China Food and Drug Administration Accepts IND for Pivotal Study of AMITIZA

Sucampo Pharmaceuticals, Inc. (Sucampo) SCMP, a global pharmaceutical company, today announced that the China Food and Drug Administration (CFDA) has accepted an Investigational New Drug (IND) application for a pivotal study of AMITIZA in patients with chronic idiopathic constipation. Harbin Gloria Pharmaceuticals Co., Ltd. (Gloria) will design and conduct the study under the terms of its exclusive license, development, commercialization and supply agreement with Sucampo for AMITIZA in China. In connection with the IND acceptance, Sucampo will receive $500,000 from Gloria, which is the second tranche of the $1.5 million upfront payment agreed to as part of the licensing agreement. "The CFDA's acceptance of this IND is an important first step for Gloria as they work to obtain approval for AMITIZA in China," said Peter Greenleaf, Chief Executive Officer of Sucampo. "This pivotal study will form the basis for marketing authorization of AMITIZA, and we believe that AMITIZA could be an important new treatment for those patients in China for whom current options are not effective or sufficient." Gloria is responsible for all development activities and costs, as well as commercialization and regulatory activities, for AMITIZA in China. Sucampo will be the exclusive supplier of AMITIZA to Gloria at an agreed upon supply price and will be eligible for an additional milestone payment upon the occurrence of a regulatory or alternatively a commercial milestone event. The term of this agreement is 13 years with renewal terms.