TaiMed Biologics Inc (中裕新藥), which manufactures drugs to treat AIDS, yesterday said that it expects its new drug for intravenous injection to enter the US market in the first half of next year and generate annual sales of US$300 million.
The company’s TMB-355 passed phase two clinical trials in April and is currently under review for orphan drug status in the US, president and CEO James Chang (張念原) said at the company’s annual shareholders’ meeting.
If it is approved as an orphan drug, the company can conduct smaller-scale phase three clinical trials, reducing the time and costs to test the drug, Chang said.
“The drug is to be used to treat terminally ill AIDS patients, which number about 50,000 to 100,000 people in the US,” Chang said, adding that people with AIDS total about 1.3 million in the US.
The number of patients who can be treated with the drug is lower than the threshold of 200,000 patients for an orphan drug, Chang said.
TaiMed filed the orphan drug application in the middle of March. It normally takes about 60 days to 90 days for the US regulators to complete the review, he added.
After the drug is launched, Chang estimated that the company could sell 10,000 units a year in the US, with each unit priced at about US$30,000.
Chang said he was hoping for a profit margin of about 80 percent to cover research and development (R&D) costs, marketing expenses and royalties.
The company is also developing TMB-355 for intramuscular and subcutaneous injection, which can be used to treat about 200,000 to 300,000 AIDS patients in the US, Chang said, adding that he expects it to hit the US market two years after the launch of the intravenous version.
Another drug under development is the TMB-360, a more potent AIDS drug that it is making in cooperation with protein drug maker EirGenix Inc (台康生技).
The company expects to file an investigational new drug application for the drug to enter phase one clinical trials in autumn next year.
Annual sales of AIDS drugs reach about US$16 billion, with the US accounting for about 55 percent of the total, Chang said.
“The US drug market is the only one around the world that does not have price controls,” he added.
Last year, the company posted a loss of NT$251.68 million (US$8.38 million), or NT$1.3 per share. That compares with a loss of NT$167.81 million, or NT$0.87 per share, a year ago, according to the company’s stock exchange filing.
The company booked R&D expenses of NT$257.46 million last year, up 25.65 percent from NT$204.91 million the previous year, the filing showed.
Jack Chen (陳怡成), the company’s financial controller, said R&D costs this year would be the same as last year.
In March, the company raised NT$1.3 billion by issuing 22.1 million new common shares, increasing its working capital to NT$1.74 billion.
TaiMed plans to shift to the GRETAI Securities Market from the Emerging Stock Market by the end of this year, where its shares closed 3.22 percent lower at NT$184.77 yesterday.
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