Chugai Pharmaceutical Co, Ltd has concluded a license agreement with Romark Laboratories obtaining exclusive rights in Japan to develop, manufacture and distribute nitazoxanide, a therapeutic agent that Romark has been developing overseas for chronic hepatitis C, and that Chugai has decided to develop nitazoxanide in Japan.

Nitazoxanide is an oral thiazolide compound with a wide spectrum of activity for protozoa, bacteria and viruses and was approved by the FDA (US Food and Drug Administration) in 2002 for the indication of diarrhoea caused by parasitic diseases (trade name: Alinia).

An overseas phase-II study conducted for hepatitis C genotype four patients, has reported that when nitazoxanide added to pegylated interferon alfa-2a, one of the current standard treatments, and ribavirin, the SVR (sustained virus response) rate at 24 weeks after the end of administration was about 30% higher than that of the standard treatment. Phase-II studies are ongoing in the United States for genotype one patient.

In addition, nitazoxanide was selected as one of the new research agents of future potential in the seven-year strategy of hepatitis study compiled by the Ministry of Health, Labour and Welfare (MHLW) in the fiscal 2008.

Chugai released Japan's first pegylated interferon agent Pegasys as a therapeutic agent for chronic hepatitis C in December 2003 and an antiviral agent Copegus to be used in combination with Pegasys in March 2007.

By introducing nitazoxanide in Japan, Chugai can not only present a new treatment option for patients with chronic hepatitis C in Japan but also strengthen its franchise for hepatitis region.

Romark Laboratories, a privately held biopharmaceutical company, has discovered and developed a new class of small molecule anti-infectives known as thiazolides.