The discussion rooms have pointed toward recent developments at BARDA outlined in the following two releases:
http://www.hhs.gov/news/press/2014pres/04/20140416a.html
http://www.hhs.gov/news/press/2014pres/03/20140311b.html
I have also raised the recent controversy around Tamiflu and the call by British researchers for independent clinical trials of NIs.
I agree that it's plausible that BARDA will take over the conduct of the rest of the clinical trial program for LANI. It will simply use the committed funds for the rest of the program and shift those to conduct the studies themselves.
They will have nationalised clinical research! In the USA!
Advantages
BARDAs clinical research network might be of higher quality and therefore able to deliver better than BOTAs selected groups. It likely that BARDAs selected contractors are not the lowest bidders when these projects are tendered.
That the take over of conduct of the trials should mean that if the drug shows effectiveness and safety, it is automatically granted FDA approval (since they in essence designed and conducted the trial)
The SP will increase 50% in the short term on that sort of announcement
Disadvantages
They have not done this before, so processes will be slow and...
Bureaucratic: I imagine the trials will take longer to complete - will they guarantee patent extensions?
Will BOTA still get it's 7% management fee?
BARDA/FDA/CDC will interpret the results; however they would do that post-hoc anyway at registration
Undoing manufacturing and other contracts - BARDAs problem I guess.
No understanding of shareholders - witness issuing a stop work order before an explanation of the reasons, decimating shareholder value. Hamfisted and stupid.
The clinical trials would need to cover seasonal influenza use not just pandemic. There are some potential differences in clinical outcomes. But the trials for registration would need to be the same and delays in trials mean delay in deals and marketing of LANI as a seasonal drug.
Unless the company has to do other trials for seasonal use/registration. That would be unacceptable.
In essence, if BARDA are taking compounds and paying for the clinical research and manufacturing for pandemic products, and then purchasing them, they are effectively acting as big pharma and consumer. They could go ahead and sign a contract direct with BOTA for rights to the compound in stockpile use. There would be no middlemen.
Problem is, they haven't made a commitment to the compound's creators/IP. And they aren't actually committing to a stockpile order.
An interesting new world for similar product development. Question is: is BOTA the golden child or the guinea pig?
Wednesday 30 April 2014
Tuesday 29 April 2014
Gulp hard: stop order just released
Stop-Work Order Received Pending In Process Review Decision From BARDA -
- Phase 2 IGLOO Top-Line Data Anticipated in Q3 2014 -
ATLANTA, April 29, 2014 (GLOBE NEWSWIRE) -- Biota Pharmaceuticals, Inc. (Nasdaq:BOTA) ( the "Company") today announced that it has been notified by the U.S. Department of Health and Human Services (HHS) office of the Assistant Secretary for Preparedness and Response (ASPR) and Biomedical Advanced Research and Development Authority (BARDA) that pending a decision regarding the outcome of a recently completed In Process Review (IPR) of the Company's contract for the development of laninamivir octanoate, ASPR/BARDA has issued a Stop-Work Order notifying the Company to discontinue work on a number of activities under its contract.
The Company's contract provides that ASPR/BARDA will conduct IPRs in its discretion during the performance period to discuss the progression of milestones and deliverables under the contract. The IPR, which was the first such review of the Company's progress since the inception of its contract in March 2011, was conducted by a team of representatives from the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE), which is led by ASPR, and in addition to BARDA, includes three primary HHS internal agency partners; the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA) and the National Institutes of Health (NIH).
As a result of the receipt of the Stop-Work Order and exceeding the original recruitment target of 636 patients in its Phase 2 IGLOO trial, the Company has concluded enrollment in the Northern Hemisphere and will not enroll patients in this trial during the upcoming Southern Hemisphere influenza season. As previously disclosed by the Company, virology data available to-date indicate approximately 40% of the patients enrolled in the trial had laboratory confirmed influenza A or B. The Company anticipates that top-line results from this trial will be available in the third quarter of 2014.
"We are surprised by this Stop-Work Order and unfortunately, do not have any additional visibility or understanding at this time as to the nature of ASPR/BARDA's pending decision related to the IPR," stated Russell H. Plumb, President and CEO of Biota Pharmaceuticals, Inc. "We anticipate that this decision will be forthcoming shortly, and we will provide a further update at that time. In the interim, we are complying with the order and focusing our efforts on critical path activities for the program not covered by the order, namely completing the conduct of and finalizing the data from our Phase 2 IGLOO trial."
- Phase 2 IGLOO Top-Line Data Anticipated in Q3 2014 -
ATLANTA, April 29, 2014 (GLOBE NEWSWIRE) -- Biota Pharmaceuticals, Inc. (Nasdaq:BOTA) ( the "Company") today announced that it has been notified by the U.S. Department of Health and Human Services (HHS) office of the Assistant Secretary for Preparedness and Response (ASPR) and Biomedical Advanced Research and Development Authority (BARDA) that pending a decision regarding the outcome of a recently completed In Process Review (IPR) of the Company's contract for the development of laninamivir octanoate, ASPR/BARDA has issued a Stop-Work Order notifying the Company to discontinue work on a number of activities under its contract.
The Company's contract provides that ASPR/BARDA will conduct IPRs in its discretion during the performance period to discuss the progression of milestones and deliverables under the contract. The IPR, which was the first such review of the Company's progress since the inception of its contract in March 2011, was conducted by a team of representatives from the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE), which is led by ASPR, and in addition to BARDA, includes three primary HHS internal agency partners; the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA) and the National Institutes of Health (NIH).
As a result of the receipt of the Stop-Work Order and exceeding the original recruitment target of 636 patients in its Phase 2 IGLOO trial, the Company has concluded enrollment in the Northern Hemisphere and will not enroll patients in this trial during the upcoming Southern Hemisphere influenza season. As previously disclosed by the Company, virology data available to-date indicate approximately 40% of the patients enrolled in the trial had laboratory confirmed influenza A or B. The Company anticipates that top-line results from this trial will be available in the third quarter of 2014.
"We are surprised by this Stop-Work Order and unfortunately, do not have any additional visibility or understanding at this time as to the nature of ASPR/BARDA's pending decision related to the IPR," stated Russell H. Plumb, President and CEO of Biota Pharmaceuticals, Inc. "We anticipate that this decision will be forthcoming shortly, and we will provide a further update at that time. In the interim, we are complying with the order and focusing our efforts on critical path activities for the program not covered by the order, namely completing the conduct of and finalizing the data from our Phase 2 IGLOO trial."
Thursday 17 April 2014
Dog days
Biota's share price continues to fall, surpassing the recent drops in Nasdaq overall Biotech Index. Certainly overnight the Index recoverd, while BOTA continued to slip.
There has been no information released since the ROTH conference a month ago.
I guess there are concerns or expectations (or maybe knowledge) that the LANI Phase 2 trial will need to be extended. That would be a bad outcome and that would be reflected in some further shareprice pressure, and more importantly no real momentum for some time.
At this point though, a positive outcome (acceptance of current Phase 2 results and moving to Phase 3 this year) would certainly improve prospects.
Also, as I've mentioned, no news of a deal with Daiichi Sankyo will also suppress the share price. This outcome isn't reliant on the weather or the science, just the management. It needs to be done to give the market clarity and confidence.
DS should be in a better mood since they have partly cut themselves loose from the millstone that was Ranbaxy.
The BMJ and Cochrane continue their ongoing ideological battle with Roche over Tamiflu. It's relevant in that it drags Relenza and other NIs into the crossfire. As best I can determine, the release of all of Roche's clinical trial data didn't actually change very much about the conclusions reached in the published data.
The problem is that the trials were not powered to demonstrate anything other than effectiveness in reducing the severity and duration of seasonal influenza. That was the target market at the time. To conduct a trial to examine mortality or influenza complications like pneumonia is a very different beast. A much bigger beast.
For the BMJ and the reviewers to argue that the trials should have been conducted independently (i.e by them?) is to make a statement about all drug trials. They do concede they are making statements about the whole system of trials and registration, but they really hate Roche. To criticise the trials as placebo trials is really getting a bit petty. There is no real alternative treatment for influenza.
Whatever they might think of the treatment effect of NIs in regular use, the Cochrane investigators are wrong to extrapolate that NIs are therefore of no value in an epidemic or pandemic. The CDC, WHO and I, think that they are. Other studies, the basic science behind NIs and post-surveillance clinical evidence supports "our" (you know me and my buddies at WHO and CDC) view. In Australia, I recall an interesting statistic during the last H1N1 outbreak: none of the people admitted to ICUs (including those who subsequently died) with influenza had received prophylactic or treatment NI prior to admission. The effectiveness of intravenous NI was established anecdotally during that outbreak, but more formal evidence of the impact of the IV form could assist in assessing the impact of NI in desperate situations more quickly than population studies. NIs will save many lives in the event of a pandemic; the notion that a vaccine will be developed in a few short months presumes that everything functions pretty much as normal for those months in a real pandemic. My guess is that it won't, and the stockpiled NIs will be the first and second line of defence.
There is a strong British anti-pharma anti-corporate bias in all this work. Indeed there is a strong British anti-treatment bias that pervades a lot of Cochrane. But they really hate Roche, and are convinced they deceived the MOH and the people. The fact that the Cochrane Tamiflu reviewers could not be ever seen to be independent themselves is a flaw in the process. They are activists, which I support and applaud, but maybe someone else should do the work.The meta-analysis process is not above interpretation or bias. Activism for evidence is wonderful as long as the community doesn't actually suffer from a lack of common sense in the absence of exhaustive evidence.
The touchy subject of the effectiveness and efficiency of influenza vaccination has always been left undiscussed. Influenza vaccine is gathered along under the voluminous skirt of vaccination support. But is it reasonable that a vaccine that changes every year and needs to be administered to the whole population every year with no guarantee about the targets and no trialling for each new formulation could be at least pondered without being seen to be anti-vaccination? I don't know why GSK escapes the ire of the anti-corporates just because it makes influenza vaccine. That's why I always thought a universal treatment for influenza was a great step forward. It's ironic that a universal vaccine would be hailed, whereas a universal treatment/cure is heavily criticised.
Of interest, many of the Relenza trials at least here in Australia were conducted by Prof Chris Silagy, one of the earliest and strongest advocates for Cochrane and evidence based medicine.
There has been no information released since the ROTH conference a month ago.
I guess there are concerns or expectations (or maybe knowledge) that the LANI Phase 2 trial will need to be extended. That would be a bad outcome and that would be reflected in some further shareprice pressure, and more importantly no real momentum for some time.
At this point though, a positive outcome (acceptance of current Phase 2 results and moving to Phase 3 this year) would certainly improve prospects.
Also, as I've mentioned, no news of a deal with Daiichi Sankyo will also suppress the share price. This outcome isn't reliant on the weather or the science, just the management. It needs to be done to give the market clarity and confidence.
DS should be in a better mood since they have partly cut themselves loose from the millstone that was Ranbaxy.
The BMJ and Cochrane continue their ongoing ideological battle with Roche over Tamiflu. It's relevant in that it drags Relenza and other NIs into the crossfire. As best I can determine, the release of all of Roche's clinical trial data didn't actually change very much about the conclusions reached in the published data.
The problem is that the trials were not powered to demonstrate anything other than effectiveness in reducing the severity and duration of seasonal influenza. That was the target market at the time. To conduct a trial to examine mortality or influenza complications like pneumonia is a very different beast. A much bigger beast.
For the BMJ and the reviewers to argue that the trials should have been conducted independently (i.e by them?) is to make a statement about all drug trials. They do concede they are making statements about the whole system of trials and registration, but they really hate Roche. To criticise the trials as placebo trials is really getting a bit petty. There is no real alternative treatment for influenza.
Whatever they might think of the treatment effect of NIs in regular use, the Cochrane investigators are wrong to extrapolate that NIs are therefore of no value in an epidemic or pandemic. The CDC, WHO and I, think that they are. Other studies, the basic science behind NIs and post-surveillance clinical evidence supports "our" (you know me and my buddies at WHO and CDC) view. In Australia, I recall an interesting statistic during the last H1N1 outbreak: none of the people admitted to ICUs (including those who subsequently died) with influenza had received prophylactic or treatment NI prior to admission. The effectiveness of intravenous NI was established anecdotally during that outbreak, but more formal evidence of the impact of the IV form could assist in assessing the impact of NI in desperate situations more quickly than population studies. NIs will save many lives in the event of a pandemic; the notion that a vaccine will be developed in a few short months presumes that everything functions pretty much as normal for those months in a real pandemic. My guess is that it won't, and the stockpiled NIs will be the first and second line of defence.
There is a strong British anti-pharma anti-corporate bias in all this work. Indeed there is a strong British anti-treatment bias that pervades a lot of Cochrane. But they really hate Roche, and are convinced they deceived the MOH and the people. The fact that the Cochrane Tamiflu reviewers could not be ever seen to be independent themselves is a flaw in the process. They are activists, which I support and applaud, but maybe someone else should do the work.The meta-analysis process is not above interpretation or bias. Activism for evidence is wonderful as long as the community doesn't actually suffer from a lack of common sense in the absence of exhaustive evidence.
The touchy subject of the effectiveness and efficiency of influenza vaccination has always been left undiscussed. Influenza vaccine is gathered along under the voluminous skirt of vaccination support. But is it reasonable that a vaccine that changes every year and needs to be administered to the whole population every year with no guarantee about the targets and no trialling for each new formulation could be at least pondered without being seen to be anti-vaccination? I don't know why GSK escapes the ire of the anti-corporates just because it makes influenza vaccine. That's why I always thought a universal treatment for influenza was a great step forward. It's ironic that a universal vaccine would be hailed, whereas a universal treatment/cure is heavily criticised.
Of interest, many of the Relenza trials at least here in Australia were conducted by Prof Chris Silagy, one of the earliest and strongest advocates for Cochrane and evidence based medicine.
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