CYPB - 6/21/10 Update Call (CYP-1020)
[Thanks to ghmm for the heads-up that this call replay is only available by phone through Friday. The # is 888-266-2081 and access code is 1465408. I can't guarantee the accuracy of my notes as I scribbled while listening to the call so please listen if interested.]
1. Both big pharma and small pharma had extensive discussions with BioLine since last year regarding CYP-1020. It was noted on the call that big pharma (GSK, PFE, AZN, etc.) is largely pulling out of CNS research due to the fact that these trials have the lowest probability of success. The fact of animal models being non-existent or at least not very good was listed as one big factor in the lack of success for CNS drugs. CYPB's mission is to take risks that big pharma won't (such as with Savella) and the company believes it may have specific insights in this area.
2. A six-month trial is needed to demonstrate cognition. Management indicated that the next trial will be a single trial of six-month duration. I inferred that CYPB will in fact be doing a Phase 2b trial next. However, management also indicated that the likely scenario is that CYPB will take CYP-1020 all the way through the NDA before contemplating a partnering deal.
3. Management estimated the cost for the next CYP-1020 trial to be $20-30M.
4. Six-month trials in schizophrenia generally have an active-arm comparator because it's unethical to give a placebo to a schizophrenia patient over that timeframe.
5. CYP-1020 has an issued patent(s) through 2023.
6. The Phase 2 trials for CYP-1020 assessed QT signal and it looked clean but a thorough QT study has apparently not been performed.
7. There was discussion of the use of the BACS scale to assess cognition as apparently the MATRICS Battery is what is primarily utilized in Phase 3 trials to assess cognition. The inventor of BACS was on the call and it was noted that BACS covers six tests and 4 of the 7 domains of cognition that are part of the MATRICS Battery and that a signal on BACS had a substantial correlation to a signal on the MATRICS Battery.
8. The FDA would likely require use of the MATRICS Battery in Phase 3 but CYPB believes it could cover just 4 of the 7 domains that essentially equate to the BACS scale used in the Phase 2b.
9. 80% of schizophrenia patients have some form of cognitive impairment.
10. Management really pushed the salesforce as a big asset to CYPB. Reps do 10 (or 11) calls/day which exceeds the industry average. CYPB is exploring the potential to leverage the salesforce and expects to conclude this initiative by the end of this calendar year. Some possibilities include bringing in another drug to co-promote through the salesforce, acquiring another drug to co-promote, or working with other companies to combine salesforces. CYPB does not want the salesforce to be a drag on earnings given that they believe the real growth for the company is in cutting-edge CNS R&D so that's why this will be done by end of year. The potential to monetize the Savella revenue was mentioned separately in the call so perhaps the company is struggling with the decision to either monetize the Savella revenue stream or bring in additional drugs to promote through its salesforce. Given that management sounded like they want to play a big part in potentially marketing CYP-1020 if it successfully reaches the market, I imagine that the salesforce is here to stay.
11. CYPB will launch an Avise test to diagnose and monitor lupus at an ACR meeting in November. CYPB anticipates this to be its biggest diagnostic and to be subject to partnering discussions.
