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astellas pharma inc-unsp adr (ALPMY) Key Developments

Astellas Names Christy Noland as New Director of Business Communications & Advocacy, Urology in Americas

Astellas named Christy Noland as its new director of Business Communications & Advocacy, Urology in the Americas. Noland will report directly to vice president, Business Communications & Advocacy, Margaret Long. Noland will be responsible for communicating Astellas' commitment to urology to patient and advocacy organizations and collaborating with the urology brand teams on key strategic initiatives.

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.

Andrew Lewis Joins Astellas to Lead Communications for Global Medical & Development

Astellas announced the appointment of Andrew Lewis as head of communications for the company's Global Medical & Development (GMD) organization. Lewis will report directly to Jeff Winton, senior vice president, chief communications officer, and will serve on the corporate communications leadership team. Lewis' appointment is the latest phase in the building of a new Corporate Communications team under Winton's leadership. Lewis has more than 15 years of broad communications experience. For the past decade, he has held global leadership positions in brand communications, employee and executive communications, investor relations, patient advocacy and public affairs at publicly traded biotechnology and pharmaceutical companies, most recently at AbbVie.


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