Drug maker Taiwan Liposome Co (TLC, 台灣微脂體) yesterday said that it has approval from the Chinese government to begin second-phase clinical trials for its new liver cancer treatment, paving the way for the company to complete the first stage of second-phase trials early next year.
The company is currently undergoing phase two trials for the drug — Lipotecan — in Taiwan, and the approval will expedite the process by allowing the company to recruit patients on both sides of the Taiwan Strait, the company said.
After the company completes the trials early next year, it plans to license the drug to other companies or invite new partners to conduct further trials together, it said.
“The phase two trials are to test whether Lipotecan can extend the overall survival of patients who develop drug resistance to first-line liver cancer drug Nexavar to more than three months,” a company official, who declined to be named, said in a telephone interview.
Surgical resection is the most commonly used course of treatment for early stage liver cancer, while late stage patients who are not able to have operations take Nexavar, the official said.
Nexavar prolonged overall survival to 10.7 months, compared with 7.9 months for patients taking a placebo, she added.
Taiwan Liposome is also mulling conducting further trials to test whether Lipotecan can replace Nexavar, she said.
Taiwan Liposome set an annual sales target for Lipotecan of between US$150 million and US$200 million in China, while German-based drug maker Bayer AG generated US$150 million a year by selling Nexavar in China, the company said.
Lipotecan is developed by using Taiwan Liposome’s technology to enhance the effectiveness and reduce the side effects of a camptothecin derivative, TLC said.
Taiwan Liposome has to pay less than US$200,000 as milestone payments to the inventor of the camptothecin derivative in the future, the company said, adding that the inventor will also receive single digit royalties from sales of Lipotecan.
There are more than 780,000 new liver cancer patients around the world every year, with half of the patients from China, the official said.
In 2012, out of 746,000 patients who died from the disease, 383,000 of them were Chinese, she added.
Taiwan Liposome shares dropped 3.26 percent to NT$208 yesterday, underperforming the over-the-counter benchmark index, which was down 0.05 percent.
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