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news.Sucampo Pharmaceuticals announced that its subsidiary, Sucampo, has signed an exclusive global manufacturing and supply agreement (EMSA) with its manufacturing and development partner, R-Tech Ueno (R-Tech), for clinical and commercial supplies of AMITIZA (lubiprostone) in most global markets.
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Under the new EMSA, Sucampo receives a new, lower price for certain components of or finished product of lubiprostone globally, except for the United States and Canada until the collaboration and license agreement with Takeda Pharmaceutical expires in 31 December, 2020, and except for Japan until the manufacturing and supply agreement for Japan expires or certain material circumstances occur.
Additionally, under the EMSA Sucampo has the right to qualify a back-up supplier for lubiprostone in expanded circumstances, such as an authorized generic, additional formulations, and/or inability to supply product in certain circumstances, among others.
The new EMSA supersedes the current manufacturing and supply agreements with R-Tech except in those situations noted above and is effective as of 01 January 2014.
Sucampo chief executive officer Peter Greenleaf said: "Continuing the growth of AMITIZA is the top imperative I outlined earlier this month in my strategic plan for Sucampo.
"The new EMSA announced today will be critical to growing AMITIZA and facilitating our global expansion plans around the world by providing us with greater operational flexibility, lowered overall cost of goods manufactured, and greater margin control.
"As we progress our plans to partner AMITIZA globally, including Europe and emerging markets outside of the U.S. and Japan, having greater control over our cost structure will enable us to access markets with tighter reimbursement restrictions.
"Ultimately, this will make AMITIZA more widely accessible to patients around the world who may benefit from its more than eight years of experience and eight million prescriptions dispensed globally."