Mesoblast Japan Strategy Highlighted at Australia-Japan Business Council Annual Meeting
October 12 2016 - 6:00AM
Mesoblast Limited (Nasdaq:MESO) (ASX:MSB) yesterday gave a
strategic update on its product commercialization plans in Japan.
Mesoblast was the sole life sciences or healthcare company
invited to participate in the 54th annual meeting of
the Australia-Japan Joint Business Council, held in
Melbourne from October 9-11.
Mesoblast Chief Executive Silviu Itescu told
more than 400 business leaders from Japan and
Australia that the Company's strategy is to leverage
results from its global Phase 2 and 3 clinical trials to support
regulatory filings for conditional and full product approvals by
its commercial partners for the Japanese market.
In February 2016, Mesoblast’s Japan licensee for
acute graft versus host disease, JCR Pharmaceuticals Co.
Ltd., launched TEMCELL® HS Inj., in Japan. TEMCELL is the
first allogeneic cell-based medicine to receive full regulatory
approval in Japan. Mesoblast is entitled to receive royalties and
other payments at pre-defined thresholds of cumulative net
sales.
Mesoblast's most advanced product candidate, MPC-150-IM, with
blockbuster potential for the treatment of heart failure, is well
positioned to meet criteria for conditional approval under the
new Japanese Pharmaceuticals, Medical Devices and Other
Therapeutic Products Act for regenerative medicines, and for full
approval.
MPC-150-IM is currently in an advanced Phase 3 trial across
multiple sites in North America with an interim analysis of the
trial's primary endpoint planned for the first quarter of 2017.
Results from this trial could support Japanese regulatory filings
and product launch, in conjunction with data in a limited
number of Japanese patients. Mesoblast is engaged in active
discussions with potential commercial partners for the Japanese and
global heart failure markets.
It is estimated that the total heart failure patient population
in Japan in 2016 is 1.45 million, with the annual direct medical
cost for heart disease estimated at ¥800 billion.
About MesoblastMesoblast Limited (Nasdaq:MESO)
(ASX:MSB) is a global leader in developing innovative cell-based
medicines. The Company has leveraged its proprietary technology
platform, which is based on specialized cells known as mesenchymal
lineage adult stem cells, to establish a broad portfolio of
late-stage product candidates. Mesoblast’s allogeneic,
‘off-the-shelf’ cell product candidates target advanced stages of
diseases with high, unmet medical needs including cardiovascular
diseases, immune-mediated and inflammatory disorders, orthopedic
disorders, and oncologic/hematologic conditions.
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. 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:
Schond Greenway
Investor Relations, Mesoblast
T: +1 212 880 2060
E: schond.greenway@mesoblast.com
Julie Meldrum
Corporate Communications, Mesoblast
T: +61 3 9639 6036
E: julie.meldrum@mesoblast.com
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