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Two for C
JERUSALEM—BioLineRx, a biopharmaceutical development company, has signed a worldwide, exclusive license agreement with Genoscience and RFS Pharma to develop and commercialize BL-8030, an orally available treatment for hepatitis C. The agreement includes upfront license fees, milestones and royalties payable to both companies. Previously, BioLineRx had signed an exclusive license agreement with Genoscience of Marseille, France, to develop and commercialize BL-8020, another orally available treatment for hepatitis C.
BioLineRx's business model is based on acquiring molecules mainly from biotechnological incubators and academic institutions. The company performs feasibility assessment studies and development through preclinical and clinical stages, with partial funding from the Israeli Government's Office of the Chief Scientist (OCS). The final stage includes partnering with medium and large pharmaceutical companies for advanced clinical development (Phase III) and commercialization.
According to Tsipi Haitovsky, BioLineRx's public relations officer, the company began discussions with the researchers leading Genoscience and RFS, Prof. Philippe Halfon and Prof. Raymond Schinazi, more than a year ago.
"During this period, we have discussed with these two distinguished researchers various aspects, opportunities and ideas for the future development plans for BL-8020 and BL-8030. Through this process, mutual trust was established and we are delighted and honored that both of them were interested in developing these compounds jointly with BioLineRx," Haitovsky states.
The projects will be developed by BioLineRx with the close counsel and cooperation of its two partners, who will participate fully in the development and decision-making process for the two projects. "We see the involvement of these individuals and companies as a key advantage in our ability to bring together unique and valuable molecules in the field of HCV," Haitovsky adds.
BL-8030 was invented by Halfon and his team at Genoscience and co- developed with assistance from scientists at RFS. BL-8030 is a potent and selective second-generation NS3 protease inhibitor. The NS3 protease is essential for the replication of the hepatitis C virus (HCV) and is an important target for HCV therapies. BL-8030 has been shown to have excellent antiviral activity against various HCV genotypes. Preclinical 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 preclinical 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 fewer drug-drug interactions.
Halfon notes that, "We were impressed by the drug development expertise of the BioLineRx team and are very pleased to collaborate with them on a second HCV project. There is clearly a huge unmet medical need in finding a safe and effective treatment for HCV, and based on preclinical results, we believe that our product, especially when combined with other available hepatitis C drugs, has the potential to become an important addition to HCV combination therapies and bring remedy to millions suffering from this devastating disease."
"We are fortunate to partner with two world-class groups in the development of viral therapeutics," says Dr. Kinneret Savitsky, CEO of BioLineRx. "Two years ago, we made a strategic decision to enter the dynamic and rapidly growing field of hepatitis C. A year ago, we identified and decided to focus on the in-licensing of the two most promising candidates: BL-8020, which we've recently licensed, and now BL-8030. We will do our utmost to develop these promising drugs as swiftly as possible for the benefit of hepatitis C infected individuals around the world. The current global hepatitis market is estimated at approximately $6.5 billion and is growing steadily. Current therapies are characterized by numerous severe side effects, long treatment duration and development of resistance."
Savitsky notes that the first of the two in-licensed molecules, BL-8020, has a demonstrated safety and efficacy profile, may shorten therapy duration and may combat resistance by acting as an add-on platform which can potentially be combined with other oral hepatitis C therapies to increase their efficacy.
RFS was founded in September 2004 and is located in a 26,500 square-foot research facility in Tucker, Ga. RFS is a privately owned biotech company that hopes to capitalize on its expertise in nucleoside chemistry to develop drugs to combat infections caused by drug-resistant HIV and hepatitis viruses. RFS' lead product candidate is amdoxovir, which is in advanced Phase II clinical studies for the treatment of HIV-1 infections.