Sorry; forgot the link. Courtesy of Iveyspivey on another BB.
There are loads of them around now all over the world. Not good news for the economies or lives. Synairgen 1 is needed asap.
Talking of that, I have been incensed that we have allowed tens of thousands of people to come into Heathrow from Delhi for the last three months, just like the flights from Wuhan in Jan to March 2020. Waiting for proof of VOR before taking action is like waiting for proof that smoking causes cancer or asbestos causes asbestosis. Lots more people die in the meantime!
F&V, Doc and Seaboy, ScInv etc. Thanks and Interesting responses.
Yes of course R&D etc needs to be reflected in pricing but the percentage of sales price that repays the risk and R&D is very much a factor of volume x longevity of sales and of course pricing affects the volume so there are various ways to skin a cat. I am sure there are pricing conventions amongst drug companies but I am just looking at it from a logical point of view. If say we had a contribution towards costs of £200 per treatment out of the sale price and sold 100,000 treatments per annum that would repay the say £200m (£100m doubled for risk) development costs in 10 years but if we sold 100,000 treatments per month (RM's 2021 target) all £200m would be recouped in less than one year. I certainly hope that the UK won't have that many patients meeting high risk criteria this year. USA and India probably will though.
Our drug, if approved will hopefully not have a short life expectancy since it's use for high risk patients will be ongoing in respect of various respiratory viral infections subject to further successful trials.
Very interesting list of average development costs per drug F&V. It is clear from that, that any approved drug that is widely required will give a value of £2b plus to the company. So much better value to buy the company or rights without all that time and risk capital.
Best Wishes to all.
Thanks Seaboy for your great work. There are a few others in the frame including the AZ and GSK and Camostat in the Activ-2 with us.
I agree with you Doc that the level of competition, say, if and when we are able to make an application for EUA may well affect the likely pricing. Does anyone know if a proposed pricing menu would need to be given as part of the EUA application? If not that would mean we could keep powder dry for a bit longer but the lack of cost information would certainly discourage Horby and UK govt. from making any early approaches for pre-orders. I guess Boris is hoping to get something sub £500 from the new anti-viral pill campaign and ideally sub £10 like Ivermectin. The time frame laid down by Boris and the expected cost limits on NHS procurement of two drugs for standard of care mean that these have to be repurposed drugs or if new drugs, already well down the road in trials as is SNG001.
I have no idea of the potential pricing of Camostat for instance but pills are usually at the cheaper end of the spectrum and take little time or set up costs to administer.. New drugs will always be more expensive than repurposed drugs though particularly if out of patent and generic. The initiative may come to nought of course. There are circumstances where £2000 would be a very good deal (if it prevented a patient needing hospitalisation and oxygen and long Covid) but this is fairly difficult to target currently. At present the NHS doesn't seem to be set up with simple procedures, ie A.I. programmed blood tests to determine markers for severe disease progression such as low interferon levels and/or genetic disposition as soon as a positive test has been made. I think we are not expecting SNG to become widespread standard treatment without such testing. I.E. we are thinking along the lines of 'Standard of Care' for obviously high risk patients only ( eg very old with co-morbidities) as the best case scenario, this year at least.
I would expect with large orders the company could make adequate margin and profits at a price to UK govt. somewhere between £400 and sub £1,000 per treatment at a guess. At these price levels even if only one out of four were saved from hospitalisation it would seem a good deal to me for UK plc.
All the best
I haven't a clue what that means but it's stated in the 19 April RNS.
It doesn't sound very scientific and I really don't know why I invested in this company, now regretting it despite buying the masks.
Good luck all.
Doc on your question re P3 they do have the chance of changing the protocol just for SNG or for all non I/V since it hasn't been published yet. However it was the intention that the P2 patients would form part of the extended trial and therefore they would not readily change the patient selection parameters without very good reason.
Thanks Doc and Ghia
I suppose accessibility issues would also cover the fact that not all drugs in the trial will be available at all locations. Overall it would probably not be possible to make the whole trial 'drug random' within the total trial patient population for various reasons.
Doc, I think you are right though that Synairgen have little or no control over either patient selection or protocol. As you say this was a decision the BoD made to relinquish control which perhaps contrasts with the decision made re UK Recovery trial. The difference is the Activ-2 inclusion came after the international P3 had been organised.
I am interested that the Acitv-2 is now going international. This may not affect us for P2 but if we are rolled into P3 more drug will be needed for availabilty in multiple locations.
Ghia Given the limited number of trial drugs in Activ-2, although the intention was to share the control group where possible I am not clear whether there will be the same number taking dummy inhaler as real SNG or dummy tablets /Camostat or whether the Control (placebo) group will be the aggregate of all those on placebos be it dummy I/V or inhaler. In the latter case if there were four drugs and four methods of administration they could have 100 people taking each real drug and 25 people each taking the complementary placebo split say 25 I/V, 25 I/M, 25 tablets and 25 inhaler. If this was done it would mean that 4 x as many people in each group would be on the real thing. I don't know therefore if the NIH would not release this information in case it could be bias inducing. I think people can understand a 50:50 chance but with only 1 in 5 or 20% chance of having a placebo this could enhance the placebo effect.
After having written that I suppose the same argument could have been made if all the treatments were say tablets and only 20% were placebo so this has obviously been taken on board in terms of the protocol and discounted so perhaps indeed there will be only 20% on placebo in each trial type. Lazily, I haven't re-read the protocol to check this is the case but I recall it does say something about matching placebo type to real drug and some number crunching being necessary.
Interesting link Doc. I had asked a question to myself whether there would be any element of choice either by the patient and or the doctor in charge as to which trial drug group each patient would enter. I assumed, but without evidence that the doctor might have a say but the patient might not. Also some of the centres may only have some of the options available. This is certainly the case for our drug which we know has not been made available to all the participating centres.
This 21 April addition of SAB 185 comes with the statement that not only will the selection of treatment be random but also that Activ-2 is recruiting centres worldwide.
I am therefore confused.
Probatis could you please post a link to your statement re low risk and high risk separation please because that does not sit squarely to the 'random' statement in the 21 April notice from NIH.
Whilst posting I saw and noted that only one trial drug in Activ-2 has been granted EUA so far and that took 3 and a bit months. At the time it was the only drug in the programme.
Extract from https://www.niaid.nih.gov/news-events/statement-four-potential-covid-19-therapeutics-enter-phase-23-testing-nih-activ-2-trial
'On August 4, 2020, NIAID announced the launch of ACTIV-2, which initially tested LY-CoV555, a monoclonal antibody made by Eli Lilly and Company. On November 10, 2020, LY-CoV555, also known as bamlanivimab, was granted Emergency Use Authorization by the U.S. Food and Drug Administration (FDA) for treating mild-to-moderate COVID-19 in adults and children over 12 years old who are at high risk for progressing to severe COVID-19 and/or hospitalization. An ACTIV-2 study testing BRII-196 and BRII-198, investigational neutralizing monoclonal antibodies manufactured by Brii Biosciences (Durham, N.C., and Beijing), was announced by NIAID on January 5, 2021, and is continuing to enroll volunteers.'
Also notable is the BRII drugs added on Jan 5th 2021 still have no read-out and were added a month or so before SNG on Feb 10th.
We have to keep patient and hope that the limited supply of SNG001/ limited number of locations where it is available will not adversely impact the overall take-up in the trial compared to the other drugs being trialed.
Best wishes all
Thanks for that Agent B. I did see it when it was published on 10 March but I don't know if the EUA application has been made for VIR 7831 . It will be all over the press if approved so I don't think that has happened yet.
The ICE trial of VIR 7831 is the treatment that GSK are appliying for EUA. This is a 14 day I/V programme so not as accessible as SNG001. Trials are ongoing for I/M injection treatment with the same drug which mode of treatment would be more comparable to SNG.
Camostat tablets are on Activ-2 and would certainly be a popular political option if trials are good.
The big plus for an inhaled treatment, as many posters have said is that the dosages required should be less as it is targeted to the lungs and therefore concerns of unwanted side effects should be less. In principle targeted techniques are increasingly preferred in cancer etc as also stated on another thread.
Still looking good for us despite the longer than hoped for time frames.
Good luck all. Spinnaker
I agree with Poised. It is a very good question; whether a false positive could be repeatedly be generated by the same person even when they weren't infected. In any event with two positive results I wouldn't want them mixing in the community. From a public health perspective the incidence of false negatives is surely more concerning for people arriving in the country. A second test after 5 days carried out by a health professional should be mandatory since they could have become infected on the plane or in the airport.
Also, I agree with jdt1990 that a negative PCR test 72 hours before flying is not adequate. Michael Mina's graphs show infectivity within 48 hours of infection.
If we are going to allow increased plane travel it will also be important from the track and trace point of view that airports do not allow mixing of passengers from different inbound flights which will be a serious management issue to resolve and does not seem to have been attempted as yet.
Looking good for Avacta though. Very positive vibes.
I understand we have been included in the UK framework for future test expenditure but am concerned whether any company or government would give future contracts to a company that they are in legal dispute with. Is it that the dispute is compartmentalised and is likely to have no effect on future contracts, for instance the name on the contract will not be Primer Design and therefore will not be red flagged?
Does anyone know?
I must say, looking at the link below I find it beyond amazing that the govt. seems to be waiting until the Indian strain is proved to be a 'Variant of Concern' before stopping flights from Delhi etc. It is totally nuts. The cost of any potential variant evading our vaccines would be huge both economically and from a public health viewpoint. We should be doing it the other way round. Shoot first and ask questions later. As an island we are able to protect our borders far better than most countries and should have done so previously and should do so now.
Thanks for reminding us about that Prion.
Having a quick look for the second time what really hits me is they are forecasting a compound annual growth rate over the next few years of just 3.5% from the 2020 sales. This is despite mentioning Synairgen hospital trial. It would appear therefore that they are not assuming any sales for our drug against Covid. It may be that the company protocol does not allow any assumptions in respect of drugs that are not approved at the time of estimate. The figures given are relating to I/V and I/M treatment for Mutliple Sclerosis.
In any event I don't think the figures give any particular insight regarding the potential sales of an inhaled version of Interferon Beta 1a either as anti Covid treatment or a general respiratory anti-viral.
There are a lot of hoops still left to jump through but I am pleased that the SP has held up pretty well and seems less volatile at present.
Best to all
Thanks Hank and F&V
Significant discussions or agreements re backing surely should be RNS'd. We have had RNSs stating production agreements are being progressed but that is all. Confidential discussions ongoing shouldn't need RNSing of course.
On pricing , Hank, the example of £50 for a nebuliser may well be £50 at present but if we produce 100,000 treatments and therefore need 100,000 nebulisers every month then I am confident we could either find a way of sterilising the used units or agree a reduced price with the current manufacturer or approach a different manufacturer. It may be that this latter would require some limited further trialing though. Similarly volume and longevity of production will inform costs of the vials.
The production for Covid-19, its variants and future respiratory viruses is potentially a market that would be orders of magnitude larger than the original asthma and COPD exacerbation target intentions. We can't expect the first years worth of purchases by customers to pay for all the 15 years research costs assuming we have a product which was originally developed for for a rather more niche although still important purpose.
Indeed the outcome of the 'At home' arm of the UK trial together with the US Activ-2 may well determine the overall market size for the future. It could be huge but if it is then downward pricing pressures could increase fairly quickly particularly since Interferons cannot be protected by IP. Recent and current panic spending will not last; see NCYT as an example.
If we get the positive results from all the trials that we expect I concur with F&V and Hank that there will be a few suitors and it will most probably then be in everyone's interest for J/V or J/Vs or takeover. The only worry is that a takeover is not a swift option and may delay optimum roll-out. The involvement of a large Pharma or Pharmas will reduce costs of production and enable faster production no doubt which would potentially increase the market size.
My long post continued.
A lower price could be negotiated with the government for a long term contract and of course production could be ramped up to and above RM suggestion of I think 100,000 plus per month. I expect us to be able to sell multi-nationally quite readily once authorisation is approved.
Sorry for my ramblings but I am interested in what everybody else thinks on this topic. If we can bring down the price to a few hundred pounds then there is scope for tens of thousands of sales to the general public. Me for one.
Good luck all
I know you have suffered a lot of adverse comment on this board because people think, wrongly in my view that you are de-ramping. However you have gone to the trouble of crunching some numbers and answering questions so thank you.
I am interested in pricing potential and accept that there is the opportunity of differential pricing across different markets. As you imply, the cheaper we can produce, the more competitive we can be in the market. However as in most industries the price of raw materials is only a small fraction of the cost of finished goods and for instance the production of the vials with such a small amount of interferon is going to be a much larger proportion of the cost than for I/V treatments . It is now clear that there are a number of drugs that will be competing. Ours may be the best in its niche but that doesn't mean that we should seek to maximise sale price over the short term. Maximising sale price is not the same as maximising profits of course. Cost efficient production and future proofing will be key.
I consider it likely that one of the reasons SNG001 is not on the Recovery trial is that Horby or whoever was responsible on the UK gov. side thought that the expected treatment price would not be attractive. The posts have shifted since then particularly in America where as we know the US gov. have contracted to buy several expensive mAb treatments at between $1,000 (AZN) and $2000 (Regeneron) a pop.
I have been thinking about this pricing today mostly because of the fall-out that has occurred between Novacyte and the DHSC notified on Friday last week. It appears it is to do with pricing although I may be wrong. The GP shown by NCYT in their latest accounts was something like 85% and I think this was for product supply, machines and tests. Now I am not certain what the proportion of the total cost of a PCR test is the kit since the lab cost will be significant. Also, using GP as an indicator is not very reliable since the recoup of R&D and trial costs need to amortised through the production numbers and lifetime of the product sales . In any event, the relationship between NCYT and government has soured. The media picked up on possibly Matt Han****'s comments and the main take was that certain private companies are seeking to make excessive profits out of government contracts. This is obviously not a good look resulting in a one day 40% SP hit for NCYT..
I suggested back in early March that perhaps we could produce treatments including vials etc for £10 per dose or £140 plus say £10 for the nebuliser. Is this feasible based on say 50,000 per month? If head office and research costs were say £50 per treatment then costs would be £20m per month. If this was the case then we could sell at say £400 per treatment and still make a reasonable profit of £20m per month. This would be a GP of 62.5%.
Thanks chaps for your responses to my post.
Doc, I am sorry but I missed the post about the email from the company confirming they had seen the initial results. Nevertheless I believe the protocol allows for a few people close to the trial within the company to see these early but still mainting the blinding as far as patients and doctors are concerned. Therefore it is quite possible that Ghia is correct and it is thought that an RNS release prior to the the last 90 day follow up could allow bias. Therefore it is still feasible that the early data may be released by RNS after that 90 day period has elapsed.
Meelie, I am sure you are correct that the BoD are not interested in the view of short term investors or traders and have consistently shown to date that they are only prepared to do things in a proper and considered manner with regard to the long term benefit of the company.
I also take on board the point that RNS's such as the one we are expecting are important and do take time to prepare. I recall there was a second RNS rushed out directly after the 20 July one for clarification. Therefore although it is possible that we will get 2 RNSs with the 60/90 day results separate and subsequent it is also possible that all will be rolled into one. In the latter case I think I am still sticking by my earlier view that we may not hear anything until 2 weeks either side of 24 May.
I think I missed my chance this morning to top up in my new ISA but see my limit trade at 145p was actioned this morning and already in profit.
A nice little move up at the moment. Strong RSI. What's happened?