Medigen Biotechnology Corp (基亞) yesterday said it had finished enrolling patients for a controlled clinical trial of its new drug for hepatocellular carcinoma (HCC). The pharmaceutical company is on track to commercialize the drug in the near future.
HCC is a common type of liver cancer in Asia. Medigen’s new drug Muparfostat, formerly known as PI-88, is an adjuvant treatment designed to reduce the risk of a post-surgery recurrence of HCC.
The Taipei-based company said in a filing to the Taiwan Stock Exchange that it finished recruiting 500 people for the phase-three trials of the drug on Friday.
The pivotal trials will be conducted with patients at 25 medical centers in Taiwan, South Korea, China and Hong Kong, Medigen said.
Once studies of patient follow-up are completed, which is expected to take place late next year, the data will form the foundation of the firm’s submission for the Food and Drug Administration’s (FDA) regulatory approval, according to the company.
“If the outcome of the studies complies with expectations, [the company] plans to apply for a drug permit next year at the earliest,” Medigen said in the filing.
Jih Sun Securities Investment Consulting Co (日盛投顧) analyst Chang Li-chun (張立群) forecast PI-88 to have a market potential of NT$5.36 billion a year.
Chang said the company might gain regulatory approval for the drug in Taiwan in the second half of next year and then secure approval in China, Hong Kong, South Korea and Southeast Asia during the first half of 2015. If the company starts conducting bridging studies on PI-88 in Europe and the US in 2015, it might receive regulatory approval there in 2016, he said.
However, Medigen has thus far announced no regional marketing or international licensing agreements for PI-88, which is competing with Bayer AG’s Nexavar to become the world’s first early-stage prevention drug for liver cancer.
“There are currently no early-stage prevention drugs for liver cancer anywhere in the world,” Medigen said in the filing. “PI-88 has the best chance of becoming the first post-surgery medication to cut the risk of liver cancer recurrence.”
Medigen reported NT$70.83 million (US$2.36 million) in sales during the first 11 months of the year, down 28.36 percent year-on-year, with net losses narrowing to NT$228.79 million in the first three quarters of the year, from NT$372.55 million during the same period last year, company data showed.
Medigen shares rose by 0.52 percent to close at NT$192.5 yesterday after the patient enrollment announcement.