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astellas pharma inc (4503) Details

Astellas Pharma Inc., a pharmaceutical company, manufactures, markets, and imports/exports pharmaceutical products worldwide. The company offers Prograf, an immunosuppressant to prevent rejection in organ transplants; Vesicare, a treatment for overactive bladder; Protopic, a treatment for atopic dermatitis in the topical immunomodulator class; Harnal, a blocking agent to treat the functional symptoms of benign prostatic hyperplasia; and Funguard, a candin antifungal agent. It also provides Geninax, an oral new-type quinolone antibacterial agent; Celecox, a COX-2 inhibitor; Lipitor, a treatment for hypercholesterolemia; Micardis, a treatment for hypertension; Gaster, a treatment for peptic ulcers and gastritis; Myslee, a hypnotic; Cefzon, an oral cephalosporin; Seroquel, an antipsychotic agent; Dorner, a treatment for chronic arterial occlusion; Nasea, a 5-HT3 receptor antagonist; Regnite, a treatment for restless legs syndrome; and Kiklin, a treatment for hyperphatemia. In addition, the company offers Lexiscan and Adenoscan, which are pharmacologic stress agents; Tarceva, a treatment for non-small cell lung cancer; Vaprisol, a treatment for euvolemic hyponatremia; AmBisome, a systemic antifungal agent; Eligard, a treatment for advanced prostate cancer; Locoid, a topical corticosteroid; Zineryt, a treatment for acne; Locobase, a treatment for dry skin; and Dificlir, a novel treatment for CDI. It has collaboration agreements with The University of Texas MD Anderson Cancer Center; Potenza Therapeutics, Inc.; Kanyos Bio, Inc.; Chromocell Corporation; and Ocata Therapeutics, Inc. The company also has license agreement with Immunomic Therapeutics, Inc.; collaborative research agreements with the National Institute of Advanced Industrial Science and Technology and GenomeDx Biosciences; and collaborative development agreement with the Institute of Medical Science, the University of Tokyo. Astellas Pharma Inc. was founded in 1923 and is headquartered in Tokyo, Japan.

17,202 Employees
Last Reported Date: 06/19/17
Founded in 1923

astellas pharma inc (4503) Top Compensated Officers

Chief Executive Officer, President & Represen...
Total Annual Compensation: ¥183.0M
Compensation as of Fiscal Year 2017.
astellas pharma inc
Astellas Pharma Inc. Reports Audited Consolidated and Company Earnings Results for the Fiscal Year Ended March 31, 2017

Astellas Pharma Inc. reported audited consolidated and company earnings results for the fiscal year ended March 31, 2017. For the year, on consolidated basis, the company reported sales of JPY 1,311,665 million against JPY 1,372,706 million a year ago. Operating profit was JPY 260,830 million against JPY 248,986 million a year ago. Profit before tax was JPY 281,769 million against JPY 261,770 million a year ago. Profit for the year was JPY 218,701 against JPY 193,687 million a year ago. Profit attributable to the owner of the parent was JPY 218,701 against JPY 193,687 million a year ago. For the year, on company basis, the company reported net sales of JYP 629,915 million against JPY 649,415 million a year ago. Operational income was JPY 15,600 million against JPY 5,590 million a year ago. Ordinary income was JPY 134,174 against JPY 8,659 million a year ago. Income before income taxes was JPY 146,877 million against JPY 9,917 million a year ago. Net income was JPY 137,818 against JPY 7,978 million a year ago.

U.S. FDA Grants Orphan-Drug Designation to Astellas Pharma Inc. for Development of FLT3 Inhibitor Gilteritinib in Acute Myeloid Leukemia

Astellas Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) granted orphan-drug designation to gilteritinib in patients with acute myeloid leukemia (AML). The Orphan Drug Designation program assigns status to drugs and biologics intended for the safe and effective treatment, diagnosis or prevention of diseases or disorders that affect fewer than 200,000 people in the United States. Gilteritinib is a receptor tyrosine kinase inhibitor of FLT3 and AXL, which are involved in the growth of cancer cells. Gilteritinib has demonstrated inhibitory activity against FLT3 internal tandem duplication (ITD) as well as tyrosine kinase domain (TKD), two common types of FLT3 mutations that are seen in up to one third of patients with AML. AML is a cancer that impacts the blood and bone marrow and most commonly experienced in older adults. According to the American Cancer Society, in 2016 there were an estimated 21,000 new cases of AML diagnosed in the United States and about 10,600 cases resulted in death. Astellas is currently investigating gilteritinib in various AML patient populations through several planned and already initiated Phase 3 trials, including the registrational ADMIRAL trial in relapsed/refractory FLT3+ AML. The safety and efficacy of the agent discussed herein are under investigation and have not been established. There is no guarantee that the agent will receive regulatory approval and become commercially available for the uses being investigated. Information about pharmaceutical products (including products currently in development) which is included in this press release are not intended to constitute an advertisement or medical advice.

Astellas Pharma Inc. Submits Supplemental New Drug Application to the U.S. Food and Drug Administration for Seeking Approval for Treatment of Overactive Bladder

Astellas Pharma Inc. announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking 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. In the United States, mirabegron and solifenacin succinate are marketed as Myrbetriq® and VESIcare®, respectively. Each is approved by the FDA as a monotherapy for the treatment of OAB with symptoms of urge urinary continence, urgency and urinary frequency. The sNDA submission is based on data from the global Phase 3 SYNERGY I, SYNERGY II and BESIDE studies. These studies, which included more than 5,000 patients with OAB, evaluated combination therapy with mirabegron and solifenacin succinate compared with each drug as monotherapy and placebo.


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