BioLineRx, a biopharmaceutical development company, has signed an out-licensing agreement with Nanjing-based, Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. (CTTQ), the leading Chinese pharmaceutical company in the liver disease therapeutic area, for the development and commercialisation 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 commercialise BL-8030 in China and Hong Kong.

CTTQ will pay BioLineRx an upfront license fee, plus future development, regulatory and commercialisation 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. BioLineRx will retain the right to develop and commercialise 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 commercialisation and regulatory purposes in all areas of the world outside of China and Hong Kong.

"We look forward to developing and commercialising BL-8030 with CTTQ, the leading pharmaceutical company in China in the field of liver diseases,” said Kinneret Savitsky, PhD., chief executive officer of BioLineRx. "We are proud that since in-licensing this promising pre-clinical asset just over one year ago, we have found a strong partner for the further development of BL-8030 in China, which is a significant market in the HCV field. We believe that given CTTQ's extensive experience in the liver disease area, it will swiftly advance the development of BL-8030 at the highest global standards. In parallel to collaborating with CTTQ to advance the drug, we intend to continue discussions with relevant partners for this project in other parts of the world.”

"We are excited to include BL-8030 as a new asset in our pipeline," said Jian Sun Emba, president of CTTQ. "Unfortunately, the prevalence of HCV is relatively significant in China, with reports of 3.2 per cent of the population (amounting to approximately 43 million individuals) suffering from this chronic and debilitating disease. Thus there is a clear and urgent need to develop new, safe and effective treatments for HCV patients in China. After conducting a thorough due diligence process, we sincerely believe that BL-8030, even though still in pre-clinical development, has the potential to become an important addition to HCV combination therapies."

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."

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 commercialise 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.

Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. (CTTQ), is a large pharmaceutical manufacturer, integrating research, production and sales. The company has a wide array of therapeutic areas, including hepatitis, cancer, cardio-vascular, anti-virus, digestion, respiratory and diabetes, with a particular emphasis on liver diseases, where it is the leading Chinese company in that field.

BioLineRx is a publicly-traded biopharmaceutical development company. BioLineRx is dedicated to building a portfolio of products for unmet medical needs or with advantages over currently available therapies.