takeda pharmaceutical co ltd (TKPHF) Key Developments
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.
Takeda Pharmaceutical Company Limited Provides Dividend Guidance for the Second Quarter and Full Year 2015
Jul 30 15
Takeda Pharmaceutical Company Limited provided dividend guidance for the second quarter and full year 2015. For the second quarter of 2015, the company expects to pay a dividend of JPY 90.00 per share.
For the year 2015, the company expects to pay a dividend of JPY 90.00 per share.
Takeda Pharmaceutical Company Limited Announces Completion of the Pioglitazone Post-Marketing Commitment and Submission of Results to EMA, FDA and PMDA
Jul 30 15
Takeda Pharmaceutical Company Limited announced the completion of the study to fulfill the post-marketing commitment and submissions of data to regulatory authorities from the Pan European Multi-Database Bladder Cancer Risk Characterization Study, (n= 112,674), multi-database retrospective matched cohort study, conducted in four European countries, for pioglitazone containing medicines, including ACTOS (pioglitazone HCI) with up to 10 years of follow-up. Findings demonstrate that there is no association between the use of pioglitazone and the risk of bladder cancer, (hazard ratio [HR] 0.99 [95% CI: 0.75, 1.30]). These results are consistent with those of a 10-year, prospective cohort study, conducted by the University of Pennsylvania (U. of Penn.) and Division of Research at Kaiser Permanente Northern California (KPNC), which demonstrated no increased risk of bladder cancer among patients ever exposed to pioglitazone ([HR] 1.06 [95% CI 0.89-1.26]). Additionally, both studies found no association between the risk of bladder cancer and cumulative dose of pioglitazone, or duration of pioglitazone exposure. The data from the Pan European Multi-Database Bladder Cancer Risk Characterization Study also shows a mortality decrease with ever use of pioglitazone (adjusted HR 0.67 [95% CI: 0.64, 0.70]). This study was completed as part of the post-marketing request from the Committee for Medicinal Products for Human Use (CHMP). In addition to the European Medicines Agency (EMA), the results from the Pan European study were also submitted to the U.S. Food and Drug Administration (FDA) and the Japanese Ministry of Health, Labour and Welfare (MHLW)/Pharmaceuticals and Medical Devices Agency (PMDA).
Takeda Pharmaceutical Company Limited Reports Consolidated Earnings Results for the First Quarter Ended June 30, 2015; Provides Earnings Guidance for the Full Year of 2015
Jul 30 15
Takeda Pharmaceutical Company Limited reported consolidated earnings results for the first quarter ended June 30, 2015. For the quarter, revenue was JPY 446.3 billion against JPY 411.1 billion a year ago. Core earnings was JPY 86.9 billion against JPY 84.3 billion a year ago. Net profit was JPY 24.6 billion against JPY 33.4 billion. Operating Profit was JPY 49.6 billion against JPY 63.7 billion a year ago. Diluted EPS was JPY 31 against JPY 42 a year ago. Core EPS was JPY 67.48 against JPY 66.60 a year ago. Profit before tax was JPY 48.7 billion against JPY 60 billion a year ago. Underlying revenue was JPY 449.9 against JPY 424.2 a year ago. Net cash from operating activities was JPY 18.6 billion against JPY 20 billion a year ago. Operating free cash flow was JPY 3 billion against negative operating free cash flow of JPY 28 billion a year ago. Capital expenditure was JPY 10 billion against JPY 10.8 billion a year ago. Acquisition of intangible assets was JPY 5.6 billion against JPY 29.2 billion a year ago. Net debt was JPY 90.1 billion against JPY 11.5 billion a year ago.
For the year ending march 31, 2015, the company expects revenue of JPY 1,820,000 million, operating profit of JPY 105,000 million, profit before tax of JPY 115,000 million, net profit attributable to the owners of the company of JPY 68,000 million and basic earnings per share of JPY 86.53.
Drugs for Neglected Diseases Initiative and Takeda Pharmaceutical Company Limited Collaborate for Lead Optimization for Aminopyrazole Series for Visceral Leishmaniasis
Jul 27 15
Drugs for Neglected Diseases initiative and Takeda Pharmaceutical Company Limited announced that they have signed an agreement to collaborate in the 'Lead Optimization Program' aimed at identifying the best compound among aminopyrazole series for developing an innovative drug for the treatment of visceral leishmaniasis (VL). The program is being funded by Global Health Innovative Technology Fund (GHIT). GHIT Fund is investing approximately ¥400 million into DNDi for the program. DNDi and Takeda are working on the lead optimization of the aminopyrazole series. In preclinical trials, the aminopyrazole series exhibited good antiparasitic activity, and are expected to be highly safe and effective. DNDi and Takeda consider that short-course oral administration of the drug is effective for the treatment, and therefore it is expected to be a novel drug which will be different from the existing therapeutics for VL. In addition to this collaboration agreement, DNDi and Takeda entered into partnership agreements such as the 'drug discovery booster for accelerating and promoting the discovery of new drugs for treating leishmaniasis and Chagas disease'. DNDi and Takeda aim to contribute towards treating 'Neglected Tropical Diseases' through these efforts.