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March 19, 2016

Takeda Pharmaceutical Company Limited of Japan announced recently that during the 2016 European Crohn’s and Colitis Organisation (ECCO) Annual Scientific Meeting in Amsterdam, the interim findings from the GEMINI Long-term Safety (LTS) study were presented. The findings revealed that patients suffering from moderately to severely active ulcerative colitis (UC) reported clinical improvements with around three years or 152 weeks of treatment with vedolizumab. Another research finding from Gemini LTS study were also presented in ECCO Meeting and it proved that clinical improvements occurred in patients with Crohn’s disease (CD) or UC after long-term treatment with vedolizumab. During the ECCO meeting, 12 Takeda-sponsored abstracts on vedolizumab, including four oral and eight poster presentations, were accepted to be featured.

European Union in 2014 approved Vedolizumab as a gut-selective humanized monoclonal antibody under the trade name Entyvio® (vedolizumab). United States (U.S.) also approved Entyvio in May 2014. At present, Entyvio is approved in 48 countries across three continents.

As shown in the Interim data from GEMINI Long-Term Safety study, 73 patients with moderately to severely active UC received vedolizumab. After demonstrating an initial response at week 6 to two induction doses, these patients received vedolizumab either every eight weeks or every four weeks during the GEMINI I maintenance phase for 152 weeks. Results indicated that improvements were reported by 39 percent and 53 percent of patients for the four-week and eight-week treatment groups, respectively. In addition, higher remission rates (57% and 43%, respectively) were observed in patients who were tumor necrosis factor-alpha (TNF) blocker naïve compared with those who had experienced prior TNF blocker failure (48% and 29%, respectively).

As mentioned by Edward V. Loftus, MD, professor of medicine, Gastroenterology, Mayo Clinic: “Interim findings revealed very encouraging levels of remission for patients with ulcerative colitis with approximately three years of treatment and also provided valuable insights about how treatment history may impact treatment success. Achieving long-term remission is the treatment goal for all patients living with inflammatory bowel diseases, so it is essential that studies like this are conducted to help us understand the long-term efficacy and safety of the treatment options we prescribe.”

The second research finding which was also based on the GEMINI Long-Term Safety study, patients reported the incidence of mucosal healing and colonic dysplasia who received every four-week maintenance dosing of vedolizumab more than one year. Complete mucosal healing was observed in 44 percent of patients and 38 percent of patients showed partial healing.

“Takeda is committed to studying the long-term efficacy and safety of vedolizumab in order to equip the medical community with the best possible tools and data to address the needs of patients who are impacted with these diseases, which are chronic in nature and require long-term treatment,” said Dr. Michael Smyth, global brand medical director, Gastroenterology, Takeda.

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