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TaiGen Biotechnology Announces Submission of New Drug Application for Nemonoxacin in Taiwan and Mainland China



5/16/2013 10:06:47 AM

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TAIPEI, Taiwan, May 16, 2013 /PRNewswire/ -- TaiGen Biotechnology Company, Limited ("TaiGen") today announced that they have submitted New Drug Application (NDA) for the oral formulation of nemonoxacin with the Taiwan Food and Drug Administration (TFDA) and China Food and Drug Administration (CFDA). Approval is expected in the first half of 2014. Nemonoxacin is the first pharmaceutical product to fall under the Cross-Strait Cooperation Agreement on Medicine and Public Health Affairs of the Economic Cooperation Framework Agreement (ECFA) between Taiwan and mainland China. It is also the first new drug from Taiwan to meet the requirements of CFDA's Category 1.1 New Drug. Drugs under this classification have to be new chemical entities (NCEs) that have not been marketed in any country in the world. Nemonoxacin, thus, represents a landmark in the continued development of cross-strait relationship between the pharmaceutical industry and regulatory agencies.

Nemonoxacin is a NCE, broad spectrum antibiotic with excellent efficacy and safety profile. The NDA submission for nemonoxacin is supported by a pivotal Phase 3 trial with 532 patients in community-acquired pneumonia (CAP). The trial was conducted in both Taiwan and mainland China (441 patients from mainland China and 91 patients from Taiwan) that met all primary and secondary endpoints including non-inferiority to the comparator, levofloxacin. TaiGen is currently conducting Phase 2 trial for the intravenous formulation of nemonoxacin in moderate to severe CAP patients. In addition to CAP, nemonoxacin has also shown efficacy in diabetic foot infections in a Phase 2 trial conducted in the US, Taiwan, and South Africa. In the clinical trials conducted to this point, nemonoxacin have demonstrated excellent 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 nemonoxacin that protects composition, use, and processes until 2029.

Dr. Ming-Chu Hsu, President and Chief Executive Officer of TaiGen, said, "Since the founding of TaiGen, we have been focusing on the development of First-in-class and Best-in-class novel drugs. The submission of the NDA for nemonoxacin is the culmination of efforts by our experienced management team and all the staff at TaiGen. I am very pleased with the groundbreaking achievement of using one NDA dossier for submissions to TFDA and CFDA. Not only nemonoxacin is our first product to the market, it is also an indication that a world class medicine can be discovered and developed in Taiwan. TaiGen is well positioned to advance in the world's fastest pharmaceutical market, mainland China."

In June 2012, TaiGen signed an agreement with Zhejiang Medicine Company, Limited ("ZMC") to out-license the exclusive marketing and manufacturing rights of nemonoxacin in China. ZMC is a leading manufacturer and marketer of antibiotics in China and is a publicly listed company in the Shanghai Stock Exchange. This partnership combines TaiGen's R&D expertise and ZMC's antibiotic marketing knowhow to compete in China's US$11 billion antibiotic market.

About TaiGen Biotechnology

TaiGen Biotechnology is a leading research-based and product-driven biotechnology company in Taiwan with a wholly-owned subsidiary in Beijing, mainland China. In addition to nemonoxacin, 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.

Disclaimer

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.

TaiGen Contact:

Peter W. Tsao, PhD, Vice President of Business Development
Tel: +886-2-8177-7072 ext 1705
ptsao@taigenbiotech.com.tw

PJ (Joe) Hsueh, Vice President of Operations
Tel: +886-2-8177-7072 ext 1704
pjhsueh@taigenbiotech.com.tw

SOURCE TaiGen Biotechnology Co., Ltd.



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