Anavex Dialog med EMA om godkendelse af 2-73 i Alzheimer!!!
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Anavex EMA og ANAVEX - og lidt fremtidsscenarie.
Siden 2016 og til 2020, er andelen af godkendte ansøgninger hos EMA, som også har resulteret i en endelig markedsgodkendelse øget fra 40 % til hele 89 %!
EMA har måske været mere kritisk og grundig i den indledende fase og filteret mere fra, inden næste fase - selve ansøgningen.
Som jeg læser EMA dialogen, som Anavex har haft over flere møder, så har EMA set de komplette data fra Alzheimer og fastlagt de retningslinjer og format de ønsker at se i en egentlig markedsansøgning fra Anavex.
Tror derfor, at Anavex har mere end en fod inden for og relativt nemt får selve ansøgningen accepteret.
Havde EMA ikke været tilfredse eller overbevist af de data Anavex præsenterede, så havde man nok sendt Anavex hjem med besked om f.eks. opstart af yderligere underbyggende forsøg.
Accepteres ansøgning må man forvente en udmelding, hvorvidt EMA vil behandle ansøgningen som acc. eller normal proces.
Acc. processen er ca. 150 dage og standard processen 210 dage.
Alene en evt. udmelding om en acc. proces, ville dog have en stor positiv påvirkning på kursudviklingen - det så vi tidligere fra både BiIIB og LLY. - dette ville signalerer, at EMA finder data overbevisende og øger sandsynligheden for en endelig markedsgodkendelse.
Lidt fremtidscenarie.
Alene i EU er der godt 7.000.000 personer med Alzheimer.
Skulle Anavex få en andel i markedet på bare 20 % om 2-3 år og med en pris på 20.000 kr./årligt (svarende til egenbetaling af f.eks. Wegovey-vægttabsmedicin), så ville omsætningen være 28 milliarder kr. eller 4 milliarder $. Med en PE på konservative 5, ville markedsværdien for Anavex skulle andrage 20 milliarder $ - med 80 millioner aktier ville aktiekursen komme op på 250 $ eller 35 gange nuværende kurs! (Man kan altid lege lidt med tallene)
Dette er alene for Alzheimer og kun i EU og uden resten af verden og uden indregnet Parkinson, RETT, 3-71 og resten af pipelinen.Nu går det jo sjældent, som man forventer og tror, men får vi den endelige blåstempling fra EMA i første omgang, så er der bestemt mulighed for, at tingene kan udvikler sig eksplosivt.
Intet er dog sikkert før den endelige godkendelse! -
Jeg er ret grøn på aktieinvesteringer, så jeg har ikke helt styr på begreberne. Derfor er jeg lidt nysgerrig. Er PE ikke et udtryk for pris i forhold til indtjening ?
Tasso, som du bruger PE, er det så ikke pris i forhold til omsætning ? Og er det sådan PE skal forståes ? -
Anavex Helt korrekt Lak - mener selvfølgelig indtjening.
P/E Price pr. Earning:)
2-73 - Blarcamesine er relativ enkel og billig at fremstille.
Den kemisk formel er også nøje beskrevet i forbindelse med div. patentansøgninger.
I forbindelse med en kvartalsrapport for 3-4 år siden, annoncerede Anavex, at de havde fået fremstillet 1 mill. doser 2-73 hos en pharmaproducent. Her kunne man så ud fra regnskabet regne sig frem til, at en dosis/ pille havde kostet ca. 1 $ at producerer.
Biogen har prissat deres nydelig godkendte og kritiserede (farlige) Alzheimer medicin til 26.000 $ årlig, hertil kommer så udgifter med infusion og skanning for hjerneblødninger - forventelig en samlet årlig udgift på over 50.000 $ - 350.000 kr.
I RETT har en konkurrent fået godkendt et stof, der har både har større bivirkninger og mindre effekt end 2-73. Her har man fordi det er en sjælden indikation kunne prissætte den årlige markedspris til over 500.000 $!Tror derfor nemt, at Anavex på bundlinjen, efter alle omkostninger og evt. partnerandel, ville kunne tjene langt mere end de 20.000 kr. jeg har leget lidt med.
Formålet alene var at illustrerer, hvor vildt tingene kan udvikle sig, hvis EMA skulle godekende 2-73 i EU.I forbindelse med EMA og deres endelige antal markedsgodkendelse, for de ansøgninger, som slap gennem nåleøjet og fik lov til at indsende en ansøgning efter forudgående dialog om kriterierne, så har en dygtig skribent fra IHUB følgende indlæg:
(Budskabet er, at bliver Anavex`s ansøgning godkendt af EMA, så er der også meget store chancer for en endelig markedsgodkendelse!)
The statistical chances of a favorable EMA recommendation for blarcamesine are now quite high.
I have looked at the EMA website regarding their most recent determinations as well as a 2013 study regarding submissions. Here is what I have found:
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During the years 2015-2022, the EMA issued 694 positive opinions for submitted drugs, and just 31 negative opinions. (There were 96 withdrawals during the eight year period.) The rate of positive opinions regarding submitted drug applications was 95.7%.
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The 2013 study examined the history of initial authorized applications during the years 2003-2010. The authors found during this eight year period that there were 70 withdrawals and 16 applications refused by the EMA. (Four refused applications were subsequently successfully resubmitted.)
If the same or similar 70/16 withdrawal/refusal ratio continues to apply today, we can estimate the dropout rate between the initial point we have reached and the time, seven months from now, when the EMA decides whether to accept the application. Adjusting, the current period's 96 applications withdrawn, as supplemented by refusals (16 times 96/70, i.e., 22), equals 116. Adding the number of 2015-2022 EMA opinions (694+31) to an estimated 2015-2022 preliminary events of 116 produces an initial eight-year estimated figure of 843 applicants who achieved Anavex's present regulatory status before the EMA. Finally, that produces a dropout rate over the next seven months of 112/843, or 13.7 percent and, conversely, an MAA submission acceptance rate of 86.3 percent.
So what are the statistical chances from here of a 2025 positive EMA opinion of blarcamesine? That equates to 86.3 percent multiplied by the 95.7 percent rate cited above, or ~ 83 percent.
EMA favorable recommendations go to the European Commission for their decision. I have found no stats on that, but I would expect deference to the EMA, absent any political issues. So I assume there's now an 80 percent chance or better that Anavex will succeed in getting blarcamesine approved for Alzheimer's Disease in the European Union.
Medicine evaluation figures | European Medicines Agency (EMA)
The European Medicines Agency (EMA) publishes information on the volume and outcome of marketing authorisation and post-authorisation applications for human and veterinary medicines that it evaluates. The documents on this page contain factual information on medicines evaluation, presented on an annual and monthly basis.
European Medicines Agency (EMA) (www.ema.europa.eu)
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10% ned....shorterne har helt styr på sagerne .... Desværre
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God ide at placere sådan en aktie i et pensionsdepot. Når kursen om et par år forhåbentlig er 250 (jævnfør Tasso1 ovenfor) kan du glæde dig over, at du kun skal betale 15,3% af afkastet mod 47%, hvis der er tale om frie midler. Jeg har netop flyttet mange af min store beholdning af Anavexaktier over på min ratepension og min aktiesparekonto for at få en lav beskatning af det store afkast, som vi alle håber på.
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Transcript af dagens CC:
https://seekingalpha.com/article/4654341-anavex-life-sciences-corp-avxl-q4-2023-earnings-call-transcript?feed_item_type=transcript&utm_medium=referral&utm_source=conferencecalltranscripts' target=Jeg har ikke selv hørt cc endnu, men af transcriptet fremgår det:
- EMA er første sted for ansøgning om approval grundet forsøget gennemføres delvist i den region. Samt at de har en lang procedure omkring ansøgning. EMA har anbefalet Anavex at søge endelig godkendelse på baggrund af de data de har set (super stærk signal)
- FDA ligner et senere ansøgningstidspunkt, idet man vil lade extensionforsøget indgå i den pakke (Det kan sagtens være, at møderne med fda har været afholdt og at fda har tilkendegivet, at det forsøg skal med i materialet ( Piotr har faktisk set det krav komme). Dette forsøg afsluttes medio næste år.
- Rett data lidt forsinket grundet et krav om safety opfølgning (efter forsøgets afslutning). Men de er på vej med top line data.
Anavex har solgt aktier så de opretholder ca $150 mln i cash. Tilsyneladende mener de, at det niveau skal holde q efter q.
Vi venter med spænding på Peer review artiklen med de gode AD data !
Shortene bankede kursen ned i åbningen, som vi har set så tit tidligere. Tiden arbejder imod dem !
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Hej
Mon ikke den også skal ned, eftersom Anavex har solgt under nuværende kurs..
De har jo penge nok, så hvorfor sælge ud til laveste markeds kurs.Så en god nyhed for shortdrenge desværre
Tog dog et swing, da faldet var noget voldsomt, kursen har så rettet sig lidt siden..
Mvh
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Mange biotekfirmaer er ved at løbe tør for kapital, og det gør dem meget sårbare. Jeg synes, at det er rettidig omhu af Anavex at holde kassebeholdningen konstant med en beskeden udvanding. Det stiller dem stærkt i eventuelle forhandlinger med Big Pharma.
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lossen ikke uenig omkring udvandingen og kassebeholdning , men efter Anavex egne udmeldinger, vælter det ind med kurspåvirkende nyheder snarest, og med penge nok i kassen pt, kunne man måske have ventet til start nyt år. Det både til aktionærernes fordel, og ikke mindst anavex selv.
Ingen udvanding, og flere penge i egenbeholdningen, hvis altså det lovet fra anavexs egene udmeldinger, udmønter sig i den ægte varer.
Mvh
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Ja det siger mig, at de ikke har nogen partneraftale eller lignende i skuffen.
Dagens meddelelse siger noget om, at man vil undersøge mulighederne for kommercielisering i EU herunder hvordan man aktiverer patientgruppen (noget i den retning) - gad vide om de påtænker ?
Lige nu ligner det at de vil partner meget sent eller slet ikke ?
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Anavex Fik nu mulighed for at høre webcastet.
Er helt på linje med Solsen, at processen med EMA er meget positiv og giver stor optimisme omkring en markedsgodkendelse i EU.
EMA har set hele den datapakke fra AD fase 2/3 forsøget, som igen bekræftes udgivet som en Peer Review i en nær fremtid - ingen angivelse, hvornår vi får denne - men det må være meget snart, når datapakken var så udspecificeret og komplet, at de var gode nok til en præsentation for EMA.
EMA synes dog modsat FDA, at være tilfredse med data fra selve fase 2/3 forsøget og behøver ikke at afvente data fra OLE forsøget, der efter 96 uger afsluttes juni 2024 - dette studie er iøvrigt blevet forlænget til 144 uger, hvor patienter der også nu har afslutte dette er overgået til compassion use.
Hele 90 % forsatte i OLE forsøget - og der var iflg. Missling forsat stor efterspørgelse af 2-73.
Lyder som om, at Anavex med aftalen med Partex, måske tænker at gå egne og nye innovative veje til en markedsføring i EU?
FDA ser ud til at vil se OLE data integreret i en evt. ansøgning i US, hvilket godt kan begrundes - men både ren etiske (pga. de mange sites i EU) og tilfredsheden med AD fase 2/3 data alene, kan denne vej med EMA være mere rigtig og hurtigere.
Missling understregede, at man sideløbende køre processen med både FDA og AUS.RETT Excellence er åbenbart lidt forsinket pga. en efterfølgende analyse af bivirkningsprofilen, hvilket nok også lyder plausibel, når man har med sårbare børn at gøre og hvis de samlede data i hele RETT programmet skal danne endelig grundlag for en ansøgning om markedsgodkendelse.
Ellers kan vi forvente flere separate udgivelser fra programmet og opstart af bl.a. et 6 mdr. langt Parkinson forsøg og opstart af andre forsøg fra pipelinen.
Anavex har åbentbart lagt sig fast på, at der hele tiden skal stå ca. 150 mill. $ på bogen, uanset hvilken kurs man løbende kan sælge aktier til.
Dette gør dem meget mindre sårbar og herre i eget hus.
At der nu er ca. 82 mill. udestående aktier er en lille pris at betale i min optik.Alt i alt ikke den bedste CC, da man igen ikke fik nogle tidspunkter sat på de kommende vigtige milepæle, hvilket derfor nok var årsagen til, at markedet straffede på aktiekursen.
Tror dog ikke Anavex selv kun er skyld i dette, da flere eksterne parter er involveret i de forskellige processer.
Alt tyder dog på, at videnskaben og resultaterne er valide, men at det hele bare tager noget længere end de fleste havde forventet. -
Endnu en fejler i Alzheimers
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Yahoo Finance (finance.yahoo.com)
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En god artikel, hvis I laver en gratis konto
Forfatteren omtaler potentiel godkendelse i foråret 2024. Det håber jeg er rigtigt, men det tror jeg ikke selv på
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Anavex Positiv og omfattende artikel, men godkendelse sidst i 2024 er nok mere realistisk - ting tager tid.
How Soon Might Anavex's Alzheimer's Drug Be Approved? The Good/Bad News
Nov. 29, 2023 7:21 AM ET
Anavex Life Sciences Corp. (AVXL)The Political Economist
Summary
The EU recommends Anavex proceed with a full approval application for Alzheimer's drug Blarcamesine based on full Phase 2b/3 trial data.
The U.S. FDA may grant accelerated approval to Anavex's Blarcamesine based on biomarker data alone. Blarcamesine is far safer than Biogen's Leqembi, which was granted accelerated approval in three months.The FDA may accept Anavex's ongoing ATTENTION-AD study as a supplement to the Phase 2b/3 trial, potentially shortening the full and regular approval timeline. That data comes out in 2023.
human brain
nopparitHere's the bad news. And the good news. From today's Anavex Life Sciences (NASDAQ:AVXL) conference call:
We have met the European Agency several times in meetings and we have shared the data which is not yet published, which is the published date of -- the planned published communication of the full data of the Alzheimer Phase 2b/3 study. And we were from this meeting recommended to proceed with this application, full approval application. And that's what we proceeded with last week accordingly.
The good news is, after showing the EU drug bureaucracy the Phase 2b/3 full data set, the EU recommended that Anavex "proceed with" a "full approval application." This implies that the EU sees the Phase 2b/3 drug trial results as sufficient at least to make a decision on approving (or not approving) Blarcamesine.
And Anavex has already applied to the EU for approval.
As discussed in previous articles, the drug looks both highly effective and safe. One of the remaining questions was whether regulatory agencies worldwide would require Anavex to do any further drug trials. The EU apparently does not see this need. That's good news.
The bad news. The EU is typically a good deal slower than the U.S. FDA in its drug evaluation and approval process. It could take over a year.
On the other hand, these regulatory agencies do not work in a vacuum. They understand the urgent need for a safe, effective, affordable Alzheimer's drug, and that patients "need it yesterday," so to speak. Might the EU fast-track the only effective Alzheimer's pharmaceutical that does not cause brain bleeding (like Biogen's Leqembi does)?
I think so.
The U.S. FDA Accelerated Approval Process
And what about the U.S. FDA?Anavex had been preparing to apply for Accelerated Approval by the FDA. This, from a previous (May 2023) quarterly conference call:
With newly available preliminary efficacy results of surrogate biomarkers, we consider initiating discussions with regulatory agencies for Accelerated Approval Pathway for ANAVEX2-73. In parallel, we plan to proceed with the initiation of our confirmatory Alzheimer's disease study.
Accelerated approval at the U.S. FDA requires that a drug demonstrate an effect on at least one related biomarker. Biogen's Alzheimer's drug, Leqembi, for instance, demonstrated an effect on amyloid plaques in the brain.
In a September press release, Anavex stated that Blarcamesine lowered the levels of amyloid plaques in the brain. Furthermore, Blarcamesine affected the ultimate Alzheimer's biomarker: brain volume. The drug slows the loss of brain volume. Both findings were statistically significant, with preventing brain loss being a result at an extremely high level of statistical significance.
So, that seems to check the biomarker box; all seems prepared for accelerated approval, right? Can they get accelerated approval with the biomarker data? How picky is the FDA regarding accelerated approval for Alzheimer's drugs? From the May conference call:
The next question is, will the AD NDA be submitted before the confirmatory trial is completed?
The answer is after discussion with the agency for Accelerated Approval Pathway, this would be the path which was also given to the other accelerated approval company approvals. So this could be the case as well. Otherwise, it would be not accelerated approval if you need a study to begin with. So that is the goal of getting the drug approved before completing a confirmatory second trial.
Here, CEO Missling repeats the goal of winning accelerated approval WITHOUT having to do a "confirmatory second trial" which might take another year. Indeed, from what the public has seen of their Phase 2b/3 trials, the drug is more effective than Leqembi in slowing cognitive decline as measured by the ADAS-Cog13 and the CDR-SB. And Leqembi was granted accelerated approval, as Missling states in the above excerpt, so Blarcamesine should be granted the same.
All is set, right? The biomarker data looks great. Leqembi won accelerated approval with biomarker data alone. Get the application into the FDA!
The U.S. FDA Regular Approval Process
The twist. During the August conference call, CEO Missling dropped this bomb on us:We have been heard from KOLs [Key Opinion Leaders] that actually this extension study [ATTENTION-AD] could be the confirmatory study of the ANAVEX2-73 Phase 2/3 study itself. So we want to basically put this in context and see how this will progress. Accordingly, so we might already have started this confirmatory study with that open-label study, but it will be determined in discussion with regulatory agencies. But we would, of course, be able to, without a problem, initiate a study, if so required, at any time.
Here, CEO Missling says that Anavex could apply for the regular approval process using the ATTENTION-AD OLE as the confirmatory study. The accelerated approval does not require a confirmatory study.
This week's quarterly conference call confirmed that Anavex would apply for FDA approval using ATTENTION-AD as part of the application package:
We have the ongoing ATTENTION-AD study ongoing and that's part of the package of the application with the Phase 2b/3 study.
Here, Missling does not specify whether he is talking about applying for regular approval or accelerated approval. Taking into account the declarations of the past three conference calls, Anavex appears to be applying for BOTH accelerated approval AND regular approval to market Blarcamesine for Alzheimer's Disease in the USA.
No matter which path they take, the timeline for approval may be about the same.
Here is the follow-up question to the August conference call excerpt from above:
Soumit Roy
I see. Do you have any date in mind when the FDA conversation could happen if this study can translate into a confirmation study?
Christopher Missling
Yes. We are planning to do this once the data is available, which is expected this year. And thereafter, agency is able to address things with data as well. And that's what will happen with data, in presence of data.
Here, the analyst Soumit Roy asks Missling when he will find out if the ATTENTION-AD study can count as a confirmatory study for the regular approval application. Missling says that the "data" will be available in 2023. I assume this means that ATTENTION-AD will be completed in 2023, which seems too early to me, considering the Phase 2b/3 study was apparently "completed" in "mid-2022" according to a 10-Q filing.
Whatever the case, it is on record that the CEO stated that the "data" will be "available" in 2023, and that data, along with the application to the U.S. FDA will move the stock value.
Stock Value and Timeline
Immediately after this week's conference call, AVXL stock tanked by about 10%. I am not sure what sellers were responding to, or if shorts brought the stock down.Recent events, press releases, and declarations by the company indicate that approval for a drug that can bring in tens of billions of dollars a year could come as early as spring 2024. AVXL has a market cap of about 500 million dollars.
It took only about three months for the FDA to grant accelerated approval to Leqembi after it reported Phase 3 results.
This is what I imagine Anavex will do: The company will put together the complete Phase 2b/3 clinical data along with Phase 2b/3 biomarker data (which just came out two months ago) along with ATTENTION-AD OLE data and hand it over to the FDA. This will represent 144 weeks of data for hundreds of patients, all of which will have taken the drug for between 96 and 144 weeks. Anavex will tell the FDA, "With all this data, please consider Blarcamesine for BOTH accelerated and for regular approval."
I imagine this data bomb will drop in early 2024, but I have been very wrong before about when data is dropped, so beware.
If I am correct, FDA approval may occur as early as spring or summer 2024.
The EU approval process has already begun, and that decision may be made in 2024, perhaps spring or summer if the EU prioritizes its 7 million dementia patients.
With dementia care costing hundreds of billions of dollars in direct and indirect costs for EACH the EU and the USA annually, approving Blarcamesine a month earlier than later could save tens of billions of dollars for the Western, democratic world. That's a major productivity boost for economies with enormous budget deficits burdened by elder-care.
Considering Leqembi costs $26,500 per patient, plus 5 MRIs and 26 IV-infusion office visits each year, the H.C. Wainwright price target announced today of $54 per AVXL share seems conservative. Blarcamesine will undercut Leqembi on price and will be far safer than Leqembi. No IV-infusions and no MRIs and no brain bleeding.
Most of all a slowing down of cognitive decline the likes of which has never been matched in any drug trial, as well as the first drug ever to demonstrate brain volume preservation.
And even the shorts will agree, the tens of millions of lives transformed is the greatest reward of all.
Addendum: More on the ATTENTION-AD OLE and the Parkinson's Dementia OLE studies
Good news regarding the ATTENTION-AD study (from this week's cc):...we had extremely high rollover from the double-blind, placebo-controlled [drug trial] into the open-label ATTENTION-AD study. I think it was over 90%. And we have a large number of patients on this study. We even have the first patients who finished that study going over and requesting an extension of this extension by another year. So it became now a 144 week study for some patients. And thereafter, we also have patients which requested to be given the drug continuously, and we provided them the drug on compassionate use. So there's a high request for patients to stay on the study drug.
With 90% of the participants from the 2b/3 trial (which saw 508 participants) continuing on to the ATTENTION-AD OLE trial, it seems that the participants really believe the drug is effective. Further, the large number of participants may allow the OLE study to be used as a confirmatory study.
Many of those in the ATTENTION-AD study have already completed the 96 weeks, so Anavex may already have some clue as to how the drug performed. The participants themselves also have some idea, as they have all taken the drug for 22 months longer than before. And it seems many have asked to extend their participation by another 48 weeks or take the drug indefinitely out of compassionate use.
If you look at the Parkinson's Disease Dementia Phase 2, placebo-controlled, double-blind, randomized drug trial of Blarcamesine, you will see tremendous improvement and slowing of decline among its participants.
And then if you look at the Parkinson's Disease Dementia open-label extension study, you will see that the effect of the drug did not disappear after the initial trial. Participants steadily benefited from the drug during that OLE.
I expect the ATTENTION-AD OLE study to demonstrate similar effects: continued consistent beneficial effects of Blarcamesine. In fact, for the twenty patients that remained (even through Covid) for the entire 48 weeks of the Parkinson's Dementia OLE, the average and the median scores actually IMPROVED in four important categories.
Finally, Anavex has already conducted a 260-week OLE of its Phase 2a (not 2b) study. This included a small number of participants. Safety was good, and those taking larger doses of Blarcamesine saw greater benefit from the drug. Other than that, little could be concluded by this small study.
The Competition's OLE
Biogen did not have to include the Leqembi OLE results for their accelerated approval process, and three OLE participants died apparently as a result of Leqembi's brain-bleeding side effects. Cynically, that may be why the Leqembi OLE study was not considered by the FDA in the decision-making process; they wanted to quickly approve Leqembi without having to answer questions about patient deaths. The FDA, after all, was found by a Congressional investigation, to have held secret, undocumented and unethical meetings with Biogen in order to get their even less effective yet also dangerous Alzheimer's drug, Aduhelm, approved.With three people dying from Leqembi in their extension study, the FDA may be more interested in the safety data from the 96-week Blarcamesine extension study.
One of those Leqembi deaths happened after only 6 weeks of Leqembi use within the extension study; it's not clear if she had been in the placebo or the medicated arm of the original Leqembi study. The makers of Leqembi interestingly did not reveal the death of this woman (in otherwise good health) at a major conference presentation. Months later, Leqembi was granted accelerated approval by the FDA, which apparently knew about all three brain-bleeding deaths.
There have been no deaths caused by Blarcamesine even after five years of use by OLE study patients.
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