TAIPEI, Taiwan, Aug. 25, 2016 /PRNewswire/ -- TaiGen
Biotechnology Company, Limited ("TaiGen") today announced that they
have signed an exclusive licensing agreement with Productos
Científicos S.A. de C.V. ("PC"), a leading Mexican pharmaceutical
company, to develop and commercialize Taigexyn®
(nemonoxacin) in Latin America. 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."
[i] Global Use of Medicines in 2020, IMS Institute for
Healthcare Informatics
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.
About Productos Científicos S.A. de C.V.
Productos Científicos S.A. de C.V. is a leading privately held
Mexican pharmaceutical company with more than 75 years in the
Latin-American markets. Part of Carnot Group, the company have its
own subsidiaries on the most important Latin-American markets such
as México, Brazil, Argentina, Colombia and Peru, and covers all Latin-American territory
through this affiliates and other partners. Its main therapeutic
areas are Gastroenterology, Women´s Health, Pediatrics and
Respiratory.
About TaiGen Biotechnology
TaiGen Biotechnology is a leading research-based and
product-driven biotechnology company in Taiwan with a wholly-owned subsidiary in
Beijing, China. In addition to
Taigexyn®, TaiGen has two other in-house discovered NCEs
in clinical development under IND with US FDA: TG-0054, a chemokine
receptor antagonist for stem cell transplantation and
chemosensitization, and TG-2349, a HCV protease inhibitor for
treatment of chronic hepatitis infection. Both TG-0054 and TG-2349
are currently in Phase 2 clinical development.
TaiGen Contact:
Peter W. Tsao, PhD, Vice President
Corporate Development
Tel: +886-2-8177-7072
Productos Científicos Contact:
Javier Mestre, Business Development
Director
Tel: +52-5488-7000
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SOURCE TaiGen Biotechnology