TaiGen Biotechnology gets QIDP, Fast Track designations from US FDA for nemonoxacin

 Tuesday, December 24, 2013, 09:00 Hrs[IST] TaiGen Biotechnology Company, a leading research-based and product-driven biotechnology company, has received Qualified Infectious Disease Product (QIDP) and Fast Track designations from the US Food and Drug Administration (FDA) for nemonoxacin (Taigexyn) in treating patients with 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-centre phase III 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 II completed and initiation of phase III plan for 1Q, 2014. In the US, TaiGen have completed two phase II 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 IIa DFI trial. Taken together, nemonoxacin is well positioned to treat ABSSSI."