TAIPEI, Sept. 30, 2020 /PRNewswire/ -- TaiGen Biotechnology Company, Limited ("TaiGen") (Taiwan: 4157) today announced that they have signed an exclusive licensing agreement with Luminarie Canada Inc. ("Luminarie"), a leading Canadian pharmaceutical company, to develop and commercialize Taigexyn® (nemonoxacin) in Canada, Australia and New Zealand. Taigexyn® is a novel safe and effective antibiotic for the treatment of bacterial infections including those caused by drug-resistant bacteria. Under the terms of the agreement, Luminarie will be responsible for the development, registration and commercialization of Taigexyn® in the territory and assume all associated costs. The territory includes Canada, Australia and New Zealand. In exchange for the exclusive rights, TaiGen will receive the additional regulatory and commercial milestones in the future. Luminarie will purchase Taigexyn® at a pre-negotiated price from TaiGen for its commercialization in the territory.
Yanick Thibeault, President-Owner of Luminarie Canada, said "We're pleased to develop a long-term partnership with TaiGen, an experienced developer of novelty drugs with Global manufacturing standards, and to offer Taigexyn® to our patients and customers. Taigexyn® will support our vision to bring novel products for unmet medical needs."
Kuo-Lung Huang, Chairman and Chief Executive Officer of Licensor, said, "We are interested in Luminarie because we share the same innovative vision for Taigexyn®. By partnering with Luminarie, TaiGen will be able to tap into these developed markets with Taigexyn® where the need for such a novel antibiotic to treat drug-resistant infection is very high."
Taigexyn® is a novel non-fluorinated quinolone available in both oral and intravenous formulations. TaiGen has completed multi-national and multi-center trials of Taigexyn® in oral and intravenous forms. The oral formulation of Taigexyn® have received market approval in Taiwan and mainland China shown activity against drug-resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) and quinolone-resistant MRSA as well as quinolone-resistant Streptococcus pneumonia. Taigexyn® is marketed in mainland China by Zhejiang Medicine Co. through an exclusive marketing and manufacturing licensing agreement. TaiGen also partnered the exclusive rights in the Russian Federation, the Commonwealth of Independent States, and Turkey to R-Pharm of Russia; in the Latin American to Productos Científicos S.A. de C.V. In addition to the oral formulation, TaiGen is going to obtain the market approval of the intravenous formulation in Mainland China and Taiwan.
In the US, TaiGen has completed two Phase 2 studies, one in CAP and the other in diabetic foot infections (DFI). In December 2013, the US FDA granted Taigexyn® Qualified Infectious Disease Product (QIDP) and Fast Track designations for CAP and acute bacterial skin and skin structure infections (ABSSSI). TaiGen owns the worldwide patent portfolio of Taigexyn® that protects composition, use, and processes until 2037.
About Luminarie Canada Inc.
Luminarie Canada is a recently created company specialized in the commercialization of innovative healthcare products and solutions in Canada. With expertise in virology, microbiology & immunology, Luminarie Canada acquired the commercial rights to pharmaceutical products and diagnostic devices to support the fight against the COVID-19 pandemic.
About TaiGen Biotechnology
TaiGen Biotechnology is a leading research-based and market-driven biotechnology company in Taiwan with a wholly-owned subsidiary in Beijing, China. In addition to Taigexyn®, TaiGen has three other in-house discovered NCEs: TG-1000, a novel pan-influenza antiviral effective against influenza-A, influenza-B, avian flu H7N7, and Tamiflu-resistant viruses, TG-3000, a chemokine receptor antagonist for stem cell transplantation and chemosensitization, and Furaprevir, a HCV protease inhibitor for treatment of chronic hepatitis infection. TG-1000 is currently in Phase 1 clinical study in China and preparing IND filing in USA, TG-3000 has completed Phase 2 clinical studies and Furaprevir is currently in Phase 3 clinical development.