Industry Update: Regulations, approvals, acquisitions

Latest business developments compiled from October 01 — November 30 2015

Latest business developments in the field of stem cell research and
regenerative medicine compiled from publicly available information and
press releases from non-academic institutions October 01 — November 30 2015, scheduled to be published in Volume 11 Issue 2 of Regenerative Medicine.

Green light

Kiadis

Kiadis Pharma (the Netherlands; www.kiadis.com) has obtained regulatory approvals from the national authorities both in Canada and in Belgium to start a further Phase II clinical trial with its lead product ATIR101â„¢. ATIR101 is a cell-based product designed to enable stem cell transplantations from haploidentical family donors for blood cancer patients who do not have a matching stem cell donor available.

Red light

Athersys and Chugai

Athersys, Inc. (OH, USA; www.athersys.com) and Chugai Pharmaceutical (Japan; www.chugai-pharm.com) have ended the license agreement between them for the exclusive development and commercialization of MultiStem® cell therapy for ischemic stroke in Japan. The parties were unable to reach an agreement on the modification of the financial terms of the agreement and on development strategy in Japan, in light of the results from the Phase 2 clinical study. All rights will revert to Athersys, and Athersys will retain the US$ 10 million license fee paid by Chugai.

Acquisitions

Astellas and Ocata

Astellas Pharma (Japan; www.astellas.com/en/index.html) has agreed to buy Ocata Therapeutics (MA, USA; www.ocata.com), which is developing regenerative medicines for eye diseases. It’s an all-cash deal worth US$ 379 million, with the Astellas offer of US$ 8.50 a share representing a 79% premium to Ocata’s share price at the end of November 6.