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Sanofi licenses cardiovascular therapy in South Korea

Phase III drug comes from Swedish company NeuroVive

Sanofi reception 

Sanofi has licensed an experimental drug from Swedish company NeuroVive that bolsters its cardiovascular therapy pipeline. 

The deal - signed by Sanofi's Asian subsidiary and covering only the South Korean market - covers a new formulation of cyclophilin inhibitor cyclosporine A - called CicloMulsion - that is in phase III development as a treatment for reperfusion injury in patients who receive therapy during a heart attack to open up blocked arteries.

Financial terms of the agreement have not been disclosed, but Sanofi's local affiliate gains "registration, launch, promotion and sale" rights to CicloMulsion in South Korea, a pharma market worth around $16bn last year according to Business Monitor data.

NeuroVive's chief executive Mikael Brönnegård said the deal with Sanofi is "further confirmation of CicloMulsion's clinical and commercial potential."

The cyclosporine formulation is being tested in a phase III trial in Europe - called CIRCUS - that is due to release headline data in the third quarter of this year.  

The study involves 972 patients with acute myocardial infarction who will receive a single bolus injection of the drug or placebo before percutaneous coronary intervention (PCI), a non-surgical approach to widening the coronary artery.

The study is testing the hypothesis that cyclosporine can interrupt the cascade of biochemical events that cause damage the heart when blood flow is suddenly restored to oxygen-starved tissue. 

The primary outcome measure will be the combined incidence of death, hospitalisation for heart failure and changes in the left ventricle of the heart indicating the early stages of heart failure and - if positive - raises the possibility that Sanofi might seek a broader license to the drug.

CicloMulsion is scheduled to start a phase III trial in Asia shortly - with the help of partner Sihuan Pharmaceuticals that has rights to the drug in China- that will form the basis of Asian regulatory filings. Meanwhile, it is also being evaluated in heart, brain and kidney injuries in phase II trials. 

The NeuroVive deal provides further evidence of the pharma industry's increasing interest in South Korea as a growth market, despite noises from the government about additional price controls on drugs to help contain escalating healthcare costs.

Other recent investments in the country include a push by Boehringer Ingelheim, which said in March that it intends to double the size of its South Korean subsidiary by 2020.

Article by
Phil Taylor

27th May 2015

From: Research



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