Astellas Pharma Inc. Details Pipeline Progress At R&D Meeting

TOKYO, July 11, 2014 /PRNewswire/ -- Astellas announced progress on the Company's efforts to reshape its research framework at its R&D meeting held in Tokyo on the 10th July. The meeting provided an opportunity for Astellas to present a comprehensive overview of the Company's late-stage clinical programmes and corporate strategy. The purpose of the meeting was to provide an update on the initiatives for Astellas innovation, drug discovery research and pipeline progress.

Astellas' ongoing focus on innovation has been a driving force behind the Company's success in Europe, with recently launched products like XTANDI™ (enzalutamide) and BETMIGA™ (mirabegron) helping achieve sales growth of more than 8% in the EMEA region in FY2013.

Yoshihiko Hatanaka, President and CEO at Astellas, opened the meeting by discussing how Astellas will continue to drive sustainable growth through maximising the value of the product portfolio, pursuing operational excellence and enhancing innovation through reshaping the Company's research framework, and developing network research systems by utilising external resources.

Sef Kurstjens, M.D., Ph.D., Chief Medical Officer, provided a development overview of the following compounds:

• In June 2013, following the regulatory review process from the European Medicines Agency (EMA) and a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), Astellas and Medivation received marketing authorisation for XTANDI (enzalutamide) from the European Commission (EC) for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) whose disease has progressed on or after docetaxel therapy. A variation to amend the Marketing Authorisation Application for XTANDI for the treatment of chemotherapy-naïve metastatic prostate cancer was submitted in April 2014. Development progress for the clinical trials for the treatment of breast cancer were also highlighted.
• Phase 2 results of roxadustat (ASP1517/FG-4592) demonstrated that the compound is effective in treating anaemia correction and maintenance in both dialysis and non-dialysis patients with chronic kidney disease. In collaboration with FibroGen, six Phase 3 studies will support the European filings for both dialysis and non-dialysis indications.
A global Phase 3 programme is now underway evaluating the safety and efficacy of the concomitant use of solifenacin (known commercially as VESICARE™) and mirabegron (known commercially as BETMIGA™), for the treatment of overactive bladder.
• Astellas has submitted a U.S. new drug application for isavuconazole for the treatment of invasive aspergillosis and invasive mucormycosis.
• The Company is preparing to start the Phase 3 programme in Japan for ASP015K, a JAK inhibitor for the treatment of rheumatoid arthritis that has recently completed Phase 2b studies. The efficacy and safety results of the studies with and without methotrexate provide a robust data package supporting advancement of the Japanese Phase 3 clinical programme.

In May last year, Astellas formed a strategic alliance with Amgen to develop and commercialise five Amgen pipeline medicines in Japan. Development updates for three of those products were also highlighted at the meeting, including rilotumumab (AMG 102) for gastric cancer, evolocumab (AMG 145) for hyperlipidemia, and romosozumab (AMG 785) for osteoporosis.

"Our late stage-pipeline is strong and tightly aligned to our commercial strategy," commented Ken Jones, President and CEO, Astellas Pharma EMEA. "R&D is a major priority in Europe, with scientists from more than 30 countries working at our drug development centre in the Netherlands. Research undertaken here and around the world is helping develop a wealth of investigational products that will support the Company's continued growth in the EMEA region and globally." "Astellas has a long track record of delivering value to shareholders through efficient investment in R&D. This investment has provided several important new treatment options that have helped to meet patients' unmet medical needs," said Kurstjens. "As a result of our efforts, we have established Global Category Leadership (GCL) positions in urology and transplantation and an emerging GCL position in oncology. We're pleased with our pipeline progress in these therapeutic categories and are excited about our future prospects to expand our R&D efforts to explore additional areas of unmet medical needs."

Wataru Uchida, Ph.D., Senior Vice President, Drug Discovery Research, discussed the Company's research initiatives and provided details of potential new therapeutic areas that Astellas is pursuing and novel technology platforms that the Company is utilising, including ClearPath, ADC and regenerative medicine. In addition, Uchida discussed the preclinical research achievements for ASP2215, a potential treatment for leukaemia, and ASP8273, a potential treatment for non-small cell lung cancer patients with EGFR mutations.

About Astellas Pharma EMEA

Astellas Pharma EMEA operates in 40 countries across Europe, the Middle East and Africa, and is the regional business of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceuticals. The organisation's focus is to deliver outstanding R&D and marketing to continue growing in the world pharmaceutical market. Astellas' presence in Europe also includes an R&D site and three manufacturing plants. The Company employs approximately 4,350 staff across these regions. For more information about Astellas Pharma EMEA, please visit http://www.astellas.eu. SOURCE Astellas Pharma Inc.

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