Mesoblast Licensee Files for Marketing Approval to Treat Epidermolysis Bullosa
March 25 2019 - 6:00AM
Mesoblast Limited (Nasdaq:MESO; ASX:MSB) today announced its
licensee in Japan, JCR Pharmaceuticals Co. Ltd., has filed to
extend marketing approval of TEMCELL®1 HS Inj. for use in patients
with Epidermolysis Bullosa (EB). TEMCELL is already
approved for the treatment of acute graft versus host disease
(aGVHD), and was the first allogeneic cellular medicine to
receive full regulatory approval in Japan.
The parties have amended their License Agreement in
order for JCR to access Mesoblast’s mesenchymal stem cell
(MSC) wound healing patents to enable it to develop and
commercialize TEMCELL for EB. Mesoblast will receive royalties on
TEMCELL product sales for EB.
JCR has received Orphan Designation for TEMCELL in
the treatment of EB based on promising results from an
investigator-initiated trial at Osaka University
Hospital where TEMCELL was subcutaneously administered. JCR
also intends to seek a label extension for TEMCELL in Japan for
intravenous delivery of TEMCELL.Mesoblast will have access to
clinical data generated by JCR in Japan to support development and
commercialization of its MSC product candidate remestemcel-L in
markets outside Japan for EB and other wound healing applications.
Mesoblast plans to file for United States FDA regulatory approval
of remestemcel-L shortly for the treatment of aGVHD.
There are many genetic and symptomatic variants of
EB, with all sharing the prominent symptom of extremely fragile
skin that blisters and tears from minor friction or trauma.
Internal organs and bodily systems can also be seriously affected
by the disease. EB is always painful, often pervasive and
debilitating, and is in some cases lethal before the age of 30. The
international branch of the Dystrophic Epidermolysis Bullosa
Research Association (DEBRA International) reports that there are
approximately 25,000 people with EB in the United States.
Currently, there are no effective treatments available2.
References 1. TEMCELL® HS Inj. is a registered
trademark of JCR Pharmaceuticals Co. Ltd. 2.
https://www.debra.org/itwonthurttowatch
About Mesoblast Mesoblast Limited (Nasdaq:
MESO; ASX:MSB) 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 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
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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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