TAIPEI, Jan. 15, 2014 /PRNewswire/ -- TaiGen Biotechnology Company, Limited ("TaiGen") today announced that they have signed an exclusive agreement with R-Pharm, a leading Russian pharmaceutical company, to develop and commercialize nemonoxacin (Taigexyn®) in the Russian Federation, Turkey and other members of the Commonwealth Independent States (CIS). Nemonoxacin is a novel antibiotic for the treatment of bacterial infections including those caused by drug-resistant bacteria. Under the terms of the agreement, R-Pharm will be responsible for the development, registration and commercialization of nemonoxacin in these territories and assume all associated costs. In exchange for the exclusive rights, TaiGen will receive an upfront payment and is eligible for additional regulatory and commercial milestones as well as royalties on product sales in the future.
Nemonoxacin is a novel non-fluorinated quinolone available in both oral and intravenous formulations. 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 has completed a multi-center Phase 2 and 3 of the oral formulation in community-acquired pneumonia (CAP) in Taiwan and mainland China and submitted NDA to regulatory authorities in both countries in 2013. In June 2012, TaiGen out-licensed the exclusive rights of mainland China to Zhejiang Medicine. In the U.S., TaiGen has completed two Phase 2 studies, one in CAP and the other in diabetic foot infections (DFI). In December 2013, the U.S. FDA granted nemonoxacin Qualified Infectious Disease Product (QIDP) and Fast Track designation
|SOURCE TaiGen Biotechnology Co., Ltd.|
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