Mesoblast and JCR Pharmaceuticals Expand Japan License Agreement to Use of Mesenchymal Stem Cells in Newborns With Insufficie...
June 11 2019 - 6:00AM
Mesoblast Limited (ASX:MSB; Nasdaq:MESO) today announced it has
expanded its partnership with JCR Pharmaceuticals Co. Ltd. in Japan
to the use of mesenchymal stem cells (MSCs) for the treatment of
newborns who lack sufficient blood supply and oxygen to the brain,
a condition termed neonatal hypoxic ischemic encephalopathy
(HIE).
HIE occurs in 2.5 per 1,000 live births1 and can cause seizures,
delayed development of motor skills and cognitive function, and
cerebral palsy2. In preclinical studies, MSCs have been shown
to have a significant positive effect on neurobehavioral outcome
following HIE injury3.
JCR is marketing the allogeneic MSC product TEMCELL®4 HS Inj.
for the treatment of steroid-refractory acute graft versus host
disease (aGVHD) in children and adults in Japan. Under the terms of
the partnership, Mesoblast receives royalties on TEMCELL product
sales for all licensed indications. The license agreement was
previously expanded for use in wound healing in patients with
Epidermolysis Bullosa (EB), and JCR filed to extend marketing
approval of TEMCELL in Japan for this indication in March
2019.
The license agreement has now been further expanded to provide
JCR with rights to sell TEMCELL for HIE and to access Mesoblast’s
broad patent portfolio for this indication. JCR plans to
initiate a clinical trial of TEMCELL in newborns with HIE in July
2019 in order to further extend the label in this indication.
Mesoblast has the right to use all safety and efficacy data
generated by JCR in Japan to support its development and
commercialization plans for its MSC product candidate remestemcel-L
in the United States and other major healthcare markets, including
for GVHD, wound healing, and now HIE. In the United States
there are approximately 6,000 new patients annually with
moderate-severe HIE2 who could potentially benefit from treatment
with remestemcel-L.
Mesoblast Chief Executive Dr Silviu Itescu stated: “We are
pleased with the strategy by our partner to expand TEMCELL
marketing approval for indications beyond aGVHD. This supports our
own strategic growth plans for our MSC product candidate
remestemcel-L beyond aGVHD in children, including other pediatric
indications such as HIE and adult conditions such as aGVHD, chronic
GVHD, biologic-refractory Crohn’s disease, and
osteoarthritis.”
Mesoblast recently initiated a rolling Biologics License
Application to the U.S Food and Drug Administration for
remestemcel-L, its proprietary MSC product candidate, in the
treatment of children with aGVHD.
1. Graham EM et al. A systematic review of the role of
intra-partum hypoxia-ischemia in the causation of neonatal
encephalopathy. Am J Obstetrics and Gynecology 2008:587-595
Lack of sufficient oxygen and blood perfusion to the brain,
resulting in brain injury. 2. Lee AC, Kozuki N,
Blencowe H, Vos T, Bahalim A, Darmstadt GL, Niermeyer S, Ellis M,
Robertson NJ, Cousens S, Lawn JE. Intrapartum-related neonatal
encephalopathy incidence and impairment at regional and global
levels for 2010 with trends from 1990. Pediatr Res 2013; 74 Suppl
1: 50-723. Archambault J, et al. Therapeutic potential of
mesenchymal stromal cells for hypoxic ischemic encephalopathy: A
systematic review and meta-analysis of preclinical studies. PLoS
ONE 2017; 12(12): https://doi.org/10.1371/journal.pone.01898954.
TEMCELL® HS Inj. is a registered product of JCR Pharmaceuticals Co.
Ltd.
About Mesoblast Mesoblast Limited (ASX: MSB;
Nasdaq: MESO) is a world leader in developing allogeneic
(off-the-shelf) cellular medicines. The Company has leveraged its
proprietary technology platform to establish a broad portfolio of
late-stage 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 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 in aGVHD; Mesoblast and its collaborators’ ability to
advance product candidates into, enroll and successfully complete,
clinical studies; the timing or likelihood of regulatory filings
and approvals for aGVHD; and the pricing and reimbursement of
Mesoblast and its collaborators’ 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 Corporate Communications T: +61 3 9639
6036E: julie.meldrum@mesoblast.com |
Schond
GreenwayInvestor RelationsT: +1 212 880
2060E: schond.greenway@mesoblast.com |
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