, Dec. 9, 2011
/PRNewswire-Asia/ -- TaiGen Biotechnology ("TaiGen") announced today that Warner Chilcott
will transfer the worldwide rights for nemonoxacin, a novel non-fluorinated quinolone antibiotic under development for treatment of antibiotic-resistant infection to TaiGen. With the transfer of the compound, a complete regulatory package and related intellectual property rights, TaiGen will hold the worldwide exclusive rights for development, manufacture, commercialization and sub-licensing of nemonoxacin.
TaiGen originally licensed nemonoxacin product rights in ten Asian countries and worldwide development rights through Phase II from Procter & Gamble Pharmaceuticals, which was acquired by Warner Chilcott in October 2009. In August 2010, Warner Chilcott regained all rights outside the TaiGen territories after TaiGen obtained positive data, including effective eradication of MRSA and quinolone-resistant MRSA in two Phase II trials for community acquired pneumonia ("CAP") and diabetic foot infection under a US IND.
Dr. Ming-Chu Hsu, President and Chief Executive Officer of TaiGen said, "The draft FDA regulatory guidelines for CAP trials that exclude patients who have prior antibiotic use pose potential hurdles for conducting clinical trials in the US. We are not aware of such restriction in countries other than the US. On the contrary, in recent announcements, EU and mainland China have encouraged the development and offered accelerate approval of new antibiotics due to rising infection rate of MRSA in these regions. This will be an opportunity for TaiGen to capture the full value of nemonoxacin in the worldwide territory."
Dr. Hsu further commented, "More importantly, 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. With the progress of the development in the past year, we have further created value for nemonoxacin. This will greatly enhance the attractiveness to any potential partner." TaiGen will be actively seeking partners for nemonoxacin outside Greater China, particularly in countries where the antibiotic resistant rate is high.
About TaiGen Biotechnology
TaiGen Biotechnology (http://www.taigenbiotech.com) is a leading development stage pharmaceutical company based in Taiwan with a wholly-owned subsidiary in Beijing, mainland China. The company has a full capacity in discovery research and clinical development in mainland China/Taiwan/US. Its current pipeline includes therapeutics for infectious diseases, diabetic complications and cancer for the worldwide market.
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.
Dr. Peter W. Tsao
VP Global 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.