TAIPEI, Taiwan, Oct. 14 /PRNewswire-Asia/ -- TaiGen Biotechnology Co., Ltd. today announced that TaiGen has entered into an amendment to its license agreement with Warner Chilcott plc regarding the development and commercialization of nemonoxacin -- a new generation quinolone antibiotic.
Under the terms of the original license agreement, entered into in December 2004, TaiGen licensed exclusive development, manufacture and commercialization rights to nemonoxacin from The Procter & Gamble Company in mainland China, Hong Kong, Taiwan, South Korea and certain other Asian countries, and assumed responsibility, at its sole cost and expense, for the conduct of a Phase Ib study and two Phase II trials in community-acquired bacterial pneumonia (CABP) and diabetic foot infection (DFI) patients, respectively, in which nemonoxacin demonstrated an excellent efficacy and safety profile. Upon Warner Chilcott's purchase of the global branded pharmaceuticals business of Procter & Gamble in October 2009, Warner Chilcott assumed Procter & Gamble's interest in the license agreement.
Under the terms of the amended agreement, entered into following the conclusion of Phase II trials, TaiGen keeps its exclusive development, manufacture and commercialization rights to nemonoxacin in the countries under the original license agreement, while Warner Chilcott retains development and commercialization rights in all other markets, including the United States and Europe. TaiGen and Warner Chilcott have agreed to cross-license their respective patent rights relating to nemonoxacin and TaiGen will transfer to Warner Chilcott its Investigational New Drug Application filed with the FDA. Upon the execution of the amended agreement, TaiGen received an upfront payment from Warner Chilcott and is eligible for certain regulatory milestone payments, as well as a royalty based on Warner Chilcott's net sales of the product.
Warner Chilcott plc is a leading specialty pharmaceutical company currently focused on the gastroenterology, women's healthcare, dermatology and urology segments of the North American and Western European pharmaceuticals markets.
"We are very encouraged by the signing of the amended agreement with Warner Chilcott," said Dr. Ming-Chu, Hsu, Chairman and CEO of TaiGen. "The deal proved TaiGen's capabilities in conducting clinical and regulatory development with high quality and at standards set by the United States Food and Drug Administration (US FDA). It also validated TaiGen's business model of building R&D portfolio through both internal R&D and external collaboration and licensing."
With China being a fast growing pharmaceutical market, TaiGen, which set up its Beijing affiliate in 2005, has been developing nemonoxacin under the China SFDA (China State Food and Drug Administration) regulation. It is expected that nemonoxacin will enter Phase III development in China very soon.
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, 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.
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SOURCE TaiGen Biotechnology Co., Ltd.