Novartis is celebrating the granting of regulatory approval for its hepatitis B treatment Sebivo in China, where more than 100 million people are affected by the disease.
The Chinese State Food and Drug Administration granted marketing approval for Sebivo (telbivudine), which is also known as Tyzeka, as a treatment for chronic hepatitis B, and the once-daily drug is expected to be available in the country in April.
Prof Jidong Jia of the Beijing Friendship Hospital, noted that chronic hepatitis B is a major health problem in China where, despite existing treatments, nearly half a million people die each year from liver damage and cancer caused by the disease. The professor added that "Sebivo's demonstrated ability to rapidly and profoundly drive down virus levels within the first 24 weeks of treatment, in addition to its favourable safety profile, make it a promising treatment option."
The drug was recently approved in the USA and Novartis says that clinical trials have suggested it is more effective than the current standard treatment, GlaxoSmithKline's Epivir-HBV/Zeffix (lamivudine), in tackling chronic hepatitis B infections. Analysts have suggested the Swiss firm's drug could achieve annual sales of around $400 million or more at peak.
Last September, Novartis got the green light from Swiss regulators for Sebivo and James Shannon, head of development at Novartis Pharma, noted that the firm is looking forward to receiving final European Commission approval soon, having just received a positive opinion from the Committee for Medicinal Products for Human Use.
Given the size of the market, it is no wonder that Novartis is excited about the Chinese approval but Kepler Equities analyst Denise Anderson noted that "the availability of cheap drugs as well as a number of recently-launched new products combined with the purchasing power for most Chinese will likely limit sales in that market."
Telbivudine was originally developed by US company Idenix, and Novartis licensed rights to the product in 2003 in a $225 million deal. The Swiss drugmaker has exclusive rights to market Sebivo internationally, except in the USA, France, Germany, Italy, Spain and the UK, where the firms have a co-marketing agreement.