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  • Takeda Pharmaceuticals North America, Inc.
  • Takeda Pharmaceuticals North America, Inc. (TPNA) is a wholly owned subsidiary of Takeda Pharmaceutical Company Limited. In the United States, TPNA currently markets oral diabetes, sleep, gastroenterology, cholesterol lowering treatments and chronic management of hyperuricemia in patients with gout, and through the Takeda Global Research & Development Center, Inc. the company has a robust pipeline with compounds in development for diabetes, cardiovascular disease and other conditions.
  • Ethical Drugs
  • Products by Therapeutic Category: The following prescription drugs are listed for physicians and other healthcare professionals. These products may not be available in all countries. Also, the brand names, indications and uses may differ between countries.
  • ANNUALREPORT2009TakedaPharmaceuticalCompanyLimited Annual Report 2009 Our Contribution to Financial and Social Responsibility Editorial Policy Takeda integrates its annual report and CSR report into a single publication with a mind to give readers a complete understanding of how our business operations are guided by Takeda-ism and other elements of our corporate philosophy. Contributes to the Health of Individuals Takeda has been supplying pharmaceuticals for more than 220 years while never forgetting the importance of protecting and preserving life. Over the years, we have developed a strong commitment to the highest ethical standards and strong sense of mission. As our operations became global in scale, demands concerning corporate social responsibility (CSR) increased. We believe that developing superior pharmaceutical products in accordance with the principles of Takeda-ism is the essence of CSR for the Takeda Group. Due to this strong link between our business activities and CSR, since fiscal 2006, Take
  • 42 Japanese Market The Wakayama Representative Office (clockwise from left): Yuuichi Ohmoto, Tomotaka Sakurai, Keita Nakajima (Manager), Megumi Tanaka, Nobukazu Takamori, Kazuhiro Hosono, Hirokazu Nakamoto A more powerful platform for global marketing enhancing Takeda's stature in Japan, the U.S., Europe and Asia Takeda positions Japan, its home country, as a primary source of growth for the entire group. However, market conditions in Japan are challenging: to bring down health care expenses, the Japanese government is promoting generic drugs and expanding DPC (Diagnosis Procedure Combination). Within this context, our goal is to retain our leading market position, and we intend to do this by reinforcing our commitment to operating from the perspective of health care professionals and, above all, patients. Japan's No. 1 Drug Company Again in Fiscal 2008 Takeda's ethical drug sales in Japan increased 3.6 percent to 549.0 billion in fiscal 2008. In addition to leadership overall, we ranked first in drug sales
  • 4 M e s s a g e Yasuchika Hasegawa President & CEO Message to Stakeholders 5 Takeda's challenge is to realize its goal of becoming a "world-class pharmaceutical company." In the fiscal year ended March 31, 2009 (fiscal 2008), Takeda made significant progress toward realizing this goal through its largest ever strategic investment. In the pursuing year, the Company successfully integrated the world-class biopharmaceutical firm Millennium Pharmaceuticals, Inc. (Millennium) into the Takeda Group, based on a medium-to-long-term growth strategy of developing our core next-generation business in oncology. In addition to this, Takeda successfully realigned its operating structure in the world's largest pharmaceutical market, the U.S., through the division of TAP Pharmaceutical Products Inc. (TAP)a 30-year joint venture with Abbott Laboratories. Following the consolidation of TAP as a wholly-owned subsidiary, the sales and marketing functions of TAP were merged into our U.S. subsidiary Takeda Pharmaceuticals North A
  • ULORIC® (TMX-67, febuxostat) Receives FDA Approval forthe Chronic Management of Hyperuricemia in Patients with Gout February 14, 2009
  • 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.
  • FFiinnaanncciiaall RReessuullttss ffoorr 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 function in each
  • 17 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 18 Development activities New Compounds Development code Drug Class (administration route) Indications Stage In-house/ In-license SYR-322 DPP-4 inhibitor (oral) Diabetes mellitus Diabetes mellitus (Fixed-dose combination with Actos) US Jpn EU US EU Jpn Filed (Dec 07) Filed (Sep 08) P-III Filed (Sep 08) P-III P-I In-house TAK-390MR Proton pump inhibitor (oral) Erosive esophagitis (healing and maintenance) and non-erosive gastro-esophageal reflux disease US Jpn Approved (Jan 09) P-II In-house TMX-67 Non-purine, selective xanthine oxidase inhibitor (oral) Hyperuricemia in patients with gout US Approved (Feb 09) In-license (Teijin) TAK-375 MT1/MT2 receptor agonist (oral) Insomnia J
  • - 1 - SUMMARY OF FINANCIAL STATEMENTS (Consolidated) Nine Months Results (April 1 to December 31, 2008) for the Fiscal Year Ending March 31, 2009 February 3, 2009 Takeda Pharmaceutical Company Limited Listed exchanges: Osaka, Tokyo, Nagoya, Fukuoka, Sapporo TSE Code: 4502 URL: Representative: http://www.takeda.co.jp Yasuchika Hasegawa, President Contact: Hirofumi Inoue, General Manager of Corporate Communications Department Telephone: +81 3 3278-2037 Scheduled date of securities report submission: February 13, 2009 1. Consolidated Financial Results (April 1 to December 31, 2008) for the Fiscal Year Ending March 31, 2009 (Millions of yen, rounded to the nearest million) (1) Consolidated Operating Results (aggregated) (Percentage figures represent changes from the same period of the previous year.) Net sales Operating income Ordinary income Net income ( million) change (%) ( million) change (%) ( million) change (%) ( million) change (%) Nine months ended December 31, 2008 1,202,760 239,884 254,578 168,573 Nin
  • 2008.5 Growth toward a WorldGrowth toward a World--classclass Pharmaceutical CompanyPharmaceutical Company Yasuchika Hasegawa, President Takeda Pharmaceutical Company Limited November 5, 2008 1 Update on ongoing NDA Reviews by US FDAUpdate on ongoing NDA Reviews by US FDA SYRSYR--322 (Diabetes)322 (Diabetes) PDUFA date: October 27PDUFA date: October 27 PostponedPostponed UpdatedUpdated PDUFA date: TBDPDUFA date: TBD TMXTMX--67 (Gout)67 (Gout) November 24:November 24: FDA Advisory CommitteeFDA Advisory Committee PDUFA datePDUFA date:: January 18, 2009January 18, 2009 TAKTAK--390MR (GERD)390MR (GERD) PDUFA date: October 31PDUFA date: October 31 PostponedPostponed UpdatedUpdated PDUFA date: January 31, 2009PDUFA date: January 31, 2009 2 20062006--2010 Medium2010 Medium--term Planterm Plan Enhancement of R&D pipeline Taking full advantage of TakedaTaking full advantage of Takeda''s characteristics and strengthss characteristics and strengths Establish and execute precise strategies with a longEstablish and execu
  • - 1 - Consolidated Financial Statements for the Fiscal Year Ended March 31, 2009 May 11, 2009 These financial statements have been prepared for reference only in accordance with accounting principles and practices generally accepted in Japan. Takeda Pharmaceutical Company Limited Stock exchange listings: Osaka, Tokyo, Nagoya (First Section of each), 1-1, Doshomachi 4-chome Fukuoka, Sapporo Chuo-ku, Osaka 540-8645, Japan Code number: 4502 URL: http://www.takeda.co.jp/ Representative: Yasuchika Hasegawa, President Contact: Hirofumi Inoue, General Manager of Corporate Communications Department Telephone: +81-3-3278-2037 Scheduled date of annual general meeting of shareholders: June 25, 2009 Scheduled date of securities report submission: June 25, 2009 Scheduled date of dividend payment commencement: June 26, 2009 1. Consolidated Results for Fiscal 2008 (April 1, 2008-March 31, 2009) (1) Sales and Income (All amounts are rounded to the nearest million yen) (Percentage figures represent changes from same period o
  • 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
  • 17 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 18 Development activities ■ New Compounds Development code Drug Class (administration route) Indications Stage In-house/ In-license SYR-322 DPP-4 inhibitor (oral) Diabetes mellitus Diabetes mellitus (Fixed-dose combination with ACTOS) US Jpn EU US EU Filed (Dec 07) Filed (Sep 08) P-III Filed (Sep 08) P-III In-house TAK-390MR Proton pump inhibitor (oral) Erosive esophagitis (healing and maintenance) and non-erosive gastro-esophageal reflux disease US Jpn Filed (Dec 07) P-II In-house TAK-375 MT1/MT2 receptor agonist (oral) Insomnia Circadian rhythm sleep disorder (CRSD) EU Jpn US P-III *Re-submission of a MAA is under consideration Filed (Feb 08) P-II In-house Vectibix TM Fully
  • Establishing ag Global Pharmaceutical Company - Key Policies for FY2009 - Yasuchika Hasegawa President Takeda Pharmaceutical Company Limited Maintaining and expanding sales Key Policies for FY2009 in Japan, the US, Europe, and Asia Enhancing R&D structure to achieve steady launch of in-house products - Strategic shift from raw IND numbers and speed to overall project quality - 1 Establishing a structure to support global business operations and accelerate human resource development Maintaining and Expanding Sales in Japan, the US, Europe, and Asia 2 Maintaining Sales of TPNA Further growth of existing mainstay products Quickest possible penetration of new products into the market M i t i i k t h f ACTOSMaintaining market share of ACTOS family through aggressive promotion KAPIDEX: Aiming to switch from PREVACID and other brand drugs ULORIC: ($MM) 3 (E) Invigorating the market as the first new gout drug in the past 40 years Maintaining No.1 Position in Japan Further growth of existing ma
  • 2008.5 Growth toward a WorldGrowth toward a World--classclass Pharmaceutical CompanyPharmaceutical Company Yasuchika Hasegawa, President Takeda Pharmaceutical Company Limited November 5, 2008 1 Update on ongoing NDA Reviews by US FDAUpdate on ongoing NDA Reviews by US FDA SYRSYR--322 (Diabetes)322 (Diabetes) PDUFA date: October 27PDUFA date: October 27 PostponedPostponed UpdatedUpdated PDUFA date: TBDPDUFA date: TBD TMXTMX--67 (Gout)67 (Gout) November 24:November 24: FDA Advisory CommitteeFDA Advisory Committee PDUFA datePDUFA date:: January 18, 2009January 18, 2009 TAKTAK--390MR (GERD)390MR (GERD) PDUFA date: October 31PDUFA date: October 31 PostponedPostponed UpdatedUpdated PDUFA date: January 31, 2009PDUFA date: January 31, 2009 2 20062006--2010 Medium2010 Medium--term Planterm Plan Enhancement of R&D pipeline Taking full advantage of TakedaTaking full advantage of Takeda''s characteristics and strengthss characteristics and strengths Establish and execute precise strategies with a longEstablish and execu
  • 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
  • Takeda Pharmaceutical Company Limited (4502) Consolidated Financial Statements for Fiscal 2008 - 4 - [Qualitative Information and Financial Statements] 1. Results of Operations (1) Analysis of Operation Results 1) Introduction In order to realize Takeda's goal of establishing itself as a "global pharmaceutical company", which was set as a target in the 20062010 Medium-term Plan, the Company has been working on various strategies. To achieve this goal, the Company completed a meaningful acquisition and restructuring last year. Firstly, we evenly separated the value of TAP Pharmaceutical Products Inc. ("TAP")a joint venture between Takeda America Holdings, Inc. ("TAH") and Abbott Laboratories ("Abbott") of the U.S.into two companies in April 2008. As part of this company separation, TAP acquired assets related to the already marketed product Prevacid, as well as those related to TAK-390MR (a drug for gastroesophageal reflux disease) and TMX-67 (a drug for hyperuricemia for patients with chronic gout, discovere

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