AsianScientist (May 20, 2013) – SciClone Pharmaceuticals, Inc. has licensed from Zensun (Shanghai) Science & Technology Co., Ltd. the exclusive rights to promote, market, distribute and sell Neucardin™, a novel, first-in-class therapeutic drug for the treatment of patients with intermediate to advanced chronic heart failure (CHF), in China, Hong Kong, and Macau.
Cardiovascular therapeutics are a large and fast-growing market in China, with a large underlying patient base of approximately five million urban CHF patients. It is expected that the prevalence of CHF in China will increase to over seven million urban patients over the next ten years, primarily due to the growing aging population in China and urbanization.
Neucardin is a genetically engineered recombinant peptide fragment of neuregulin-1 that has been shown in clinical trials to directly improve cardiac function, reverse ventricular remodeling, and increase the survival of heart failure patients.
Six Phase II studies with Neucardin have been conducted in China, Australia, and the United States, including three Phase IIb studies in China. The China Phase IIb survival study demonstrated that Neucardin was well tolerated and showed a significant decrease in mortality and improved survival in patients with CHF. A New Drug Application (NDA) was submitted to and accepted by the China Food and Drug Administration (CFDA) in 2012.
Neucardin has strong patent protection on a worldwide basis, with 12 issued patents and more than 30 applications pending. Zensun is also actively preparing to conduct Phase III trials in the United States in order to commercialize Neucardin beyond the China market.
“Neucardin addresses a large unmet need in the treatment of CHF, and targets an indication in China with a significant underlying patient base. Neucardin is an excellent fit for our company, enabling us to leverage the deep experience and expertise of our cardiovascular sales and marketing team and expand our penetration into this growing market segment,” said Friedhelm Blobel, Ph.D., CEO of SciClone.
Under the terms of the agreement, Zensun will be responsible for the manufacturing and supply of Neucardin, and SciClone will be responsible for all aspects of commercialization, including the pre- and post-launch activities.
Financial terms of the agreement include aggregate potential milestone payments of up to US$18.5 million. SciClone has agreed to make additional payments of US$10 million should Zensun receive approval of Neucardin by subcutaneous infusion. Further indications and improved product forms of Neucardin could result in additional payments.
Also included in the agreement is a US$12 million collateralized loan facility by which SciClone would provide a secured loan to Zensun that Zensun may use in future.
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Source: SciClone Pharmaceuticals, Inc.
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