Takeda Pharmaceuticals North America Inc. announced the incorporation of Takeda Pharmaceuticals Mexico, S.A. de C.V. This expansion strengthens the company's North American presence, bolstering existing operations in the United States and Canada. Takeda Pharmaceuticals Mexico will be headquartered in Mexico City. Takeda Mexico plans to file a new drug application with the Federal Commission for the Protection against Sanitary Risk (COFEPRIS) in 2010. Takeda focuses on a variety of therapeutic areas, including lifestyle-related diseases, oncology and urological diseases, central nervous system diseases, and gastroenterological diseases.

Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceutical Co. Ltd. and its wholly owned subsidiary, Takeda Pharmaceuticals North America, Inc. have reported that the FDA has approved Sucampo's supplemental new drug application or sNDA for Amitiza 8mcg capsules twice daily to treat irritable bowel syndrome with constipation in women 18 years of age or older. As a result of this sNDA approval, Sucampo Pharmaceuticals will receive a development milestone payment of $50 million from Takeda in accordance with the collaboration and licensing agreement signed in October 2004 between Sucampo Pharmaceuticals and Takeda to jointly market Amitiza in the US and Canada. The sNDA was based on a clinical study program that included two Phase III, multi-center, double-blinded, randomized, placebo-controlled trials involving 1,154 adults, followed by one long-term, open-labeled extension trial involving 476 adults diagnosed with irritable bowel syndrome with constipation (IBS-C).

Sucampo Pharma Americas 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 twelve 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. Approximately 58% of subjects treated with placebo in the 632 trial experienced more than three SBMs per week during each week of the trial.