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July 22, 2014
15:12 EDTSCMPSucampo says FDA approves addition of Nitto Medic as Rescula production site
Sucampo Pharmaceuticals disclosed in a regulatory filing that on July 15 the company received an approval letter from the FDA to its prior approval supplement in response to FDAs review of the revised Drug Master File of R-Tech Ueno. The approval provides for the addition of Nitto Medic of Toyama, Japan as a new production site for Rescula 0.15%. "The company has adequate supply of RESCULA to be able to supply the U.S. market into the first quarter of 2015," Sucampo added.
News For SCMP From The Last 14 Days
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May 20, 2015
09:13 EDTSCMPSucampo expects approvals for AMITIZA in additional European markets in 1H15
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09:08 EDTSCMPSucampo backs FY15 EPS 55c-65c, consensus 63c
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07:21 EDTSCMPUBS to hold a conference
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May 11, 2015
16:34 EDTSCMPSucampo enters into licensing agreement with Harbin Gloria Pharmaceuticals
Sucampo announced that it entered into an exclusive license, development, commercialization and supply agreement with Harbin Gloria Pharmaceuticals for AMITIZA 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, or CFDA. Under the terms of the agreement, Sucampo will receive an upfront payment of $1.5M and a milestone payment from Gloria. The upfront payment will consist of $1M 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. 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.

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