South Korea’s Ildong Pharm said Tuesday that Besivo, its first novel drug to treat hepatitis B infection, has been approved in Korea. The new drug represents the 28th original drug developed by a Korean pharmaceutical company and the country’s second home-grown HBV treatment following Bukwang Pharm’s Levovir.

The drug’s active ingredient besifovir dipivoxil maleate treats chronic hepatitis B infection in adults by inhibiting DNA synthesis in virus replication. HBV infection can lead to serious liver disease including cirrhosis and hepatocellular carcinoma.

The drug as a candidate molecule was first discovered by LG Life Sciences (currently LG Chem) in early 2000 and its non-clinical and phase I and II studies were completed before Ildong Pharm acquired rights to the drug with a license deal in 2012.

Besivo was in the spotlight for its non-inferiority to leading HVB drugs Baraclude and Viread and fewer side effects in a head-to-head phase III study involving 197 patients with chronic hepatitis B infection for 48 weeks.

In 2006, another Korean pharmaceutical company Bukwang Pharm launched Levovir, Korea’s first home-grown HVB drug, but its side effects including muscular disease prompted authorities to recommend only Baraclude of BMS and Viread of Gilead Sciences as a first-line therapy for the treatment of HVB. Prescription sales of the two blockbuster drugs came to 100 to 150 billion won ($134 million) last year, according to sources.

"In a comparison study with Viread, the most hitherto effective HVB drug available, the new drug demonstrated its anti-viral effect and caused no side effects like reduced bone density and renal dysfunction. The new drug will bring more treatment options to Korean patients and doctors,” said Prof. Ahn Sang-hoon, a gastroenterologist at Severance Hospital.

Ildong Pharm aims to launch Besivo in the second half of this year.

By Kim Hye-soon

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