TaiGen Biopharmaceuticals Holdings Ltd (太景醫藥研發控股) on Monday said that its Russian partner has completed patient enrollment of a phase III clinical trial of antibiotic Taigexyn (nemonoxacin), as part of plans to commercialize the drug in the nation.
Moscow-based R-Pharm JSC has enrolled 342 patients in a study to compare the efficacy and safety of intravenous and oral formulations of Taigexyn against Tavanic (levofloxacin) in treating community-acquired pneumonia, TaiGen said.
The study is designed as an intravenous-to-oral therapy, where patients are given the intravenous formulation of Taigexyn for three days, followed by five to seven days of single-dose oral administration.
Patients would be administered a single daily dose of 500mg of Taigexyn during the intravenous and oral segments of the study.
“The trial, which studies both the oral and intravenous formulations simultaneously, is expected to speed up the commercialization process,” TaiGen chief operating officer Hsu Ming-chu (許明珠) said.
A new drug application is expected to be submitted to Russian health regulators in the first half of next year, TaiGen said.
The company in 2014 inked a contract with R-Pharm to oversee the commercialization of Taigexyn in Russia, Turkey and 13 other nations, and it is eligible to further milestone and royalty payments from its Russian partner, TaiGen said.
Taigexyn is a broad spectrum non-fluorinated quinolone antibiotic with excellent efficacy against drug-resistant bacteria and has an improved side-effect profile compared with fluoroquinolones such as levofloxacin, the company said.
The company reported that net income in the first nine months totaled NT$877 million (US$29.23 million), compared with a net loss of NT$194 million during the same period the previous year.
TaiGen earlier this month said that a phase III clinical trial conducted in Taiwan was successful and showed that the intravenous formulation of Taigexyn is not inferior to levofloxacin.
TaiGen shares gained 1.61 percent to close at NT$22.1 in Taipei trading yesterday.
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