- The minimum of 20M€ funding of the Joint Venture over the next three years is secured by local financial investors led by Hong Kong based Medisun International Ltd.
- The clinical program aims to lead to the commercialization of C-Cure® in the People’s Republic of China, Hong Kong and Taiwan.
- Medisun will also bring local regulatory, clinical and market access knowledge, while Cardio3 BioSciences will bring clinical and operational knowhow and expertise.
- With this additional clinical program in Asia, Cardio3 BioSciences will have access to the third largest pharmaceutical market in the world.
- The quality standards of the Asian operations will be managed by Cardio3 BioSciences, with the same rigor as the European and American operations.
Mont-Saint-Guibert, Belgium – Cardio3 BioSciences SA (C3BS) (Euronext Brussels and Paris : CARD), leader in the discovery and development of advanced regenerative therapies for heart disease, today announces it has entered into an agreement with Medisun International Limited, a financial investor based in Hong Kong aiming to build a life science portfolio, for the purpose of creating a joint venture to conduct Phase III clinical trials in Greater China (the People’s Republic of China, Hong Kong and Taiwan) potentially leading to the commercialization of C-Cure® in these territories. Medisun International Limited is also a shareholder of Cardio3 following a capital increase, the first phase of which became effective today.
The Joint Venture, named Cardio3 BioSciences Asia Holdings Ltd, will be created with the purpose to conduct pivotal clinical trials in Greater China, ie the People’s Republic of China, Hong Kong and Taiwan. Cardio3 BioSciences will bring to the Joint Venture the required IP rights to conduct a clinical trial in those geographies, the use of its C-Cure® manufacturing capabilities based in Mont-Saint-Guibert (Belgium) that will produce the clinical lots for the Phase III program, and its clinical and operational knowhow and expertise. Medisun will bring to the joint venture the funding required for the execution of the clinical trials, with a minimum committed of 20M€ over a three year period, as well as local knowledge of the clinical and regulatory environment.
Cardio 3 BioSciences’s ownership in the Joint Venture will be 40%, to be reduced to 30% when clinical trials are running in the three geographies.
A successful outcome of the Phase III clinical program in those geographies would trigger the right for the joint venture company to commercialize C-Cure® in those territories with royalties ranging between 20 and 30% of net sales depending on total revenue of the Joint Venture.
The obligations under the joint venture agreement are still subject to the completion of the second tranche (for 12.5M€) of a 25 M€ investment in Cardio 3 BioSciences by Medisun on 30 June 2014.
With clinical programs ongoing in Europe and Israel, and soon in the USA and Greater China (People’s Republic of China, Hong Kong and Taiwan), Cardio3 BioSciences confirms its leadership in the cardiac regenerative field with its global presence.
Dr Christian Homsy, CEO of Cardio3 BioSciences, said: “We are delighted to have the opportunity to access the world’s third largest pharmaceutical market at limited costs to Cardio3. In cooperation with a reputable local partner, we look forward to soon initiating one or more pivotal trials that would lead us towards commercialization in the world’s fastest growing economy. We are also delighted that both partners are committed to the most rigorous standards of pharmaceutical practices and scientific integrity.”
Mr Michel Lussier, Chairman of Cardio3 BioSciences, added: “With this presence in Greater China, we are very proud to become the first global player in the field of cardiac regenerative medicines, aiming to commercialize our leading edge cell therapy to patients all across the globe.”
Mr Danny Wong, Chairman of Medisun International Holdings Ltd., added: “I am very proud that we are able to pioneer the clinical development of this exciting technology in China and potentially later on in Asia. Our ultimate goal is to deliver this live-saving treatment to countless patients with heart problems.
We shall organize symposia this August in Beijing and Shanghai to promote cell based medicines as well as Cardio3’s technology. Leading experts from Europe, US and Asia will attend this event which will enable us to reach out and unite biomedical experts in this part of the globe.
We are passionate about this project and I am certain that our involvement with Cardio3 as a leader in this field, combined with our local knowledge of the regulatory, healthcare and market access capabilities and expertise, will bring success to all the parties involved.”
Conference call details
The company will host a conference call on Monday 16 June 2014 at 3:00 pm CET – 2:00 pm UK – 9:00 am EST.
The conference call will be held in English. Dial in numbers: International +44 (0) 1452 555566 / UK 08444933800 / Belgium 081700061 / France 0176742428 / USA 16315107498.
Conference ID: 61483860
Access to the conference call 10 minutes prior to its start time.