DEERFIELD, Ill., and OSAKA, Japan, August 28, 2009 – Takeda Pharmaceutical Company Limited (“Takeda”) and Takeda Global Research & Development Center, Inc., a wholly owned United States (U.S.) subsidiary, today jointly announced that the latter has received notification that the U.S. Food and Drug Administration (FDA) has agreed to the study design for a cardiovascular (CV) outcomes trial titled EXAMINE (EXamination of CArdiovascular OutcoMes: AlogliptIN vs. Standard of CarE in Patients with Type 2 Diabetes Mellitus and Acute Coronary Syndrome) for alogliptin, a selective dipeptidyl peptidase IV inhibitor under investigation for the treatment of type 2 diabetes as an adjunct to diet and exercise.
DEERFIELD, Ill., June 26, and OSAKA, Japan, June 27, 2009 – Takeda Pharmaceutical Company Limited (“Takeda”) today announced that Takeda Global Research and 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.
Osaka, Japan, June 4, 2009 -Takeda Pharmaceutical Company Limited ("Takeda") announced today that it has reviewed the development strategy for the Marketing Authorization Applications (MAAs) for its investigational compounds, alogliptin and alogliptin/ACTOS (generic name: pioglitazone HCl), in Europe, and accordingly, has initiated an additional long-term clinical study for alogliptin.
OSAKA, Japan, March 6, 2009 - Takeda Pharmaceutical Company Limited today announced that Takeda Global Research and Development Center, Inc., a wholly owned United States (U.S.) subsidiary, was informed as part of regular discussions about the alogliptin New Drug Application (NDA) with the United States Food and Drug Administration (FDA), that although the alogliptin NDA was filed prior to issuance of FDA’s December 2008 guidance on new Type 2 diabetes treatments, the FDA will apply these guidelines when reviewing the alogliptin NDA.
ANNUALREPORT2008 Annual Report 2008 Our Contribution to Financial and Social Responsibility TakedaPharmaceuticalCompanyLimited Contributes to The Health of Individuals Worldwide 1 This annual report includes forward-looking statements regarding Takeda's plans, prospects, strategies and accomplishments, etc. These prospects are the result of assessment obtained from information currently available, and since the actual performance could be influenced by various risks and uncertainties, it shall be noted that the course of action could differ substantially from those prospects. Factors that could affect future prospects would include, but are not limited to, economic circumstances surrounding Takeda's domain identity, competitive pressures, relevant laws and regulations, change in the status of product development, exchange rate risk and so on. Precautions Regarding Forward-Looking Statements Takeda has issued an integrated Annual and CSR Report since fiscal 2006, in order to facilitate a comprehensive underst
40 Setting Blopress on a Further Upward Trajectory Despite the difficult market circumstances, net sales of ethical drugs in the Japanese market reached 529.7 billion (a 2.9 percent increase over the previous year) and firmly maintaining the top market share in Japan. Net sales of the anti-hypertension drug: Blopress (generic name: candesartan cilexetil)our ultimate growth driverreached 137.1 billion (a 6.1 percent increase over the previous year), obtaining the top sales position among all the ethical drugs sold in Japan for the third consecutive year. In November 2007, the study results of HIJ- CREATEa large scale clinical trialwere released at the AHA: the American Heart Association's Scientific Sessions 2007 and the outcome showed that therapy based on Blopress significantly inhibits the incidence of major adverse cardiovascular events of new-onset patients with diabetes and those with impaired renal function. The implementation of HIJ-CREATE was targeted at coronary artery disease patients with hyperten
OSAKA, Japan, December 24, 2008 - Takeda Pharmaceutical Company Limited (“Takeda”) today announced that Takeda Global Research and Development Center, Inc., a wholly owned United States (U.S.) subsidiary received notification that the U.S. Food and Drug Administration (FDA) will respond to the alogliptin New Drug Application (NDA) by June 26, 2009.
OSAKA, Japan, October 10, 2008 - Takeda Pharmaceutical Company Limited (“Takeda”) today announced that Takeda Global Research and Development Center, Inc., a wholly owned United States (U.S.) subsidiary received notification that the U.S. Food and Drug Administration (FDA) will not be able to complete its review of the alogliptin New Drug Application (NDA) by the Prescription Drug User Fee Act (PDUFA) date of October 27, 2008.
Osaka, Japan, September 29, 2008-Takeda Pharmaceutical Company Limited ("Takeda") announced today that it filed a New Drug Application to the Ministry of Health, Labour and Welfare for Alogliptin (development code: SYR-322) for treatment of type 2 diabetes. Alogliptin is a dipeptidyl peptidase-IV (DPP-4) inhibitor taken once a day, and were created by Takeda San Diego, Inc., Takeda's wholly-owned subsidiary located in San Diego, California.
San Francisco, Calif., June 07, 2008 – Results from five pivotal phase 3 studies of alogliptin were announced today at the American Diabetes Association (ADA) 68th Scientific Sessions by Takeda Global Research & Development Center, Inc. Alogliptin, which has been shown to be a highly selective inhibitor of dipeptidyl peptidase-4 (DPP-4), is currently under investigation as an oral treatment for type 2 diabetes. Alogliptin administered once daily demonstrated statistically significant reductions in hemoglobin A1c(HbA1c) versus placebo as a monotherapy and as an add-on therapy with the major classes of type 2 diabetes medications: metformin, thiazolidinediones, insulin and sulfonylureas.
Osaka, Japan, January 4, 2008 --- Takeda Pharmaceutical Company Limited (Takeda) announced today that Takeda Global Research & Development Center, Inc. submitted a new drug application (NDA) to the United States Food and Drug Administration (FDA) for alogliptin (development code: SYR-322), a highly selective dipeptidyl peptidase-IV (DPP-4) inhibitor under investigation for the treatment of type 2 diabetes. Discovered by Takeda San Diego, Inc., alogliptin was designed to selectively inhibit DPP-4 taken orally once-daily.
ANNUALREPORT2007 Annual Report 2007 Our Contribution to Financial and Social Responsibility TakedaPharmaceuticalCompanyLimited Contributes to The Health of Individuals Worldwide The image in the globe: the molecular representation of ramelteon (Rozerem ), insomnia medication This annual report includes forward-looking statements regarding Takeda's plans, prospects, strategies and accomplishments, etc. These prospects are the result of assessment obtained from information currently available, and since the actual performance could be influenced by various risks and uncertainty, it shall be noted that the course of action could differ substantially from those prospects. Factors that could affect future prospects would include, but are not limited to, economic circumstances surrounding Takeda's domain identity, competitive pressures, relevant laws and regulations, change in the status of product development, exchange rate risk and so on. Precautions Regarding Forward-Looking Statements Aiming to facilitate unde
Takeda Pharmaceuticals North America, Inc. (TPNA) 18 Takeda Pharmaceuticals North America, Inc. TPNA Takeda Global Research & Development Center Inc. TGRD Takeda San Diego, Inc. TSD Takeda Research Investment, Inc. TRI (marketing) (development) (research) (venture capital) The U.S. market is the largest in the world, with around half of the share in the global pharmaceutical market. Although its pace of growth is slowing compared to the double-digit growth in the past, we see it as a promising market for continued sustainable growth in future due to the stable population growth and aging of the general population. It may be no exaggeration to say that Takeda's global growth would not be possible without its success in the U.S. market. Takeda has four functions in the U.S. market - a venture capital function: Takeda Research Investment, Inc. (TRI), a research function: Takeda San Diego, Inc. (TSD), a development function: Takeda Global Research & Development Center Inc. (TGRD) and a marketing function: Takeda
1 Takeda Pharmaceutical Company Limited R&D Pipeline UpdateR&D Pipeline Update Fiscal 2006Fiscal 2006 Kiyoshi Kitazawa Managing Director General Manager, Strategic Product Planning Department MM PP DD RR AA PP 2 Takeda Pharmaceutical Company Limited Franchise I: Lifestyle-related diseases Franchise II: Oncology and urological diseases Franchise III: CNS, bone/joint diseases Franchise IV: Gastroenterological diseases TakedaTakeda''s Core therapeutic areass Core therapeutic areas 2 3 Takeda Pharmaceutical Company Limited Franchise I: LifestyleFranchise I: Lifestyle--related diseases (1)related diseases (1) ○ Fixed-dose combination drug of ACTOS/Metformin (Europe) AD-4833MET (Competact) ○ Fixed-dose combination drug of ACTOS/SU (Europe) AD-4833SU (Tandemact) ○ Delay in progression of Atherosclerosis (US) AD-4833 ○ Fixed-combination drug of Actos and TAK-536 (US) AD-4833/TAK-536 *Secondary prevention of CV events (Europe, US) AD-4833 PROactive ○ Fixed-combination drug with sustainedrelease metformin (US) AD
1 1 Takeda Pharmaceutical Company Limited Takeda Pharmaceutical Company Limited President Yasuchika Hasegawa May 11, 2007 Management PolicyManagement Policy 2 Takeda Pharmaceutical Company LimitedTakeda Pharmaceutical Company Limited 2006-2010 Medium-Term Management Plan Enhancement of R&D pipeline Comprehensive improvement of strengths as a Japanese company Establishment and in-depth implementation of strategies from a long-term perspective High productivity and efficiency Growth toward a World-class Pharmaceutical Company with Japanese Origin, based on Takeda-ism Growth toward a World-class Pharmaceutical Company with Japanese Origin, based on Takeda-ism Securing human resources Improvement of the presence 2 3 Takeda Pharmaceutical Company LimitedTakeda Pharmaceutical Company Limited 2006-2010 Medium-Term Management Plan Operational targets FY06 (Actual) FY07 (Estimate) Net sales: mid-single digit growth 1,305.2 billion yen (+7.7%) 1,390.0 billion yen (+6.5%) R&D expenses: late-single digit increase 193.3
FFiinnaanncciiaall RReessuullttss ffoorr 11st HHaallff FFYY22000055st DATA BOOK Takeda Pharmaceutical Company Limited (TSE code 4502) Contact: Corporate Communications Dept. TEL: +81-3-3278-2039 FAX: +81-3-3278-2741 http://www.takeda.com/ Financial News http://www.takeda.com/english/financial/index.html [Takeda-ism] We, the members of the Takeda Group, pledge to act with integrity at all times, especially when facing difficulties or challenges. "Integrity" refers to our compliance with the highest ethical standards, our fairness and honesty in conducting every activity, and our perseverance in pursuing the ideal forms for our operations and management. Through the demonstration of these qualities, we show our commitment to building trust and confidence in all the people around us, and our determination to continue to expand the business. These empower our progress in our global endeavors to fulfill our mission to "strive toward better health for individuals and progress in medicine by developing superior pha
FFiinnaanncciiaall RReessuullttss ffoorr FFYY22000055 DATA BOOK Takeda Pharmaceutical Company Limited (TSE code 4502) Contact: Corporate Communications Dept. TEL: +81-3-3278-2039 FAX: +81-3-3278-2741 http://www.takeda.com/ Financial News http://www.takeda.com/financial/index.html [Takeda-ism] We, the members of the Takeda Group, pledge to act with integrity at all times, especially when facing difficulties or challenges. "Integrity" refers to our compliance with the highest ethical standards, our fairness and honesty in conducting every activity, and our perseverance in pursuing the ideal forms for our operations and management. Through the demonstration of these qualities, we show our commitment to building trust and confidence in all the people around us, and our determination to continue to expand the business. These empower our progress in our global endeavors to fulfill our mission to "strive toward better health for individuals and progress in medicine by developing superior pharmaceutical products." 2
Osaka, Japan/Wilmington, N.C., July 14(JST) and 13(ET), 2005 --- Takeda Pharma-ceutical Company Limited ("Takeda") and PPD, Inc. (Nasdaq: PPDI) today announced an agreement in which Takeda acquired the development and marketing rights to all dipeptidyl peptidase IV (DPP4) inhibitors previously granted to PPD under an agreement between PPD and Syrrx, Inc. Takeda acquired Syrrx, Inc., now known as Takeda San Diego, Inc., in March 2005.
Takeda Pharmaceutical Company Limited (Osaka, Japan, "Takeda", President and Chief Operating Officer: Yasuchika Hasegawa) announced today that Takeda and Syrrx Inc. (San Diego, CA, "Syrrx", Chairman of the Board: Samuel D.Colella) agreed on February 5, 2005 (PST) to merge Syrrx, Inc. into the Takeda Group. The merger is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act and is subject to the satisfaction of other customary closing conditions. Upon successful completion of the transaction, which is anticipated to occur in the first quarter of 2005, Syrrx will become a subsidiary of Takeda America Holdings, Inc., a wholly owned subsidiary of Takeda.