Shares of TaiMed Biologics Inc (中裕新藥), which manufactures drugs to treat AIDS, soared 12.93 percent yesterday after its new TMB-355 drug for intravenous injection was granted orphan drug status in the US.
The company’s shares closed at NT$151.2 yesterday, outperforming the over-the-counter benchmark index, which ended up 0.56 percent.
The granting of orphan status could shorten the time it takes for TMB-355 to enter the US market, TaiMed financial controller Jack Chen (陳怡成) said over the telephone yesterday.
“By getting orphan status, we are able to negotiate with the US Food and Drug Administration to see if we can waive the phase-three clinical trials for the drug, or conduct them on a smaller scale,” Chen said.
An orphan drug is one that satisfies an unfilled medical need for a specific group of people numbering less than 200,000, TaiMed said, adding that as a result, clinical trials for such drugs do not require as many patients as those for other pharmaceuticals.
He said the result of the company’s negotiations with the administration will depend on whether the data on the drug acquired so far are deemed sufficient by the US regulator.
TaiMed has said it expects TMB-355 for intravenous injection to be approved to enter the US market by the end of next year.
IBT Securities Co (台灣工銀證券) investment consultant Liao Chang-liang (廖昌亮) wrote in a note yesterday that if the US agency decides to waive phase-three trials, TMB-355 for intravenous injection will enter the US market in the second quarter of next year.
However, if the administration rules that TaiMed still needs to recruit more patients to conduct phase-three trials, TMB-355 will likely hit the US market in the first quarter of 2016 instead, Liao said.
The drug is used to treat terminally ill AIDS patients, who number about 50,000 to 100,000 from a total population of 1.3 million AIDS patients in the US, according to TaiMed.
The company aims to sell 10,000 units of TMB-355 a year in the US at about US$30,000 per unit, it said.
In the first half of the year, the company reported losses of NT$122.24 million (US$4 million), a surge of 44.75 percent from the NT$84.45 million in losses it posted the previous year, according to a filing with the Taiwan Stock Exchange.
Elsewhere in Taipei trading, shares of Orient EuroPharma Co (OEP, 友華生技), which manufactures powdered milk, drugs and nutritional supplements, increased 3.41 percent to NT$74.2 yesterday after the company announced a deal with Tokyo-based Toray Industries Inc to sell the Japanese firm’s itch relief TRK-820 drug to hemodialysis patients in Taiwan.
The company’s shares yesterday outperformed the TAIEX, which was up 1.09 percent.
Orient EuroPharma said it still needs to apply for a drug permit before it can sell the drug locally, but expects to be approved to launch the drug in 2016.
“Although itching is a common side effect experienced by hemodialysis patients, the market for anti-itching drugs for this group is still untapped in Taiwan,” Orient EuroPharma spokesperson Anita Chen (陳嬿娟) said over the phone yesterday.
“TRK-820 is likely to be the first drug of its kind in the nation,” Anita Chen added.
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