TAIPEI, March 13, 2014 /PRNewswire/ -- TaiGen Biotechnology Company, Limited ("TaiGen") today announced that the Taiwan Food and Drug Administration (TFDA) has approved the new drug application (NDA) of Taigexyn® (nemonoxacin) oral formulation (500 mg) for the treatment of community-acquired bacterial pneumonia (CAP). With this NDA approval, Taiwan is the first region to grant marketing approval to Taigexyn®. An NDA for Taigexyn® was also submitted to China FDA (CFDA) in April 2013 and is currently under review.
Taigexyn® is a new chemical entity (NCE), broad spectrum, non-fluorinated quinolone antibiotic available in both oral and intravenous formulations. TaiGen have completed multi-national and multi-center clinical trials of Taigexyn® in over 1280 subjects with demonstrated efficacy and safety. In the clinical trials conducted to this point, Taigexyn® have shown activity against drug-resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) and quinolone-resistant MRSA as well as quinolone-resistant Streptococcus pneumoniae. TaiGen owns the worldwide patent portfolio of Taigexyn® that protects composition, use, and processes until 2029. The clinical development of the intravenous formulation in CAP is ongoing in Taiwan and mainland China.
Dr. Ming-Chu Hsu, Chairman and CEO of TaiGen said, "This is the first drug approval for TaiGen and we hope 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. 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, TaiGen out-licensed the exclusive rights of Taigexyn® in mainland China to Zhejiang Medicine Co. and in January 2014, TaiGen out-licensed the exclusive rights in Russian Federation, Commonwealth Independent States, and Turkey to R-Pharm of Russia. Discussions of Taigexyn® partnerships in other territories are ongoing.
About TaiGen Biotechnology
TaiGen Biotechnology is a leading research-based and product-driven biotechnology company in Taiwan with a wholly-owned subsidiary in Beijing, China. In addition to Taigexyn®, TaiGen has two other in-house discovered NCEs in clinical development under IND with US FDA: TG-0054, a chemokine receptor antagonist for stem cell transplantation and chemosensitization, in Phase 2 and TG-2349, a HCV protease inhibitor for treatment of chronic hepatitis infection, in Phase 2. Both TG-0054 and TG-2349 are currently in clinical trials in patients in the US.
Certain statements in this press release are forward-looking. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimated" and "intend," among others. These forward-looking statements are based on TaiGen's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain regulatory authority clearances or approvals and noncompliance with regulatory regulations. As with any drugs under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. TaiGen does not undertake an obligation to update or revise any forward-looking statement.
Peter W. Tsao, PhD, Vice President of Business Development
Tel: +886-2-8177-7072 ext 1705
PJ (Joe) Hsueh, Vice President of Operations
Tel. +886-2-8177-7072 ext 1704
SOURCE TaiGen Biotechnology Co., Ltd.