A drug that can help mend broken hearts is coming to China. Zensun (Shanghai) Science & Technology Co., has agreed to grant SciClone Pharmaceuticals a license and the exclusive rights to promote, market, distribute, and sell Neucardin™ in China, Hong Kong, and Macau. Neucardin is a novel, first-in-class therapeutic drug for the treatment of patients with intermediate to advanced chronic heart failure (CHF).
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 for Neucardin. Financial terms of the agreement include aggregate potential milestone payments of up to $18.5 million. The company has agreed to make additional payments of $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 $12 million collateralized loan facility by which SciClone would provide a secured loan to Zensun that Zensun may use in future.
Neucardin is a genetically engineered recombinant peptide fragment of neuregulin-1 that has been clinically shown 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 reportedly demonstrated that Neucardin was well tolerated and showed a significant decrease in mortality and improved survival in patients with CHF. A New Drug Application was submitted to and accepted by the China Food and Drug Administration in 2012.
"We believe that Neucardin, a first-in-class biologic that works through a novel mechanism of action, has the potential to bring significant benefits to patients with CHF," Mingdong Zhou, Ph.D., Zensun's CEO, said. "We are also proud of the innovative approach that Neucardin represents, which has enabled us to be recognized in China's 11th and 12th five-year plans."