Pluristem sets up Japanese stem cell JV

Zami Aberman

In partnership with Sosei, Pluristem has formed NewCo for the clinical development and commercialization of Pluristem’s PLX-PAD cell therapy in Japan.

Israeli stem cell developer Pluristem Therapeutics Ltd. (Nasdaq:PSTI; TASE: PSTIPLTR) and Japanese Sosei Group Corp. unit Corporate Venture Capital Ltd. today announced the signing of a binding term sheet for the establishment of a new Japanese corporation (NewCo) for the clinical development and commercialization of Pluristem’s PLX-PAD cell therapy product in Japan.

Following completion of fund-raising, the parties plan to establish NewCo in Japan. Pluristem will own 35% of NewCo in return for its contribution of a perpetual license to commercialize PLX-PAD for Critical Limb Ischemia (CLI) in Japan. All proprietary rights related to PLX-PAD will be exclusively owned by Pluristem. Sosei CVC’s investment fund, Sosei RMF1, together with additional Japanese investors, will raise and invest approximately $11 million, equivalent to approximately ‎¥‎1.3 billion, in return for ownership of 65% of NewCo.

The first indication to be developed by NewCo will be CLI. The design of a 75-patient study of PLX-PAD in CLI was previously agreed upon with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) under an accelerated regulatory pathway for regenerative medicine. This single study may lead to early conditional marketing approval and early reimbursement. Future marketing activities are planned to be undertaken by NewCo. The parties plan to enter into a definitive agreement no later than March 31 2017.

Pluristem chairman and CEO Zami Aberman said, “We are pleased to partner with Sosei CVC to commercialize PLX-PAD in Japan. The development of our CLI program through the accelerated regulatory pathway could allow a more rapid entrance into the sizeable Japanese market, as has been our strategy. Our cooperation with Sosei CVC also creates the potential to develop additional indications in this market, by drawing on our robust portfolio of cell therapy product candidates in development."

“We are eager to begin the joint development of PLX-PAD in critical limb ischemia with the goal of commercialization, and believe that our cooperation could lead to an efficient and successful entry into Japan’s substantial market,” said Toshimi Miyoshi, Director, Sosei CVC. “The NewCo is expected to be a meaningful investment by Sosei RMF1 into the regenerative medicine space, and will support our goal to stimulate the biotechnology industry in Japan."

Published by Globes [online], Israel business news - www.globes-online.com - on December 20, 2016

© Copyright of Globes Publisher Itonut (1983) Ltd. 2016

Zami Aberman
Zami Aberman
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