Philip R. Krause, M.D., Former FDA Deputy Chief for Vaccines, Joins Mesoblast Board
March 23 2022 - 8:40PM
Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in
allogeneic cellular medicines for inflammatory diseases, today
announced that Philip R. Krause, M.D. has joined its Board of
Directors. Dr. Krause was for the past decade Deputy Director,
Office of Vaccines Research and Review (OVRR) at the US Food and
Drug Administration (FDA)’s Center for Biologics Evaluation and
Research (CBER). Dr. Krause is currently Chair of the World Health
Organization COVID Vaccines Research Expert Group, and most
recently he shared responsibility for regulatory authorizations of
COVID-19 vaccines in the US.
His experience encompasses regulation and development of
biological products, including interdisciplinary team-based review
process for clinical (safety and efficacy) and CMC (product
quality) issues throughout the product life-cycle, through Phase 3
clinical development and post-marketing phases. At OVRR, the
largest product office in CBER, Dr. Krause had joint responsibility
for three Divisions (>250 employees) in regulating vaccines and
biotherapeutic products.
In a 30-year career at FDA Dr. Krause has collaborated at the
highest levels with international and US domestic stakeholders
including the European Medicines Association (EMA), Biomedical
Advanced Research and Development Authority (BARDA), and the
National Institutes of Health (NIH).
Commenting on his appointment Dr. Krause said “I have followed
Mesoblast’s development programs closely and am very much looking
forward to help guide the company as it brings its lead products to
the market. Mesoblast has a cutting-edge technology that can make a
great deal of difference to patients with conditions that are
highly refractory to other approaches. I believe I can make a
substantial contribution at this very important time in the
company’s transition towards commercialization.”
Mesoblast Chief Executive Dr. Silviu Itescu stated “We are
delighted to have Dr. Krause join our board. The biologics
development and regulatory expertise that he brings will be
invaluable in our ongoing FDA interactions on our lead and
follow-on product candidates.”
About Mesoblast Mesoblast is a world leader in
developing allogeneic (off-the-shelf) cellular medicines for the
treatment of severe and life-threatening inflammatory conditions.
The Company has leveraged its proprietary mesenchymal lineage cell
therapy technology platform to establish a broad portfolio of
late-stage product candidates which respond to severe inflammation
by releasing anti-inflammatory factors that counter and modulate
multiple effector arms of the immune system, resulting in
significant reduction of the damaging inflammatory process.
Mesoblast has a strong and extensive global intellectual
property portfolio with protection extending through to at least
2041 in all major markets. The Company’s proprietary manufacturing
processes yield industrial-scale, cryopreserved, off-the-shelf,
cellular medicines. These cell therapies, with defined
pharmaceutical release criteria, are planned to be readily
available to patients worldwide.
Mesoblast is developing product candidates for distinct
indications based on its remestemcel-L and rexlemestrocel-L
allogeneic stromal cell technology platforms. Remestemcel-L is
being developed for inflammatory diseases in children and adults
including steroid refractory acute graft versus host disease,
biologic-resistant inflammatory bowel disease, and acute
respiratory distress syndrome. Rexlemestrocel-L is in development
for advanced chronic heart failure and chronic low back pain. Two
products have been commercialized in Japan and Europe by
Mesoblast’s licensees, and the Company has established commercial
partnerships in Europe and China for certain Phase 3 assets.
Mesoblast has locations in Australia, the United States and
Singapore and is listed on the Australian Securities Exchange (MSB)
and on the Nasdaq (MESO). For more information, please see
www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter:
@Mesoblast
Forward-Looking StatementsThis press release
includes forward-looking statements that relate to future events or
our future financial performance and involve known and unknown
risks, uncertainties and other factors that may cause our actual
results, levels of activity, performance or achievements to differ
materially from any future results, levels of activity, performance
or achievements expressed or implied by these forward-looking
statements. We make such forward-looking statements pursuant to the
safe harbor provisions of the Private Securities Litigation Reform
Act of 1995 and other federal securities laws. Forward-looking
statements should not be read as a guarantee of future performance
or results, and actual results may differ from the results
anticipated in these forward-looking statements, and the
differences may be material and adverse. Forward-looking statements
include, but are not limited to, statements about: the initiation,
timing, progress and results of Mesoblast’s preclinical and
clinical studies, and Mesoblast’s research and development
programs; Mesoblast’s ability to advance product candidates into,
enroll and successfully complete, clinical studies, including
multi-national clinical trials; Mesoblast’s ability to advance its
manufacturing capabilities; the timing or likelihood of regulatory
filings and approvals (including BLA resubmission), manufacturing
activities and product marketing activities, if any; the
commercialization of Mesoblast’s product candidates, if approved;
regulatory or public perceptions and market acceptance surrounding
the use of stem-cell based therapies; the potential for Mesoblast’s
product candidates, if any are approved, to be withdrawn from the
market due to patient adverse events or deaths; the potential
benefits of strategic collaboration agreements and Mesoblast’s
ability to enter into and maintain established strategic
collaborations; Mesoblast’s ability to establish and maintain
intellectual property on its product candidates and Mesoblast’s
ability to successfully defend these in cases of alleged
infringement; the scope of protection Mesoblast is able to
establish and maintain for intellectual property rights covering
its product candidates and technology; estimates of Mesoblast’s
expenses, future revenues, capital requirements and its needs for
additional financing; Mesoblast’s financial performance;
developments relating to Mesoblast’s competitors and industry; and
the pricing and reimbursement of Mesoblast’s product candidates, if
approved. You should read this press release together with our risk
factors, in our most recently filed reports with the SEC or on our
website. Uncertainties and risks that may cause Mesoblast’s actual
results, performance or achievements to be materially different
from those which may be expressed or implied by such statements,
and accordingly, you should not place undue reliance on these
forward-looking statements. We do not undertake any obligations to
publicly update or revise any forward-looking statements, whether
as a result of new information, future developments or
otherwise.
Release authorized by the Chief Executive.
For more information, please contact:
Corporate Communications / Investors |
Media |
Paul Hughes |
Sumit Media |
T: +61 3 9639 6036 |
Grant Titmus |
E: investors@mesoblast.com |
T: +61 419 388 161 |
|
E: grant@sumitmedia.com.au |
|
|
|
Rubenstein |
|
Nadine Woloshin |
|
T: +1 917-699-9456 |
|
E: nwoloshin@rubenstein.com |
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