Jerusalem, April 4, 2011. BioLineRx (TASE:BLRX) announced today that a Notice of Allowance has been 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. This patent, when formally issued, will be valid until September 2022 and may be eligible for a patent term extension of up to five years.
This Notice of Allowance follows approval of the BL-1020 patent in China, Japan, Korea and Australia. In addition, several other complementary patent applications are pending worldwide claiming the crystalline form of BL-1020 and the use of BL-1020 for improving cognitive function. These patents, when issued, would be valid at least through December 2030.
In July 2010, BioLine out-licensed BL-1020 to Cypress Bioscience for continuation of development and commercialization (under the name CYP-1020) in North America (US, Canada and Mexico). BioLine has retained the rights to BL-1020 for the rest of the world outside of North America (which constitutes 50% of the world market).
Dr. Kinneret Savitsky, BioLine's CEO, stated, "We are extremely pleased at receiving the notice of USPTO approval for the patent application covering BL-1020. We believe this represents significant further progress in the development and commercialization of BL-1020. Today over 1% of the US population suffer from schizophrenia, many with cognitive impairment, an unmet medical need not addressed by current therapies. BL-1020 has demonstrated improved cognitive function in clinical trials for schizophrenia, giving new hope to schizophrenia patients the world over. In addition, we are pleased with the intensive efforts being made by Cypress, our partner in this project, in connection with the upcoming clinical trial for BL/CYP-1020, which will focus on its cognition enhancement aspects."
Jeffrey Meckler, interim CEO of Cypress Bioscience stated, "We regard this notice of allowance as a very positive step in the commercialization of CYP-1020. We believe that CYP-1020, with its unique properties, especially regarding the improvement of cognitive function, will become an important part of schizophrenia therapy.”
About BL-1020 (CYP-1020)
BL-1020 is a novel, first in class, oral therapeutic for schizophrenia. Pre-clinical and clinical trials to date have shown that BL-1020 is effective at treating schizophrenia symptoms and has a good safety profile. These trials have shown that BL-1020 blocks activity of the neurotransmitter dopamine and enhances the activity of another neurotransmitter, GABA. These characteristics may contribute to the efficacy and safety of the drug. In addition, clinical trials have shown that BL-1020 improves cognitive function in schizophrenia patients. Many schizophrenia patients suffer from a significant decrease in cognitive function, which is an unmet medical need not addressed by current therapies.
In July 2010, BioLine out-licensed BL-1020 to Cypress Bioscience for continuation of development and commercialization (under the name CYP-1020) in North America. BioLine retained the rights to BL-1020 in the rest of the world.
In January 2011, Cypress was acquired by Royalty Pharma, a leading company in acquiring revenue-producing intellectual property - principally royalty interests in marketed and late stage biopharmaceutical products - with approximately $4.8 billion in royalty assets and over $1 billion in cash. Royalty Pharma has declared its commitment to continuing the development of CYP-1020, including the upcoming clinical trial expected to commence in the next few months.
BioLineRx Ltd. is a publicly-traded (TASE:BLRX) biopharmaceutical development company. BioLineRx is dedicated to building a portfolio of products for unmet medical needs or with advantages over currently available therapies. BioLineRx's business model is based on acquiring molecules mainly from biotechnological incubators and Israeli academic institutions. The next stages, which include feasibility assessment studies and development through pre-clinical and clinical stages, are performed with partial funding from the Israeli Government's Office of the Chief Scientist (OCS). The final stage includes partnering with medium to large pharma companies to continue advanced clinical development (Phase III) and commercialization.
BioLineRx’s current portfolio consists of three clinical stage projects (BL-1040, BL-1020 and BL-5010) as well as nine products in various pre-clinical development stages spanning a variety of indications, including central nervous system diseases, oncology, infectious diseases, cardiovascular and autoimmune diseases. BioLineRx also operates a unique Early Development Program (EDP) to develop innovative early-stage projects until sufficient data is obtained for entry into the Company's main portfolio.
To date BioLineRx has signed two out-licensing agreements. In July 2009, BL-1040, for treatment following acute myocardial infarction, was out-licensed to Ikaria Inc. for a total deal value of $282.5 million, in addition to sales royalties. In June 2010, BL-1020 (CYP-1020), for schizophrenia treatment, was out-licensed to Cypress Bioscience Inc., for continuation of development and commercialization in North America, for a total deal value of $365 million, in addition to sales royalties.
For more information about BioLineRx, please visit www.biolinerx.com.
The estimates and judgments with respect to the projects included in this release are considered forward-looking statements, which involve certain risks and uncertainties, and are based on information available to the Company at the time of this release. Such estimates, including clinical trial commencement dates, may not be realized or may be only partially realized, due to the significant uncertainty characterizing research and development activities in general, particularly those of drug development, including changes in regulation or uncertainty relating to the application of regulation, unexpected delays in obtaining regulatory approval, unexpected delays in patient recruitment for clinical trials, unexpected delays in other clinical trial preparatory activities, inefficiencies, inability to manufacture, toxicity, a high level of risk/reward in comparison to current treatments available, as well as new information regarding intellectual property rights which may affect the economic viability of continued product development. The Company assumes no responsibility for updating forward-looking statements made herein or otherwise.