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Astellas Research & Development Meeting HighlightsAstellas Pharma Inc. (Tokyo: 4503, President and CEO: Yoshihiko Hatanaka, "the Company") announced that it is holding a research and development (R&D) meeting for securities analysts, institutional investors and the press today on December 8, 2016. "The environment surrounding the pharmaceutical industry continues to undergo changes. Also, the daily advances in scientific innovation represent new opportunities for Astellas. Against the social issue of expanding healthcare cost, Astellas conducts proactive efforts to achieve a balance between patients' access to medicines and innovation as a pharmaceutical company." said Yoshihiko Hatanaka, President and CEO of Astellas. "We endeavor to achieve sustained growth by making ongoing investments in R&D to create innovative medical solutions and efforts to deliver such innovation to patients around the world. Astellas is on the forefront of healthcare change to turn innovative science into value for patients." R&D Meeting highlights are described as follows. 1. Projects Contributing to Short to Medium Term Growth (Development Strategy) Clinical development resources are concentrated on high-priority projects, to promote more efficient and expedited development, and to maximize product value. Development Project Update
In the oncology area, Astellas is advancing development projects that
will establish its position of leadership. Efforts are being made to
evaluate the efficacy and safety in treatment-resistant populations and
areas of highest unmet medical need and to expand into earlier stages of
disease and/or other tumor types if appropriate as typified by ongoing
studies of enzalutamide. 2. Projects Supporting Medium to Long Term Growth (Research Strategy) Astellas is strengthening its new drug discovery capabilities and cultivating new opportunities by leveraging its network research system based upon the principles of "Best Science, Best Talent, Best Place." Efforts to Improve Productivity Astellas reshaped its research structure in 2013 and is actively leveraging external innovation and promoting open innovation based upon its research network to achieve further improvements in productivity. Furthermore, the Company has created a supervisory system called "FAST (News - Alert)-Ex-NEW-standard"(FASTEN), which segments R&D projects into three types of processes in pre-clinical and early clinical testing stages. These efforts have achieved significant results in cost and time reductions between the initiation of research and the completion of phase I clinical trials and in significant increase of number of projects, which advance to the clinical studies. Strengthening Our Research Infrastructure In order to promote further innovation, Astellas implemented the following human resources and hiring systems:
Strategy in Various Therapeutic Areas Astellas promotes research in select areas where the potential for scientific feasibility is high and where demand in unmet medical needs also is high. The Company also promotes innovation by utilizing new approaches and technologies that leverage not only our own research but also resources from networks outside of our Company.
Regenerative Medicine
Astellas Institute for Regenerative Medicine is conducting multiple
programs including a retinal pigment epithelium (RPE) cell program,
which is in the clinical stage, as part of its efforts to pursue the
potential of regenerative medicine as a new treatment method, and
Phase-Ib/II dose-ranging and proof-of-concept trial for dry age-related
macular degeneration is planned to start with a new cell line and
formulation in 1H/2017. NOTE: For further information on our R&D Meeting, please refer to the following About Astellas Astellas Pharma Inc., based in Tokyo, Japan, is a company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. We focus on Urology, Oncology, Immunology, Nephrology and Neuroscience as prioritized therapeutic areas while advancing new therapeutic areas and discovery research leveraging new technologies/modalities. We are also creating new value by combining internal capabilities and external expertise in the medical/healthcare business. Astellas is on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at www.astellas.com/en. Cautionary Notes The safety and efficacy of the agents discussed herein are under investigation and have not been established. There is no guarantee that the agents will receive regulatory approval and become commercially available for uses being investigated. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice. In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties.
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