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.
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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.
