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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 for the prevention of 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 agreement with the National Institute of Advanced Industrial Science and Technology; 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.

17,217 Employees
Last Reported Date: 06/20/16
Founded in 1923

astellas pharma inc (4503) Top Compensated Officers

Chief Executive Officer, President and Repres...
Total Annual Compensation: ¥216.0M
Chief Administrative Officer, Chief Complianc...
Total Annual Compensation: ¥108.0M
Compensation as of Fiscal Year 2016.

astellas pharma inc (4503) Key Developments

Astellas Pharma Inc. and Pfizer Inc. Announces FDA Approval for Supplemental New Drug Application for XTANDI® (enzalutamide) Capsules in Advanced Prostate Cancer

Astellas Pharma Inc. and Pfizer Inc. announced the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) to update the U.S. product labeling for XTANDI® (enzalutamide) capsules to include new clinical data versus bicalutamide from the TERRAIN study. The data demonstrate improvement in radiographic progression-free survival (rPFS) in patients with metastatic castration-resistant prostate cancer (CRPC) who were treated with enzalutamide compared to patients who were treated with bicalutamide. The TERRAIN study evaluated men with metastatic CRPC and the results from this study were published in the Lancet Oncology. The updated label includes data that enzalutamide reduces the risk of radiographic progression or death by 40% compared with bicalutamide, showing a median rPFS of 19.5 months for the enzalutamide group versus a median of 13.4 months for the bicalutamide group (hazard ratio = 0.60 [0.43, 0.83]; 95% confidence interval) based on an analysis recommended by the FDA. The safety profile of enzalutamide was consistent with results of earlier enzalutamide trials.

Chromocell and Astellas Announce FDA Fast Track Designation and First Subject Dosing with Lead Candidate CC8464/ASP1807 for the Management of Neuropathic Pain Associated with iSFN

Chromocell Corporation and Astellas Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the development program of the drug candidate CC8464/ASP1807, for the management of neuropathic pain associated with idiopathic small fiber neuropathy (iSFN). In 2015, Chromocell and Astellas entered into a license and collaboration agreement for the development and commercialization of CC8464/ASP1807 for the management of neuropathic and other pain indications. Chromocell submitted the IND for CC8464/ASP1807 in July, 2016, and recently dosed the first subject in a Phase I clinical trial to evaluate the safety, tolerability, and pharmacokinetics of the oral formulation of CC8464/ASP1807. The FDA's Fast Track program is intended to help ensure that therapies intended for serious or life threatening conditions that address unmet medical needs are approved and available to patients as soon as it can be concluded that the therapies' benefits justify their risks. Features of Fast Track designation include actions that expedite development and review including frequent interactions with the FDA Division responsible for review.

Astellas Pharma, Inc. Presents at The Cell & Gene Meeting on the Mesa, Oct-05-2016 08:35 AM

Astellas Pharma, Inc. Presents at The Cell & Gene Meeting on the Mesa, Oct-05-2016 08:35 AM. Venue: La Jolla, CA 92037, United States. Speakers: Akihiko Iwai, Corporate Executive.


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