takeda pharmaceutic-sp adr (TKPYY) Key Developments
Takeda Pharmaceutical Company Limited Obtains New Drug Application Approval in Japan for Copaxone® Subcutaneous Injection 20 mg Syringe
Sep 28 15
Takeda Pharmaceutical Company Limited obtained the New Drug Application approval for Copaxone® Subcutaneous Injection 20 mg Syringe, a drug for the treatment of multiple sclerosis, from the Japanese Ministry of Health, Labour and Welfare. Developed by Teva Pharmaceutical Industries Ltd., Copaxone® is a subcutaneous injection administered once daily to prevent the relapse of multiple sclerosis. Copaxone® is one of the most frequently-used drugs in multiple sclerosis therapy and is approved in more than 50 countries worldwide. In Japan, glatiramer acetate was developed as an Unapproved New Drug by Teva Pharmaceutical K.K., at the request of the Japanese Ministry of Health, Labour and Welfare. In March, 2013, Takeda and Teva signed a licensing agreement in which Teva granted Takeda the right to commercialize glatiramer acetate in Japan. Takeda submitted thex NDA in December 2014 under the terms of this agreement. The approval is based on the safety and efficacy results of an open-label, 52-week clinical trial conducted in Japan by Teva Pharmaceutical K.K. in patients with relapsing-remitting multiple sclerosis as well as 3 clinical trials from overseas conducted by Teva in patients with relapsing-remitting multiple sclerosis.
Takeda Pharmaceutical Company Limited Presents at FT Latin America Healthcare and Life Sciences Conference 2015, Sep-29-2015 02:05 PM
Sep 25 15
Takeda Pharmaceutical Company Limited Presents at FT Latin America Healthcare and Life Sciences Conference 2015, Sep-29-2015 02:05 PM. Venue: Viceroy Miami, 485 Brickell Avenue, Miami, FL 33131, United States. Speakers: Ricardo Marek, Area Head of LATAM and General Manager, Brazil.
Gencia LLC and Takeda Pharmaceutical Company Limited Announces Partnership to Develop New Class of Small Molecule Drugs as Potential Treatments for Hematological and Inflammatory Diseases
Sep 10 15
Gencia LLC and Takeda Pharmaceutical Company Limited announced a partnership to develop a new class of small molecule drugs as potential treatments for hematological and inflammatory diseases. Called Mitochondrial Agonists of the Glucocorticoid Receptor (MAGR), such compounds may offer the therapeutic potential of conventional glucocorticoid drugs (steroids). However, MAGR are chemically distinct and may function differently than steroids. The initial aim of the collaboration will be joint research and development leading to two preclinical drug candidates, one each in the areas of inflammation and oncology. Takeda will explore opportunities to conduct clinical trials for drug candidates identified by the partnership. Under the agreement, Gencia will receive upfront payments and preclinical milestones for the two compounds and aggregate clinical, commercialization and sales milestones with the potential for approximately $500 million in payments by Takeda. Gencia also will receive royalties on sales of any successfully commercialized products arising from the partnership. Further details of the agreement were not disclosed. Glucocorticoid drugs are used in front-line, combination, maintenance and relapse therapy in the treatment of many hematological and inflammatory diseases. However, side-effects, lack of response or induced resistance frequently limit glucocorticoid use. Gencia’s MAGR agonists have shown activity in numerous steroid-sensitive and steroid-resistant pharmacology models. Gencia and Takeda will explore potential therapeutic uses of MAGRs and the possibilities for their safe and effective chronic use.
Takeda Pharmaceutical Company Limited Announces the U.S. Food and Drug Administration Grants Priority Review Status to New Drug Application for Ixazomib
Sep 9 15
Takeda Pharmaceutical Company Limited announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review status to the New Drug Application (NDA) for ixazomib, the first investigational oral proteasome inhibitor for the treatment of patients with relapsed and/or refractory multiple myeloma. The FDA may grant Priority Review status, which includes expedited review, to the evaluation of applications for drugs that treat a serious condition and, if approved, would provide a significant improvement in safety or efficacy over existing treatment. Ixazomib was recently granted accelerated assessment by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The NDA submission for ixazomib was primarily based on the results of the first pre-specified interim analysis of the pivotal Phase 3 trial, TOURMALINE-MM1. This study is an international, randomized, double-blind, placebo controlled clinical trial of 722 patients designed to evaluate the superiority of ixazomib plus lenalidomide and dexamethasone over placebo plus lenalidomide and dexamethasone in adult patients with relapsed and/or refractory multiple myeloma. Patients continue to be treated to progression in this trial and will be evaluated for long-term outcomes. Multiple myeloma is a cancer of the plasma cells, which are found in the bone marrow. In multiple myeloma, a group of plasma cells, or myeloma cells, becomes cancerous and multiplies, increasing the number of plasma cells to a higher than normal level. Because plasma cells circulate widely in the body, they have the potential to affect many bones in the body, possibly resulting in compression fractures, lytic bone lesions and related pain. Multiple myeloma can cause a number of serious health problems affecting the bones, immune system, kidneys and red blood cell count, with some of the more common symptoms including bone pain and fatigue, a symptom of anemia. Multiple myeloma is a rare form of cancer, with approximately 20,000 new cases in the U.S. and 114,000 new cases globally per year. Ixazomib is an investigational oral proteasome inhibitor which is being studied in multiple myeloma, systemic light-chain (AL) amyloidosis, and other malignancies. Ixazomib was granted orphan drug designation in multiple myeloma in both the U.S. and Europe in 2011 and for AL amyloidosis in both the U.S. and Europe in 2012. Ixazomib received Breakthrough Therapy status by the U.S. FDA for relapsed or refractory AL amyloidosis in 2014. It is also the first oral proteasome inhibitor to enter Phase 3 clinical trials. Ixazomib’s clinical development program further reinforces Takeda’s ongoing commitment to developing innovative therapies for people living with multiple myeloma worldwide and the healthcare professionals who treat them. Five global Phase 3 trials are ongoing are: TOURMALINE-MM1, investigating ixazomib vs. placebo, in combination with lenalidomide and dexamethasone in relapsed and/or refractory multiple myeloma; TOURMALINE-MM2, investigating ixazomib vs. placebo, in combination with lenalidomide and dexamethasone in patients with newly diagnosed multiple myeloma; TOURMALINE-MM3, investigating ixazomib vs. placebo as maintenance therapy in patients with newly diagnosed multiple myeloma following induction therapy and autologous stem cell transplant (ASCT); TOURMALINE-MM4, investigating ixazomib vs. placebo as maintenance therapy in patients with newly diagnosed multiple myeloma who have not undergone ASCT; and TOURMALINE-AL1, investigating ixazomib plus dexamethasone vs. physician choice of selected regimens in patients with relapsed or refractory AL amyloidosis.
H. Lundbeck A/S and Takeda Pharmaceutical Company Limited Announce FDA Accepts a Supplemental New Drug Application for Review of Brintellix (Vortioxetine) Clinical Trial Data
Aug 10 15
H. Lundbeck A/S and Takeda Pharmaceutical Company Limited announced the US Food and Drug Administration has accepted a supplemental New Drug Application (sNDA) for review to add clinical data regarding the effect of Brintellix (vortioxetine) on certain aspects of cognitive dysfunction in adults with Major Depressive Disorder (MDD) to the current product label. Brintellix is currently approved and available in the US for the treatment of MDD in adults. The FDA is expected to take action on this filing by 28 March 2016. Depression includes a range of symptoms including cognitive ones. The cognitive symptoms of depression may go unrecognized by both healthcare providers and patients. Common cognitive complaints include difficulty concentrating, indecisiveness, trouble thinking and forgetfulness. These symptoms are common and many of them often persist between major depressive episodes. According to a three-year prospective study of people treated for depression, cognitive symptoms (defined as diminished ability to think or concentrate and/or indecisiveness) were reported 94% of the time during major depressive episodes and 44% of the time between major depressive episodes (or during periods of partial remission). The sNDA is primarily based on the FOCUS and CONNECT studies, which were specifically designed to assess the effect of Brintellix on certain aspects of cognitive function in adult patients with MDD utilizing objective measures of cognitive function. These two 8-week, randomized, double-blind, placebo-controlled studies of Brintellix 10 and 20 mg/day used a well-established neuropsychological test (the Digit Symbol Substitution Test or DSST). The DSST performance measurement involves executive function, processing speed and attention. The FDA approved Brintellix on 30 September 2013 for the treatment of MDD in adults. Brintellix is furthermore approved in 55 countries (including Europe, Canada, Chile, Mexico, Argentina, South Korea, Turkey, Australia, Hong Kong, Singapore and South Africa). It is available in approximately 30 countries to date.