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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.

Contact: http://www.mesoblast.com

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Title Annotation:Strategic Alliances
Publication:Stem Cell Business News
Geographic Code:9JAPA
Date:Oct 6, 2014
Words:215
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