The U.S. Food and Drug Administration (FDA) has granted TaiGen Biotechnology Company, Limited (TaiGen) Qualified Infectious Disease Product (QIDP) and Fast Track designations for community-acquired bacterial pneumonia (CAP) and acute bacterial skin and skin structure infections (ABSSSI) for nemonoxacin (Taigexyn®)
These two designations should enable TaiGen 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 inTaiwan 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-resistantStreptococcus pneumoniae.
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."
Click here for the complete issue.