Mesoblast Wins 2020 Fierce Biotech Innovation of the Year Award for remestemcel-L
September 15 2020 - 6:00AM
Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in
allogeneic cellular medicines for inflammatory diseases, today
announced that its lead product candidate remestemcel-L has been
selected as the winner of the Fierce Innovation Awards - Life
Sciences Edition 2020 for Biotech Innovation. The Fierce
Innovation Awards is a peer-reviewed program from the publisher
of FierceBiotech and FiercePharma.
Mesoblast Chief Executive Dr Silviu Itescu stated: “This
important award is recognition of Mesoblast’s leadership as an
innovator in the cell therapy industry, and of the potential for
remestemcel-L to profoundly impact the lives of children suffering
with steroid-refractory acute graft versus host disease
(SR-aGVHD).”
Remestemcel-L is under priority review by the United States Food
and Drug Administration (FDA) for pediatric SR-aGVHD and, if
approved, product launch in the United States is expected in 2020.
The FDA has set a Prescription Drug User Fee Act (PDUFA) action
date of September 30, 2020.
Remestemcel-L is an investigational therapy comprising
culture-expanded mesenchymal stem cells derived from the bone
marrow of an unrelated donor. It is thought to have
immunomodulatory properties to counteract the cytokine storms that
are implicated in various inflammatory conditions by
down-regulating the production of pro-inflammatory cytokines,
increasing production of anti-inflammatory cytokines, and enabling
recruitment of naturally occurring anti-inflammatory cells to
involved tissues.
Given the extensive inflammatory response in COVID-19 infection,
remestemcel-L is also being evaluated in a randomized, controlled
Phase 3 trial in up to 300 ventilator-dependent adults with
moderate to severe acute respiratory distress syndrome (ARDS), the
primary cause of mortality in COVID-19 patients. The trial aims to
confirm results from a pilot study at New York’s Mt Sinai hospital
which showed that nine of 12 patients (75%) were successfully
discharged from hospital a median of 10 days after receiving two
intravenous doses of remestemcel-L within five days. The
trial’s independent Data Safety Monitoring Board (DSMB) recently
completed an interim analysis of the trial’s first 30% enrolled
patients and recommended that the trial should continue as planned
after reviewing all safety data and results for the trial’s primary
endpoint of all-cause mortality within 30 days of
randomization. The DSMB will perform a second interim analysis
when 45% of the enrollment target has completed 30 days of
follow-up. About Fierce
Innovation Awards – Life Sciences Edition 2020These awards
highlight companies that demonstrate innovative solutions,
technologies, and services that have the potential to make the
greatest impact for biotech and pharma companies. The
evaluation criteria are effectiveness, technical innovation,
competitive advantage, financial impact, and true
innovation. The awards program’s applications were reviewed by
a panel of executives from major biotech and
pharma companies including Astellas, Accenture,
AstraZeneca, Angiocrine Bioscience, Biotech Research Group, NIHR
Clinical Research Network, Medidata Solutions and PPD.
About MesoblastMesoblast Limited (Nasdaq:MESO;
ASX:MSB) is a world leader in developing allogeneic (off-the-shelf)
cellular medicines. The Company has leveraged its proprietary
mesenchymal lineage cell therapy technology platform to establish a
broad portfolio of commercial products and late-stage product
candidates. Mesoblast has a strong and extensive global
intellectual property (IP) portfolio with protection extending
through to at least 2040 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’s Biologics License Application to seek approval of
its product candidate RYONCIL™ (remestemcel-L) for pediatric
steroid-refractory acute graft versus host disease has been
accepted for priority review by the United States Food and Drug
Administration (FDA), and if approved, product launch in the United
States is expected in 2020. Remestemcel-L is also being developed
for other inflammatory diseases in children and adults including
moderate to severe acute respiratory distress syndrome (ARDS).
Mesoblast is completing Phase 3 trials for its product candidates
for advanced 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 announcement
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 timing,
progress and results of Mesoblast’s preclinical and clinical
studies; Mesoblast’s ability to advance product candidates into,
enroll and successfully complete, clinical studies; the timing or
likelihood of regulatory filings and approvals; and the pricing and
reimbursement of Mesoblast’s product candidates, if approved;
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. 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 further information, please contact:
MediaJulie MeldrumT: +61 3 9639
6036E: julie.meldrum@mesoblast.com |
Kristen BothwellT: +1 917 613
5434E: kbothwell@rubenstein.com |
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InvestorsSchond
GreenwayT: +212 880 2060E: schond.greenway@mesoblast.com |
Paul Hughes T:
+61 3 9639 6036E: paul.hughes@mesoblast.com |
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