Key Developments For Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc. (SCMP.O) (Consolidated Issue listed on NASDAQ Global Market)
Sucampo Pharmaceuticals, Inc.'s Sucampo Pharma Europe Receives Marketing Authorization For Amitiza In Switzerland For Treatment Of Chronic Idiopathic Constipation
Sucampo Pharma Europe Ltd., a subsidiary of Sucampo Pharmaceuticals, Inc announced that Swissmedic, the Swiss Agency for Therapeutic Products, has granted a marketing authorization for Amitiza (lubiprostone) 24 microgram (mcg) gel capsules for the long-term treatment of patients with chronic idiopathic constipation (CIC). Amitiza is already approved by the U.S. Food and Drug Administration (FDA) for the long-term treatment of CIC in adults and for the treatment of irritable bowel syndrome with constipation (IBS-C) in adult women.
Sucampo Pharmaceuticals, Inc. Withdraws European Marketing Application For Lubiprostone
Sucampo Pharma Europe, Ltd., a wholly owned subsidiary of Sucampo Pharmaceuticals, Inc., announced the withdrawal of its European marketing authorization application (MAA) for lubiprostone, 24 mcg, for the indication of Chronic Idiopathic Constipation (CIC). Sucampo stated that its decision to withdraw the MAA was strategic based upon lubiprostone's projected commercial position in the global market. Sucampo will evaluate its opportunities to obtain an appropriate label in the European Union based on the fact that lubiprostone is the only product registered for chronic therapy for CIC and Irritable Bowel Syndrome with Constipation (IBS-C).
Takeda Pharmaceuticals North America And Sucampo Pharmaceuticals, Inc.'s Sucampo Pharma Americas, Inc. Announces Top-Line Results of Two Phase 3 Trials of Lubiprostone
Sucampo Pharma Americas, Inc., a wholly owned subsidiary of Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals North America, Inc., announced top-line results from two identically-designed phase 3 clinical trials of lubiprostone (24 mcg, twice daily) for the management of opioid-induced bowel dysfunction (OBD) in subjects with chronic, non-cancer pain. In study OBD0631 (631), the primary endpoint of a statistically significant change from baseline in the frequency of spontaneous bowel movements (SBMs) at Week 8 of treatment was met when lubiprostone was compared to placebo. Additionally, statistical significance was achieved for eight of the 12 secondary endpoints, including key symptoms associated with OBD. Study OBD0632 (632) did not achieve statistical significance for the same primary endpoint. Statistically significant improvements with lubiprostone were achieved for two of the secondary endpoints and positive trends were observed in four of the other secondary endpoints. Subjects treated with lubiprostone showed a statistically significant increase in the frequency of SBMs at Week 8 from their baseline, from 1.42 to 4.54 SBMs in the 631 trial and from 1.60 to 4.10 SBMs in the 632 trial. The increase for placebo over their baseline was from 1.46 to 3.81 SBMs for the 631 trial and 1.60 to 3.95 SBMs for the 632 trial. There was a high rate of response in the placebo arm of the 632 trial.
Sucampo Pharmaceuticals, Inc. Announces Top-Line Results Of Phase 2 Clinical Trial Of Cobiprostone For Prevention Of NSAID-Induced Gastrointestinal Injuries
Sucampo Pharma Americas, Inc., a wholly owned subsidiary of Sucampo Pharmaceuticals, Inc., announced top-line results from its phase 2 clinical trial of orally administered cobiprostone for the prevention of gastric ulcers and other gastrointestinal injuries in patients treated with non-steroidal anti-inflammatory drugs (NSAIDs). A total of 124 patients with osteoarthritis and/or rheumatoid arthritis at 12 sites in the U.S. were enrolled in this 12-week, double-blinded, randomized, dose-ranging and placebo-controlled phase 2 trial. All patients in the trial received 500 mg of naproxen twice a day. There were four treatment cohorts: one cohort received placebo while the other three cohorts received 18 mcg of cobiprostone either once, twice or three times a day (daily totals of 18, 36 or 54 mcg, respectively). Efficacy endpoints that were evaluated included: the overall incidence of gastric ulcers during the 12 week treatment period; overall incidence of duodenal ulcers; change in the number of ulcers and/or erosions by patient; time-to-onset analysis of ulcer and/or erosion development; and the severity of overall gastrointestinal injury measured on a standardized grading scale. Analysis of data from the trial indicates that patients receiving cobiprostone experienced a lower overall incidence of ulcers: at Week 12, patients receiving the 54 mcg dose experienced a 50.0% reduction in the overall incidence of gastric ulcers when compared to patients taking placebo.
Sucampo Pharmaceuticals, Inc. Issues Statement Regarding Sales Performance By Takeda Pharmaceutical Co. Ltd.'s Takeda Pharmaceuticals North America For AMITIZA
Sucampo Pharmaceuticals, Inc. announced that the Board of Directors expressed its disappointment with the level of U.S. AMITIZA sales being generated by Takeda Pharmaceuticals North America, a wholly owned subsidiary of Takeda Pharmaceutical Co. Ltd. Sucampo is looking into ways to address the situation and is engaged in ongoing discussions with Takeda to explore ways to improve AMITIZA sales. In addition, Sucampo intends to exercise its rights to pursue a performance audit under its contract with Takeda.
