New Japanese Regenerative Medicine Legislation and Commercial …

November 24, 2013 19:16 | Source: Mesoblast

NEW YORK and MELBOURNE, Australia, Nov. 25, 2013 (GLOBE NEWSWIRE) -- Regenerative medicine company Mesoblast Limited (ASX: MSB; USOTC: MBLTY) today gave an update on new legislation which provides a framework for accelerated approval of stem cell products in Japan, the world's second-largest mature healthcare market.

Japan's parliament, the Diet, enacted a Bill last week which revised the existing Pharmaceutical Affairs Law to define new medical products which contain stem cells to be termed regenerative medicine products. The Bill allows the Japanese Government to give conditional approval to such products if their safety is confirmed in clinical trials, as may occur on completion of Phase 2.

Chief Executive Silviu Itescu discussed how the new legislation in Japan could positively impact the Company, during an interview with Inside Business on ABC-TV yesterday. To view the interview, please visit: http://www.abc.net.au/insidebusiness/

As a result of the new legislation, a pathway now exists in Japan for Mesoblast to commercialize its mesenchymal lineage stem and precursor cell products within a significantly shorter timeframe. Mesoblast intends to establish strategic partnerships for its suite of products to facilitate earlier Japanese regulatory approvals and commercial launches.

Mesoblast's first strategic partnership in Japan is with JCR Pharmaceuticals for its culture-expanded mesenchymal stem cell (MSC) product to treat steroid refractory graft-versus-host disease. JCR intends to file for Japanese marketing approval of its MSC product JR-031 before the end of the first quarter 2014 under the existing regulatory framework. If the filing is successful, JR-031 will be the first allogeneic or 'off-the-shelf' cell-based product approved in Japan.

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New Japanese Regenerative Medicine Legislation and Commercial ...