Drugmaker Taiwan Liposome Co (TLC, 台灣微脂體) yesterday said that its new drug for liver cancer is about to enter phase two clinical trials in Taiwan and China.
The company has submitted an application for Lipotecan to be put under expedited review in China, and the company is set to start phase two trials after it receives approval, Taiwan Liposome president George Yeh (葉志鴻) said.
The company plans to launch the drug first in China and Taiwan. It is designed to be used as the second-line drug prescribed by doctors after patients have developed resistance to the first-line liver cancer medicine Nexavar, Yeh said.
Taiwan Liposome expects the drug to complete the first stage of phase two clinical studies by early next year, when it plans to license the drug to other companies or invite new partners to conduct further studies, Yeh said.
The company plans to recruit 62 patients for the trials, according to Yeh. He did not disclose the amount of money the company plans to spend on the trials.
Taiwan Liposome was in talks with China to conduct phase two trials for Lipotecan to replace FOLFOX, a chemotherapy medicine most commonly used in China as the first-line drug to treat liver cancer, Yeh said.
Only 2 to 3 percent of liver cancer patients in China take Nexavar because the drug costs US$30,000 to US$40,000 for treatment, while FOLFOX is more affordable, Yeh said.
According to Yeh, sales of Nexavar in China are about US$100 million to US$150 million a year.
Taiwan Liposome estimated that a new cancer drug like Lipotecan could generate sales of around US$150 million to US$200 million a year.
Commenting on the recent correction in share-prices for new domestic drugmakers, Yeh said the company’s primary concern was to live up to its promises for the next two to three years.
If we are not planning to raise money in the capital market, declining shares will have less of an effect on our business,” Yeh said, adding that the company currently has NT$3.2 billion (US$106.67 million) of cash at hand.
“We estimate that Taiwan Liposome will swing back into the black after we launch the new drug for a full year in one region which could be China, Europe, the US or Japan,” Yeh said.
Last quarter, the company reported losses of NT$129.72 million, or NT$2.37 per share, compared with losses of NT$6.09 million, or NT$0.14 per share, a year ago, but the company forecast losses would be lower in the upcoming quarters.
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