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DEERFIELD, Ill., June 26, and OSAKA, Japan, June 27, 2009 – Takeda Pharmaceutical Company Limited (“Takeda”) today announced that Takeda Global Research & Development Center, Inc., a wholly owned United States (U.S.) subsidiary received on June 26 (U.S. time) a complete response letter from the U.S. Food and Drug Administration (FDA) regarding the Company’s New Drug Application (NDA) for alogliptin, a selective dipeptidyl peptidase IV (DPP-4) inhibitor under investigation for the treatment of type 2 diabetes as an adjunct to diet and exercise. In recent months, the FDA and Takeda have been in discussions about conducting an additional cardiovascular study for alogliptin. As previously announced on March 6, 2009, the FDA informed Takeda that, although the alogliptin NDA was filed prior to the release of the December 2008 FDA Guidance titled, “Guidance for Industry: Diabetes Mellitus — Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes,” the FDA did not believe that the amount of existing alogliptin clinical data was sufficient to meet certain statistical requirements outlined in that Guidance. The FDA has asked Takeda to conduct an additional cardiovascular safety trial that satisfies the December 2008 FDA Guidance. “Takeda will continue to promote key initiatives in order to realize sustained growth from a medium- to long-term perspective,” said Takeda President & CEO, Yasuchika Hasegawa. About Takeda Pharmaceutical Company Limited Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. Additional information about Takeda is available through its corporate Web site, www.takeda.com. About Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc. Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc. are subsidiaries of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The respective companies currently market oral diabetes, insomnia, rheumatology and gastroenterology treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for diabetes, cardiovascular disease, gastroenterology, neurology and other conditions. To learn more about these Takeda companies, visit www.tpna.com. Published on BRAND PR WIRE Related Posts - 92Osaka, Japan and Deerfield, Ill. (October 16, 2006) – Takeda Pharmaceutical Company Limited, Osaka, Japan (“Takeda”) and its wholly owned subsidiary, Takeda Pharmaceuticals North America, Inc., Deerfield, Ill. (“TPNA”) announced today their official sponsorship of The LaSalle Bank Chicago Marathon, which will expand Takeda’s commitment to endurance sports across the… - Takeda Provides Update on the Investigational Fixed-Dose Combination of alogliptin and ACTOS® (pioglitazone HCl)91DEERFIELD, Ill., July 22, and OSAKA, Japan, July 23, 2009 – Takeda Pharmaceutical Company Limited (“Takeda”) today announced that Takeda Global Research & Development Center, Inc., a wholly owned United States (U.S.) subsidiary, received notification from the U.S. Food and Drug Administration (FDA) that the FDA extended the review of… - Takeda Celebrates U.S. Growth with the Grand Opening of New Home Office, Milestone Reflects Rapid Growth in Product Portfolio and Progress in Becoming a World Class Pharmaceutical Company90DEERFIELD, Ill. (October 20, 2006) – Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc. celebrate today the grand opening of the companies’ new, 70-acre corporate home office in Deerfield, Ill. Several representatives from the companies’ Japanese parent company, Takeda Pharmaceutical Company Limited, will join local…
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Zgrada Takeda Midosuji, sjedište Takeda Pharmaceutical Company, gradski dio Chuo-ku, Osaka, Japan Takedina misija je predvođenjem inovacija u medicini poboljšati zdravlje ljudi diljem svijeta. Takeda je najveća farmaceutska kompanija u Japanu, a posluje i u više od 70 zemalja svijeta. Osobito je snažno prisutna u Aziji, Sjevernoj Americi, Europi i na brzorastućim tržištima, uključujući Latinsku Ameriku, Rusiju i druge države ZND-a te Kinu. Takedini lijekovi prisutni su na tržištima više od 100 zemalja. Po prodaji lijekova na recept, Takeda zauzima 12. mjesto u svijetu, 14. mjesto u zemljama BRIC-a (Brazil, Rusija, Indija i Kina) te 18. mjesto u Europi. Takeda je u okviru svoje djelatnosti prisutna na područjima metaboličkih bolesti, gastroenterologije, onkologije, kardiovaskularnih bolesti, bolesti središnjeg živčanog sustava, upalnih i imunoloških bolesti te liječenja boli. Usmjerena je na plasiranje širokog portfelja proizvoda, poboljšanje prodaje novih proizvoda te neprestano usavršavanje konkurentnih proizvoda u kasnim fazama istraživanja i razvoja. Najnoviji godišnji izvještaj tvrtke Takeda Pharmaceuticals dostupan je ovdje Više podataka o tvrtki Takeda možete pronaći na mrežnim stranicama www.takeda.com. Reference: [1] Godišnji izvještaj tvrtke Takeda Pharmaceutical za 2015. godinu