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Agreements

Date: 2014-06-16

Type of information: Joint-venture agreement

Compound: C-Cure®

Company: Cardio3 BioSciences (Belgium) Medisun International (China)

Therapeutic area: Cardiovascular diseases

Type agreement:

joint-venture

Action mechanism:

Cardio3 BioSciences teams up with Medisun International to create Cardio3 BioSciences Asia Holdings Ltd, a Joint Venture aimed at conducting pivotal clinical programs in Greater China 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 -

Disease:

Details:

* On June 16, 2014, Cardio3 BioSciences, a belgian company dedicated to the discovery and development of advanced regenerative therapies for heart disease, announced 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 the same day.
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 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.

Financial terms:

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Is general: Yes