TAIPEI, Taiwan, Dec. 15, 2015 /PRNewswire/ -- TaiGen Biotechnology Company, Limited ("TaiGen") today announced that together with its distribution partner, Holding Distribution, it has launched Taigexyn® (nemonoxacin) capsules in Taiwan, the first market where Taigexyn® is available. Taigexyn® is a novel non-fluorinated quinolone antibiotic for the treatment of bacterial infections with both oral (capsule) and intravenous formulations. TaiGen successfully completed multiple clinical trials (Phase 1-3) of Taigexyn® in community acquired pneumonia in Taiwan and mainland China and have filed for New Drug Application (NDA) of the oral formulation in both markets in March and April 2013 respectively. In December 2014, the Taiwan Food and Drug Administration approved the NDA and granted the new drug license for the oral formulation of Taigexyn® to TaiGen. Taigexyn® is out-licensed to Zhejiang Medicine in mainland China and to R-Pharm in Russia, Commonwealth Independent States, and Turkey.
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: burixafor (TG-0054), a chemokine receptor antagonist for stem cell transplantation and chemosensitization and furaprevir (TG-2349), a HCV protease inhibitor for treatment of chronic hepatitis C infection, both in Phase 2.
Certain statements in this press release are forward-looking. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimated" and "intend," among others. These forward-looking statements are based on TaiGen's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain regulatory authority clearances or approvals and noncompliance with regulatory regulations. As with any drugs under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. TaiGen does not undertake an obligation to update or revise any forward-looking statement.
Peter W. Tsao, PhD, Vice President, Corporate Development
SOURCE TaiGen Biotechnology