TAIPEI, Taiwan, Dec. 3, 2015 /PRNewswire/ -- TaiGen Biotechnology Company, Limited ("TaiGen") made a public announcement today that the intravenous formulation of Taigexyn® has achieved the primary endpoint (clinical success rate at Visit 4 in the evaluable-mITT population) in the Phase 3 clinical trial of community acquired pneumonia (TG-873870-C-6). This trial was a randomized, double-blinded study comparing intravenous formulations of Taigexyn® 500mg vs. levofloxacin 500 mg and has recruited 525 patients from Taiwan and mainland China. The clinical success rates for Taigexyn® 500 mg and levofloxacin 500 mg were 92.8% and 87.0%, respectively, in evaluable-mITT subjects. Taigexyn® 500 mg was shown to be non-inferior to levofloxacin 500 mg in that the lower limit of the 95% CI of the treatment difference was greater than -10% (p<0.05). Based on these results, TaiGen will prepare for the filing of New Drug Application (NDA) with China's FDA in 2016.
Taigexyn® (nemonoxacin) is designated as a Class 1.1 new drug under China's FDA. It is a novel non-fluorinated quinolone with both oral and intravenous formulations. TaiGen have completed multiple clinical trials (Phase 1-3) for community acquired pneumonia in Taiwan and mainland China and have filed for NDA of the oral formulation in both markets in March and April 2013 respectively. The Taiwan FDA granted new drug license for the oral formulation of Taigexyn® to TaiGen in January 2015.
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 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 of Corporate Development
SOURCE TaiGen Biotechnology