Last ¥4,860 JPY
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As of 8:16 PM 09/17/14 All times are local (Market data is delayed by at least 15 minutes).

takeda pharmaceutical co ltd (4502) Snapshot

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takeda pharmaceutical co ltd (4502) Details

Takeda Pharmaceutical Company Limited is engaged in the research, development, manufacturing, marketing, sale, and import/export of pharmaceutical drugs worldwide. It provides products in various therapeutic areas, including cardiovascular and metabolic, respiratory and immunology, oncology, central nervous system, general medicine, vaccines, and consumer healthcare drugs and quasi-drugs. The company was founded in 1781 and is headquartered in Osaka, Japan.

31,225 Employees
Last Reported Date: 06/27/14
Founded in 1781

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takeda pharmaceutical co ltd (4502) Key Developments

Orexigen Therapeutics, Inc. and Takeda Pharmaceutical Company Limited Enter into Manufacturing Services Agreement

In preparation for the potential launch of NB32, Orexigen Therapeutics, Inc. and Takeda Pharmaceutical Company Limited (Takeda) entered into a Manufacturing Services Agreement, dated September 2, 2014, in accordance with the collaboration agreement between the company and Takeda, effective as of September 1, 2010, as amended by amendment number 1 to collaboration agreement effective as of September 26, 2013. Pursuant to the agreement, among other things, the company will supply to Takeda, and Takeda will, subject to certain exceptions as set in the agreement and collaboration agreement, exclusively purchase from the company, all of Takeda’s requirements of NB32 for commercialization in the United States, Canada and Mexico during the term of the collaboration agreement. The agreement will continue in full force and effect until the expiration or termination of the collaboration agreement. Notwithstanding the foregoing, the agreement will also terminate automatically (prior to the expiration or termination of the collaboration agreement) upon (1) the completion of the transfer of the right and responsibility to manufacture or have manufactured NB32 to Takeda pursuant to the collaboration agreement and (2) if elected by Takeda, the assignment to Takeda of all of the third party manufacturer agreements required for the manufacture of NB32 in the applicable territory.

Takeda Pharmaceutical Co Submits a New Drug Application for Leuplin 6 Month Depot in Japan for the Treatment of Prostate Cancer and Premenopausal Breast Cancer

Takeda Pharmaceutical Company Limited announced that it has submitted a New Drug Application to the Japanese Ministry of Health, Labour and Welfare for 'Leuplin' 6 month depot (generic name: leuprorelin acetate, hereafter Leuplin), a treatment for prostate cancer and premenopausal breast cancer. Created and developed by Takeda, Leuplin is an LH-RH agonist that consistently stimulates the pituitary gland, resulting in suppressed production of male/female hormone. Leuplin is used as a treatment for hormone-dependent diseases such as prostate cancer and premenopausal breast cancer, and it is currently available worldwide. Leuplin was initially launched as a once-daily administration by injection, and Takeda has applied multiple innovations, based on its expertise in drug formulation technology, to turn it into a sustained-release microcapsule depot formulation, enabling to maintain stable blood concentration levels over a long period of time. At present, both 1 month and 3 month formulations have been approved and are marketed in Japan. With the application of further technological breakthrough, the 6 month depot, which enabled the treatment with one administration at every 24 weeks, are currently available in markets such as the United States, Europe and some countries in Asia.

FDA Approves Takeda Pharmaceutical Company Limited's VELCADE(R) (bortezomib) Retreatment in Patients with Multiple Myeloma

Takeda Pharmaceutical Company Limited announced that the U.S. Food and Drug Administration (FDA) has approved VELCADE(R) (bortezomib) for the retreatment of adult patients with multiple myeloma (MM) who had previously responded to VELCADE therapy and relapsed at least six months following completion of prior VELCADE treatment. The labeling update includes dosing guidelines as well as safety and efficacy findings for the use of VELCADE as a single agent or VELCADE in combination with dexamethasone in patients previously treated with VELCADE. VELCADE retreatment may be started at the last tolerated dose. The approved retreatment sNDA consisted of a Phase 2 study and other supportive data. The Phase 2 international RETRIEVE trial showed a 38.5% overall response rate (ORR) in multiple myeloma patients who had been previously treated with a VELCADE-based regimen (median of two prior lines of therapy) and had previously achieved a partial response or better. The safety profile seen with VELCADE retreatment was consistent with the known safety profile of intravenous VELCADE in relapsed multiple myeloma; no cumulative toxicities were observed upon retreatment. The most common adverse drug reaction was thrombocytopenia, which occurred in 52% of the patients. RETRIEVE was a single arm, open-label trial. The study enrolled 130 patients ages 18 years and older who had previously responded to VELCADE-based therapy and relapsed at least six months after prior treatment with VELCADE. The study met its primary endpoint of best confirmed response to retreatment as assessed by European Group for Blood and Marrow Transplantation (EBMT) criteria. Patients had received a median of two prior therapies (range of 1-7); Dexamethasone was administered in combination with VELCADE in 94 patients. Of the 130 patients, one patient achieved complete response and 49 achieved partial response (50/130; ORR 38.5%). In the 50 responding patients, the median duration of response was 6.5 months (range of 0.6 to 19.3 months). The incidence of grade >=3 thrombocytopenia was 24%. Peripheral neuropathy occurred in 28% of patients, with the incidence of grade >=3 peripheral neuropathy reported at 6%. The incidence of serious adverse reactions was 12.3%; the most commonly reported serious adverse reactions were thrombocytopenia (3.8%), diarrhea (2.3%), herpes zoster and pneumonia (1.5% each). Adverse reactions leading to discontinuation occurred in 13% of patients.


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