SciClone Gains China Rights to Zensun’s Heart Failure Drug

may19, 2013

SciClone Pharma in-licensed China rights to a heart failure drug from Zensun (Shanghai) Science & Technology Co. SciClone, which is headquartered in the US, usually markets western drugs in China. This time, the company has acquired a China-developed drug for China.

 

The deal gives SciClone exclusive rights to market Neucardin™, a novel treatment for chronic heart failure, in China, Hong Kong and Macau. Zensun filed for approval of Neucardin with the CFDA last year

NEUCARDIN^TM is a genetically engineered recombinant peptide fragment of neuregulin-1 (β2a isoform). It is expressed in E.coli , lyophilized for storage and used for the treatment of moderate to severe heart failure.

Mechanisms : It has been shown that neuregulin-1 is importantly involved in development, differentiation and function of myocardial cells. Based on research on molecular and cellular level, Zensun found that NEUCARDINTM couldattenuate myofibrillar disarray in impaired myocardial cells and strengthen the intercalated disc connections between them. In addition, in vivo administration of NEUCARDINTM greatly reduced myocardial cell damage induced by ischemia, hypoxia or viral infection, allowing repair of sarcomere structure, with improvement in cardiac performance, hemodynamics and survival.

Indications : NEUCARDIN^TM is indicated for the treatment of patients with intermediate to advanced heart failure and dilated cardiomyopathy.

Pharmacological Action : Using various animal models, including (1) rat sub-acute and chronic heart failure, (2) mouse viral myocarditis, (3) rat toxic myocarditis induced by adriamycin, and (4) dog congestive heart failure caused by constriction of inferior venue cava, it has been demonstrated that NEUCARDIN^TM improves impaired myocardial structure, decreases the extent of ischemia injury, and improves heart function and hemodynamics. This results in enhanced survival in these animal models.

Safety : Safety pharmacology studies indicate that NEUCARDIN^TM has no adverse effects on cardiovascular or respiratory system function in normal monkeys. Acute toxicity studies in mice showed that the minimum fatal dose was 3000 times the clinical equivalent dose. Safety evaluations in monkeys after administration of multiple doses of NEUCARDIN^TM revealed that a high dosage (above the therapeutic dose) could cause some local microcapillary vessel leakage, but no significant side effects had been found with doses in low to moderate ranges, indicating a safe therapeutic dosage range.