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astellas pharma inc (YPH) Details

Astellas Pharma Inc. manufactures, markets, and imports/exports pharmaceutical products worldwide. The company focuses on therapeutic areas of urology, immunology and infectious diseases, oncology, neuroscience, and diabetes mellitus complications and kidney diseases. Its products include Prograf, an immunosuppressant to prevent rejection in organ transplants; Protopic for the treatment of atopic dermatitis in the topical immunomodulator class; Vesicare, a treatment for overactive bladder; Harnal, an a1 blocking agent for the treatment of benign prostatic hyperplasia; and Funguard, a candin antifungal agent. The company’s products also comprise Geninax, an oral quinolone antibacterial agent; Celecox, a selective COX-2 inhibitor; Lipitor, a treatment for hypercholesterolemia; Micardis, a treatment 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, an antagonist; Regnite, a treatment for restless legs syndrome; and Kiklin, a treatment for hyperphatemia. In addition, it 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 a strategic alliance with Amgen Inc.; a collaborative research agreement with Immuno-Biological Laboratories Co., Ltd.; a compound library sharing partnership with Daiichi Sankyo Company, Limited; and a strategic partnership with ClearPath Development Company. The company was founded in 1923 and is headquartered in Tokyo, Japan.

17,649 Employees
Last Reported Date: 06/18/14
Founded in 1923

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astellas pharma inc (YPH) Key Developments

Astellas Pharma Inc. and Medivation, Inc. Announce U.S. Food and Drug Administration Approval for the Use of XTANDI (Enzalutamide) Capsules

Astellas Pharma Inc. and Medivation, Inc. announced that the U.S. Food and Drug Administration (FDA) approved a new indication for the use of XTANDI (enzalutamide) capsules to treat patients with metastatic castration-resistant prostate cancer (CRPC). This new approved use follows a priority review of the supplemental New Drug Application (sNDA) that was based on results of the Phase 3 PREVAIL trial. The FDA initially approved XTANDI, an oral, once-daily androgen receptor inhibitor for use in patients with metastatic CRPC who previously received docetaxel (chemotherapy). The new indication approves XTANDI for use in men with metastatic CRPC who have not received chemotherapy. In the Phase 3 PREVAIL trial, men receiving XTANDI and GnRH therapy exhibited a statistically significant improvement in both overall survival and delayed time to radiographic progression or death as compared to those on placebo and GnRH therapy. XTANDI significantly reduced the risk of death by 29% compared with placebo (HR=0.71; p < 0.0001). XTANDI significantly reduced the risk of radiographic progression or death by 83% compared with placebo (HR=0.17; p < 0.0001).

Pfizer Japan Terminates Caduet Combination Tablet Contract with Astellas Pharma

Pfizer Japan has agreed to cancel the distribution and co-promotion agreement with Astellas Pharma for Caduet combination tablets. The contract for Caduet combination tablets, a combination drug of hypertension and hypercholesterolemia, will expire on March 31, 2015. Both parties have agreed to cancel the contract. According to the contract, promotion of Caduet, which to date has been carried out jointly by the two companies, will be conducted solely by Pfizer from 1 October 2014. Until the termination of the contract, Astellas will continue its distribution, while the distribution will be transferred to Pfizer on 1 April 2015.

Astellas Receives Notification from FDA of Acceptance of Filing of Isavuconazole NDA for the Treatment of Invasive Aspergillosis and Invasive Mucormycosis

Astellas announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for isavuconazole for the treatment of invasive aspergillosis and invasive mucormycosis (also known as zygomycosis), which are life-threatening fungal infections predominantly occurring in immunocompromised patients. In accordance with the FDA Prescription Drug User Fee Act (PDUFA), the FDA designated the date of March 8, 2015 for the completion of the review. The FDA designated isavuconazole as a Qualified Infectious Disease Product (QIDP) for both invasive aspergillosis and invasive mucormycosis. QIDP status provides priority review and a five-year extension of market exclusivity in the United States. QIDP incentives were granted under the 2012 U.S. Generating Antibiotic Incentives Now (GAIN) Act as a part of the FDA Safety and Innovation Act. Also, in 2013, isavuconazole was granted Orphan Drug status for invasive aspergillosis and invasive mucormycosis which, if approved, will result in the product having seven years of market exclusivity in addition to that provided under the GAIN Act.


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