China Pharma Holdings (CPHI.OB) obtained approval from the SFDA to begin Phase I and Phase II clinical trials of Rosuvastatin, a generic version of the cholesterol-lowering statin drug Crestor. The trials will test the compound for efficacy. China Pharma will move to begin the trials immediately with the goal of winning approval by the end of 2010.
Crestor lowers LDL cholesterol (the harmful form of cholesterol). In tests, the drug proved to reduce cardiac events by 60% and stroke by 17%. The drug was developed by Shionogi & Co., Ltd., and first introduced in Europe in 2002 by AstraZeneca. In 2007, Astra Zeneca reported total revenues from Crestor of $2.8 billion. The company launched Crestor in China in 2007. China Pharma Holdings did not address the issue of the Crestor patent, which remains in force in the US until 2016. In 2007, several generic pharma companies brought suit to break AstraZeneca‚Äôs patent, including Indian companies Glenmark Pharmaceuticals, Aurobindo Pharma and MSN Laboratories, as well as Israels Teva Pharmaceutical Industries (NYSE: TEVA) and the China Changzhou Pharmaceutical Factory. Although Crestor has proved to be as powerful as Pfizer statin drug Lipitor, Lipitor has been the sales champ, with worldwide revenues of more than $13 billion. Lipitor is losing its patent in the US in 2010.