07.20.18
Headquarters: Tokyo, Japan
twitter.com/AstellasUS
www.astellas.com
Headcount: 16,617
Year Established: 2005
Revenues: $12,238 (-1%)
Net Income: $1,836 (-4%)
R&D: $1,984 (+6%)
Top Selling Drugs
This year was fruitful in the area of acquisitions for Astellas Pharma, with the company rounding out December 2017 with an agreement to acquire Mitobridge for an upfront fee of $225 million. Mitobridge will also be eligible for additional payments that total up to $225 million, depending on the progress of various programs in clinical development. Before the $450 million dollar deal was inked, the two companies had an existing R&D collaboration in place focused on discovering and developing novel drugs that target mitochondrial function. These drug candidates have the potential to treat genetic, metabolic or neurodegenerative disorders as well as conditions of aging. MA-0211, the most advanced program emerging from the collaboration, is currently in Phase I trials for Duchenne Muscular Dystrophy (DMD). In another acquisition, Astellas bought Universal Cells in February 2018 for an upfront payment of $102.5 million plus milestones. Through that deal, Astellas gains Universal Cells’ proprietary Universal Donor Cell technology to create cell therapy products that do not require Human Leukocyte Antigen (HLA) matching, potentially overcoming a huge treatment challenge by reducing the risk of rejection.
While Astellas did not have any major approvals during the year, they are expected soon. In late May 2018, the FDA accepted the company’s New Drug Application (NDA) for Priority Review for gilteritinib, for the treatment of adult patients who have relapsed or refractory Acute Myeloid Leukemia (AML) with a FLT3 mutation. Previously, gilteritinib was granted both Orphan Drug designation and Fast Track designation by the U.S. FDA and the European Commission. Additionally, in a collaboration with Pfizer, in September 2017 Astellas announced positive top-line results of the Phase III PROSPER trial evaluating XTANDI for the treatment of Castration-Resistant Prostate Cancer, and in March 2018, XTANDI Tablets in 40 mg and 80 mg dosage received manufacturing and marketing approval in Japan for the same indication. Also in September, the FDA accepted a supplemental New Drug Application for review that seeks approval for the use of mirabegron in combination with solifenacin succinate 5 mg for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. That submission is based on positive data from the global Phase III SYNERGY I, SYNERGY II and BESIDE studies.
Astellas was very active in partnerships and collaborations during the year. In collaboration with Seattle Genetics, Inc., Astellas was granted Breakthrough Therapy Designation in March 2018 by the FDA for enfortumab vedotin, an antibody-drug conjugate (ADC), for locally advanced or metastatic urothelial cancer who were previously treated with checkpoint inhibitors (CPI). Also, in March, Actinium Pharmaceuticals entered into research and option agreement with Astellas to develop Actinium-225 Radio-Conjugates (ARCs) using its Actinium Warhead Enabling (AWE) Platform Technology. Under this collaboration, Actinium will utilize its AWE Platform to conjugate and label selected Astellas targeting agents with the actinium-225 (225Ac) payload. Actinium will also be responsible for conducting preclinical validation studies on the novel ARCs generated. Actinium will receive a seven-digit payment, which includes upfront fee and research funding from Astellas.
twitter.com/AstellasUS
www.astellas.com
Headcount: 16,617
Year Established: 2005
Revenues: $12,238 (-1%)
Net Income: $1,836 (-4%)
R&D: $1,984 (+6%)
Top Selling Drugs
Drug | Indication | 2017 Sales | (+/-%) |
XTANDI | prostate cancer | $2,288 | 1% |
Prograf | immunosuppressant | $1,690 | -9% |
Myrbetriq | overactive bladder | $1,183 | 27% |
Vesicare | overactive bladder | $1,054 | -14% |
This year was fruitful in the area of acquisitions for Astellas Pharma, with the company rounding out December 2017 with an agreement to acquire Mitobridge for an upfront fee of $225 million. Mitobridge will also be eligible for additional payments that total up to $225 million, depending on the progress of various programs in clinical development. Before the $450 million dollar deal was inked, the two companies had an existing R&D collaboration in place focused on discovering and developing novel drugs that target mitochondrial function. These drug candidates have the potential to treat genetic, metabolic or neurodegenerative disorders as well as conditions of aging. MA-0211, the most advanced program emerging from the collaboration, is currently in Phase I trials for Duchenne Muscular Dystrophy (DMD). In another acquisition, Astellas bought Universal Cells in February 2018 for an upfront payment of $102.5 million plus milestones. Through that deal, Astellas gains Universal Cells’ proprietary Universal Donor Cell technology to create cell therapy products that do not require Human Leukocyte Antigen (HLA) matching, potentially overcoming a huge treatment challenge by reducing the risk of rejection.
While Astellas did not have any major approvals during the year, they are expected soon. In late May 2018, the FDA accepted the company’s New Drug Application (NDA) for Priority Review for gilteritinib, for the treatment of adult patients who have relapsed or refractory Acute Myeloid Leukemia (AML) with a FLT3 mutation. Previously, gilteritinib was granted both Orphan Drug designation and Fast Track designation by the U.S. FDA and the European Commission. Additionally, in a collaboration with Pfizer, in September 2017 Astellas announced positive top-line results of the Phase III PROSPER trial evaluating XTANDI for the treatment of Castration-Resistant Prostate Cancer, and in March 2018, XTANDI Tablets in 40 mg and 80 mg dosage received manufacturing and marketing approval in Japan for the same indication. Also in September, the FDA accepted a supplemental New Drug Application for review that seeks approval for the use of mirabegron in combination with solifenacin succinate 5 mg for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. That submission is based on positive data from the global Phase III SYNERGY I, SYNERGY II and BESIDE studies.
Astellas was very active in partnerships and collaborations during the year. In collaboration with Seattle Genetics, Inc., Astellas was granted Breakthrough Therapy Designation in March 2018 by the FDA for enfortumab vedotin, an antibody-drug conjugate (ADC), for locally advanced or metastatic urothelial cancer who were previously treated with checkpoint inhibitors (CPI). Also, in March, Actinium Pharmaceuticals entered into research and option agreement with Astellas to develop Actinium-225 Radio-Conjugates (ARCs) using its Actinium Warhead Enabling (AWE) Platform Technology. Under this collaboration, Actinium will utilize its AWE Platform to conjugate and label selected Astellas targeting agents with the actinium-225 (225Ac) payload. Actinium will also be responsible for conducting preclinical validation studies on the novel ARCs generated. Actinium will receive a seven-digit payment, which includes upfront fee and research funding from Astellas.