Mesoblast Appoints Dr. Eric Rose as Chief Medical Officer
February 01 2022 - 7:20PM
Mesoblast Limited (Nasdaq:MESO ASX:MSB), global leader in
allogeneic cellular medicines for inflammatory diseases, is pleased
to announce the appointment of Dr. Eric Rose as the Company’s Chief
Medical Officer (CMO). Dr. Rose has been a non-executive director
of Mesoblast since 2013. In his new role as a key executive, Dr.
Rose brings to Mesoblast an extensive record of excellence in
clinical development and successful interactions at the highest
levels with key regulatory, industry and government stakeholders
including the United States Food and Drug Administration (FDA), the
National Institutes of Health (NIH), and the Biomedical Advanced
Research and Development Authority (BARDA).
Dr. Rose is a highly respected physician scientist with focus on
clinical investigation, drug discovery, biodefense, and health
policy. As a world-renowned heart surgeon and scientist, Dr. Rose
led the Columbia Presbyterian heart transplantation program from
1982 through 1992 and made history in 1984 when he performed the
first successful pediatric heart transplant. From 1994 through
2007, he served as Chairman of Columbia University’s Department of
Surgery and Surgeon-in-Chief of Columbia Presbyterian Medical
Center in New York. During this time his leadership of the NIH
supported program Randomized Evaluation of Mechanical Circulatory
Support in Heart Failure (REMATCH) resulted in the first FDA
approval of an implantable left ventricular assist device for long
term circulatory support, spawning an entire new industry. Dr. Rose
continues to be a non-executive director of leading implantable
cardiovascular device company, ABIOMED.
From 2007-2011, Dr. Rose served on the National Biodefense
Scientific Board which advises the United States Health and Human
Services Secretary on biodefense, influenza, and emerging diseases.
In 2007 he was appointed Chairman and CEO of SIGA Technologies
where he oversaw development of the first antipoxviral drug
approved in the United States, TPOXX for the treatment of smallpox.
Dr. Rose played a key role in obtaining FDA approval of the drug in
2019, and he was responsible for securing contracts with BARDA
under which the US Government has procured 1.7 million courses of
TPOXX for more than US$1billion into the Strategic National
Stockpile (SNS).
Dr. Rose said, “I very much look forward to being an integral
part of Mesoblast’s leadership management team at such a pivotal
moment in the Company’s history. Having seen first-hand at Board
level the tremendous potential of our technology to achieve
remarkable clinical outcomes in the most refractory of inflammatory
conditions, I feel privileged to be able to contribute in a more
comprehensive way to help steer our therapies through the final but
crucial stages of regulatory approval and commercialization.”
Mesoblast Chief Executive Dr. Silviu Itescu thanked outgoing CMO
Dr. Fred Grossman for his important contributions, particularly in
regard to the regulatory progress of remestemcel-L in children with
steroid-refractory acute graft versus host disease (SR-aGVHD) and
his role in the Company’s pivot to COVID-19 acute respiratory
distress syndrome. Dr. Grossman will continue to provide support to
the Company in an ongoing advisory role.
Dr. Itescu said, “We are delighted to have Dr. Rose move into
the critical CMO position for Mesoblast at such an important period
in the Company’s development. He is a world-renowned physician with
extensive commercialization experience and a proven track record in
successfully navigating products through the FDA in addition to his
extensive network across government, regulatory bodies and the
pharma industry.”
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 stromal
cell technology platforms. Remestemcel-L is being developed for
inflammatory diseases in children and adults including steroid
refractory acute graft versus host disease and moderate to severe
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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