Hvem bliver mon Hansa Biopharmas næste partner i Genterapi? Pfizer, Norvartis, Astellas, Roche eller en helt femte? CEO udtalte sidste år at der er dialog med en ganske bred vifte af førende spillere. Om der så er tale om 3, 5 eller 10 kan vi kun gætte på men mon ikke de lander en ny aftale indenfor en overkommelig fremtid. Forhåbentlig vil en ny aftale være lidt i lighed med Sarepta aftalen hvor Hansa udover 2,5 mia dk i milepæle får imponerende 100% af IDEFIRIX salget + andel i sareptas genterapi salg hvor IDEFIRIX skal bruges. Fælles problem i mange genterapier er NABS som forekommer i 5%-70% af patienterne afhængig af indikation. Igen, et problem uden nogen god behandlingsmulighed idag. Eftersom diverse store spillere har henvendt sig til Hansa ovenpå de flotte tidlige data i 2020 bekræfter det mig i, at de tror på, at løsningen på NABS-problemet hedder IDEFIRIX. Da der er flere spillere indenfor hver genterapi-indikation kunne man forestille sig at der er lidt kapløb om at få netop IDEFIRIX med om bord ligesom at Sarepta har enerettighederne til at bruge IDEFIRIX indenfor Duchenne og Limb-Girdle, så genterapiselskaberne kan fremvise de bedste samlede data når de en dag lander på markedet, det at de også kan løse problemer med NABS. En ny aftale vil også bekræfte at Hansa Biopharma for alvor nu også er en spiller indenfor genterapi, et potentielt multiblockbuster marked. Spændende bliver det at følge....
Af hjertet tak for endnu et velunderbygget indlæg, som velsigner os andre med nyttig viden om en ekstrem Interessant investeringscase.
23/1 2021 11:29 Pappano 0
90050 Jeg er ked af, at sige det. Men til "jubelkoret" over Hansa Biopharma, vil jeg med lidt sarkasme glæde mig over, at jeg ikke har tabt ca. 23% på aktien i den seneste måned.
Men det bliver interessant, at følge aktien i Q 1-2, hvor der forventes konkrete kursdrivende nyheder. Måske hopper jeg på aktien igen på et tidspunkt
Men det bliver interessant, at følge aktien i Q 1-2, hvor der forventes konkrete kursdrivende nyheder. Måske hopper jeg på aktien igen på et tidspunkt
23/1 2021 11:54 Helge Larsen/PI-redaktør 390051 Der er vel intet "jubelkor" i forbindelse med kursudviklingen. Tværtimod.
Derimod er der mange som er ser et godt potentiale i selskabets produkter og udvikling.
Derimod er der mange som er ser et godt potentiale i selskabets produkter og udvikling.
23/1 2021 13:59 Havneholmen 490054 Imlifidase/IDEFIRIX blev testet i hemophilia indikationen og her er aktørerne Spark, BioMarin, Uniqure, Takeda og Pfizer. Pfizer blev som bekendt "snydt" for Duchenne indikationen da Sarepta satte sig på denne. Vil de lade dette ske med hemophilia indikationen også?
Pappano...meget kortsigtet tankegang 
Såvidt jeg husker var den omkring kurs 100 sidste år hvor havneholmen anbefalte den..
Den har vist også været i 270.. tror man skal kigge langsigtet på denne aktie.
Såvidt jeg husker var den omkring kurs 100 sidste år hvor havneholmen anbefalte den..
Den har vist også været i 270.. tror man skal kigge langsigtet på denne aktie.
Ja, men hvis jeg havde købt aktien i efteråret på kurs 250-270, så ville min personlige evaluering etc. se anderledes ud, bl.a. på grund af Covid-19 usikkerheden. I perioden siden efteråret, har der også, så vidt jeg husker været en hel del "tomgang" i forventningerne til nye potentielle kursdrivende nyheder etc.
Mæglerstatistikken for den seneste måned viser også store forskelle i aktionærernes "kortsigtede og langsigtede tankegang og forventninger i relation til aktien. F.eks. har Avanza Bank kunder været storkøbere og J.P. Morgan kunder været storsælgere i den konkrete periode etc.
https://trader.di.se/index.php/quote/maklarstat/1065
P.S. Jeg har selv i konkrete perioder haft aktien i min portefølge.
Mæglerstatistikken for den seneste måned viser også store forskelle i aktionærernes "kortsigtede og langsigtede tankegang og forventninger i relation til aktien. F.eks. har Avanza Bank kunder været storkøbere og J.P. Morgan kunder været storsælgere i den konkrete periode etc.
https://trader.di.se/index.php/quote/maklarstat/1065
P.S. Jeg har selv i konkrete perioder haft aktien i min portefølge.
24/1 2021 12:04 Pappano 090067 A propos J.P. Morgan, der har været storsælger af Hansa Biopharma aktier i løbet af den seneste måned. Her en status og opdatering fra Hansa Biopharma forud for JP Morgan Global Healthcare Conference, der fandt sted den 11.-14. januar d.å.
https://investors.hansabiopharma.com/English/press-releases/press-releases-details/2021/Hansa-Biopharma-provides-business-update-incl.-certain-key-financials-ahead-of-the-JP-Morgan-Global-Healthcare-Conference/default.aspx
https://investors.hansabiopharma.com/English/press-releases/press-releases-details/2021/Hansa-Biopharma-provides-business-update-incl.-certain-key-financials-ahead-of-the-JP-Morgan-Global-Healthcare-Conference/default.aspx
24/1 2021 12:19 Pappano 090069 Clinical pipeline update 11.1.2021
GBS (Guillain Barré Syndrome)
Five out of 30 targeted patients with Guillain Barré Syndrome, GBS, have been enrolled in a phase 2 study with imlifidase. The recruitment process to the phase 2 study was temporarily paused due to the COVID-19 pandemic and reinitiated in the fourth quarter 2020 as previously guided.
Antibody Mediated Rejection (AMR)
Four of 30 targeted patients with active AMR episodes have been enrolled in a phase 2 study with imlifidase. The recruitment process to the phase 2 study was temporarily paused due to the COVID-19 pandemic and was reinitiated in the fourth quarter 2020 as previously guided.
Anti-Glomerular Basement Membrane (anti-GBM) antibody disease
On September 24, 2020, positive high-level data was presented from the investigator-initiated phase 2 trial with imlifidase to treat anti-GBM disease with two-thirds of patients achieving dialysis independence six months after treatment. The positive data marked an important milestone for Hansa Biopharma's expansion of imlifidase outside transplantation.
Regulatory discussions with the European Medicines Agency (EMA) and FDA will be initiated to determine the regulatory path forward for imlifidase in anti-GBM.
Pre-clinical programs
NiceR next generation enzymes for repeat dosing
Development of Hansa's next generation enzymes for repeat dosing is progressing according to plan and initiation of IND-enabling toxocology studies is expected to commence in the first half of 2021.
Imlifidase as pre-treatment ahead of gene therapy in DMD and LGMD
On July 2, 2020, Hansa announced an exclusive agreement with Sarepta Therapeutics to develop and promote imlifidase as a potential pre-treatment prior to the administration of gene therapy in Duchenne muscular dystrophy (DMD) and Limb-girdle muscular dystrophy (LGMD).
The partnership has progressed as planned and during the second half of 2020, Sarepta initiated ongoing pre-clinical investigations with imlifidase as a potential pre-treatment in the gene therapy setting.
On January 7, Sarepta announced top-line results for part 1 of Study 102 evaluating SRP-9001, one of its investigational gene therapy candidates for the treatment of Duchenne Muscular Dystrophy. Imlifidase was not given to any patients in this study. For further information, please refer to www.sarepta.com.
https://investors.hansabiopharma.com/English/press-releases/press-releases-details/2021/Hansa-Biopharma-provides-business-update-incl.-certain-key-financials-ahead-of-the-JP-Morgan-Global-Healthcare-Conference/default.aspx
GBS (Guillain Barré Syndrome)
Five out of 30 targeted patients with Guillain Barré Syndrome, GBS, have been enrolled in a phase 2 study with imlifidase. The recruitment process to the phase 2 study was temporarily paused due to the COVID-19 pandemic and reinitiated in the fourth quarter 2020 as previously guided.
Antibody Mediated Rejection (AMR)
Four of 30 targeted patients with active AMR episodes have been enrolled in a phase 2 study with imlifidase. The recruitment process to the phase 2 study was temporarily paused due to the COVID-19 pandemic and was reinitiated in the fourth quarter 2020 as previously guided.
Anti-Glomerular Basement Membrane (anti-GBM) antibody disease
On September 24, 2020, positive high-level data was presented from the investigator-initiated phase 2 trial with imlifidase to treat anti-GBM disease with two-thirds of patients achieving dialysis independence six months after treatment. The positive data marked an important milestone for Hansa Biopharma's expansion of imlifidase outside transplantation.
Regulatory discussions with the European Medicines Agency (EMA) and FDA will be initiated to determine the regulatory path forward for imlifidase in anti-GBM.
Pre-clinical programs
NiceR next generation enzymes for repeat dosing
Development of Hansa's next generation enzymes for repeat dosing is progressing according to plan and initiation of IND-enabling toxocology studies is expected to commence in the first half of 2021.
Imlifidase as pre-treatment ahead of gene therapy in DMD and LGMD
On July 2, 2020, Hansa announced an exclusive agreement with Sarepta Therapeutics to develop and promote imlifidase as a potential pre-treatment prior to the administration of gene therapy in Duchenne muscular dystrophy (DMD) and Limb-girdle muscular dystrophy (LGMD).
The partnership has progressed as planned and during the second half of 2020, Sarepta initiated ongoing pre-clinical investigations with imlifidase as a potential pre-treatment in the gene therapy setting.
On January 7, Sarepta announced top-line results for part 1 of Study 102 evaluating SRP-9001, one of its investigational gene therapy candidates for the treatment of Duchenne Muscular Dystrophy. Imlifidase was not given to any patients in this study. For further information, please refer to www.sarepta.com.
https://investors.hansabiopharma.com/English/press-releases/press-releases-details/2021/Hansa-Biopharma-provides-business-update-incl.-certain-key-financials-ahead-of-the-JP-Morgan-Global-Healthcare-Conference/default.aspx
8/2 2021 13:59 Havneholmen 190804 Det dufter af ny genterapi deal i indeværende år (Fra Q4 transcript om spørgsmål om nye deals): But let me move on to the second question you asked around our discussions with potential partners in the gene therapy space. So clearly there is very strong interests, I would say. But anything, the interest overall has increased over the last year. Much of space to impact, but exciting pre-clinical data on imlifidase has been published. But also due to the challenges that the gene therapy companies clearly have encountered in terms of much as to neutralizing antibodies per se, if they are preexisting or if they develop post-aid reverse dosing. But also because of the regulatory kind of push-back in the issues that we've seen surplus around response at podium level and the ability of the response. So clearly, strong interest from a broad range of players. Obviously, it's important for us to do the right partnerships with the right partners. So it's impossible to predict if and when will the agency announce additional agreements and we agree short term. But certainly, there is as high liable of activity in the space and I would say.
17/2 2021 08:39 Makingmoney 291086 Herunder svar fra IR på mit spørgmål om hvornår de ville doserer den første kommercielle patient. Vær opmærksom på at det er fra 4 dec. Ja, det trækker ud, hvilket dog ikke har afskrækket mig fra at supplerer i mandags. Et lille sidespring angående ordet hvis: Min Farfar sagde altid: Hvis ræven ikke havde pisset havde den fanget haren....Til refleksion for en af skribenterne i denne tråd. Nu jeg ikke har den fine kommunikations tilgang som dig Helge (fik din bog i julegave). En masse smileye
From:<klaus.sindahl@hansabiopharma.com>
Sent: Friday, December 4, 2020 2:08:17 PM
To: Morten1966@LIVE.DK <Morten1966@LIVE.DK>
Cc: Riva Todorov <riva.todorov@hansabiopharma.com>
Subject: Re: First dosing of patients in EU
Hi Morten
We are preparing the launch activities in select countries as we speak and expect to communicate around the launch as indicated in our milestones. This is typically how healthcare companies communicate rather than first commercial sale (accounting related) or first dosing (more study related). As we have communicated it will be a very targeted launch focusing on a few but leading transplantation centers initially in countries with early patient access and reimbursement is possible. Also, since imlifidase is a paradigm shift in transplantation and probably the most innovative drug in this areas for the last 20-30 years we need to navigate local legislative systems and allocation systems. So don't expect a large roll out like a traditional launch process also because we got approval on phase 2 data, we need to conduct a post approval study in parallel in the absent of a full phase 3 study.
Lastly, the thinking behind this is also that clinics and clinicians will be monitored very closely so we ensure that the product is used according to protocol and the first clinics gain positive experience and follow-up data. It is critical for the long term success of our technology that is being used as intended so we don't risk the product potentially being withdrawn from the market because someone is using it off-label or in the wrong patients.
Hope this helps clarify our launch strategy
Best
Klaus
From:<klaus.sindahl@hansabiopharma.com>
Sent: Friday, December 4, 2020 2:08:17 PM
To: Morten1966@LIVE.DK <Morten1966@LIVE.DK>
Cc: Riva Todorov <riva.todorov@hansabiopharma.com>
Subject: Re: First dosing of patients in EU
Hi Morten
We are preparing the launch activities in select countries as we speak and expect to communicate around the launch as indicated in our milestones. This is typically how healthcare companies communicate rather than first commercial sale (accounting related) or first dosing (more study related). As we have communicated it will be a very targeted launch focusing on a few but leading transplantation centers initially in countries with early patient access and reimbursement is possible. Also, since imlifidase is a paradigm shift in transplantation and probably the most innovative drug in this areas for the last 20-30 years we need to navigate local legislative systems and allocation systems. So don't expect a large roll out like a traditional launch process also because we got approval on phase 2 data, we need to conduct a post approval study in parallel in the absent of a full phase 3 study.
Lastly, the thinking behind this is also that clinics and clinicians will be monitored very closely so we ensure that the product is used according to protocol and the first clinics gain positive experience and follow-up data. It is critical for the long term success of our technology that is being used as intended so we don't risk the product potentially being withdrawn from the market because someone is using it off-label or in the wrong patients.
Hope this helps clarify our launch strategy
Best
Klaus
26/3 2021 08:09 Helge Larsen/PI-redaktør 192316 Hansa Biopharma Call 24 March (ABGSC).mp Dr. Bengt von Zur Mühlen
https://abgsc.sharefile.com/share/view/sbe72657c1e7d4cc6b50109f6a6ab7035?fbclid=IwAR1eVkC7dbdZG0JXofO8OLw8dZiWx3PFGTxvqL5bAG6cROol5gNaBTqSSl0
https://abgsc.sharefile.com/share/view/sbe72657c1e7d4cc6b50109f6a6ab7035?fbclid=IwAR1eVkC7dbdZG0JXofO8OLw8dZiWx3PFGTxvqL5bAG6cROol5gNaBTqSSl0
HEALTHCARE DIREKT: SEB:S TOPPVAL INOM NORDISKA SEKTORN
Här finns en ilänk/i till det senaste avsnittet av programmet.
STOCKHOLM (Nyhetsbyrån Direkt) Healthcare Direkt är programmet där vi pratar om veckans händelser inom life science. I veckans avsnitt undersöker vi hur välbalanserad en portfölj bestående av SEB:s toppval inom sektorn skulle bli.
Bland SEB:s toppval finns sju nordiska bolag, Demant, Getinge, GN Store Nord, Hansa Biopharma, Humana, Nanoform och Novo Nordisk. Vi tittar lite extra på SEB:s köprekommendation för Hansa Biopharma och vad som banken tror ligger i korten under 2021.
25.03.21 Nyhetsbyrån Direkt
© Direkt
Här finns en ilänk/i till det senaste avsnittet av programmet.
STOCKHOLM (Nyhetsbyrån Direkt) Healthcare Direkt är programmet där vi pratar om veckans händelser inom life science. I veckans avsnitt undersöker vi hur välbalanserad en portfölj bestående av SEB:s toppval inom sektorn skulle bli.
Bland SEB:s toppval finns sju nordiska bolag, Demant, Getinge, GN Store Nord, Hansa Biopharma, Humana, Nanoform och Novo Nordisk. Vi tittar lite extra på SEB:s köprekommendation för Hansa Biopharma och vad som banken tror ligger i korten under 2021.
25.03.21 Nyhetsbyrån Direkt
© Direkt
30/3 2021 06:49 Helge Larsen/PI-redaktør 092432 Hansa Biopharma enters preclinical research collaboration with argenx
Collaboration to evaluate potential combination of companies' IgG-modulating approaches
Lund, Sweden March 29, 2021 Hansa Biopharma AB "Hansa" (Nasdaq Stockholm: HNSA), a pioneer in enzyme technology for rare immunological conditions, today announced that they have entered into a preclinical research collaboration agreement with argenx BV to evaluate the therapeutic potential of combining the two companies' IgG-modulating technologies.
The preclinical research collaboration is set up to explore the potential of combining imlifidase, Hansa's IgG antibody-cleaving enzyme, and efgartigimod, argenx's FcRn antagonist, which are both in development for indications known to be driven by disease-causing IgGs. A combination of imlifidase and efgartigimod could potentially be used in both the acute and chronic setting of autoimmune diseases and transplantation.
Under the preclinical research collaboration agreement, both parties will contribute equally in terms of resource allocation and will share all intellectual property and data developed through the collaboration. Both parties will maintain exclusive rights to their respective technologies and products.
This is information that Hansa Biopharma AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below, at 20:00 CET on March 29 2021.
About imlifidase
Imlifidase is an enzyme derived from the bacterium Streptococcus pyogenes, with the ability to specifically target and cleave all classes of immunoglobulin G (IgG) antibodies. Imlifidase has a rapid onset of action, cleaving IgG-antibodies and inhibiting their activity within two to six hours after administration. Imlifidase was granted conditional European Marketing Authorization from the European Medicine's Agency (EMA) in August 2020 for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch test against an available deceased donor. Beyond kidney transplantation imlifidase is also being developed for potential treatment of acute episodes in relation to post-transplantation management and acute autoimmune diseases.
About Hansa Biopharma
Hansa Biopharma is a pioneering commercial-stage biopharmaceutical company on a mission to develop and commercialize innovative, lifesaving and life altering treatments for patients with rare immunological conditions. Hansa has developed a first-in-class immunoglobulin G (IgG) antibody cleaving enzyme therapy, which has been shown to enable kidney transplantation in highly sensitized patients. Hansa has a rich and expanding research and development program, based on the Company's proprietary IgG-cleaving enzyme technology platform, to address serious unmet medical needs in transplantation, autoimmune diseases, gene therapy and cancer. Hansa Biopharma is based in Lund, Sweden and has operations in Europe and the U.S. The Company is listed on Nasdaq Stockholm under the ticker HNSA. Find out more at https://hansabiopharma.com.
For further information, please contact:
Klaus Sindahl, Head of Investor Relations
Hansa Biopharma
Mobile: +46 (0) 709-298 269
E-mail: klaus.sindahl@hansabiopharma.com
