Astellas announced progress on the company's efforts to reshape its research framework at its R&D meeting held in Tokyo on July 10. The meeting provided an opportunity for Astellas to present a comprehensive overview of its late-stage clinical programs 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.
Yoshihiko Hatanaka, president and CEO, opened the meeting by discussing how Astellas will continue to drive sustainable growth through maximizing the value of product portfolio, pursuing operational excellence and enhancing innovation through reshaping the company's research framework, and developing network research systems by more utilizing external resources. The full presentation, including details of the corporate strategy can be found in the webcast available here: http://www.astellas.com/en/ir/library/presentation_02.html.
Sef Kurstjens, M.D., Ph.D., chief medical officer, provided a development overview of the following compounds:
-- In May 2014, Astellas and Medivation received priority review from the U.S. Food and Drug Administration for enzalutamide (known commercially as XTANDI) in chemotherapy-naive advanced prostate cancer. Development progress in clinical trials for the treatment of breast cancer was also highlighted.
-- Phase 2 results of roxadustat (ASP1517/FG-4592) demonstrated that the compound is effective in treating anemia 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 program is now underway evaluating the safety and efficacy of the concomitant use of solifenacin (known commercially as VESIcare) and mirabegron (known commercially as Myrbetriq@) 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 program in Japan for ASP015K, a JAK inhibitor for the treatment of rheumatoid arthritis that has recently completed Phase 2b studies.
In May 2013, Astellas formed a strategic alliance with Amgen to develop and commercialize 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.
"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 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 our research initiatives and provided details of potential new therapeutic areas that Astellas is pursuing, as well as novel technology platforms that the company is utilizing, including ClearPath, ADC and regenerative medicine. In addition, Uchida discussed the preclinical research achievements for ASP2215, a potential treatment for leukemia, and ASP8273, a potential treatment for non-small cell lung cancer patients with EGFR mutations.