TaiGen’s Nemonoxacin Receives US FDA Fast Track Designation
December 31, 2013
TaiGen Biotech’s nemonoxacin has received fast track designation and Qualified Infectious Disease Product status by the US FDA.
AsianScientist (Dec. 31, 2013) – TaiGen Biotechnology Company, Limited’s nemonoxacin (Taigexyn®) has received fast track designation and Qualified Infectious Disease Product (QIDP) status by the US Food and Drug Administration for community-acquired bacterial pneumonia (CAP) and acute bacterial skin and skin structure infections (ABSSSI).
These two designations should enable TaiGen and 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 market exclusivity, priority review, and fast track status provided under the Generating Antibiotic Incentives Now (GAIN) act.
Nemonoxacin is a broad-spectrum antibiotic available in both oral and intravenous formulations. TaiGen has completed a multi-center Phase III of the oral formulation in CAP in Taiwan and 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 China with Phase II completed and initiation of Phase II plan for 1Q, 2014. In the US, TaiGen has 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 has 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.
“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,” said Dr. Ming-Chu Hsu, CEO of TaiGen. “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.”
Source: TaiGen Biotechnology Company.
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