news.US-based Sucampo Pharmaceuticals has entered into an exclusive license, development, commercialization and supply agreement with Harbin Gloria Pharmaceuticals for Amitiza (lubiprostone) in China.
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Amitiza is a chloride channel activator that acts locally in the small intestine to restore motility and to address the underlying pathophysiology and secondary symptoms of constipation.
Under the deal, Gloria secured rights to develop and commercialize Amitiza in China, subject to regulatory approval of the product by the China Food and Drug Administration (CFDA).
Sucampo CEO Peter Greenleaf said: "We are committed to making Amitiza available to patients worldwide, and our agreement with Gloria now enables us to access this important market.
"Current treatment options for constipation are not effective for all patients, and Gloria’s local expertise and established commercial infrastructure may provide the patient population in China with a new alternative."
The deal will see Sucampo receive an upfront payment of $1.5m and a milestone payment from Gloria, and it also be eligible for an additional milestone payment upon the occurrence of a regulatory or alternatively a commercial milestone event.
Sucampo will be the exclusive supplier of Amitiza to Gloria at an agreed-upon supply price and the term of the deal is 13 years with renewal terms.
Gloria will be responsible for all development activities, costs as well as commercialization and regulatory activities in China.
In the US, Amitiza 24mcg twice daily is indicated to treat adults with CIC and OIC with chronic, non-cancer pain, while in Japan the drug is indicated for the treatment of chronic constipation.