Refurbished building, new research equipment and I think they're putting a pub in there too, it's a good place to exchange ideas.
From the same mystery document:
"My last slide [SLIDE 17], indicates that we’ve had several interactions with the FDA to date on this compound."
(snip from the slide 17)
Regulatory • FDA interactions regarding a non-clinical development program to support an
NDA for BCX4430 for the treatment of EBOV under the “Animal Rule”
• File IV IND as planned in Q2 2016
My Note: IND filing planned for Q2....how about Q-Tuesday!
"not that the facts count"
Just this week we learned:
1. IV Z did not meet primary endpoint. IV P the only approved IV antiviral!!!
2. EMA discussing pediatric Peramivir this week.
3. BCRX schedule to file for pediatric Peramivir use 2H16
4. BARDA scheduled to perform PH2 safety study in 16 on 4430
5. BCRX has capacity to manufacture large quantities of 4430
FYI, 4430 is funded via existing contract from HHS and Ebola funds, we DON'T need zika funding. Come on TUESDAY what news doth thou bringeth?
The PH1 safety trial is complete for the I.M. The I.V. PH1 study is already funded and starting "soon".
The PH2 likely refers to a larger human study necessary under the animal rule, this trial will be larger requiring about 2 to 3 times the number of patients ~240. This is NEW NEWS and accelerated timeline as BCRX has not mentioned this yet for 2016. This approved funding will come from the Ebola funding not Zika...so we don't need congress for this money.
Shown on timeline graph for 2H16:
Per Seqirus May 12, 2016 slide presentation update.
2016 National Adult and Influenza Immunization Summit
12 May 2016
from another document (recent but not saying where or when, that's my prerogative):
"Another aspect to the program is process development for scaling up manufacturing to enable much larger quantities of drug to be made [SLIDE 14]. Early on, BioCryst scientists invented a first-generation synthetic process; recently we’ve been working on an improved process.
Often purine nucleosides are quite difficult to make and this one is in that bucket. However, these types of problems are solvable, and we have successfully taken drug synthesis from offshore to onshore in the United States, and introduced process changes that have improved the yield.
We are quite confident that this drug can be scaled up to, ultimately, metric ton quantities with due diligence and good manufacturing quality."
Yep, metric ton quantities. BCRX is working behind the PR scenes, relax and cut them some slack.
Fiscal Year 2017
...Further, BARDA partnered with BioCryst to support
development of a small molecule antiviral drug candidate that has broad spectrum activity against viral
hemorrhagic fever viruses.
BARDA is supporting manufacturing efforts and non-clinical studies to
support NIAID’s Phase I clinical studies of this molecule and will support additional Phase 1 and 2 studies
The FY 2017 Request for Advanced Research and Development is $511,700,000, which is the same as
the FY 2016 Enacted level.
The Request supports the advanced development of the highest priority
MCMs against all 13 threats identified by DHS and prioritized in the PHEMCE Strategy and
Implementation Plan (2014). Specifically, ASPR requests funding for investments in new projects in the
following programs, in addition to broad spectrum antimicrobials:
3. Existing antiviral drug and vaccine candidates against Ebola and Marburg viruses;
The money is coming...relax fellas.
Zika only benefits BCRX if the benefit can be demonstrated in men (for the near term). Safety in pregnant women needs a strong scientific evidence.
Influenza is different. Much higher population concern (US, global) and P is safe in children and been used in pregnant women.
I disagree with other comments regarding Stonehouse not having a plan. BCRX is executing the plan to get P approved in EU and Canada and for other indications (all likely). The govt. controls the purchase process and when they go to make a move or a new strain is detected investors will benefit big time...as of now, BCRX is the only IV game in town!
Husky, how much money does the govt. have if a new influenza strain breaks out? I appreciate your point that an obvious threat helps generate orders but the cost of not being prepared is well above stockpiling Peramivir.
For NOT wanting to be perceived as an antiviral company, right now IV P and 4430 are the near term catalysts.
Mid July will be the read-out for the new HAE tablet formulation.
Thanks for your question.
The summary results are posted on the GSK Clinical Study Register:
The primary endpoint did not meet statistical significance.
We are pursuing regulatory approval in the EU. We have not provided any comments on plans for other regions.
Hope this helps,
Director, Investor Relations
stockpiling has never been up to Stonehouse. HHS is required to keep about 25% of antivirals for the US population. The SNS isn't for an existing concern it's insurance for what-if.
A new strain of influenza travels fast.
Assuming IV Z is out, HHS now has to make a plan.
Stonehouse said in the last CC that they have to consider replacing outdated stockpile of antivirals NOW.
Yes, CSLs influenza division for retails sales and BCRX receives milestone payments, double digit royalties on retail and x-U.S. stockpiling.
BCRX receives all benefit from US stockpiling and it takes 9-12 months to fill an SNS order...so they say.
IV Z is likely out so HHS has only one IV antiviral to chose from. If you remember back in 09 when BCRX got $2,250 per dose for 10K courses...BCRX now has a great chance for significant revenue flow.
Come on thumbs...talk it out...you present no reasonable argument.
If BCRX is the only company with an IV antiviral and there's a demonstrated need then we own the market....explain otherwise.
Copper, was the govt. waiting on these results in order to make a stockpile order? Am I buying the blue and the red...nope....only one available.
This would make Peramivir the only IV antiviral which is a big deal for US stockpiling and sales into other countries.
Zanamivir IV study completed since Feb.. No word on the street or results but 3 months of silence doesn't bode well for Zanamivir but very positive for Peramivir being the only IV available.
A Study of Intravenous Zanamivir Versus Oral Oseltamivir in Adults and Adolescents Hospitalized With Influenza (ZORO)
Last verified: February 2016
This study has been completed.
Paediatric Committee (PDCO)
Draft agenda for the meeting on 25-27 May 2016
Discussion of applications
Peramivir - EMEA-001856-PIP01-15
Treatment of influenza / Treatment of influenza
Day 90 discussion
: For discussion
More Pressure...and this is a sign to the Republicans that these types of headlines are going to keep coming.
Some 157 pregnant women in the United States and another 122 in U.S. territories have tested positive for infection with the Zika virus, the U.S. Centers for Disease Control and Prevention said on Friday.
It was the first time the agency had disclosed the number of Zika-infected pregnant women in the U.S. and its territories.
Published: 19 May 2016
Geneva, 19 May 2016: Fears are growing that a deadly yellow fever outbreak in Angola – which has already spread to Democratic Republic of the Congo, Kenya and China - will continue to spread internationally without immediate action to prevent it, the International Federation of Red Cross and Red Crescent Societies (IFRC) warned today.
Volume 22, Number 7—July 2016
Development of Medical Countermeasures to Middle East Respiratory Syndrome Coronavirus
Preclinical development of and research on potential Middle East respiratory syndrome coronavirus (MERS-CoV) medical countermeasures remain preliminary; advancements are needed before most countermeasures are ready to be tested in human clinical trials. Research priorities include standardization of animal models and virus stocks for studying disease pathogenesis and efficacy of medical countermeasures; development of MERS-CoV diagnostics; improved access to nonhuman primates to support preclinical research; studies to better understand and control MERS-CoV disease, including vaccination studies in camels; and development of a standardized clinical trial protocol. Partnering with clinical trial networks in affected countries to evaluate safety and efficacy of investigational therapeutics will strengthen efforts to identify successful medical countermeasures.
MERS-CoV small molecule and biologics treatment candidates*
...BioCryst Pharmaceuticals Durham, NC, USA
Active in cell culture and (Ad5) -DPP4 mouse
Clinical trial for Ebola virus
10 other drugs also mentioned in the line-up. Exciting to see CDC list 4430 against MERS....just one more reason for them to fund BCRX.