TAIPEI, Taiwan, June 25, 2012 /PRNewswire-Asia/ -- TaiGen Biotechnology Company, Limited ("TaiGen") and Zhejiang Medicine Company, Limited ("ZMC") today announced that they 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 3 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. TaiGen will retain full development and commercialization rights outside the licensed territory including Taiwan, the United States, European Union, and Japan. Under the terms of the agreement, TaiGen will receive an upfront payment of US$ 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 multi-center 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. Nemonoxacin is taken once-a-day and available in both oral and intravenous formulations. Currently, TaiGen is completing a Phase 3 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 US$ 11 billion (RMB 68 billion) and account for almost 20% of the total pharmaceuticals sales. Rate of antibiotic resistant infections in China is among the highest in the world.
Mr. Li Chun Bo, Chairman of the ZMC, commented, "We are impressed with nemonoxacin's broad spectrum activity towards drug-resistant bacteria, in particular, MRSA, and excellent safety profile. We are excited to establish this partnership with TaiGen because of its reputation as a premier research-based biotech company in Asia. This partnership will break new ground for cross-strait collaboration in the pharmaceutical industry. Nemonoxacin will be a major addition to ZMC's antibiotic product line and significant profit driver".
Dr. Ming-Chu Hsu, President and Chief Executive Officer of TaiGen, said, "China is the world's fastest growing pharmaceutical market. It is poised to overtake Japan as the second largest pharmaceutical market. We are extremely please to establish our nemonoxacin partnership with ZMC, a first-class pharmaceutical company and major player in the Chinese antibiotics market. With nemonoxacin, TaiGen and ZMC together will bring new medicine to treat unmet medical needs in China. This partnership will not only set a new record for pharmaceutical licensing involving a Taiwanese and a mainland Chinese company but hopefully will also become a model of the future collaborations," Dr. Hsu also added, "With the conclusion of the partnership in China, we will actively pursue nemonoxacin licensing discussions in other territories such as European Union."
About Zhejiang Medicine
Zhejiang Medicine Company, Limited is a leading pharmaceutical company in China specializing in sales and distribution of pharmaceuticals and manufacturing of active pharmaceutical ingredients (vitamins and antibiotics). Its sales revenue in 2011 is US $740 million (RMB 4.8 billion). ZMC is a leader in the Chinese antibiotic market with levofloxacin, vancomycin, and teicoplanin in the product line. ZMC's Lai Li Xin, a branded levofloxacin, is one of the top selling antibiotics in China with 2011 sales exceeding US $110 million (RMB 735 million). In addition to pharmaceuticals sales, ZMC is also known for its manufacturing quality. Its vancomycin active pharmaceutical ingredient has obtained GMP qualification from US Food and Drug Administration (FDA) and exported to western countries. ZMC is publicly listed in the Shanghai Stock Exchange (600216) and has a market capitalization of RMB 11 billion.
About TaiGen Biotechnology
TaiGen Biotechnology is a leading research-based and product-driven biotechnology company in Taiwan with a wholly-owned subsidiary in Beijing, mainland China. TaiGen has full discovery research capacity in Taiwan and clinical development in mainland China/Taiwan/US. In addition to nemonoxacin, TaiGen has two other in-house discovered new chemical entities in clinical development under IND with US FDA: TG-0054, a chemokine receptor antagonist for stem cell transplantation and chemosensitization, in Phase 2 and TG-2349, a HCV protease inhibitor for treatment of chronic hepatitis infection, in Phase 1. Both TG-0054 and TG-2349 are currently in clinical development in the US.
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 Business Development
Tel: +886-2-8177-7072 ext 1705
PJ (Joe) Hsueh, Vice President of Operations
Tel. +886-2-8177-7072 ext 1704
SOURCE TaiGen Biotechnology Co., Ltd.