Hansa Biopharma receives positive CHMP opinion for IdefirixTM (imlifidase) for kidney transplant in EU
The positive opinion marks an important milestone as the Company prepares its transformation into a commercial stage biopharmaceutical company.
Lund, Sweden June 25, 2020. Hansa Biopharma, the leader in immunomodulatory enzyme technology for rare IgG mediated diseases, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending conditional approval of IdefirixTM (imlifidase) for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor. Endorsement of the positive opinion by the European Commission is expected in the third quarter of 2020.
"We are very excited to receive a positive opinion from the CHMP. This brings hope to the thousands of highly sensitized patients across Europe waiting for a life-saving kidney transplant and takes Hansa Biopharma one important step closer to becoming a commercial stage biopharmaceutical company" says Søren Tulstrup, President and CEO of Hansa Biopharma.
"Today's decision by the CHMP further serves to validate the potential of Hansa Biopharma's proprietary drug development engine to develop approvable immunomodulatory drug candidates for rare and serious diseases and comes at a time when we are significantly expanding our activities into autoimmune diseases, gene therapy and oncology".
The Marketing Authorization Application for imlifidase in kidney transplant was accepted for review by the European Medicines Agency on Feb. 28, 2019 based on data from four completed phase 2 studies across Sweden, France and the United States. Imlifidase met all primary and secondary endpoints in each study.
Imlifidase was supported through EMA's PRIority MEdicines (PRIME) scheme, which provides early and enhanced scientific and regulatory support to medicines that have a particular potential to address patients' unmet medical needs. Imlifidase was granted eligibility to PRIME in May 2017.
In the US, following overall agreement with the FDA, Hansa Biopharma submitted a study protocol to the FDA on June 17, 2020. The randomized, controlled clinical study is planned to be initiated in Q4 this year and could support a future BLA submission in the US by 2023, as communicated earlier. The Company aims to recruit 45 highly sensitized patients at 10-15 centers in the US for this study.
Clinical pipeline
Enrollment in the investigator initiated Anti-GBM study was completed at the end of January 2020 and the first data read-out is expected in the third quarter of 2020 as previously guided.
In the AMR and GBS phase 2 studies, 4 of the targeted 30 patients have been treated with imlifidase in the respective studies. Enrollment in the AMR and GBS studies is expected to be completed in H1 2021 and H2 2021, respectively, as communicated previously.
The positive opinion marks an important milestone as the Company prepares its transformation into a commercial stage biopharmaceutical company.
Lund, Sweden June 25, 2020. Hansa Biopharma, the leader in immunomodulatory enzyme technology for rare IgG mediated diseases, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending conditional approval of IdefirixTM (imlifidase) for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor. Endorsement of the positive opinion by the European Commission is expected in the third quarter of 2020.
"We are very excited to receive a positive opinion from the CHMP. This brings hope to the thousands of highly sensitized patients across Europe waiting for a life-saving kidney transplant and takes Hansa Biopharma one important step closer to becoming a commercial stage biopharmaceutical company" says Søren Tulstrup, President and CEO of Hansa Biopharma.
"Today's decision by the CHMP further serves to validate the potential of Hansa Biopharma's proprietary drug development engine to develop approvable immunomodulatory drug candidates for rare and serious diseases and comes at a time when we are significantly expanding our activities into autoimmune diseases, gene therapy and oncology".
The Marketing Authorization Application for imlifidase in kidney transplant was accepted for review by the European Medicines Agency on Feb. 28, 2019 based on data from four completed phase 2 studies across Sweden, France and the United States. Imlifidase met all primary and secondary endpoints in each study.
Imlifidase was supported through EMA's PRIority MEdicines (PRIME) scheme, which provides early and enhanced scientific and regulatory support to medicines that have a particular potential to address patients' unmet medical needs. Imlifidase was granted eligibility to PRIME in May 2017.
In the US, following overall agreement with the FDA, Hansa Biopharma submitted a study protocol to the FDA on June 17, 2020. The randomized, controlled clinical study is planned to be initiated in Q4 this year and could support a future BLA submission in the US by 2023, as communicated earlier. The Company aims to recruit 45 highly sensitized patients at 10-15 centers in the US for this study.
Clinical pipeline
Enrollment in the investigator initiated Anti-GBM study was completed at the end of January 2020 and the first data read-out is expected in the third quarter of 2020 as previously guided.
In the AMR and GBS phase 2 studies, 4 of the targeted 30 patients have been treated with imlifidase in the respective studies. Enrollment in the AMR and GBS studies is expected to be completed in H1 2021 and H2 2021, respectively, as communicated previously.
25/6 2020 17:42 Aps invest 0
84829 Positiv nyhed....Nogen gæt på, hvad det vil give på kursen imorgen?
Toer ikke gætte på hvor meget den vil gå op, men den går op det er helt sikkert.
Jeg kan rigtig godt lide hvad de sagde:"Today's decision by the CHMP further serves to validate the potential of Hansa Biopharma's proprietary drug development engine to develop approvable immunomodulatory drug candidates for rare and serious diseases and comes at a time when we are significantly expanding our activities into autoimmune diseases, gene therapy and oncology".
Det lover godt for fremtiden, men man skal værre tålmodig.
Jeg kan rigtig godt lide hvad de sagde:"Today's decision by the CHMP further serves to validate the potential of Hansa Biopharma's proprietary drug development engine to develop approvable immunomodulatory drug candidates for rare and serious diseases and comes at a time when we are significantly expanding our activities into autoimmune diseases, gene therapy and oncology".
Det lover godt for fremtiden, men man skal værre tålmodig.
25/6 2020 18:08 Aps invest 084832 Jeg er MEGET tålmodig, og ignorerer fuldstændig de daglige udsving. Utrolig spændende selskab, med stort langsigtet potentiale ????????
25/6 2020 22:29 Havneholmen 784835 Døren er nu åbnet til et potentialt multia-mia salg alene for nyreindikationen i EU. Potentielt nogle tusinder patienter pr år x ca. +-1 mio kr i behandlingspris. Derudover kan der blandt andet komme godkendelse i ROW og i indikationerne AMR, GBS og Anti-GBM. Man skal ej forglemme de flotte data i genterapi. Måske vil vi se dem indgå partneraftale med Big Pharma? Med tanke på nuværende markedsværdi på ca. 4mia dkr må der være et stort potentiale. Jeg har tidligere talt om at Hansa var potentiel 10 x dobler (fra 3mia-30mia dkr over 4-6år) og denne CHMP anbefaling var et vigtigt skridt på vejen. Disclaimer: Jeg er hverken læge eller mangeårige proinvestor. Husk det kun er dig selv der har ansvaret for om du vil investere. Jeg har aktier i Hansa Biopharma.://medwatch.dk/Medicinal___Biotek/article12245376.ece
Havneholmen og Helge.
Mange tak for inspirationen til at kikke lidt nærmere på dette spændende selskab. Foranlediget af jer købte jeg et lille "frimærke", som vidst skal gemmes godt i aktieskuffen de næste mange år.
Det bliver spændende at følge udviklingen frem over.
Mange tak for inspirationen til at kikke lidt nærmere på dette spændende selskab. Foranlediget af jer købte jeg et lille "frimærke", som vidst skal gemmes godt i aktieskuffen de næste mange år.
Det bliver spændende at følge udviklingen frem over.
26/6 2020 10:44 Don Joning 284838 Hej Havneholmen, super inspiration til en lille perle der kan få lov at gro i aktieskuffen :) Har du nogen ideer om hvad de næste store milestones bliver for dem og hvornår man kan forvente salget starter mm. ?
Spændende nyhed... Jeg var med i Veloxis tilbage fra den gang de sendte der først ansøgning til FDA og frem til salget af Asahi. Samme indikationer man søger indenfor - Lunge, lever osv. om dog forskellige behandlingsformer. Veloxis værdi var alene bundet op af USA, da markedet i EUROPA og ASIA var svære at penetrerer pga eksisterende produkter på markedet. Værdien af virksomheden var ene og alene bundet op på fremtiden, da Europa ikke var nok til at genere positiv driftsindtjening.
- Veloxis lærte mig at der var store udsving mellem bunde og toppe.
Med de informationer jeg kort havde fundet på HANSA egen hjemmeside samt ProInvestor, købte jeg ind i 135 sidste måned med hensigt at sælge på selve dagen for CHMP afgørelse. Fik solgt i 173.
Hvis man var tilstede på euroinvestor tilbage i tiden, kan man huske Alpenyt/Alphue gode indlæg samt guidelines. - Han sagde altid, sælg på nyheder.
Jeg vil i den kommende tid prøve at sætte mig mere end i marekdspotentialet, indtjengningsmuligher, samt trusler.
Kan set at brugeren Match (tilbage fra euroinvestor) også figurerer aktivt på provinvestor. Han var en sand ekspert i markedet. Kunne være fedt at få hans view på Hansa.
Mit udgangspunkt er at swingtrade i aktien på kortsigt - 2-4 uger. Min forventning at aktien vil falde de næste par uger, Q regnskaber plejer at have en negativ effekt på virksomheder i disse faser, CASH BURN, EMISSION osv. Virkeligheden rammer aktionærerne når de får tal. - Omvendt er jeg langsigtet positiv på casen. Jeg kan godt lide at kigge på Heikin Ashi graf - teknisk Fisher og MACD.
Fisher er på dagsniveau krydset nedad, derudover er der et gap ned til kurs 140
- Veloxis lærte mig at der var store udsving mellem bunde og toppe.
Med de informationer jeg kort havde fundet på HANSA egen hjemmeside samt ProInvestor, købte jeg ind i 135 sidste måned med hensigt at sælge på selve dagen for CHMP afgørelse. Fik solgt i 173.
Hvis man var tilstede på euroinvestor tilbage i tiden, kan man huske Alpenyt/Alphue gode indlæg samt guidelines. - Han sagde altid, sælg på nyheder.
Jeg vil i den kommende tid prøve at sætte mig mere end i marekdspotentialet, indtjengningsmuligher, samt trusler.
Kan set at brugeren Match (tilbage fra euroinvestor) også figurerer aktivt på provinvestor. Han var en sand ekspert i markedet. Kunne være fedt at få hans view på Hansa.
Mit udgangspunkt er at swingtrade i aktien på kortsigt - 2-4 uger. Min forventning at aktien vil falde de næste par uger, Q regnskaber plejer at have en negativ effekt på virksomheder i disse faser, CASH BURN, EMISSION osv. Virkeligheden rammer aktionærerne når de får tal. - Omvendt er jeg langsigtet positiv på casen. Jeg kan godt lide at kigge på Heikin Ashi graf - teknisk Fisher og MACD.
Fisher er på dagsniveau krydset nedad, derudover er der et gap ned til kurs 140
3/7 2020 16:10 B.Andersen 184928 Fantastisk rejse vi tålmodige investorer endelig langt og længe er kommet på i Hansa. Jeg håber på, at den forsætter nogle år endnu.
