"Representatives of five companies presented
updates on the status of their respective MERS-CoV therapeutic candidates in anticipation of potential clinical trials."
There's every reason to think BCRX was one of the 5. BARDA was there...period.
A human clinical trial of 4430 for MERS would be a huge boost to BCRX. They already have over 45 patients in the safety study completed.
Things that likely can't be discussed by Stonehouse...he's not going to screw up his chances by getting ahead of BARDA on announcements.
Disagree...more funding coming for MERS. In Sept. there was a meeting in Saudi Arabia and discussion for animal and clinical testing.
Overview of Funded Research on MERS 12 -CoV October, 29 2015
BARDA and FDA participated in the September 9-10, 2015 MERS-CoV Research Initiatives
Workshop, sponsored by the College of Public Health and Health Informatics and King Saud bin
Abdulaziz University for Health Sciences, in Riyadh, Saudi Arabia.
The workshop included a
robust discussion of clinical trial design, including the potential for using a common master
protocol to evaluate candidate therapeutics. Representatives of five companies presented
updates on the status of their respective MERS-CoV therapeutic candidates in anticipation of
potential clinical trials.
The goals of the meeting were to:
Engender national and international research collaboration across sectors and disciplines
relevant to MERS-CoV;
Identify specific promising therapeutics to consider for evaluation in the context of
appropriately staged clinical research leading to clinical trials in KSA;
Develop action-oriented research recommendations to fill gaps in knowledge in the prevention
and clinical care of patients with MERS-CoV
Participants in the meeting agreed that:
A research infrastructure should employ an adaptive design that allows either efficient
sequential or parallel evaluation of treatments, in comparison to a concurrent control group,
ideally taking the form of a randomized, blinded (to the intervention) clinical trial.
While much has already been done, further work towards these evaluations should commence
immediately, including collaborative national and international intellectual, scientific, logistical,
regulatory and financial support.
Read the report, the pursuit of broad spectrum small molecule solution is discussed. We could see funding in Dec...35 Mln left.
From the Nov. 5 cc:
Jon P. Stonehouse - President and Chief Executive Officer
Yes, so the Phase 1 is continuing to move forward, we won’t have the results by the end of this year. And I think one point I would like to make is, the timelines are difficult to manage for us because they are not within our control. We have got a government funder that moves at a different pace.
And so unlike the HAE programs and the speed at which we move in Phase 1s, this is clearly a different pace with 4430. Having said that, I think in total between BARDA and NIAID it’s a $70 million contract in total. Probably less than 50% of that has been drawn thus far. And so there is still real interest by the government. There is still a real need in terms of a broad spectrum of antiviral and we are just moving at a different pace.
And so I think as an investor the way I’d look at this is these things are funded by the government and the value for the company and for investors is any non-dilutive capital that we can get out of these in the form of stock piling orders or anything else, is cash that we would otherwise have to sell shares into the marketplace. And so that’s the value of these programs. And we will continue to work on that. It’s just a little bit frustrating for us because the pace is a bit different than the HAE program.
BTW, at Jeffries he said the 7353 trial may start next month...
Read the article. They say it might have helped the nurse. "“We can’t say that the drug helped her recover, but we can certainly speculate that it could have been part of it,” "
Remember Zmapp getting glowing PRs and now they're not sure it helps and it's been tested on many ebola patients.
10/2014 "Tobacco Plants Hold Key To Ebola Virus Cure ZMapp"
Not saying GILD doesn't have a good drug. However, one patient's observational results do not determine the effectiveness of a drug. Especially considering many ebola patients survived with SOC.
What's important is who is our govt. funding? BARDA has funded BCRX twice for 4430 (once in March and again early Sept.). I'm sure BARDA is and has been aware of GILD's drug too, maybe they will fund it but as of now their $$$ is going to BCRX.
Don't get me wrong...the ambiguous process of 4430 is BS and GILD doesn't appear to have these road blocks.
"The text of the article mentions Tekmira, ZMapp, Fujifilm, but not Biocryst"
"Tekmira pulled the plug on a Phase II study of its RNAi-based drug TKM-Ebola-Guinea after an early analysis of the data suggested it wasn’t effective."
"ZMapp isn’t a slam dunk either trial had built-in checkpoints that allowed a data-monitoring board to look for early signs of efficacy. If the drug were obviously working—or obviously not working—the trial would be halted." "ZMapp, for example, is tailored to Ebola."
"Preliminary data from a study of favipiravir, from the Japanese firm Fujifilm, suggest the antiviral does not work for patients who have a high viral load but that it might help those with milder symptoms. Some researchers even question that result because the study lacked a control arm."
Nice piece for GILD...no doubt. But what's important here is BARDA is now in control of 4430 NOT USAMRIID where the GILD comments stem in this article.
BARDA is not funding the GILD drug.
Remember, 4430 was written up in NATURE when USAMRIID was in charge of its progress.
The nurse treated with GS-5734 was in England where GILD is located and England gave it compassionate use.
The biotech chess game changes dynamics from one press piece to the next. GILD is a powerhouse who gets more attention and control of their drug development than BCRX...4430 will have its day.
The interesting part of that statistic is it refers to Out-Patients not hospitalized patients. CSL is trying to get Drs. to give Rapivab in an office.
Remember this discussion at ICAAC 2014:
From ICAAC in Sept.:
Dr. Whitley: "If you see the patient once, you’re lucky," "If you give him a prescription, and you expect him to get it filled, the probability of that happening is maybe 20%-25%. So, if you’re worried about that individual, direct-observed therapy in the health care provider’s office is a good way to help solve this problem."
...In theory, intravenous peramivir should be "relatively easy for any physician’s office that can handle relatively short IV infusions," according to Dr. Sheridan, who said that physicians would have a choice of using either a butterfly needle on the back of the hand, or an IV cannula in any other accessible vein, infusing the drug in between 15 and 30 minutes
Any neuraminidase inhibitor may be
used for treatment of outpatients
5-day course of oseltamivir or inhaled zanamivir
1-day of IV peramivir
I keep saying, CDC will change their guidelines to favor an IV if possible (same as benefits shown in previous post). How else is the CDC going to help get more antiviral treatments to be taken??? Schuchat: "We will work, along with our government colleagues, academic, and industry partners, to improve use of antiviral treatment"
60 percent of patients prescribed an oral antiviral therapy for
influenza will fail to take treatment as directed.
How can YOU ensure that a complete course of
treatment for influenza is delivered?
One quarter of patients presenting
with influenza report vomiting,
or other GI symptoms
Many patients cannot
tolerate multi-dose, oral,
or inhaled therapies
Many patients discontinue
oral therapies before a full
course is completed
Patients unable to take oral medications due to
nausea, vomiting or other gastrointestinal sensitivity
y Patients who would prefer one-dose treatment
y Patients who require IV rehydration or IV medications
y Patients who struggle with inhaled therapies or
have pulmonary disease
y Patients with comorbid conditions putting them
at risk for complications from flu
Thursday, November 19, 2015
Expected at 10:00 a.m.
Testimony before the
Committee on Energy and Commerce
Subcommittee on Oversight and
United States House of Representatives
"CDC’s recommendations for using influenza antiviral medications aim to protect the people who are
most vulnerable to serious complications from flu. The recommendations for antiviral drugs are based on data
from randomized clinical trials as well as from observational studies of patients receiving treatment in medical
practice. CDC recognizes that currently recommended influenza antiviral drugs have limitations; however, these drugs are the only influenza-specific therapy approved by FDA with activity against circulating influenza viruses."
... "Although many gains in seasonal and pandemic influenza preparedness
and control have been made over the years, continued improvements are needed. We will work, along with our
government colleagues, academic, and industry partners, to improve use of antiviral treatment, to make more
effective influenza vaccines, and to speed production of existing vaccines for all Americans."
Back in 2012 Stonehouse cut 38 employees due to concern of 5191 and clinical hold on 4161.
2013 They employed 37 (Wiki)
2014 They employed 40 (nasdaq)
2015 They employ 68 (Biocryst)...and counting and putting a new roof over their heads.
When things are bleak they cut back, when future looks great...
From the 10-K
"We lease approximately 35,000 square feet in Birmingham through June 30, 2016. Beginning in October 2015, we will lease an additional approximate 35,000 square feet in Birmingham to house our new research facilities. We expect to begin construction on our new research facility in 2015."
Funded by...SNS, 4430? Lease is up in 6/16 so it will be completed before then.
SLIDES have no bullet points anymore for 4430 or SNS leaving them to be unexpected surprises whenever...just as the CSL Rapivab partnership came out of nowhere w/out expectation.
Plus adding costs of HAE PH1 on 4161 for hard tablet option is a positive sign. If 4161 was dead they wouldn't add this cost to the program.
Small biotechs do not flounder cash w/out good reasoning. BCRX won't even spend a few grand an PR if they push it out to a scheduled event.
Stonehouse isn't bluffing. If you don't have the cards you don't keep increasing your costs.
They're building and growing in confidence.
What's the cost of a new 35,000 sq. ft. research facility loaded with top docs?
Husky...they're growing their head count, new research facility...this confidence has strong reasoning and some of that reasoning is not always shared.
Not sure if BCRX expects a large SNS or strong funding for 4430. Stoney said before that the govt. support of P provided BCRX with structural support (building / staff / equipment). That new research facility will cost some serious $$$. Stoney isn't going out on a limb hoping he can pay for it.
Here's the requirements for the latest hiring opportunity:
Job Title: Research Chemist III
PhD in Organic Chemistry with a minimum of 6 years of industry experience in Chemical Development & Scale-up
Experience working in the area of process development as demonstrated with relevant peer-reviewed publications, and patents
In-depth knowledge of GMP, US and EU regulations and ICH guidelines required
Did you look at the number of offices in the plan drawings? BCRX is still adding to their 68 head count (was 45 not so long ago).
DYAX is not a guarantee. Good results on the surface but patients with low attack rates easier to help...what if?
Oral is the leader for treatment.
Japan...we own it. 5 doctors who work with HAE patients and fast track approval with new SakiGake system.
4161 may come out stronger than you thought and 2 pills twice a day convenience.
If we get HAE right, likely other oral solutions for rare disease successes to follow.
We got the cash through 2017, we're not slowing down. 7353 results out in ~6 months.
Buy me now or buy me later for much more.
Agreed Husky...HHS is talking to BCRX, investors should be told why 4430 is taking longer to complete...not just "it's the govt.".
Re: their drug design approach...Stoney indicates they practically got it down (to a science) and can repeat the process successfully for future rare diseases. Just what big pharma needs to create pipeline and why Baker Bros. own 20% of the company.
Ask yourself...when was the last time BCRX spent the dough to do an overseas healthcare conference? Can't find one.
They passed up on 2 in Sept. located in NY.
BCRX is frugal, they didn't fly out to London just for a healthcare conference.
They just did a presentation Nov. 5th from the comfort of their home office in NC and they are schedule for 2 conferences in NY in a couple weeks (Oppenheimer, Jaffray).
Something is up.
From the Jefferies slide:
Benefits to drug sponsors under the Sakigake system
− Priority PMDA Consultations
− Ability to submit materials for pre-marketing review in English
− NDA Review period shortened to 6-months
− Ability to submit Phase 3 study results following NDA submission
− Re-examination period extended up to 10 years