Tue, Dec 24, 2013 - Page 14 News List

TaiGen drug put on US FDA fast track

MEETING NEEDS:The drug, created to treat pneumonia and skin infections, is believed to have been fast-tracked because it would meet a need in the US market

By Camaron Kao  /  Staff reporter

Drug maker TaiGen Biotechnology Co (太景生技) said yesterday that a drug it developed to treat pneumonia and skin infections was approved on Dec. 20 for the US Food and Drug Administration (FDA) fast track development system, which could result in it receiving a drug permit at an earlier date.

FREQUENT MEETINGS

“Being on the fast track will allow us to meet with officials from the US Food and Drug Administration more frequently, allowing us to provide them with necessary data and meet their requirements within a shorter period of time,” TaiGen vice president Peter Tsao (邵榮凱) said by telephone yesterday. Tsao did not give an estimate for when the drug will be approved.

Tsao said the reason the medication was put on the fast track was because the drug — nemonoxacin — targets an unmet medical need in the US.

Meanwhile, the US government also agreed to grant TaiGen and its partners exclusive rights to sell the drug for 10 years after it goes on sale in the US market, the company said.

PATENT ISSUES

The company already has a patent for nemonoxacin until 2029, and the rights granted by the US government will provide the firm with extra protection as the patent is likely to be challenged by other companies, Tsao said.

CLINICAL TRIALS

Having passed Phase II clinical trials in the US, the TaiGen drug is ready Phase III trials and the company is looking for firms to purchase the drug, Tsao said. The fast track status and exclusive rights will make the drug more attractive for potential partners, he added.

From January through last month, TaiGen registered revenues of NT$63.35 million, up 84.51 percent from NT$34.33 million a year ago, according to the company’s filing to the Taiwan Stock Exchange.

However, the company still posted losses of NT$271.86 million in the January to September period as the result of its high research and development costs, the filing showed. The figure was down 48.39 percent from losses of NT$526.73 million last year.

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