HAIFA, Israel, Sept. 16, 2014 (GLOBE NEWSWIRE) — Pluristem Therapeutics Inc. (PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapy products, announced today it is evaluating strategic opportunities to co-develop and commercialize its PLacental eXpanded (PLX) cell therapies in Japan.
Recent changes in Japan’s laws governing regenerative medicine and the approval of stem cell therapies indicate the country may now offer the fastest track to commercialization in the world for regenerative medicine treatments. As part of Pluristem’s strategy in Japan, on September 16, 2014, Company executives presented to a group of Japanese pharmaceutical executives in Tokyo, and conducted a series of one-on-one meetings with Japanese companies exploring a potential partnership with Pluristem.
To support its strategy in Japan, Pluristem is working with The Sage Group, a consulting firm specializing in healthcare industry transactions and business strategy, and Sage’s partner Waterfield HealthCom, a Japan-based firm managed by Yoshi Mizuta. Mr. Mizuta is a highly experienced pharmaceutical industry executive with more than 40 years in the business of financial healthcare transactions in the Japanese arena.
Japan’s government passed a bill in 2013, which goes into effect in November of this year, effectively fast-tracking the approval of stem cell therapies for marketing. According to the law, stem cell regenerative medicine therapies can receive conditional, time-limited approval for marketing, and be eligible for reimbursement, upon proof of safety but prior to verification of efficacy; safety and effectiveness need to be confirmed after the conditional approval.
Waterfield HealthCom’s Mr. Mizuta commented, “With its broad portfolio of indications and its commercial scale 3D cell manufacturing capabilities, Pluristem is a very desirable partner for Japanese pharmaceutical companies looking to bring cell therapies to the market in the near term.”
“As a result of Japan’s favorable new law, cell therapies like Pluristem’s PLX cells can receive market approval in Japan upon completion of Phase II trials when good safety and efficacy data is available. This could potentially reduce approval time down to two or three years,” Mr. Mizuta concluded.
Pluristem CEO Zami Aberman added, “The opportunity in Japan opens an accelerated path for the global regenerative medicine industry to prove the efficacy of cell therapies in a broad patient population in Japan. Japan has one of the most advanced healthcare systems, and the second largest healthcare market in the world.”
Pluristem currently has co-development and out-licensing partnership agreements with United Therapeutics (UTHR) and South-Korea-based CHA Bio&Diostech (CHA).
