Monday, May 20, 2013

Scilone pharma inlicenses heart failure drug rights for China from

SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) has entered into an agreement with 
Zensun (Shanghai) Science & Technology Co., Ltd. which grants SciClone a license and the
exclusive rights in China , Hong Kong and Macau 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.
 
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 2 studies with Neucardin have been conducted in China, Australia and the United States, including three Phase 2b studies in China. The China Phase 2b 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.
 

Terms of the Agreement

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 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. The agreement provides for the principal terms of the arrangement between SciClone and Zensun, and the companies have agreed
to negotiate a supplemental license and supply agreement.
 
About Scilone
SciClone is a US-based, China-focused specialty pharmaceutical company with a substantial revenue-generating and profitable commercial business and a broad, marketed product portfolio of differentiated therapies for oncology, infectious diseases and cardiovascular, urological, respiratory, and central nervous system disorders.
 
About ZensunZensun (Shanghai) Science & Technology Co., Ltd. (www.zensun.com) is an international biopharmaceutical company focused on the development of innovative "first-in-class" biotherapeutic products for the treatment of serious and life-threatening unmet medical needs. It is focused on discovering new medicines using novel disease-specific targets and innovative technologies.
Zensun's patented discoveries are then developed into therapies. With adherence to the tenet of "healing for life," Zensun hopes to transform the lives of heart failure and cancer patients by providing them with drugs that treat their disease, not just their symptoms.
To meet the world's highest standards, incorporate international intelligence, and expand the coverage of patients, Zensun has infrastructure established in China, Australia, and the US. As a globalized biopharmaceutical company, Zensun has gathered experts and pioneers from throughout the world aiming at global commercialization of the novel therapies, and has attracted investors with a forward vision and broad outlook. Zensun leverages the leading technology to best serve its patients and deliver maximum return for investors. Zensun is a paradigm-shifting company which has led the way in novel heart failure and cancer therapies.