Mesoblast Highlights 2019 Key Priorities for its Leading Cellular Medicines Pipeline at Biotech Showcase in San Francisco
January 07 2019 - 7:44PM
Mesoblast Limited (ASX:MSB; Nasdaq:MESO), world leader in the
development and commercialization of cellular medicines, today
reported on commercial and development plans for its lead cellular
therapies to Biotech Showcase 2019 being held this week in San
Francisco, CA.
Mesoblast Chief Executive Dr Silviu Itescu said: "We enter
calendar 2019 building upon the successful advancement of our
late-stage pipeline where we successfully completed a Phase 3 trial
in steroid-refractory acute graft versus host disease (aGVHD) which
has near-term commercial potential in the United States (U.S.), and
another product candidate having achieved clinical outcomes in line
with the U.S. Food and Drug Administration (FDA) guidance for a
registrable clinical indication for market authorization, and two
additional Phase 3 assets with blockbuster potential. With the
momentum of these marquee therapies, we are preparing for multiple
milestones and inflection points across these product candidates in
the coming year.”
Dr Itescu told meeting attendees that in 2019 Mesoblast plans to
work diligently with the FDA to submit a rolling Biologics License
Application for use of remestemcel-L in treating aGVHD in children,
and will execute on the product candidate’s market access and
commercialization strategy.
The meeting attendees were also told that 2019 will be a pivotal
year for the Company’s heart failure product candidate Revascor.
Mesoblast will meet with the FDA in the first half of 2019 to
discuss a potential approval pathway for Revascor in patients with
end-stage heart failure and a left ventricular assist device. This
follows the clinically meaningful outcomes of reduction in major
gastrointestinal bleeding and related hospitalizations achieved in
the 159-patient U.S. National Institutes of Health-funded trial in
these patients. In addition, Dr Itescu provided the key takeaways
on the Phase 3 trial of Revascor for patients with advanced heart
failure which has completed recruitment of approximately 570
patients.
A webcast of the presentation is available via
https://event.webcasts.com/starthere.jsp?ei=1226368&tp_key=1f4916da2
and as an archived webcast for 90 days on the Investors & Media
section of the Company’s website at www.mesoblast.com
About MesoblastMesoblast Limited (ASX:MSB;
Nasdaq:MESO) has leveraged its proprietary 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.
Through a proprietary process, Mesoblast selects rare mesenchymal
lineage precursor and stem cells from the bone marrow of healthy
adults and creates master cell banks, which can be industrially
expanded to produce thousands of doses from each donor that meet
stringent release criteria, have lot to lot consistency, and can be
used off-the-shelf without the need for tissue matching. 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
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. 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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