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BioLineRx has signed an agreement with Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. (CTTQ) for the development and commercialization of BL-8030, an oral treatment for the Hepatitis C virus (HCV).
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KINNERET SAVITSKY, CEO OF BIOLINERX
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/ Jewish Business News Correspondent /
Drug development company BioLineRx Ltd. (Nasdaq: BLRX); TASE:BLRX) announced today 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 oral 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. CTTQ will pay BioLineRx an upfront license fee, plus future development, regulatory and commercialization milestones, for a total potential deal value of $30 million.
BioLineRx also has the right to receive high single-digit royalties on future sales of the drug, and will retain the right to develop and commercialize BL-8030 in other parts of the world.
CTTQ will adhere to US Food and Drug Administration (FDA) and European Medical Association (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.
The company’s share price rose 10.65% on the TASE this afternoon to NIS 6.70, and closed yesterday on Nasdaq at $1.65, giving a market cap of $36.72 million.
Professor Philippe Halfon, world-renowned scientist for his work on HIV, HPV (human papilloma virus causing cervical cancer) and Hepatitis, and a co-inventor of BL-8030, said, “BL-8030 has shown promising results in pre-clinical studies, and may become an important part of combination therapies for HCV. Current treatments are only partially effective and adverse effects are common, so there is a clear need for new drugs that will be both safe and effective.”
About BL-8030
BL-8030, an orally available treatment for Hepatitis C, is a potent and selective second generation NS3 protease inhibitor. The NS3 protease is essential for replication of the Hepatitis C virus and is an important target for HCV therapies. BL-8030 has been shown to have excellent antiviral activity, in the low nanomolar range, against a wide range of 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 safety 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. PK studies in animals indicated the BL-8030 has good oral bioavailability, suggesting the potential for once-daily dosing in the clinic.
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. Prof. Halfon, Co-Founder and President of Genoscience, is a specialist in molecular virology and infectious diseases, especially HIV, HPV and Hepatitis. In addition 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.
