In order to reduce impacts on the environment, as well as risks related to accidents, we continue to implement the assessment and audit at each stage of the business activities.
34 Emissions of environmental load substances; and impacts on local communities and the natural environment Impact within sites and surrounding areas Production stage Research and development stage Market Environmental Impact Associated with Business Activities Issues Related to Environmental Risks Reduction Measures Addressing Such Issues ResearchandDevelopmentStageProductionStage When preparing to make drug manufacturing approval applications for new products, Takeda implements appropriate actions in accordance with the relevant countries' guidelines. Takeda develops new products and new production processes with consideration for the environment. It evaluates their environmental impacts during the product life-cycle spanning manufacture, use, and disposal according to its environmental impact assessment checklist. The assessment covers energy conservation, waste generation, releases of chemical substances and prevention of natural resources depletion. Volumes of materials used in pharmaceutical products a
Tokyo and Osaka, Japan, February 14, 2009 – Teijin Pharma Limited (Head office: Chiyoda-ku, Tokyo; President: Osamu Nishikawa, hereafter “Teijin Pharma”) and Takeda Pharmaceutical Company Limited (Head office: Chuo-ku, Osaka; President: Yasuchika Hasegawa, hereafter “Takeda”) announced today that on February 13, 2009, Teijin Pharma’s U.S. licensee for febuxostat and Takeda’s wholly owned subsidiary, Takeda Pharmaceuticals North America, Inc., (Head office: Deerfield, Illinois) received FDA marketing approval for ULORIC (febuxostat) for the chronic management of hyperuricemia in patients with gout. Takeda Pharmaceuticals North America is the sole developer and marketer of the product, ULORIC in the U.S.
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
FFiinnaanncciiaall RReessuullttss ffoorr 11sstt HHaallff FFYY22000088 DATA BOOK Takeda Pharmaceutical Company Limited (TSE code 4502) Contact: Corporate Communications Dept. TEL: +81-3-3278-2037 FAX: +81-3-3278-2741 http://www.takeda.com/ Financial News http://www.takeda.com/financial/index.html 2006-2010 Medium-Term Plan Growth toward a World-class Pharmaceutical Company 1. Enhancement of capability to create new drugs through in-house R&D activities ・ Thorough review of the R&D management scheme and investments focused on the global research infrastructure ・ Building a structure that will enable continued launch of new products from its in-house R&D from fiscal 2011 ・ Enhancement of the R&D pipeline to a level where the company can expect ethical drugs sales* (consolidated basis) of 2 trillion yen in fiscal 2015 *Excluding sales of products for which Takeda acts as a distributor to wholesalers 2. Formulation of a tri-polar marketing function (Japan, USA, Europe) ・ Solidifying market
Osaka, Japan, November 21, 2008 --- Takeda Pharmaceutical Company Limited (Takeda) today announced that Takeda Global Research & Development Centre (Europe), Ltd. submitted a marketing authorization application for a prolonged-release formulation of its combination treatment for type 2 diabetes, Competact® (pioglitazone HCI and metfomin HCI) to the European Medicines Agency (EMEA). The submission was through the centralized procedure and this new formulation allows once-daily dosing: Competact® is currently available in some European countries as a product to be taken twice-daily.
THOUSAND OAKS, Calif. (Nov. 19, 2008) – Amgen (NASDAQ:AMGN) and Millennium: The Takeda Oncology Company, a subsidiary of Takeda Pharmaceutical Company Limited (TSE: 4052), today announced that enrollment in the Phase 3 MONET1 trial evaluating motesanib (AMG 706) in combination with paclitaxel and carboplatin for the first-line treatment of advanced non-small cell lung cancer (NSCLC) has been temporarily suspended following a planned safety data review of 600 patients by the study’s independent Data Monitoring Committee (DMC). Motesanib is part of a broad co-development program between Amgen and Takeda.
Osaka, Japan, September 26, 2008 --- Takeda Pharmaceutical Company Limited ("Takeda") announced today that its wholly-owned subsidiary Takeda Global Research & Development Centre (Europe) Ltd. (London, United Kingdom; "TGRD (EU)") has withdrawn its Marketing Authorization Application (MAA) for ramelteon in Europe.
CAMBRIDGE, Mass., USA and OSAKA, Japan, June 20, 2008 (US Time) – Millennium Pharmaceuticals, The Takeda Oncology Company, and Takeda Pharmaceutical Company Limited (“Takeda”, TSE: 4502) today announced that the U.S. Food and Drug Administration (FDA) approved VELCADE for patients with previously untreated multiple myeloma (MM). The Company's co-development partner, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) also has filed a corresponding application with the European Medicines Evaluation Agency (EMEA).
Osaka, Japan, June 17, 2008 – Takeda Pharmaceutical Company Limited (“Takeda”) announced today that its wholly owned subsidiary, Takeda Global Research & Development Centre (Europe) Ltd. (“TGRD(EU)”), has requested a re-examination of the opinion given by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA).
OSAKA, JAPAN, February 29, 2008 --- Takeda Pharmaceutical Company Limited (“Takeda”) today announced its submission of a New Drug Application of ramelteon for treatment of insomnia to the Ministry of Health, Labour and Welfare in Japan.
Liestal, Switzerland and Osaka, Japan, August 16, 2007 – Santhera Pharmaceuticals (SWX: SANN, “Santhera”), a Swiss specialty pharmaceutical company with a focus on neuromuscular diseases, and Takeda Pharmaceutical Company Limited (TSE:4502, “Takeda”), jointly announced today that the European Medicines Agency (EMEA) has accepted the filing of Marketing Authorization Application (MAA) for Santhera’s lead compound SNT-MC17 (INN: idebenone, originally developed by Takeda) for the treatment of Friedreich’s Ataxia (FRDA). SNT-MC17, which has been granted orphan drug designation in the EU, could become the first approved product for the treatment of FRDA and will be marketed in Europe by Santhera’s partner Takeda. SNT-MC17 has shown clinical efficacy in FRDA patients on neurological as well as cardiac endpoints in several clinical studies and proved to be well tolerated in all studies so far.
OSAKA, JAPAN, March 20, 2007 --- Takeda Pharmaceutical Company Limited (Takeda)today announced that, Takeda Global Research & Development Centre (Europe), Ltd. submitted a marketing authorization application for insomnia medication, ramelteon, to the European Medicines Agency (EMEA) through the centralized procedure. The application is for the treatment of primary insomnia.
Osaka, Japan, January 17, 2007 --- Takeda Pharmaceutical Company Limited ("Takeda") today announced that on January 8, 2007, Takeda Global Research & Development Centre (Europe), Ltd. ("TGRD Europe") was granted a marketing authori-sation for Tandemact™, a fixed combination tablet of ACTOS®(pioglitazone HCl) and glimepiride HCl from the European Commission.
FFiinnaanncciiaall RReessuullttss ffoorr 11sstt HHaallff FFYY22000066 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 2006-2010 Medium-Term Management Plan 〜 Growth toward a World-class Pharmaceutical Company with Japanese Origin 〜 1. Enhancement of capability to create new drugs through in-house R&D activities ・ Thorough review of the R&D management scheme and investments focused on the global research infrastructure ・ Building a structure that will enable continued launch of new products from its in-house R&D from fiscal 2011 ・ Enhancement of the R&D pipeline to a level where the company can expect sales of in-house ethical products of 2 trillion yen in fiscal 2015 2. Formulation of a tri-polar marketing function (Japan, USA, Europe) ・ Solidifying market function in each region with self-sustaining
18 X. Pipeline Development Activities ■ New compounds ■ Additional indications / new formulations ■ Characteristics of projects ■ Other alliance projects ■ Clinical study protocol summaries ■ Outcome studies Research Activities ■ Main joint research activities ■ Recent fruits of Takeda research ■ Notes Indications or formulations Brand name (country/region) Progress in stage Non-erosive reflux disease Takepron (Jpn) Filed→Approved (Jun 06) Combination drug of Actos / SU Duetact TM (U.S.) Filed→Approved (Jul 06) Combination drug of Actos / TAK-536 < Not decided yet > (U.S.) P-III Fixed combination with diuretic Blopress,Amias, Kenzen (EU) P-III Chronic kidney disease (CKD) / cancer-related anemia Hematide TM (U.S. , EU/ Jpn ) P-II / P-I Hypertension < Not decided yet > (U.S.,EU) P-II Gastric cancer, non-small cell lung cancer (NSLC), colorectal cancer < Not decided yet > (Jpn) P-II Secondary eradication of Helicobactor pylori Takepron (Jpn) Filed (Aug 06) Combination drug of Actos and metformin Com
Osaka, Japan, December 20, 2006 --- Takeda Pharmaceutical Company Limited ("Takeda") today announced that on December 14, 2006, its wholly owned subsidiary, Takeda Global Research & Development Centre (Europe), Ltd. ("TGRD Europe") received positive opinion from The Committee for Medicinal Products for Human Use ("CHMP") of the European Medicines Agency ("EMEA"), recommending to grant the new indication for ACTOS® (pioglitazone HCl).
Osaka, Japan, October 23, 2006 --- Takeda Pharmaceutical Company Limited ("Takeda") today announced that on October 18, 2006, Takeda Global Research & Development Centre (Europe), Ltd. ("TGRD Europe") received positive opinion from The Committee for Medicinal Products for Human Use ("CHMP") of the European Medicines Agency ("EMEA"), recommending to grant a marketing authorization for Tandemactェ, a fixed combination tablet of ACTOSィ (pioglitazone HCl) and glimepiride. The two recommended strengths for Tandemact are pioglitazone HCl/ glimepiride; 30mg/4mg and 45mg/4mg respectively. TGRD Europe submitted that application on July 29, 2005.
Osaka, Japan, August 3, 2006 --- Takeda Pharmaceutical Company Limited ("Takeda") today announced that on July 31, 2006, Takeda Global Research & Development Centre (Europe), Ltd. ("TGRD Europe") was granted a marketing authori-sation for Competact™, a fixed combination tablet of ACTOS® (pioglitazone HCl) 15mg and metformin HCl 850mg from the European Commission. TGRD Europe submitted that application on February 28, 2005, and received a positive opinion on June 2, 2006 from The Committee for Medicinal Products for Human Use ("CHMP") of the European Medicines Agency ("EMEA").
Osaka, Japan, June 6, 2006 --- Takeda Pharmaceutical Company Limited ("Takeda") today announced that on June 2, 2006, Takeda Global Research & Development Centre (Europe), Ltd. ("TGRD Europe") received positive opinion from The Committee for Medicinal Products for Human Use ("CHMP") of the European Medicines Agency ("EMEA"), recommending to grant a marketing authorization for Competact™, a fixed combination tablet of ACTOS® (pioglitazone HCl) 15mg and metformin HCl 850mg. TGRD Europe sub-mitted that application on February 28, 2005.