FDA Agrees to Rolling Review of Mesoblast’s Biologics License Application for Its Cell Therapy in Children With Steroid-Ref...
April 16 2019 - 6:00AM
Mesoblast Limited (Nasdaq:MESO; ASX:MSB) global leader in cellular
medicines for inflammatory diseases, announced today that the
United States Food and Drug Administration (FDA) has agreed that
Mesoblast can submit on a rolling basis a Biologics License
Application (BLA) for its allogeneic cellular medicine
remestemcel-L in children with steroid-refractory acute Graft
Versus Host Disease (SR-aGVHD).
Mesoblast will submit each module of the BLA to the FDA on a
rolling basis as it is completed. The rolling process will provide
opportunity for ongoing and frequent communication, and during this
process the Company expects it will be able to adequately address
any substantial matters raised by the FDA. Mesoblast has previously
received Fast Track designation from the FDA for remestemcel-L in
SR-aGVHD and is eligible for priority review once the BLA filing is
completed and accepted by the FDA. Mesoblast expects to submit the
first module shortly.
About Steroid-refractory Acute Graft Versus Host
Disease SR-aGVHD is a life-threatening complication
of a bone marrow transplant in patients primarily being treated for
blood cancers. There are more than 30,000 allogeneic bone marrow
transplants performed globally, with a total of over 20,000 in the
United States and the EU5 annually. Approximately 20% occur in
children. Currently, there are no approved products for SR-aGVHD in
children outside Japan, where Mesoblast licensee JCR
Pharmaceuticals markets TEMCELL®1 HS Inj. for both children
and adults with aGVHD.
About MesoblastMesoblast Limited (Nasdaq:MESO;
ASX:MSB) has leveraged its proprietary immunomodulatory cellular
technology platform to establish a broad portfolio of late-stage
allogeneic (off-the-shelf) product candidates with three product
candidates in Phase 3 trials – acute graft versus host disease,
chronic heart failure and chronic low back pain due to degenerative
disc disease. Mesoblast has developed proprietary cell
manufacturing processes, including use of immunoselection, master
cell banks, industrialized culture expansion, potency assays, and
stringent lot release criteria, to enable large-scale production of
cellular therapies that can be used with off-the-shelf logistics
from a single donor to thousands of unrelated recipients.
Mesoblast has facilities in Melbourne, New York, Singapore
and Texas and is listed on the Australian Securities Exchange (MSB)
and on the Nasdaq (MESO). www.mesoblast.com
1. TEMCELL® HS Inj. is a registered trademark of JCR
Pharmaceuticals Co. Ltd.
Forward-Looking Statements This 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. 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.
For further information, please contact:
Julie Meldrum |
Schond Greenway |
Corporate Communications |
Investor Relations |
T:
+61 3 9639 6036 |
T:
+1 212 880 2060 |
E:
julie.meldrum@mesoblast.com |
E:
schond.greenway@mesoblast.com |
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