Mesoblast Presents Commercial Plans at 2020 Biotech Showcase in San Francisco
January 15 2020 - 6:00AM
Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in
allogeneic cellular medicines for inflammatory diseases,
today reported that the United States Food and Drug
Administration (US FDA) has agreed to the selection
of Ryoncil™ as the commercial name for its lead
allogeneic cell therapy remestemcel-L in
the treatment of pediatric steroid-refractory acute graft
versus host disease (aGVHD). Commercial plans for Ryoncil™ were
presented at the 2020 Biotech Showcase being held this week in
San Francisco, CA.
Mesoblast Chief Executive Dr. Silviu Itescu said:
“We begin 2020 with great excitement as we prepare for
potential FDA approval and US launch of our lead product
candidate Ryoncil™ in pediatric aGVHD, a potentially
life-threatening complication of an allogeneic bone marrow
transplant. The continued growth in revenues from royalties on
sales in Japan of the related product TEMCELL®1 for aGVHD by our
licensee provides important insight for our own US commercial
plans. Together with our strategic partners, we are also looking
forward to readouts of Phase 3 trials for our blockbuster
product candidates in advanced chronic heart failure and chronic
low back pain due to degenerative disc disease.” The final module
of the rolling Biologics License Application for Ryoncil™ will
be filed with the FDA in January, following which the Company will
request a priority FDA review of the BLA under the product
candidate’s existing Fast Track designation. If approved, Ryoncil™
is planned to be launched in the US in 2020.
A webcast of the presentation is available via
https://event.webcasts.com/starthere.jsp?ei=1278810&tp_key=f1494febd2
and as an archived webcast for 90 days on the Investors & Media
section of the Company’s website at www.mesoblast.com.
About Ryoncil™ (remestemcel-L)Mesoblast’s lead
product candidate, Ryoncil™, is an investigational therapy
comprising culture-expanded mesenchymal stem cells derived from the
bone marrow of an unrelated donor. It is administered to patients
in a series of intravenous infusions. Ryoncil™ is believed to have
immunomodulatory properties to counteract the inflammatory
processes that are implicated in aGVHD 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.
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 cell
therapy technology platform to establish a broad portfolio of
commercial products and late-stage product candidates. Two products
have been commercialized in Japan and Europe by its licensees, and
it has established commercial partnerships in Europe and China for
certain Phase 3 assets. In the United States, Mesoblast has
initiated submission of a rolling Biologics License Application to
the FDA to seek approval of its product candidate for acute graft
versus host disease following a successful Phase 3 trial, and is
completing Phase 3 trials for its advanced heart failure and
chronic low back pain product candidates. Mesoblast’s
proprietary manufacturing process yields industrial-scale, frozen,
off-the-shelf, cellular medicines based on its mesenchymal lineage
cell platform technology. These cell therapies, with defined
pharmaceutical release criteria, are planned to be readily
available to patients worldwide. Mesoblast has locations in
Melbourne, New York, Singapore and Texas 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
Mesoblast’s 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.Release authorized by the Chief Executive.
1.TEMCELL HS Inj. is a registered trademark of JCR
Pharmaceuticals Co. Ltd.
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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