Two for C

JERUSALEM—BioLineRx, a biopharmaceutical developmentcompany, has signed a worldwide, exclusive license agreement with Genoscienceand RFS Pharma to develop and commercialize BL-8030, an orally availabletreatment for hepatitis C. The agreement includes upfront license fees,milestones and royalties payable to both companies. Previously, BioLineRx hadsigned an exclusive license agreement with Genoscience of Marseille, France, todevelop and commercialize BL-8020, another orally available treatment forhepatitis C.

BioLineRx's business model is based on acquiring moleculesmainly from biotechnological incubators and academic institutions. The companyperforms feasibility assessment studies and development through preclinical andclinical stages, with partial funding from the Israeli Government's Office ofthe Chief Scientist (OCS). The final stage includes partnering with medium andlarge pharmaceutical companies for advanced clinical development (Phase III)and commercialization.

According to Tsipi Haitovsky, BioLineRx's public relationsofficer, the company began discussions with the researchers leading Genoscienceand RFS, Prof. Philippe Halfon and Prof. Raymond Schinazi, more than a yearago.

"During this period, we have discussed with these twodistinguished researchers various aspects, opportunities and ideas for thefuture development plans for BL-8020 and BL-8030. Through this process, mutual trustwas established and we are delighted and honored that both of them wereinterested in developing these compounds jointly with BioLineRx," Haitovskystates.

The projects will be developed by BioLineRx with the closecounsel and cooperation of its two partners, who will participate fully in thedevelopment and decision-making process for the two projects. "We see theinvolvement of these individuals and companies as a key advantage in ourability to bring together unique and valuable molecules in the field of HCV,"Haitovsky adds.

BL-8030 was invented by Halfon and his team at Genoscienceand co-developed with assistance from scientists at RFS. BL-8030 is a potentand selective second-generation NS3 protease inhibitor. The NS3 protease isessential for the replication of the hepatitis C virus (HCV) and is animportant target for HCV therapies. BL-8030 has been shown to have excellentantiviral activity against various HCV genotypes. Preclinical studies havedemonstrated an improved resistance profile against common protease inhibitormutants, resulting in a lower probability that the virus will developresistance to treatment. In addition, BL-8030 has demonstrated a good toxicityprofile in preclinical studies, exhibiting specificity only to the viral proteaseand lack of activity against a relevant panel of human proteases, as well as aclean profile versus human liver enzymes, which is expected to lead to fewerdrug-drug interactions.

Halfon notes that, "We were impressed by the drugdevelopment expertise of the BioLineRx team and are very pleased to collaboratewith them on a second HCV project. There is clearly a huge unmet medical needin finding a safe and effective treatment for HCV, and based on preclinicalresults, we believe that our product, especially when combined with otheravailable hepatitis C drugs, has the potential to become an important additionto HCV combination therapies and bring remedy to millions suffering from thisdevastating disease."

"We are fortunate to partner with two world-class groups inthe development of viral therapeutics," says Dr. Kinneret Savitsky, CEO ofBioLineRx. "Two years ago, we made a strategic decision to enter the dynamicand rapidly growing field of hepatitis C. A year ago, we identified and decidedto 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 todevelop these promising drugs as swiftly as possible for the benefit ofhepatitis C infected individuals around the world. The current global hepatitis market is estimated atapproximately $6.5 billion and is growing steadily. Current therapies arecharacterized by numerous severe side effects, long treatment duration anddevelopment of resistance."

Savitsky notes that the first of the two in-licensedmolecules, BL-8020, has a demonstrated safety and efficacy profile, may shortentherapy duration and may combat resistance by acting as an add-on platformwhich can potentially be combined with other oral hepatitis C therapies toincrease their efficacy.

RFS was founded in September 2004 and is located in a 26,500square-foot research facility in Tucker, Ga. RFS is a privately owned biotechcompany that hopes to capitalize on its expertise in nucleoside chemistry to developdrugs to combat infections caused by drug-resistant HIV and hepatitis viruses.RFS' lead product candidate is amdoxovir, which is in advanced Phase IIclinical studies for the treatment of HIV-1 infections.