Taiwanese firm projects completing Phase III trials with oral nemonoxacin in China and Taiwan during 2012.
TaiGen Biotechnology acquired worldwide rights to the nonfluorinated quinolone antibiotic nemonoxacin from Warner Chilcott. Taiwanese firm TaiGen had previously licensed rights to nemonoxacin in 10 Asian countries, and worldwide development rights to the drug through Phase II development from Procter & Gamble, whose branded prescription pharmaceuticals business Warner Chilcott acquired in October 2009. In August 2010 Warner Chilcott regained all rights to nemonoxacin outside the 10 TaiGen territories, after the latter reported positive data from two Phase III trials in community acquired pneumonia, and diabetic foot infection.
The new deal with Warner Chilcott means TaiGen now holds the whole nemonoxacin regulatory package and related IP, including worldwide exclusive rights to develop, manufacture, commercialize, and sublicense nemonoxacin. The firm says the FDA regulatory guildelines for CAP trials currently exclude patients who have had prior antibiotic use, which makes carrying out trials in the U.S. difficult. In contrast, territories such as the EU and mainland China are encouraging the development of antibiotics because of rising MRSA rates.
“This will be an opportunity for TaiGen to capture the full value of nemonoxacin in the worldwide territory,” comments Ming-Chu Hsu, M.D., president ahd CEO. “TaiGen is targeting to complete Phase III oral trial for nemonoxacin in mainland China and Taiwan in 2012. The initiation of the Phase II/III clinical trial for intravenous formulation is also planned in 2012…We will be actively seeking partners for nemonoxacin outside Greater China, particularly in countries where the antibiotic resistant rate is high.”