>>JERUSALEM June 20 (Reuters) - Israeli drug development company BiolineRx (BLRX.TA) has signed a $365 million out-licensing deal with Cypress Bioscience (CYPB.O) for its anti-psychotic drug BL-1020.
Under the deal, Cypress will market the schizophrenia treatment in the United States, Canada and Mexico but BIOLINE retains the rights for the rest of the world, enabling additional licensing deals for the product at a later stage, BIOLINE Rx said in a statement on Sunday.
BiolineRx will receive a $30 million upfront payment at the deal's closing -- which is subject to approval of Israel's chief scientist -- and will receive future payments up to $335 million based on regulatory and development and sales milestones, it said.
BiolineRx will also receive royalties of 12 to 18 percent based on sales.
Cypress will manage all future development of the drug and will be responsible for filing regulatory applications including the additional clinical trials required for obtaining U.S. Food and Drug Administration approval.
BiolineRx received the right to all regulatory data and may use them to obtain regulatory approvals outside of North America.
Last September, BiolineRx said results of a Phase2b trial of BL-1020 demonstrated a positive impact on the cognitive funtion of patients. It estimated the global market for anti-psychotic drugs at $17 billion by 2016 and BiolineRx expects to capture 20 to 30 percent. [ID:nLN595423]<<
biolinerx.com
Hat tip to Biomaven for the above link. What was missing at the time the article went to press was the extension results. Here they are:
>>BioLineRx Announces Positive Results from Its Phase 2b EAGLE Extension Trial Assessing the Safety and Efficacy of BL-1020
Jerusalem, Israel, January 17th, 2010: Following our previous press releases (published September 14th and 23rd, 2009) announcing that BL-1020 has successfully met its primary and secondary efficacy endpoints, as well as significantly improved cognition in the 6-week phase 2b EAGLE (Effective Anti-psychosis via GABA Level Enhancement) trial, we are pleased to report positive results from the 6-week extension trial.
The new results show that patients receiving BL-1020 (20-30mg/day) for 6 additional weeks maintained the improvements in PANSS and CGI (widely recognized measures of severity and improvement in schizophrenia) after 6 weeks of treatment and, more importantly, showed an additional improvement in cognitive function as assessed by BACS (“Brief Assessment of Cognition in Schizophrenia”). The 12-week treatment was not associated with any increased toxicities - there were no clinically relevant changes in the measurements of the ECG, laboratory or vital signs (BP, HR, Temp). In addition, patients treated with 20-30mg/day BL-1020 showed either no change or a reduction in their Extra-Pyramidal Symptoms Rating Scale (ESRS).
These results strengthen previous findings and show that longer term BL-1020 treatment is safe, effective and has the potential to improve cognition in schizophrenia patients.
Dr. Kinneret Savitsky, PhD - CEO of BioLineRx, states: “We are very pleased with the findings of the extension trial. These results strengthen our belief that BL-1020 may provide great benefit and relief to schizophrenia patients and their families. The additional positive results should strengthen the basis for collaboration with a global pharmaceutical company in order to complete BL-1020’s development. We are grateful to the inventors and their academic affiliations, Prof. Abraham Nudelman (department of Chemistry, Bar-Ilan University), and Prof. Abraham Weizmann, Dr. Ada Rephaeli and Dr. Irit Gil-Ad (Faculty of Medicine, Tel Aviv University)”.
About EAGLE Main and Extension Trials
The EAGLE study was conducted under a U.S. Food and Drug Administration Investigational New Drug (IND) at 40 sites in the U.S., Europe and India, and included patients suffering from acute exacerbation of schizophrenia. In the main 6-week study, 363 patients were randomized to treatment with 10 mg/day or 20-30mg/day of BL-1020, Risperidone (2-8mg/day) or placebo. The study was designed to demonstrate statistically significant superiority of BL-1020 to placebo on the primary efficacy measure, the total score of the Positive and Negative Symptom Scale (PANSS). Key secondary efficacy measures included the Clinical Global Impression of Severity (CGI-S), the Clinical Global Impression of Change (CGI-C) from baseline, and effect on cognition as measured by the Brief Assessment of Cognition in Schizophrenia (BACS). Risperidone was included as a positive control to validate the study results.
The 6-week extension trial involved patients that completed the main study. 75 patients were randomized as follows: patients that were treated with BL-1020 (10 or 20-30mg/day) or Risperidone continued their treatment; patients that were treated with placebo were re-randomized to one of the BL-1020 groups.
About BL-1020
BL-1020 is a first-in-class GABA-enhanced antipsychotic that combines dopamine antagonism with GABAergic activity. BL-1020 has demonstrated high efficacy and safety with minimal EPS and no metabolic side effects. Most importantly, BL-1020 may have the potential to improve cognition, which is a significant unmet medical need in schizophrenia and other neurological/psychiatric disorders. Three other clinical studies have confirmed the safety and efficacy of BL-1020, while pre-clinical studies have also shown that BL-1020’s GABA enhancement may provide the basis for improved cognition. <<
Note that the BL-1020's GABA agonism is general, whereas the positive cognitive effects of GABA agonism on schizophrenia appear to be due to certain GABA subtypes (seems to be GABA a5, a1 agonism to be avoided). So far, the safety profile looks pretty good, and the trial sizes have been of reasonable size, but there is still the possibility that late stage trials show that general GABA agonism could be a liability . . . or a help. This is where the development risk is, as far as I can tell.
There is no question that Ramius is right about the need for a capital raise or a partnership. But the latter possibility begs the question as to why big pharma hadn't signed directly with Bioline. It's a big enough market, so it has to be the development risk. Or Bioline's business development team is very lame.
One caveat on my trial size comment: the expected enrollment for the extension trail -- according to the above linked review article -- was 220 patients. They only got 75!?
What happened to imidazenil? It and its derivatives do not seem to be getting developed. Why not?
Cheers, Tuck |
