FDA approves TaiGen’s pneumonia antibiotic

By Camaron Kao  /  Staff reporter

Fri, Mar 14, 2014 - Page 13

Drugmaker TaiGen Biotechnology Co Ltd (太景生技) has received Food and Drug Administration (FDA) approval to sell an oral formulation of an antibiotic for treating community-acquired pneumonia.

The company said yesterday that local sales of nemonoxacin — trade name Taigexyn — could reach NT$1 million (US$32,950) to NT$5 million a year, similar to other antibiotics in Taiwan.

The company is in price talks with the National Health Insurance Administration, TaiGen chief financial officer Max Chan (詹孟恭) said by telephone.

“We hope the government can set a higher price for the drug, since we chose Taiwan to be the first market to launch it and the drug was developed locally in accordance with Western standards,” Chan said.

TaiGen will subcontract the manufacturing of the drug in Taiwan to Lotus Pharmaceutical Co (美時化學製藥), which makes and distributes oral and injection medicines, but the two companies are still negotiating the production amount, Chan said.

TaiGen also expects to acquire a permit for the oral formulation of the drug in China by the end of the first half of this year, benefiting from the cross-strait Economic Cooperation Framework Agreement (ECFA).

Chan said the cross-strait cooperation agreement on medicine would help expedite approval by allowing TaiGen to conduct clinical trials in Taiwan and China and apply to both governments using the same data.

TaiGen applied for a drug permit for the oral formulation of nemonoxacin in Taiwan and China between March and April of last year.

The company’s intravenous formulation of nemonoxacin is still in the second stage of clinical trials in China and Taiwan, and TaiGen expects the formulation to enter the market in 2017, Chan said.

The company has set an annual sales target of 1 billion yuan (US$162.96 million) for both intravenous and oral formulation of the drug in China, he said.

TaiGen also plans to apply for drug permits in Southeast Asia, as many countries in the region are willing to allow sales of drugs approved by Taiwan, the company said.

Chan said both China-based Zhejiang Medicine Co (浙江醫藥集團), TaiGen’s partner in China, and Lotus Pharmaceutical are likely to make nemonoxacin for TaiGen for countries in the region.

Patents for nemonoxacin last until 2029, according to the company.

TaiGen shares rose 1.97 percent to NT$62.20, while those of Lotus Pharmaceutical soared 6.64 percent to NT$144.50 yesterday on the GRETAI Securities Market, outperforming the over-the-counter benchmark index, which was up 1.03 percent.