Date: 2011-05-11
Type of information: Establishment of a new subsidiary in the EU
Compound: BL-1020
Company: BiolineRx (Israel) Cypress Bioscience (USA)
Therapeutic area: Mental diseases - Psychiatric diseases
Type agreement: licensing
development
commercialisation
Action mechanism: 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.
Disease: schizophrenia
Details: * On May 11, 2011, BioLineRx, a biopharmaceutical development company, has announced the signing of an agreement with Cypress Bioscience for the reacquisition of rights to BL-1020. BioLineRx had previously reported in June 2010 the signing of an agreement with Cypress, pursuant to which Cypress was granted an exclusive sub-license to BL-1020 (for the treatment of schizophrenia) in North America (US, Canada and Mexico) for its continued development and commercialization. Pursuant to a request by Cypress, BioLineRx has agreed to reacquire, effective June 1, 2011, all of the development and commercialization rights to BL-1020 in North America, and to terminate the license agreement with Cypress.
Based on information received from Cypress, through the date of this announcement, approximately $10 million has been invested in preparation for the trial (in addition to the $30 million upfront payment that was paid to the Company upon signing of the License Agreement), and it is estimated that an additional $10-12 million will be required to complete the trial. As of the date of this announcement, BioLineRx has the financial resources to complete the trial.
Financial terms: In consideration for the reacquisition of rights by BioLineRx, the Company will pay Cypress a 1% royalty on worldwide net sales of the product up to an aggregate cumulative royalty of $80 million. In addition, the Company will pay Cypress 10% of all future one-time payments, not to exceed a total of $10 million, as reimbursement for costs that Cypress has incurred in developing the intellectual property portfolio, designing the trial and conducting substantially all the preparations to launch the trial.
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