BL-1020 / BioLineRx - LARVOL DELTA

BioLineRx announces grant of European patent covering BL-1020, an orally available treatment for schizophrenia (BioLineRx) - BioLineRx announced that a European patent has been granted claiming BL-1020's composition & its use for the treatment of schizophrenia; This patent will be valid until September 29, 2022

Patent update • Schizophrenia

BioLineRx reports second quarter 2012 results (Businesswire) - BioLineRx CLARITY study (P2/3, N=435) results are expected in H2 2013, which is extended from previous targeted timeframe of Q2-Q3 2013; The extension is due to recent unanticipated delay in the enrollment of participants; R&D expenses for Q2 2012 increased NIS 16.0M($4.1M), resulted primarily from expenses associated with CLARITY clinical trial; Sales and marketing expenses also increased for Q2 2012 as a result of reorganization of company’s business development team as well as related to reacquisition of rights to BL-1020

Anticipated P2/3 data • Commercial • Schizophrenia

BioLineRx draws approaches for schizophrenia pill, CFO says (Bloomberg Business Week) - P2/3, N=435; Study ID: NCT01363349; BL-1020 improved pts’ cognitive function in a mid-stage trial in 2010 & BioLineRx expects results from a more advanced study in 2013

Anticipated P2/3 data • Schizophrenia

BioLineRx shares rise over 11% on drug results (Proactiveinvestors) - Shares of BioLineRx rose 11.22% to reach $3.37 apiece on Tuesday afternoon after the company released results from a P2b trial for its drug to treat patients with schizophrenia revealed improved cognitive functions

Stock price • Schizophrenia

BioLineRx provides clarification regarding interim analysis of CLARITY trial for BL-1020 (Businesswire) - "BioLineRx Ltd., notes that, as previously disclosed...interim analysis of the phase II/III CLARITY (N=435) clinical trial of BL-1020, are expected to be reported during the week of March 18, 2013.The interim analysis will be performed...fully independent, external Data Monitoring Committee (DMC), which will maintain complete blinding of all study data from the company. As a result of the analysis, the DMC will provide the company with an estimate of the total number of patients required in the study in order to achieve statistical significance on the cognitive endpoints of the study."

Anticipated P2/3 data • Schizophrenia

BioLineRx announces results from interim analysis of phase II/III CLARITY trial of BL-1020 for schizophrenia (BioLineRx) - P2/3, N=435; CLARITY (NCT01363349); Sponsor: BioLineRx; "BioLineRx...announced that results from a pre-planned interim analysis of the Phase II/III CLARITY trial of BL-1020...treatment of schizophrenia, indicate that the trial would not meet the pre-specified primary efficacy endpoint. The analysis indicated no efficacy of BL-1020, in comparison to Risperidone, relative to the cognitive primary and secondary (12-week and 24-week) endpoints. The company intends to perform a complete analysis...un-blinded study data on all patients enrolled to date in order to ascertain whether there may be future potential for the product."

P2/3 data • Trial termination • Schizophrenia

BL-1020, A new γ-aminobutyric acid–enhanced antipsychotic: Results of 6-week, randomized, double-blind, controlled, efficacy and safety study (J Clin Psychiatry) - P2, N=360; EAGLE; There were no differences in the maximum change on extrapyramidal symptom rating scale between risperidone and BL-1020 20–30mg, and both were worse (p<.001) than PBO; BL-1020 20–30mg was associated with greater improvements on cognitive functioning as measured by the brief assessment of cognition in schizophrenia composite score when compared to PBO (p=0.009), risperidone (p=0.019), and BL-1020 10mg (p=0.013) after 6 weeks

P2 data • Schizophrenia

Bl-1020, a new γ-aminobutyric acid-enhanced antipsychotic: Results of 6-week, randomized, double-blind, controlled, efficacy and safety study (J Clin Psychiatry) - P2, N=360; NCT00567710; BL-1020 20-30 mg was better than PBO on PANSS (p=0.02) and CGI (p<0.001) measurements, with no differences noted between BL-1020 20-30mg and risperidone; BL-1020 20-30 mg was associated with significantly greater improvements on cognitive functioning as measured by the Brief Assessment of Cognition in schizophrenia composite score when compared to PBO (p=0.009), risperidone (p=0.019), and BL-1020 10mg (p=0.013) after 6 weeks

P2 data • Schizophrenia

BioLineRx announces publication of EAGLE study results demonstrating BL-1020's efficacy in improving cognitive function in schizophrenia patients (BioLineRx) - P2b, N=220; EAGLE; Results shows that BL-1020 was better than PBO and comparable with Risperidone in both PANSS and CGI scores, which are widely recognized measures of severity and improvement in schizophrenia; P2/3 results for CLARITY trial are expected in H2 2013

Anticipated P2/3 data • P2 data • Schizophrenia

Investigational Dopamine Antagonists for the Treatment of Schizophrenia (SIRS 2020) - "Brexpiprazole and cariprazine, which were agents listed as ‘investigational dopamine antagonists,’ have just received FDA approval...However, three other agents, including BL-1020, ITI-007, and JNJ-37822681, have solid published data showing their efficacy and the potential to provide enhanced safety than the currently available atypical antipsychotics. Other agents such as L-THP, Lu AF35700, S33138, and SB- 773812 are currently under vigorous investigation...Thus, it may become the first new pharmacotherapy, after clozapine, for patients with treatment-resistant schizophrenia if the phase III trial shows positive results...However, much as ‘all roads lead to Rome’ all the studied agents to date lead to alteration of dopamine receptors, either in the form of agonist/partial agonist or antagonist activity. Thus, the development of agents with dopamine antagonist properties will and should continue, unless a novel agent with an extradopaminergic mechanism, with its..."