JCR pharmaceuticals files for Japanese marketing approval of stem cell product.
MELBOURNE, Australia, September 30, 2014 -- JCR Pharmaceuticals Co Ltd (JCR), the Japanese partner of Mesoblast Limited (USOTC: MBLTY), has filed with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) to receive approval for manufacturing, marketing, and product registration of the allogeneic or "off-the-shelf' Mesenchymal Stem Cell (MSC) product JR-031 for the treatment of acute graft versus host disease (GVHD) in children and adults.
The product registration filing by JCR will be subject to a priority review as JR-031 has been granted orphan drug status. If the filing is successful, JR-031 will be the first allogeneic cell-based product approved in Japan.
Mesoblast is entitled to receive milestone payments on JR-031 product regulatory filings, approvals, royalties and other payments at pre-defined thresholds of cumulative net sales.
In addition, Mesoblast has the worldwide rights to develop JR-031 for all clinical indications, other than for hematologic malignancies in Japan. JCR has a right of first negotiation to obtain rights to commercialize other MSC-based orphan designations in Japan.
Mesoblast plans a product registration filing with the FDA for its allogeneic MSC product in children with steroid-refractory acute GVHD in 2016.
Mesoblast says it remains on track for commercial launch of its allogeneic MSC product in Canada and New Zealand in 2016 in children with GVHD.
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|Title Annotation:||Strategic Alliances|
|Publication:||Stem Cell Business News|
|Date:||Oct 6, 2014|
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