Key Developments: Astellas Pharma Inc (4503.T)

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Latest Key Developments (Source: Significant Developments)

UMN Pharma Inc and Astellas Pharma Inc announces summary results in phase III clinical trials of seasonal flu vaccine ASP7374
Wednesday, 15 Jan 2014 01:30am EST 

UMN Pharma Inc and Astellas Pharma Inc:Says the summary results for two Phase III clinical trials of the recombinant seasonal influenza HA vaccine ASP7374.Says one of these clinical trials enrolled 900 healthy volunteers aged from 20 to 64 years to compare the immunogenicity and safety of subcutaneously-administered ASP7374 with approved egg-derived trivalent inactivated vaccine as well as non-inferiority of ASP7374 to the egg-derived vaccine.Says this clinical trial showed non-inferiority of the recombinant seasonal influenza HA vaccine ASP7374 in comparison with the egg-based vaccine in terms of immunogenicity, and no major safety problem was observed in ASP7374.Says another clinical trial enrolled 55 healthy volunteers aged 61 and over to evaluate the immunogenicity and safety of intramuscularly-administered ASP7374.Says this clinical trial showed favorable immunogenicity with no major safety problem observed in ASP7374.  Full Article

Astellas Pharma Inc to form strategic partnership with ClearPath to build vaccine portfolio
Monday, 6 Jan 2014 02:00am EST 

Astellas Pharma Inc:Says strategic partnership with ClearPath Development company to form a portfolio of development companies focused on vaccines targeting infectious diseases.Says the partnership was established to support Astellas' goal of building a global vaccine franchise and launched its first company, RSV Corporation (RSVC), in Dec. 2013.Says Astellas will fund RSVC's development of a virosome vaccine technology, licensed from Mymetics Corporation for respiratory syncytial virus (RSV) through completion of a Phase 2b human proof-of-concept study.Says based on the strategic partnership, Astellas received exclusive rights to acquire RSVC as well as further develop and commercialize the vaccine product.  Full Article

Astellas Pharma Inc receives approval for additional indication for Hypnosedative, Dormicum in Japan
Friday, 20 Dec 2013 01:00am EST 

Astellas Pharma Inc:Says it received the approval of an additional indication for hypnosedative, Dormicum Injection 10 mg (generic name: midazolam) from the Ministry of Health, Labour and Welfare in Japan.Says the new indication is for use in sedation during surgery and procedures for dental, oral and maxillofacial care.  Full Article

Astellas Pharma Inc updates on plan to transfer business to Nichi-iko Pharmaceutical Co., Ltd.
Friday, 13 Dec 2013 01:00am EST 

Astellas Pharma Inc and Nichi-iko Pharmaceutical Co., Ltd:Say Astellas Pharma Inc will establish a new sub-subsidiary, which will take over the Fuji plant business from Astellas Pharma Tech Co., Ltd., a subsidiary of Astellas Pharma Inc.Say Astellas Pharma Tech Co., Ltd. will transfer the holdings in the new company to Nichi-iko Pharmaceutical Co., Ltd. on Apr. 1, 2014.  Full Article

Cytokinetics Inc announces results from first-time-in-humans clinical trial of CK-2127107, developed in collaboration with Astellas Pharma Inc
Tuesday, 10 Dec 2013 07:31am EST 

Cytokinetics Inc:Says the results from a first-time-in-humans clinical trial of CK-2127107 in healthy male volunteers were presented during a Late Breaking Clinical Trials session at the seventh International Conference of the Society on Sarcopenia, Cachexia and Wasting Disorders in Kobe, Japan.Says Cytokinetics, in collaboration with Astellas Pharma Inc, is developing CK-2127107, a small molecule activator of the fast skeletal muscle troponin complex, for potential application in non-neuromuscular diseases and medical conditions associated with muscle weakness.Says this Phase I clinical trial was a double-blind, randomized, placebo-controlled study designed to assess the safety, tolerability, and pharmacokinetics of single ascending oral doses of CK-2127107 administered to healthy adult males in a three period, escalating dose, crossover design.Says the primary objective of this trial was to evaluate the safety and tolerability of single doses of CK-2127107 administered orally to healthy male volunteers.Says the secondary objective was to evaluate the pharmacokinetic profile of single doses of CK-2127107.Says planned single doses of CK-2127107 up to 4000 mg, the highest dose administered in this trial, were well-tolerated without an emerging pattern of adverse events; therefore, a maximum tolerated dose could not be defined.  Full Article

Astellas Pharma Inc's subsidiary and Vical Incorporated announce initiation of phase two trial of ASP0113
Tuesday, 10 Dec 2013 07:00am EST 

Astellas Pharma Inc and Vical Incorporated:Says Astellas Pharma Global Development, Inc., a subsidiary of company and vical initiaties a Phase two trial of ASP0113 in about 140 solid organ transplant (SOT) recipients.The global, randomized, double-blind, placebo-controlled trial is designed to evaluate the efficacy of ASP0113 compared to placebo as measured by the incidence of cytomegalovirus (CMV) viremia in CMV-seronegative subjects receiving a kidney from a CMV-seropositive donor.Says the study will also evaluate the safety of ASP0113 in this patient population.Says follow-up for each subject will continue for one year following enrollment.Says Astellas is conducting the trial under an exclusive worldwide license agreement with Vical to develop and commercialize ASP0113.Says Vical is providing development, regulatory and manufacturing support.  Full Article

Medivation, Inc. and Astellas Pharma Inc Announce Phase 3 PREVAIL Trial of Enzalutamide Meets Both Co-Primary Endpoints of Overall Survival and Radiographic Progression
Tuesday, 22 Oct 2013 06:45am EDT 

Medivation, Inc. and Astellas Pharma Inc. announced that the Independent Data Monitoring Committee (IDMC) has informed the companies of positive results from a planned interim analysis of the global Phase 3 PREVAIL trial of enzalutamide in more than 1,700 men with metastatic prostate cancer that has progressed despite androgen deprivation therapy and who have not yet received chemotherapy. Given the observed benefits in the trial’s co-primary endpoints of overall survival and radiographic progression-free survival, and considering the observed safety profile, the IDMC concluded enzalutamide demonstrated a favorable benefit-risk ratio. The IDMC recommended the study be stopped and patients treated with placebo be offered enzalutamide.  Full Article

Astellas Pharma Inc and Mitokyne, Inc to Pursue Mitochondria-related Disease Therapies
Sunday, 6 Oct 2013 07:00pm EDT 

Astellas Pharma Inc and Mitokyne, Inc announced that the two companies have entered into an exclusive R&D collaboration focused on discovering and developing drugs that improve mitochondrial functions. These drug candidates have the potential to treat genetic, metabolic or neurodegenerative disorders as well as conditions of aging. Under the collaboration agreement, Astellas and Mitokyne will collaborate to discover and develop compounds that target mitochondrial function. Mitokyne will lead all the research and drug discovery activities and be responsible for delivering IND candidates, whereupon Astellas will assume all clinical development activities as well as commercialization.  Full Article

Basilea Pharmaceutica AG And Astellas Pharma Inc Reports Positive Topline Phase 3 Results For Antifungal Isavuconazole
Monday, 30 Sep 2013 01:36am EDT 

Basilea Pharmaceutica AG announced positive topline data from the isavuconazole phase 3 invasive aspergillosis study (SECURE). The antifungal agent isavuconazole is being co-developed with Astellas Pharma Inc. The randomized, double-blind isavuconazole study (SECURE) achieved its primary objective in demonstrating non-inferiority versus voriconazole for the primary treatment of invasive fungal disease caused by Aspergillus species or certain other filamentous fungi. Isavuconazole was effective as determined by the primary endpoint of all-cause mortality through day 42 in the intent-to-treat population (N=516). The all-cause-mortality was 18.6% in the isavuconazole treatment group and 20.2% in the voriconazole group. The 95% confidence interval of the treatment difference between isavuconazole and voriconazole was within the pre-specified non-inferiority margin of 10%.  Full Article

Astellas Pharma Inc's Subsidiary to Sell Business to Nichi-iko Pharmaceutical Co., Ltd.
Friday, 27 Sep 2013 02:00am EDT 

Astellas Pharma Inc announced that its subsidiary, Astellas Pharma Tech Co., Ltd., will sell its Fuji plant business to Nichi-iko Pharmaceutical Co., Ltd., effective April 1, 2014.  Full Article

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Aveo, Astellas end pact to develop cancer drug tivozanib

- Aveo Oncology and Astellas Pharma Inc said they would end an agreement to develop Aveo's lead experimental drug that has seen a string of failures in multiple cancer indications.

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