TaiGen Biotechnology Company (TaiGen) has received approval from the Taiwan Food and Drug Administration (TFDA) for its new drug application of Taigexyn oral formulation to treat community-acquired bacterial pneumonia (CAP).
Taigexyn, which is a new chemical entity (NCE) broad spectrum and non-fluorinated quinolone antibiotic, is available in both oral and intravenous formulations.
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The approval follows completion of multi-national and multi-centre clinical trials of Taigexyn that were carried out in more than 1,280 subjects with demonstrated efficacy and safety.
In the trials, Taigexyn demonstrated activity against drug-resistant bacteria such as methicillinresistant Staphylococcus aureus (MRSA), quinolone-resistant MRSA as well as quinolone-resistant Streptococcus pneumoniae.
With NDA approval, Taiwan has become the first region to grant marketing approval to Taigexyn.
In April 2013, a new drug application for Taigexyn was also submitted to China FDA and is currently under review.
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By GlobalDataThe company owns the worldwide patent portfolio of Taigexyn that protects composition, use and processes until 2029.
Clinical development of the intravenous formulation in CAP is currently on-going in Taiwan and China.
TaiGen chairman and CEO Ming-Chu Hsu said this is the first drug approval for TaiGen and the company hopes that there are more to come.
"It proves that an NCE drug can be developed by a company in Taiwan and approved by the Taiwan regulatory authorities ahead of the rest of the world," Hsu said.
"This is a very important milestone for the TFDA and the entire Taiwan pharmaceutical industry, especially for the future development of NCE drugs in Taiwan."
In June 2012, the company had out-licensed the exclusive rights of Taigexyn in China to Zhejiang Medicine, and in the Russian Federation, Commonwealth independent states and Turkey, to R-Pharm of Russia, in January this year.
TaiGen has two other in-house discovered NCEs in clinical development that are under investigational new drug programmes with the US FDA. They are TG-0054, a chemokine receptor antagonist for stem cell transplantation and chemosensitisation, which is in phase two, and TG-2349, a HCV protease inhibitor for the treatment of chronic hepatitis infection, also in phase two.
The company said that both TG-0054 and TG-2349 are currently in clinical trials in patients in the US.
