Dr. Savitsky added, “The strategic decision we undertook nearly two years ago to enter the dynamic and rapidly growing field of Hepatitis C has recently gained serious traction for BioLineRx. In the first quarter of 2012, we in-licensed BL-8020 and BL-8030, two promising orally-available treatments for Hepatitis C, both of which will be developed toward the clinic at an accelerated pace. Other high value therapeutic areas, like Celiac Disease, are also being pursued. Also, in 2012, we plan to evaluate alternative funding arrangements for pre-clinical projects that do not benefit from our special funding arrangement with the Office of the Chief Scientist of Israel’s Ministry of Trade, Industry and Labor.
“In February 2012, BioLineRx completed a $15 million private placement to healthcare-focused U.S. institutional investors. This financing places us on a secure financial footing, with enough capital to implement our development plans over the next two years. The private placement in the U.S. followed the listing of our American Depositary Shares on NASDAQ in mid-2011. We see both these accomplishments as important steps in the development and growth of our company, as we look to establish and expand our presence in the U.S. financial markets, as well as in the global biopharmaceutical industry,” concluded Dr. Savitsky.
Highlights for 2011 and 2012 to Date:
- ADS listing on NASDAQ: In July 2011, BioLineRx listed its American Depositary Shares (ADSs) for trading on NASDAQ. The Bank of New York Mellon was appointed as the Company’s depositary bank. Each BioLineRx ADS represents 10 ordinary shares.
- Capital Raising: In February 2012, BioLineRx completed a private placement to healthcare-focused U.S. institutional investors of 5.2 million ADSs at a purchase price of $2.86 per ADS, and warrants to purchase up to 2.6 million additional ADSs at an exercise price of $3.57 per ADS. The offering raised $15.0 million, with net proceeds of approximately $14.1 million.
- New VP of Business Development: In October 2011, the Company hired Mr. David Malek as its new Vice President of Business Development in order to enhance the Company’s business development strategies and accelerate its commercialization efforts. Mr. Malek joined BioLineRx from Sanofi, where he served as Director of Oncology - New Products and Business Development.
- Compugen Partnership: In December 2011, BioLineRx entered into a collaboration agreement with Compugen Ltd. for the purpose of developing and commercializing mutually selected Compugen-discovered drug candidates for the treatment of various diseases, ranging from acute and chronic inflammatory diseases through cardiac diseases, retinopathy and cancer.
- BL-1020 : In May 2011, BioLineRx re-acquired all of the rights to develop and commercialize BL-1020, an orally available molecule for the treatment of schizophrenia, from Cypress Bioscience and currently holds full global rights to the product. BioLineRx is continuing to develop BL-1020, and commenced the Phase 2/3 CLARITY trial in June 2011 in Romania and India. This 450-patient trial aims to determine the cognitive benefit and anti-psychotic efficacy, safety and tolerability of BL-1020 in schizophrenia patients, compared with Risperidone (one of the leading schizophrenia treatments). In April 2011, BioLineRx announced that a Notice of Allowance was issued by the United States Patent and Trademark Office (USPTO) for a patent application covering the BL-1020 drug and its use for the treatment of schizophrenia. The patent, when formally issued, will be valid through September 2022 and may be eligible for a patent term extension of up to five years. In March 2012, BioLineRx announced that a European patent was granted claiming BL-1020’s composition and its use for the treatment of schizophrenia, which will also be valid through September 2022.
- BL-1040: In December 2011, Ikaria commenced the PRESERVATION I trial, a CE Mark registration trial for BL-1040 (also known as “Bioabsorbable Cardiac Matrix,” or BCM), a novel resorbable polymer solution for use in the prevention of cardiac remodeling in patients following an AMI, which is being developed as a medical device. In February 2012, BioLineRx announced that a Notice of Allowance was issued by the United States Patent and Trademark Office (USPTO) for a patent application claiming the composition of BL-1040. This patent, when issued, will be valid until August 2026. Ikaria is developing BCM/BL-1040 under an exclusive, worldwide license agreement signed with BioLineRx in 2009.
- BL-5010: In September 2011, BL-5010, a novel formulation for the non-surgical removal of skin lesions, received European confirmation from the British Standards Institution Notified Body (BSI) in the UK regarding its regulatory pathway classification as a medical device Class IIa. This considerably reduces the time and resources required for marketing authorization for the product in comparison to the drug approval process. BL-5010 has completed a Phase 1/2 clinical trial in which it demonstrated efficacy in complete removal of benign skin lesions and safety. BL-5010 is applied topically on the lesion for a few minutes and causes the lesion to gradually dry out and shed from the skin within 1-3 weeks.
- BL-1021: In December 2011, BioLineRx announced positive results from the Phase 1a study of BL-1021, a new chemical entity for the treatment of neuropathic pain. In the study, it was demonstrated that a single administration of BL-1021 in the dose range examined was safe and well tolerated, with no significant changes noted in vital signs, ECG or laboratory safety parameters at any dose when compared either to baseline measurements or to the placebo group. In addition, BL-1021 demonstrated a favorable pharmacokinetic profile and the potential for once daily oral administration.
- BL-7040: In June 2011, BioLineRx in-licensed BL-7040, an orally available Phase 2 ready oligonucleotide polymer for treating Inflammatory Bowel Disease (IBD). In March 2012, the Company received approval from the Israeli Ministry of Health for commencing a Phase 2 study to evaluate the safety and effectiveness of BL-7040 for the treatment of IBD.
- HCV Therapeutic Candidates: In January 2012, BioLineRx signed a worldwide, exclusive license agreement with Genoscience, a French company focused on viral disease therapeutics, to develop and commercialize BL-8020, an orally available treatment for Hepatitis C. BL-8020’s safety and efficacy have been demonstrated in pre-clinical studies, which show that BL-8020, when combined with other anti-Hepatitis C virus (HCV) agents, has a synergistic effect. In February 2012, BioLineRx signed a worldwide, exclusive license agreement with Genoscience and RFS Pharma to develop and commercialize BL-8030, an orally available treatment for Hepatitis C. 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.
- Addition and Termination of Therapeutic Candidates: As part of its business strategy, BioLineRx continues to actively source, rigorously evaluate and in-license selected therapeutic candidates. Since the beginning of 2011 through the date of this announcement, BioLineRx in-licensed a total of nine projects – eight in pre-clinical stages and one (BL-7040) in clinical development. The Company also terminated three projects during this time period due to lack of efficacy or other scientific considerations – all in early pre-clinical stages, in line with its business strategy.
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