- As previously reported, the third phase 3 clinical trial of lubiprostone for the treatment of OBD in patients with chronic non-cancer pain, excluding those taking methadone, met the primary endpoint of the overall spontaneous bowel movement (SBM) response rate. We expect to submit to the FDA a sNDA at mid-year and plan to seek priority review. We also plan to use these data to file submissions this year with the European Union (EU) and Swiss regulatory authorities to seek marketing approvals for this indication.
- With regards to the RESCULA label, we have received a complete response letter from the FDA which recommended improvements to the label. These improvements include removal of second line therapy language to enable first line use, removal of the prostaglandin description, and inclusion of BK potassium channel and ClC-2 chloride channel activator to the mechanism of action section. However we will continue to seek further revisions to the label to more accurately reflect current scientific understanding through the FDA’s administrative appeal process. We anticipate agreement on the final RESCULA label during the third quarter of this year.
- We have had final labeling meetings with the Japanese Pharmaceuticals and Medical Devices Agency and anticipate receiving approval of the NDA for AMITIZA for CIC in the second quarter of 2012. If successful, this NDA approval will be followed by a reimbursement negotiation with the Japanese regulatory authorities.
- In the United Kingdom, we have responded to the questions from the Medicines and Healthcare products Regulatory Agency on our marketing authorization application (MAA) for lubiprostone for the treatment of CIC, submitted under the national procedure. We anticipate receiving a decision in the third quarter. If this application is successful we will file an application under the mutual recognition procedure to seek approval in a number of other European Union states.
- In the United States, we continued to plan for the binding decision from the International Court of Arbitration, International Chamber of Commerce (ICC) in our dispute with Takeda. The ICC has notified us that the date on which it renders its decision has been extended from April 30, 2012 to May 31, 2012 though the decision may not be issued on that date.
Sucampo Pharmaceuticals, Inc. Reports First Quarter 2012 Financial And Operating Results
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