Date: 2015-05-11
Type of information: Licensing agreement
Compound: Amitiza® (lubiprostone)
Company: Sucampo Pharmaceuticals (USA - MD) Harbin Gloria Pharmaceuticals (China)
Therapeutic area: Digestive diseases
Type agreement: licensing development commercialisation
Action mechanism: prostaglandin. Amitiza® (lubiprostone) 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. Amitiza® is indicated in the United States for the treatment of chronic idiopathic constipation (CIC) in adults and opioid-induced constipation (OIC) in adults with chronic, non-cancer pain (24 mcg twice daily). The effectiveness in patients with OIC taking diphenylheptane opioids (e.g., methadone) has not been established. Amitiza® is also indicated in the U.S. for irritable bowel syndrome with constipation (8 mcg twice daily) in women 18 years of age and older in the U.S. In Japan , Amitiza® (24 mcg twice daily) is indicated for the treatment of chronic constipation (excluding constipation caused by organic diseases). In the U.K. , Amitiza® (24 mcg twice daily) is indicated for the treatment of CIC and associated symptoms in adults, when response to diet and other non-pharmacological measures (e.g., educational measures, physical activity) are inappropriate. In Switzerland, Amitiza® (24 mcg twice daily) is indicated for the treatment of CIC in adults and for the treatment of OIC and associated signs and symptoms such as stool consistency, straining, constipation severity, abdominal discomfort, and abdominal bloating in adults with chronic, non-cancer pain. The efficacy of Amitiza® for the treatment of OIC in patients taking opioids of the diphenylheptane class, such as methadone, has not been established.
Disease: chronic idiopathic constipation (CIC) in adults, opioid-induced constipation (OIC) in adults with chronic, non-cancer pain
Details: * On May 11, 2015, Sucampo Pharmaceuticals announced that it entered into an exclusive license, development, commercialization and supply agreement with Harbin Gloria Pharmaceuticals for Amitiza® (lubiprostone) in the People\'s Republic of China. Through this agreement, Sucampo has granted Gloria the rights to develop and commercialize Amitiza® in China, subject to regulatory approval of the product by the China Food and Drug Administration (CFDA). Sucampo will be the exclusive supplier of Amitiza® to Gloria at an agreed-upon supply price. The term of this agreement is 13 years with renewal terms. Gloria will be responsible for all development activities and costs. In addition, Gloria will be responsible for all commercialization and regulatory activities in China.
Financial terms: Under the terms of the agreement, Sucampo will receive an upfront payment of $1.5 million and a milestone payment from Gloria. The upfront payment will consist of $1 million within 30 days of signing the agreement and $500,000 within 30 days of investigational new drug application approval in China. Sucampo will also be eligible for an additional milestone payment upon the occurrence of a regulatory or alternatively a commercial milestone event.
Latest news:
