Thu, Nov 26, 2015 - Page 13 News List

TaiMed drug might gain FDA approval next year

By Ted Chen  /  Staff reporter

TaiMed Biologics Inc (中裕新藥) could receive US approval for its new HIV/AIDS drug TMB355 before the end of next year, Yuanta Securities Investment Consulting Co (元大投顧) said on Tuesday, citing a positive outcome of the drug’s phase II trials.

In addition, the company is to introduce an intramuscular variant of the drug, which is estimated to have a larger potential market than the intravenous version, Yuanta analyst Peggy Lee (李珮菁) said in a client note.

Other drugs the company has in the pipeline include TMB365, a monoclonal antibody, and TMB607, a small-molecule protease inhibitor, which are due to start clinical trials next year, she said.

The company plans to submit a biological product license application to the administration before the end of this year, which would grant the new drug an expedited review timetable.

The US Food and Drug Administration (FDA) has put TMB355 on its Breakthrough Therapy Designation and Fast Track lists.

“We have been in close contact with the US FDA in an effort to reduce the number of test patients required for phase-three trials from 300 to 30, which would bring expenses down to less than US$5 million from between US$50 million and US$60 million,” TaiMed president and CEO James Chang (張念原) said at an investors’ conference early this month.

Chang said that the drug disrupts HIV entry into CD4 T lymphocyte cells without interfering with immune functions.

“HIV/AIDS patients need to be on medication for the rest of their lives and many develop resistance to drugs following prolonged treatment,” Chang said.

According to Yuanta, the FDA has agreed to conduct rolling reviews for the new drug and its final review is scheduled to be completed within six months.

“We are upbeat on the company’s phase-three clinical trials for intravenous TMB355, which could be approved by the FDA toward the end of next year,” Lee said in the note.

The new drug is expected to be used by between 8,000 and 12,000 patients per year by 2019, with one year’s treatment costing between US$40,000 and US$50,000, she said.

TaiMed is expected to top US$130 million in net profits next year, she added.

TaiMed shares closed at NT$202 yesterday in Taipei trading, a rise of 75 percent from its Monday initial public offering price of NT$115.

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