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March 14, 2014
17:33 EDTSCMP, TKPYYSucampo, Takeda say that Amitiza NDA will not be filed in second half of 2014
Sucampo Pharma Americas, a wholly owned subsidiary of Sucampo Pharmaceuticals (SCMP), and its development and commercialization partner's subsidiary Takeda Pharmaceuticals (TKPYY) announced that the New Drug Application, NDA, for the liquid formulation of Amitiza will not be filed in the second half of 2014. In preliminary pre-NDA meeting comments, the FDA informed Sucampo that it would require additional data to characterize pharmacokinetics of the new formulation. As a result of this outcome in conjunction with the FDA feedback, Sucampo and Takeda are now assessing next steps, which may include formulation modification.
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August 21, 2014
16:40 EDTSCMPSucampo announces exclusive manufacturing, supply agreement for Lubiprostone
Sucampo Pharmaceuticals (SCMP) announced that its subsidiary, Sucampo AG, has signed an exclusive global manufacturing and supply agreement, or EMSA, with its manufacturing and development partner, R-Tech Ueno, for clinical and commercial supplies of AMITIZA, or lubiprostone, in most global markets. Under the new EMSA, Sucampo receives a new, lower price for certain components of or finished product of lubiprostone globally, except for the U.S. and Canada until the collaboration and license agreement with Takeda Pharmaceutical Company (TKPYY), expires in December 31, 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 January 1.

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