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Tuesday, June 26, 2012

TaiGen Biotech out-licenses China rights for nemonoxacin, to Zhejiang Medicine

 Article | 26 June 2012 Taiwan-based TaiGen Biotechnology and China's Zhejiang Medicine Company (SHA: 600216) have signed an exclusive agreement to manufacture and commercialize nemonoxacin, a novel broad-spectrum antibiotic, in China (excluding Hong Kong, and Macau). Nemonoxacin is a novel broad-spectrum non-fluorinated quinolone antibiotic under development for respiratory infections. TaiGen will be responsible for completing the Phase III clinical trial for community acquired pneumonia (CAP) in China. ZMC will be responsible for manufacturing, sales and marketing of nemonoxacin in China through its wholly-owned subsidiary, XinChang Pharmaceuticals. Enjoying this article? Have the leading Biopharma news & analysis delivered daily on email by signing up for our FREE email newsletter here. TaiGen gained worldwide rights nemonoxacin from Ireland-headquartered Warner Chilcott (Nasdaq: WCRX) last year. Financial terms of the accord were not disclosed (The Pharma Letter December 11, 2011).

TaiGen to get $8 million upfront TaiGen will retain full development and commercialization rights outside the licensed territory including Taiwan, the USA, European Union and Japan. Under the terms of the deal, TaiGen will receive an upfront payment of $8 million from ZMC and will receive additional milestones as well as royalties on product sales. The term of the agreement is 20 years. Nemonoxacin has demonstrated efficacy and safety in CAP and diabetic foot infection in multinational and multicenter clinical trials conducted by TaiGen. In particular, nemonoxacin has excellent activity against drug-resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) and quinolone-resistant MRSA, the Taiwanese company noted. Nemonoxacin is taken once-a-day and available in both oral and intravenous formulations. Currently, TaiGen is completing a Phase III CAP trial with more than 500 patients from Taiwan and mainland China and expects to file new drug applications in Taiwan and mainland China simultaneously in early 2013. China is one of the major antibiotic markets in the world. According to IMS, the sales of antibiotics in 2011 were approximately $11 billion and account for almost 20% of the total pharmaceuticals sales. The rate of antibiotic resistant infections in China is among the highest in the world. 

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