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news.TaiGen Biotechnology Company has signed an exclusive licensing agreement with Mexican pharmaceutical firm Productos Científicos (PC) to develop and commercialize Taigexyn (nemonoxacin) in Latin America.
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Taigexyn is a novel antibiotic for the treatment of bacterial infections including those caused by drug-resistant bacteria. Under the terms of the agreement, PC will be responsible for the development, registration and commercialization of Taigexyn in the territory and assume all associated costs.
The territory includes Mexico, Brazil, Colombia, Peru, Uruguay, Paraguay, Bolivia, Venezuela, Argentina, Chile, Costa Rica, Honduras, Nicaragua, Panama, Guatemala, El Salvador and Ecuador.
In exchange for the exclusive rights, TaiGen will receive an upfront payment and is eligible for additional regulatory and commercial milestones in the future. PC will purchase Taigexyn at a pre-negotiated price from TaiGen for its commercialization in the territory.
QFB. Juan Angeles Uribe, CEO of PC, said “Taigexyn is a significant step for the company that allows us to enter in the antibiotics market with a novel drug which has fully demonstrated through several different PI, PII and PIII clinical studies its safety and efficacy. Latin-American pharmaceutical markets are eager to have such important developments to improve people´s health and we are very proud to be part of that improvement along with TaiGen."
Dr. Ming-Chu Hsu, President and Chief Executive Officer of TaiGen, said, "We are interested in PC because we share the same innovative vision for Taigexyn. The pharmaceutical market in Latin-America is forecast by IMS Health to grow at 9-12% from 2016-2020 and will outpace the 3-6% growth in the developed markets such as US, EU and Japan[i]. By partnering with PC, TaiGen will be able to tap into this high growth market with Taigexyn® where the need for such a novel antibiotic to treat drug-resistant infection is very high."
About Taigexyn
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 addition to the oral formulation, TaiGen is planning to file for market approval of the intravenous formulation in China in the second half of 2016.
In the US, TaiGen have 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 2029.