- 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.
Regulatory News:
Cardio3 BioSciences SA (C3BS) (Paris:CARD) (Brussels: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.
*** END ***
About Medisun International Limited
Medisun International Limited is a Hong Kong registered company
and its vision is to improve human health and well-being through
the delivery of cutting-edge cell based medicines. Medisun aims to
provide innovative cell therapies and advanced biological
medicinal products to China and other countries in the Asia Pacific
region.
Medisun is committed to quality. The company is built upon
strong leadership and management skills with proven competencies
that understand the healthcare needs and market of Asia. Medisun’s
capabilities are underscored by a strong team of technical and
clinical specialists within the fields of regenerative medicine and
cell based therapies.
About Cardio3 BioSciences
Cardio3 BioSciences is a Belgian leading biotechnology
company focused on the discovery and development of regenerative
and protective therapies for the treatment of cardiac diseases. The
company was founded in 2007 and is based in the Walloon region of
Belgium. Cardio3 BioSciences leverages research collaborations
in the US and in Europe with Mayo Clinic and the Cardiovascular
Centre Aalst, Belgium.
The Company’s lead product candidate C-Cure® is an innovative
pharmaceutical product that is being developed for heart failure
indication. C-Cure® consists of a patient’s own cells that are
harvested from the patient’s bone marrow and engineered to become
new heart muscle cells. This process is known as Cardiopoiesis.
Cardio3 BioSciences has also developed C-Cathez®, the most
technologically injection catheter with superior efficiency of
delivery of bio therapeutic agents into the myocardium.
Cardio3 BioSciences’ shares are listed on Euronext Brussels and
Euronext Paris under the ticker symbol CARD.
C3BS-CQR-1, C-Cure, C-Cath, Cardio3 BioSciences and the Cardio3
BioSciences and C-Cath logos are trademarks or registered
trademarks of Cardio3 BioSciences SA, in Belgium, other countries,
or both. Mayo Clinic holds equity in Cardio3 BioSciences as a
result of intellectual property licensed to the company. In
addition to historical facts or statements of current condition,
this press release contains forward-looking statements, which
reflect our current expectations and projections about future
events, and involve certain known and unknown risks, uncertainties
and assumptions that could cause actual results or events to differ
materially from those expressed or implied by the forward-looking
statements. These risks, uncertainties and assumptions could
adversely affect the outcome and financial effects of the plans and
events described herein. These forward-looking statements are
further qualified by important factors, which could cause actual
results to differ materially from those in the forward-looking
statements, including timely submission and approval of anticipated
regulatory filings; the successful initiation and completion of
required Phase III studies; additional clinical results validating
the use of adult autologous stem cells to treat heart failure;
satisfaction of regulatory and other requirements; and actions of
regulatory bodies and other governmental authorities.
Cardio3 BioSciencesDr Christian Homsy, CEO, Tel : +32 10
39 41 00Anne Portzenheim, Communication
Manageraportzenheim@c3bs.comwww.c3bs.comorCitigate
Dewe RogersonChris GardnerTel : +44 (0) 207 638 9571
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