Christie M. Ballantyne M.D., Professor of Medicine at Baylor College of Medicine and the Chief of the Sections of Cardiovascular Research and Cardiology, a noted cardiologist, principal investigator of many lipid and cardiovascular outcome studies and a member of the Matinas BioPharma Scientific Advisory Board, commented, "This was a very ambitious first-in-human head-to-head study and it is very exciting to see that MAT9001 achieved all endpoints in this study."
"These statistically significant results support the premise that the purposeful design of our MAT9001 omega-3 fatty acid composition and delivery system has the potential to be a best-in-class product for the treatment of dyslipidemia. The unique ability of MAT9001 in reducing PCSK9 underlines its differentiation potential. We believe the outcome of this study also underscores our ability to develop highly differentiated products with the potential to address areas of unmet need," remarked Roelof Rongen, President and Chief Executive Officer of Matinas BioPharma.
Very remarkable results...not sure how much room to run given the recent spike leading up to this but tomorrow's LD Micro presentation should be interesting.
BEDMINSTER, N.J., June 1, 2015 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. ("Matinas BioPharma" or the "Company") (MTNB), a clinical-stage biopharmaceutical company, today announced top-line results for its head-to-head comparative pharmacokinetic and pharmacodynamic study versus Vascepa(R) (icosapent ethyl). Data from this study demonstrated that its lead cardiovascular/metabolic disease drug candidate MAT9001 met all primary and secondary endpoints in a head-to-head comparative pharmacokinetic and pharmacodynamic study versus Vascepa(R) (icosapent ethyl).
In addition to meeting the statistical non-inferiority test for all primary and secondary endpoints, further statistical analysis demonstrated superiority of MAT9001 over Vascepa for omega-3 bioavailability (baseline adjusted AUC and Cmax, approximately 6-fold higher with MAT9001 on day 14, with very high statistical significance) and triglyceride reduction (median TG-reduction from baseline: -33.2% for MAT9001 versus -10.5% for Vascepa; p less than 0.0001). MAT9001 also demonstrated a statistically significantly greater reduction in total-cholesterol, VLDL-cholesterol and non-HDL-cholesterol for MAT9001 versus Vascepa. Although both study drugs exhibited a reduction of LDL cholesterol, the difference between the two was not statistically significant. In addition, MAT9001 demonstrated a statistically significant reduction in PCSK9 versus Vascepa, which did not decrease PCSK9 levels.
"These statistically significant results support the premise that
If she works for ABC, I don't think they do any drug development. Supporting a clinical trial otoh would be right in their wheelhouse:
AmerisourceBergen is one of the largest global pharmaceutical sourcing and distribution services companies, helping both healthcare providers and pharmaceutical and biotech manufacturers improve patient access to products and enhance patient care. With services ranging from drug distribution and niche premium logistics to reimbursement and pharmaceutical consulting services, AmerisourceBergen delivers innovative programs and solutions across the pharmaceutical supply channel in human medicine and animal health.
I agree a -499 partner would be bigger news but I just don't see it as likely...assuming we are really talking about ABC.
Beepeeess - you had said your nurse contact had said a June 1 start date for the PIII trials but clinicaltrials.gov says September. Do you think June 1 is the start of the prep work (i.e. supplying the study sites with drug, protocol distribution etc) or do you think the enrollment will start sooner than Sept?
for the phase one data read out.
Makes sense given they stopped it early after meeting endpoints....unlike most PI studies, those endpoints included efficacy comparisons to an active compound. Should be very good results.
That's certainly my expectation..and Tung stated that view clearly today. Avanir wasn't going to formulate a study until they met with and had agreement with the FDA....I think this is pretty clear that the FDA agrees with this plan.
Personally I think it's a big deal but the market is just yawning.
There's no alternative any more. The direct move from PI to PIII testing based on data generated with the non-deuterated formulation was a novel step. There had been tacit approval by 2 different FDA agencies but you just never know with the FDA until it's official.
They are almost sure to dilute going forward as milestones are not likely to be sufficient to fund all they'd like to do and royalties are a long way out. I think dilution is fine as long as they value they get for developing compounds exceeds the "cost" of dilution. They could sell off individual compounds and fund other using those proceeds instead of dilutiing (unlikely imo). They could be bought out any time (esp. now that PIII is a go!) and avoid dilution that way (likely imo).
"What are the chances that, as they grow, they dilute, to never reach above 25$ a share ?" That is a very complex scenario...if 786 is approved for agitation then CNCE will be $60/share. Don't see them diluting that much...but there is a big IF in there.
But if we look at it from an impact to Market cap level it's bigger for CNCE. Plus, Otsuka has all the development, manufacture, distribution, and marketing costs. CNCE has the cost of cashing a check.
Otsuka's market cap is 57x CNCE's
Excerpts from Bank of America Initiation of Coverage for Avanir from October 2014:
AVNR’s next generation compound AVP-786, which could have fewer drug-drug
interactions and a better safety profile (and longer patent life) than Nuedexta, will
begin phase 3 trials for Alzheimer’s agitation (AA). Our conversations with treating
physicians and our 51-doctor survey indicate early use of Nuedexta off-label to treat
AA. Phase 2 data (done with Nuedexta) showed significant improvements in
endpoints for treating AA. In our view, this use provides real world evidence for
efficacy and bodes well for the chances of approval for ‘786 in this area of under
met need for which there are no approved drugs. We model a 2019 US launch and
peak risk-adjusted sales of $2.3bn in 2028 for ‘786 in AA...We model a 65% probability of approval as the drug enters phase 3.
Parkinson’s Disease (PD). We model a 2022 US launch for ‘786 in Levodopainduced
dyskinesia (LID) in PD. We model a 30% probability of US approval for
this drug as we await phase 2 data (early 2015). We assume peak market share
of 25% of the addressable population
Major Depressive Disorder (MDD). We model a 2020 US launch for ‘786 in MDD. We model a 30% probability of approval for this drug as we await phase 2 data in 2015 or 2016. We model peak share of 10% of the refractory depression market, a space in which low priced generics dominate. Our 12% WACC is consistent with how we model other drugs at a similar development stage.
I think it's time for a recap of some back of the napkin valuation calculations. Criticisms WELCOMED…tell me if there's something missed.
From 4/14 presentation:
1. AVP786 royalties should meet maximal levels (low double digits) if agitation indication is approved and meets analyst projections for sales.
2. $2M milestone when/if they start PIII for agitation
What is chance of approval? Given the strong PII agitation results one Avanir analyst commented that it was extraordinary to have a "de-risked" CNS treatment in the pipeline. Another put the chance of eventual AVP-786 approval at 65%.
The market for off-label use of antipsychotics for agitation is multibillion.
The treatment effect of D/Q in the PII trial was as good or better than that seen in trials assessing the antipsychotics for agitation while unlike the antipsychotics, D/Q did not impair cognitive function.
Eventual sales for an approved AVP-786 should be $1-2 billion/year of which CNCE gets ~11% ("low double digits"). On $1 billion that comes to $110 million/year with essentially 100% margin. We can discount that by the likelihood of approval (65% -though that seems low and then discount the cash flow by 10%/year for the 3-4 years before it is approved - assuming they don't need a 2nd PIII trial). Combining this we get:
$110M * 0.65 = $71.5M
$71.5M/1.1^4 = $71.5/1.464 = $49M/year current value
With 21.7M shares outstanding (May corporate presentation) this comes to present value per share of $2.25 for only the agitation indication. Add back in however you value AVP-786 for depression, AVP-786 for pain/dyskinesias/PBA/ other indications, the rest of the current pipeline, and the deuteration platform that will continue to crank out new candidates.
Just using the $2.25/share and a PE of 20 (which I'd justify with all the rest of the pipeline prospects) gets us to a pps of $45 ….methinks we are undervalued at $14!!!
2 different trials listed but they are similar - one with a single dose level and the other with 2 different dose levels. Only AVP-786 to be used vs. placebo. Each study is over 300 patients.
I'm thinking there is actually only one PIII trial and one of these will be removed. Probably the one with 2 doses is correct IMO.
I really think the import is still under the radar
I'd expect it to be Concert's version...is there any way she'd have to confirm?
That's really the last piece of the puzzle and, if confirmed, it means we are woefully undervalued given the prospects (IMO).
IMO that would be quite momentous however I'd be surprised that we didn't hear about the FDA meeting and that they could get it going that fast.
Any chance he's/she's referring to initiating the depression trial at their center rather than the agitation study? Any other mistake? If you can nail down that he/she is correct I'd be very very interested/appreciative.