The shares of thinly traded BioLineRx (NASDAQ:BLRX) soared as high as $5.86 following early Monday morning news that the firm had 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 stock was not able to hold on to the gains. Before the day was done, the stock sold off but still managed to close the day up 7.77% to at $4.44 +0.32 on Monday.
The agreement included upfront license fees, milestones and royalties payable to both companies, which terms are consistent with BioLineRx's standard in-license agreements. The agent, which has not yet even begun human clinical trials is known as BL-8030 and 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. 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.
Last month, BioLineRx licensed another preclinical hepatitis C compound from France's Genoscience called BL-8020-- which acts via a unique mechanism of action, by inhibiting Hepatitis C virus HCV-induced autophagy. That differs from the mechanism of currently used anti- HCV agents. In addition BL-8020 may reduce therapy duration, which is currently up to 48 weeks. The use of two drugs acting by different mechanisms is also likely to be beneficial for patients who have developed resistance to current treatments and is an effective strategy used against other viruses such as HIV.
These compounds were invented by Professor Philippe Halfon and his team at Genoscience and co-developed with assistance from scientists at RFS Pharma, LLC -- which was founded by Professor Raymond F. Schinazi; also a founder of Pharmasset (VRUS), Idenix (NASDAQ:IDIX), Triangle and ActivBiotics Pharma.
Prof. Philippe Halfon said, "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 pre-clinical 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 worked closely with the group at Genoscience to determine the optimum characteristic that led to the discovery of BL-8030 and related protease inhibitors," said Dr. Steven J. Coats, Senior Director of Chemistry at RFS Pharma.
That shares were not able to hold on to their gains on Monday was likely the result of traders seeing that the firm usually trades on very little volume. Once people made money, they took profits for the day. That isn't to say, however, that people may not be more aware of the firm going forward and decide to take positions in the stock.
What we know is that BioLineRx is based in Israel and that their business model involves three stages: It specialized at evaluating potential drug candidates from both scientific and marketing perspectives; It performs development through Phase 2 proof of concept studies and it partners with pharmaceutical companies to complete the clinical development and bring the product to market.
BioLineRx pipeline consists of clinical and pre-clinical candidates spanning a variety of indications including: central nervous system diseases, oncology, cardiovascular and autoimmune diseases. The company's product pipeline includes: BL-1040 for the treatment of acute myocardial infraction, BL-1020 for the treatment of schizophrenia, BL-5010 for the treatment of skin lesions, BL-1021, for the treatment of neuropathic pain, BL-2030 for the treatment of inflammation, BL-4040 for the treatment of acute kidney failure and BL-5040 for the treatment of inflammatory bowel diseases.
There are several catalysts listed for BioLineRx in the BioMedReports FDA Catalyst and Worldwide Regulatory Calendar. For example, in June, when the firm reported its results for the second quarter, they announced that they had added two new projects to their portfolio-- including BL-7040 for treatment of inflammatory bowel disease, which is expected to enter Phase II clinical trials at the beginning of 2012.
Based on a previous note from the firm to the markets, we are also expecting that the firm's breakthrough treatment for Acute Myocardial Infarction (BL-1040) should get an expedited regulatory pathway which would allow marketing of the product sometime this year (2012).
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.