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TOPIC: Japan News From Mesblast

Japan News From Mesblast 03 Sep 2015 21:08 #5150

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New York, USA, and Melbourne, Australia; 4 September 2015: Mesoblast Limited (ASX:
MSB; USOTC: MBLTY) today announced that the allogeneic mesenchymal stem cell-based
regenerative medicine product JR-031, developed by Mesoblast's Japanese partner JCR
Pharmaceuticals Co. Ltd., was recommended for approval on 2 September at a meeting organized
by the Committee on Regenerative Medicine Products and Biological Technology of Pharmaceutical
Affairs and Food Sanitation Council of the Japan Ministry of Health, Labour and Welfare. JCR said
marketing approval of JR-031 is anticipated in the near future.

JR-031 is a treatment for acute Graft Versus Host Disease (GVHD), a severe complication arising
from hematopoietic cell transplants, which JCR has been developing in Japan utilizing technology
under a licence from Mesoblast. JCR stated that clinical trials demonstrated the efficacy and safety
of JR-031 which led to their filing for a marketing approval in September 2014.
Under its agreement with JCR, Mesoblast is entitled to receive milestone payments on JR-031
product regulatory approvals, as well as royalties and other payments at pre-defined thresholds of
cumulative net sales.

Mesoblast is conducting an additional open-label Phase 3 study in the United States of its
allogeneic MSC product in approximately 60 children, the results of which are expected to support
a Biologics License Application to the United States Food and Drug Administration for pediatric
product registration.

Graft Versus Host Disease
In patients who have received a bone marrow transplant, donor cells may attack the person
receiving the transplant, causing acute GVHD. According to the Center for International Blood and
Marrow Transplant Research, there are approximately 30,000 allogeneic bone marrow transplants
globally per year for diseases including hematological cancers. Nearly 50% of all allogeneic bone
marrow transplants develop acute GVHD which is associated with the greatest risk of death with
mortality rates of up to 90%.

Mesoblast Limited
Mesoblast Limited (ASX: MSB; USOTC: MBLTY) is a global leader in regenerative medicine. 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 or ‘off-the-shelf’ cell product candidates target
significantly advanced stages of diseases where there are highly unmet medical needs, including
cardiovascular conditions, orthopedic disorders, immunologic/inflammatory disorders and
oncology/hematology conditions. The lead therapeutic product candidates under investigation
include MPC-150-IM for chronic heart failure, MPC-06-ID for chronic discogenic low back pain,
MSC-100-IV for acute graft versus host disease, and MPC-300-IV for diabetic nephropathy and
biologic refractory rheumatoid arthritis.

For further information, please contact:
Julie Meldrum
Global Head of Corporate Communications
Mesoblast Limited
T: +61 (0) 3 9639 6036
E: This email address is being protected from spambots. You need JavaScript enabled to view it.

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