Main benefits of BCX4430:
1. Broad spectrum against 20 viruses. NOT a one-bug-one-drug solution. This is a HUGE benefit.
2. Low cost to manufacture
4. Stored at 4c - 25c
5. Transports well
6. Can be given days after infected
7. Drug delivery, at this time, IM or IV.
8. "BCX4430 currently represents the only single drug that has demonstrated a survival benefit in non-human primates infected with Marburg or Ebola viruses,"
$700,000,000 was spent in the SNS for anthrax...just one disease.
oh no…he's back…
hey jack, wanna see "a ridiculous call by you"? here's one-
"Biocryst won't sell one drop of Peramivir with out a partner.."
The VP/ ED Global Strategic Marketing, is a new role within Biocryst which will be responsible for global strategic marketing for Biocryts’s portfolio of products for rare and serious medical conditions. A key responsibility will be the development of global branding and global launch plans for Biocryst’s portfolio of HAE products. This is a key leadership role, responsible for developing, marketing strategy consolidating revenue forecasts and providing commercial input into defining Biocyst’s evolving pipeline. This position is hands-on and has multi-faceted responsibility with numerous contact points. It will require a diverse talented individual who excels in cross-functional collaborations, both internal and external.
Experience / Qualifications
BA/BS required; life sciences degree or equivalent desirable, MBA/graduate degree preferred.
10-15 years industry and minimum of 5+ years global marketing experience required. Individual should have proven track record demonstrating breadth and depth across marketing competencies
Marketing within rare / orphan diseases is strongly preferred. Specialty pharmaceutical or oncology experience will also be considered
Experience in development and execution of global marketing strategies and global product launch experience is a requirement...
• Emergency Department (ED)
• Observation Setting
• Hospital provider-based clinics
Physician offices include:
• Urgent Care Clinics
• Private practices
• Free-standing Infusion Centers
ALSO covered by some medicaid and private insurance companies.
One CODE on the reimbursement form refers to the following:
96365 Intravenous infusion, for therapy,
prophylaxis, or diagnosis; initial, up to 1 hour
"I do believe they'll get a stockpile order for P. Something in the range to allow 15%-20% of all 200,000 flu patients hospitalized for flu to be treated."
Jack, the SNS isn't for the potential 200,000 seasonal flu patients, that's what retail sales are for.
SNS antiviral inventory is mandated to cover 25% of US population for pandemic purposes. The revised inventory mix of oral / inhaled and IV is not known but 2% of the 25% would seem reasonable. The contract will likely be spread over a given timeline.
BCRX will likely have 1 to 2 years of cash burn from this stockpile order expected sometime this year. BCX4430 will dwarf this potential and it's up for an NDA next year. BCX7353 will be the real game changer for the HAE market and this is what BCRX has been saying all along. 4161 will beat DX-2930 to market developing an ORAL solution adaption in the HAE market.
From the NATURE publication last March:
treated with BCX4430 beginning 24 or 48 h after infection survived.
Five out of six (83%) animals treated with BCX4430 beginning 1 h after
infection survived (Fig. 3a). Consistentwith the proposed antiviral mechanism
of action, BCX4430 significantly and substantially reduced serum
MARV burden (Fig. 3b), without inducing type I interferon responses
(Extended Data Fig. 4d), as has been observed for c3
-Npc A in mice15.
Additionally, BCX4430 ameliorated haemorrhagic disease manifestations,
as evidenced by shorter PT and aPTT times and reduced laboratory indices of liver damage, such as serum AST and bilirubin concentrations,
compared with vehicle treatment (Fig. 3c–f).
Outbreaks in 2012 involving MARV, SUDV and BDBV reported in
Uganda and the Democratic Republic of the Congo highlight the urgent
need for development of an effective antiviral product to counter filovirus
disease. For the first time, to our knowledge, we report the identification
of a small molecule with efficacy against filovirus disease in
non-human primates. Furthermore, we have provided evidence that
BCX4430 exhibits broad-spectrum antiviral activity against other highly
virulent RNA viruses (Table 1 and Extended Data Fig. 2). Additional
evaluations arein progress to assess the in vivo efficacy of BCX4430 against
EBOV and other highly virulent pathogens in non-human primates or
other disease models that most closely recapitulate human disease.
BCX4430 was well tolerated, producing no overt signs of systemic
toxicity or adverse local reactions in any of the efficacy studies. The substantial
efficacy of BCX4430 observed with the i.m. route, which provides
high bioavailability and rapid absorption, is conducive for use during
outbreaks, potentially enabling administration by individuals lacking
advanced medical training.
Jack...I don't even have words for you right now. All I can say is that you're a shameless, hypocritical creature. I was one of the few who actually held your feet to the fire when the BOTA news flopped the stock significantly, with you as a holder and pumper of a government stockpile order, but 99% of the guys here did not say anything to you about it. Now a competitor puts out data (that isn't nearly as impressive to me as the OpUS-1 data was due to the fact that they treated ONLY the sickest of patients, unlike the DYAX trial) and the stock goes down AH on light volume and you can't get on here quick enough to mock and say I told you so?
Just pathetic. Karma's a bit*h little #$%$.
I would have to say you are a total ignorant idiot. DYAX injected a humanized protein in a tiny number subjects just 2 x times over a 4 week period.This is by far insufficient time or a population size sufficient to determine the biocompatabilty of the protein If the protein exhbits a 3-4 % per year incidence of analyphalaxis (which in my mind is likely) the drug would be toast especially if a small non-haptene like drug was available with a significant efficacy. As to the relative effectiveness of BCRX and DYAX drugs there is in fact no significant meaningful data to compare them. Jackit is time to take you Litium .
"DYAX knows they're going to be required to do a much tougher trail"
And a tougher TRIAL...which will make it a tougher "trail" for DYAX.
On the other hand, 4161 is coming down the mountain from a trial treating patients with over 70 attacks a year with a PH 2 / 3 trial with an easier patient population who have more "gas in the tank". Positive results = high probability.
"All programs are on track"
FYI, BCX4430 has been reviewed by NIAID prior to continued funding. We don't know how many dose adjustments the trial has been through yet but before each one there is a review of safety. As you know, the project is funded and PH1 to complete 3Q...estimated funding by BARDA before then. Estimated value is 700 mln to 1 bln. NDA projected 2016.
Rapivab: Dist. Partner and stockpiling order in the works, timing unknown.
Haha. Jim Cramer is at it again. Of course, he didn't like BCRX when it was $3, so I guess his loyal followers missed out on 300% + appreciation.
LIE after LIE after LIE…if anybody invests their money reading this BS, you deserve to loose your money.
" if 4161 doesn't get over 60-70% and DYAX 2930 MAB nails their target, $3-$4 could be in order here by summer."
YOUR NOT GOING TO HAVE RESULTS ON 416 TILL YEAR END ON 4161!!!!
jack, take your meds, learn to read, and get another hobby, because you suck at this one…
why don't you look this one up? "DYAX 2930 MAB nails their target" what the target jack?
And BCRX just sits here for 8 months now...incredible. The market is clearly waiting for something. Is it waiting for HAE results later this year? DYAX data in a few months? It has to be waiting on HAE because nothing else - not peramivir, not 4430, not a biotech index explosion, not market pullbacks or rips - can move this stock out of its range.
All I know is, the short interest keeps creeping up. So they are clearly trying to break this thing down, but it just won't budge.
You don't know what you're talking about. Nothing you said is significant because they treated a very aggressive population with attack frequencies of 1 attack per day (which is an extremely high attack rate population for HAE). Again the p-value showed significant results...and Opus 2 is treating a larger population with less frequent attack rates so the efficacy data should actually show more favorable results making it almost a guarantee of positive results.
Stonehouse: "Make sure that you look at the baseline or placebo attack rate when making comparisons; as I had mentioned before if you're working with an empty gas tank of Endogenous C1-INH, it makes it much, much more diffucult to show a benefit...and on the flip side, if these are less frequent attack patients it's easier to get them to attack free."