TaiGen Biotechnology Receives Qualified Infectious Disease Product And Fast Track Designations From The FDA For Nemonoxacin (Taigexyn®)
12/23/2013 9:04:17 AM
TAIPEI, Dec. 23, 2013 /PRNewswire/ -- TaiGen Biotechnology Company, Limited ("TaiGen") today announced that the U.S. Food and Drug Administration (FDA) has granted nemonoxacin (Taigexyn®) Qualified Infectious Disease Product (QIDP) and Fast Track designations for community-acquired bacterial pneumonia (CAP) and acute bacterial skin and skin structure infections (ABSSSI). These two designations should enable TaiGen and/or its partners to benefit from certain incentives for the development of nemonoxacin as a new antibiotic, including an additional five year extension to new chemical entity (NCE) market exclusivity, priority review, and fast track status provided under the Generating Antibiotic Incentives Now (GAIN) act. GAIN was included in the FDA Safety and Innovation Act (FDASIA) that was signed into law by US President Obama in 2012.
Nemonoxacin is a NCE, broad spectrum antibiotic available in both oral and intravenous formulations. TaiGen have completed a multi-center Phase 3 of the oral formulation in CAP in Taiwan and mainland China and submitted NDA to regulatory authorities in both countries earlier this year. The clinical development of the intravenous formulation in CAP is ongoing in Taiwan and mainland China with Phase 2 completed and initiation of Phase 3 plan for 1Q, 2014. In the US, TaiGen have completed two Phase 2 clinical studies, one in CAP and the other in diabetic foot infections (DFI) with demonstrated efficacy and safety. In the clinical trials conducted to this point, nemonoxacin 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 nemonoxacin that protects composition, use, and processes until 2029.
Dr. Ming-Chu Hsu, Chairman and CEO of TaiGen said "The recognition of nemonoxacin for QIDP and Fast Track designations highlights the need of new antibiotics in the treatment of life-threatening bacterial infections and the value of nemonoxacin to treat CAP, which is one of the most common respiratory infections that can lead to hospitalization. In addition, we have seen efficacy and high tissue penetration in the Phase 2a DFI trial. Taken together, nemonoxacin is well positioned to treat ABSSSI."
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 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.
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.
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