Mont-Saint-Guibert, Belgium - Celyad SA (Euronext Brussels, Euronext Paris and Nasdaq: CYAD), a leader in the discovery and development of engineered cell therapies, today announced that it has entered into a new collaboration and distribution agreement with its Hong-Kong based partner, Medisun International Limited (“Medisun”). This license agreement confirms Celyad’s intention to expand the global footprint of its lead cardiac disease cell therapy candidate for the treatment of ischemic heart failure, C-Cure®.
Under the terms of the new license agreement, Celyad will conduct all clinical development and undertake any regulatory steps necessary for market approval in China, Hong-Kong, Taiwan and Macau (collectively “Greater China”). With a minimum of €20 million, these activities will be funded by Medisun. Celyad expects initial clinical development activities to take place in Hong-Kong with the potential addition of clinical sites in Celyad’s CHART-2 trial, which is expected to be initiated before the end of 2015.
In exchange for the license, and in addition to the benefit of the funding provided by Medisun to support clinical development , Celyad will receive royalties and profit sharing. The royalty rates ranging from 10% to 30% are calculated on total revenues of C-Cure®, and profit sharing ranging from 20 to 25% are calculated on total revenues less royalties.
This agreement will last for an initial period of fifteen years, subject to earlier termination as specified in the agreement.
Dr. Christian Homsy, CEO of Celyad, commented, “We are pleased to have this new license agreement in place with our local partner Medisun which give us full control over clinical developments in these territories, fully funded by our local partner. Pending receipt of necessary approvals, we look forward to giving access to this technology to patients in Greater China”.
C-Cure® is Celyad's most advanced product candidate based on its cardiopoiesis platform and is being developed for heart failure indications. The Company expects to release the full clinical data set for CHART-1, its Phase III trial in Europe and Israel, in the middle of 2016. The research underlying this technology was originally conducted at Mayo Clinic by the research team of Professor André Terzic and Atta Behfar, and has been published in numerous peer-reviewed publications. C-Cure® consists of a patient's own cells harvested from bone marrow, treated with cardiopoietic growth factors and then re-injected into the heart. It is designed to produce new autologous heart muscle cells which behave identically to those lost as a result of infarction, without the risk of rejection.
C-Cure®’s potential has been demonstrated in a multi-centre randomized controlled Phase II trial conducted in Europe. The results of the C-Cure® Phase II trial were published in April 2013 in the Journal of American College of Cardiology.