Date: 2013-06-10
Type of information: Development agreement
Compound: BL-8030
Company: BiolineRx (Israel) CTTQ (China)
Therapeutic area: Infectious diseases
Type agreement: development
commercialisation
Action mechanism: BL-8030 is a potent and selective second generation NS3 protease inhibitor. It has been shown to have excellent antiviral activity against various HCV genotypes. Pre-clinical studies have demonstrated an improved resistance profile against common protease inhibitor mutants, resulting in a lower probability that the virus will develop resistance to treatment. In addition, BL-8030 has demonstrated a good toxicity profile in pre-clinical studies, exhibiting specificity only to the viral protease and lack of activity against a relevant panel of human proteases as well as a clean profile versus human liver enzymes, which is expected to lead to less drug-drug interactions. BL-8030 was invented by Professor Philippe Halfon and his team at Genoscience and co-developed with assistance from scientists at RFS Pharma.
Disease: hepatitis C
Details: * On June 10, 2013, BioLineRx, a biopharmaceutical development company, has announced that it has signed an out-licensing agreement with Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. (CTTQ), the leading Chinese pharmaceutical company in the liver disease therapeutic area, for the development and commercialization of BL-8030, an orally available treatment for the Hepatitis C virus (HCV). Under the terms of the agreement, BioLineRx will grant CTTQ exclusive rights to develop, manufacture and commercialize BL-8030 in China and Hong Kong. BioLineRx will retain the right to develop and commercialize BL-8030 in other parts of the world. CTTQ will adhere to FDA and EMA guidelines in pre-clinical development and manufacturing of BL-8030. BioLineRx will have access to all development and regulatory data generated by CTTQ, as well as the right to use this data for commercialization and regulatory purposes in all areas of the world outside of China and Hong Kong.
In February 2012, BioLineRx signed a worldwide, exclusive license agreement with Genoscience and RFS Pharma, LLC to develop and commercialize BL-8030. BL-8030 was invented by Professor Philippe Halfon and his team at Genoscience, and co-developed with scientists at RFS Pharma, LLC. He is the founder of several biotechnology companies focusing on antiviral drug discovery and development, including ACTgene, Alphabio and Genoscience. RFS Pharma was founded in 2004 by Professor Raymond Schinazi; he currently serves as the Frances Winship Walters Professor of Pediatrics at Emory University. He is also a principal founder of Pharmasset Inc., Idenix Inc. and Triangle Pharmaceuticals.
Financial terms: CTTQ will pay BioLineRx an upfront license fee, plus future development, regulatory and commercialization milestones, for a total potential deal value of approximately $30 million. In addition, BioLineRx has the right to receive high single-digit royalties on future sales of the drug.
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