Upåagtet kursen, så lad os Fundamental aber lige dvæle ved:
2009: Arzerra (Godkendt) - Markedspotentiale 6 mia USD årligt
2010: EGFR (Fase 3 - Late stage Phase 3) - Markedspotentiale 1,7 mia USD
2011: Roche 1507: se vedhæftede.
Isvinteren varme højepunkter -
Asco December
Roche News
EGFR
Og så selvfølgelig takeover, som vi skal talkover
2009: Arzerra (Godkendt) - Markedspotentiale 6 mia USD årligt
2010: EGFR (Fase 3 - Late stage Phase 3) - Markedspotentiale 1,7 mia USD
2011: Roche 1507: se vedhæftede.
Isvinteren varme højepunkter -
Asco December
Roche News
EGFR
Og så selvfølgelig takeover, som vi skal talkover
Måske har Roche ikke helt fået koordineret oplysningerne ellers venter de blot et lidt længere fase III forløb. Projekteret filing er i deres onkologiske pipeline angivet som 2012 for så vidt angår R1507 i Ewings Sarcoma, mens der ikke er sat en filingsdato på de øvrige indikationer.
http://www.roche.com/research_and_development/pipeline/roche_pharma_pipeline.htm
Af væsentlige begivenheder er vel i øvrigt også at Genmab i den nærmeste fremtid formentlig vil indlede en lind strøm af fase III forsøg, herunder head-to-heads mod Rituxan.
http://www.roche.com/research_and_development/pipeline/roche_pharma_pipeline.htm
Af væsentlige begivenheder er vel i øvrigt også at Genmab i den nærmeste fremtid formentlig vil indlede en lind strøm af fase III forsøg, herunder head-to-heads mod Rituxan.
opdateret d.27.10.09 så har Genmab mon regnet med at man kan file direkte fra pivotal phase 2?
20/11 2009 14:43 troldmanden 0
22363 Genmab har længe fremhævet det som et pivotal studie, underforstået at det skulle være nok til at få stoffet registreret. Men det ser ikke ud til det er noget Roche selv mener. Og det er hvis også kun MEGET få stoffer der kan skippe fase 3. Jeg kan ikke lige komme i tanke om et eksempel.
Men måske det er fordi de hentyder til et no name patient program. Altså det program Neurosearch vil registrere Huntexil under hvis og såfremt der kommer gode fase 3 data. Det betyder at man godt kan sælge stoffet inden en godkendelse. Men patienten skal selv betale + der er en række andre restriksioner. Mener dog kun sådan et program findes i Europa
Men måske det er fordi de hentyder til et no name patient program. Altså det program Neurosearch vil registrere Huntexil under hvis og såfremt der kommer gode fase 3 data. Det betyder at man godt kan sælge stoffet inden en godkendelse. Men patienten skal selv betale + der er en række andre restriksioner. Mener dog kun sådan et program findes i Europa
men ellers går ligningen, som jeg ser den ikke rigtigt op? Der må være filing enten fra phase 2 direkte eller det som du har fremhævet før, som er dette no name program
20/11 2009 15:20 troldmanden 022369 Nej det går ikke rigtig op. Men når nu Roche som er dem der står for hele programmet siger filing 2012 så er det nu dem jeg tror på fremfor genmab. De ved trods alt bedst hvad der sker.
Mig bekendt kan no name program salg først begynde efter fase 3 data og i perioden frem til evt godkendelse. Og det peger igen på 2012 som det tidligste
Mig bekendt kan no name program salg først begynde efter fase 3 data og i perioden frem til evt godkendelse. Og det peger igen på 2012 som det tidligste
20/11 2009 15:04 gentogen 022368 Den europæiske godkendelse vil vel også tælle lidt. Om ikke andet så på stemningsanalysen...
20/11 2009 14:22 troldmanden 022358 Jeg hæftede mig også ved at Lisa på gårdagens Børsen interview sagde at der potentielt kunne være 3 stoffer godkendt i 2011. Men når man ser præsentationen fra Roche så kan jeg da ikke se hvordan det skulle lade sig gøre. Som vi alle ved så er cancer forsøg relativ langvarige fordi der skal måles på hvor længe patienterne overlever. Så når ikke engang fase 3 beslutningen er taget endnu, og indrulleringen derfor af naturlige årsger heller ikke er begyndt så har jeg svært ved at se stoffet på marekdet før tidligst ultimo 2012
Fase III i "solid tumors" må være den eventuelle fortsættelse af dette:
A Multiple Ascending Dose Study of R1507 in Patients With Advanced Solid Tumors.
This study is ongoing, but not recruiting participants.
First Received: November 15, 2006 Last Updated: September 16, 2009 History of Changes
Sponsor: Hoffmann-La Roche
Information provided by: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00400361
Purpose
This study will determine the maximum tolerated dose and pharmacokinetic profile of R1507 in patients with metastatic or locally advanced malignant solid tumors, non-Hodgkin's lymphoma or Hodgkin's lymphoma. Groups of patients will be sequentially enrolled to receive ascending doses of R1507 either weekly or three-weekly by intravenous infusion. The starting dose of 1mg/kg iv for each dosing regimen will be escalated in subsequent groups of patients after a satisfactory assessment of safety, tolerability and pharmacokinetics of the previous dose. The anticipated time on study treatment is until disease progression or dose-limiting toxicity, and the target sample size is
A Multiple Ascending Dose Study of R1507 in Patients With Advanced Solid Tumors.
This study is ongoing, but not recruiting participants.
First Received: November 15, 2006 Last Updated: September 16, 2009 History of Changes
Sponsor: Hoffmann-La Roche
Information provided by: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00400361
Purpose
This study will determine the maximum tolerated dose and pharmacokinetic profile of R1507 in patients with metastatic or locally advanced malignant solid tumors, non-Hodgkin's lymphoma or Hodgkin's lymphoma. Groups of patients will be sequentially enrolled to receive ascending doses of R1507 either weekly or three-weekly by intravenous infusion. The starting dose of 1mg/kg iv for each dosing regimen will be escalated in subsequent groups of patients after a satisfactory assessment of safety, tolerability and pharmacokinetics of the previous dose. The anticipated time on study treatment is until disease progression or dose-limiting toxicity, and the target sample size is
Og / eller dette:
A Multiple Ascending Dose Study of R1507 in Children and Adolescents With Advanced Solid Tumors.
This study is ongoing, but not recruiting participants.
First Received: November 16, 2007 Last Updated: November 17, 2009 History of Changes
Sponsor: Hoffmann-La Roche
Information provided by: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00560144
Purpose
This 3 arm study will determine the dose of R1507 which will achieve a mean drug exposure in children and adolescents with advanced solid tumors equivalent to the exposure achieved in adults at the recommended dose of 9mg/kg/week. It will also determine the maximum tolerated dose (if appropriate) and the pharmacokinetic profile of R1507. Groups of patients will be sequentially enrolled in one of up to 3 dose levels (3,9mg/kg or a PK-derived dose, not to exceed 16 mg/kg) of R1507 administered weekly by intravenous infusion.An expanded cohort of patients will be enrolled at the optimal dose/MTD. The anticipated time on study treatment is until disease progression or dose limiting toxicity, and the target sample size is
A Multiple Ascending Dose Study of R1507 in Children and Adolescents With Advanced Solid Tumors.
This study is ongoing, but not recruiting participants.
First Received: November 16, 2007 Last Updated: November 17, 2009 History of Changes
Sponsor: Hoffmann-La Roche
Information provided by: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00560144
Purpose
This 3 arm study will determine the dose of R1507 which will achieve a mean drug exposure in children and adolescents with advanced solid tumors equivalent to the exposure achieved in adults at the recommended dose of 9mg/kg/week. It will also determine the maximum tolerated dose (if appropriate) and the pharmacokinetic profile of R1507. Groups of patients will be sequentially enrolled in one of up to 3 dose levels (3,9mg/kg or a PK-derived dose, not to exceed 16 mg/kg) of R1507 administered weekly by intravenous infusion.An expanded cohort of patients will be enrolled at the optimal dose/MTD. The anticipated time on study treatment is until disease progression or dose limiting toxicity, and the target sample size is
20/11 2009 15:40 tumult 022370 Vi skal heller ikke glemme denne mulige trigger.
http://www.genmab.com/PressCentre/RecentNewsReleases/I08GenmabtoPresentDatafromMultipleStudiesatASH/Language/Danish.aspx
Det kunne jo være der kom nyt frem i den forbindelse.
Så skrive RB Børsen idag:
Pipelinemedikament Zalutumumab er i fokus grundet nyt fra Erbitux fra tyske Merck KGAA, som faldt 2,5 pct., efter at EUs sundhedsmyndigheder torsdag aften har afvist Erbitux til brug mod lungekræft, og dermed bekræftes myndighedernes meldinger fra juli 2009. Det skyldes de store risici forbundet med behandlingen sammenlignet med fordelene. Credit Suisse skriver efterfølgende, at man nu må anse sandsynligheden for, at Erbitux bliver godkendt til behandling af lungekræft for usandsynlig. Credit Suisse giver Merck KGAA en negativ undervægt-anbefaling, mens sektoren har fået en overvægt-anbefaling.
Jeg ved ikke rigtig om det er godt eller skidt for Zalutumumab?
http://www.genmab.com/PressCentre/RecentNewsReleases/I08GenmabtoPresentDatafromMultipleStudiesatASH/Language/Danish.aspx
Det kunne jo være der kom nyt frem i den forbindelse.
Så skrive RB Børsen idag:
Pipelinemedikament Zalutumumab er i fokus grundet nyt fra Erbitux fra tyske Merck KGAA, som faldt 2,5 pct., efter at EUs sundhedsmyndigheder torsdag aften har afvist Erbitux til brug mod lungekræft, og dermed bekræftes myndighedernes meldinger fra juli 2009. Det skyldes de store risici forbundet med behandlingen sammenlignet med fordelene. Credit Suisse skriver efterfølgende, at man nu må anse sandsynligheden for, at Erbitux bliver godkendt til behandling af lungekræft for usandsynlig. Credit Suisse giver Merck KGAA en negativ undervægt-anbefaling, mens sektoren har fået en overvægt-anbefaling.
Jeg ved ikke rigtig om det er godt eller skidt for Zalutumumab?
Ja, mens Akademikeren øjensynlig allerede glæder sig til ASCO så er vi andre kun nået til at bekymre os om ASH-konferencen 6-9 dec, hvor der bl.a. gives en oral presentation af CLL, 1st line, fase II forsøget
sikkert ude af kontekst....
Basel, 9 November 2009
Invitation to Roche investor science event from ASH 2009
Conference call on 8 December 2009
We kindly invite investors and analysts to participate in a conference call to discuss new clinical data and results presented during the 2009 ASH annual meeting (The 51st Annual Meeting and Exposition of the American Society of Hematology, 5-8 December 2009, New Orleans, Louisana):
Tuesday, 8 December 2009 from 17:30 CET / 11:30 am EST / 10:30 am CST
Conference call
The conference call can be accessed using the following dial-in numbers:
+41 91 610 5600(Continental Europe)
+44 207 107 0611(UK)
+1 866 291 4166(USA)
Please dial in to the conference call 10 ? 15 minutes before the call is scheduled to start.
A replay of the conference call will be available one hour after the conference call and then for 48 hours. The replay can be accessed using the following dial-in numbers:
+41 91 612 4330(Continental Europe)
+44 207 108 6233(UK)
+1 866 416 2558(USA)
Enter the ID 17725 followed by the # sign
Webcast
The live conference call can also be accessed via http://www.roche.com/home/investors.htm." title="http://www.roche.com/home/investors.htm." target="_new111">http://www.roche.com/home/investors.htm. Following the event, an MP3 file will be made available for download.
Presentation slides
At the time of the conference call, the accompanying presentation will be available from the IR website at http://www.roche.com/home/investors.htm." title="http://www.roche.com/home/investors.htm." target="_new111">http://www.roche.com/home/investors.htm.
Basel, 9 November 2009
Invitation to Roche investor science event from ASH 2009
Conference call on 8 December 2009
We kindly invite investors and analysts to participate in a conference call to discuss new clinical data and results presented during the 2009 ASH annual meeting (The 51st Annual Meeting and Exposition of the American Society of Hematology, 5-8 December 2009, New Orleans, Louisana):
Tuesday, 8 December 2009 from 17:30 CET / 11:30 am EST / 10:30 am CST
Conference call
The conference call can be accessed using the following dial-in numbers:
+41 91 610 5600(Continental Europe)
+44 207 107 0611(UK)
+1 866 291 4166(USA)
Please dial in to the conference call 10 ? 15 minutes before the call is scheduled to start.
A replay of the conference call will be available one hour after the conference call and then for 48 hours. The replay can be accessed using the following dial-in numbers:
+41 91 612 4330(Continental Europe)
+44 207 108 6233(UK)
+1 866 416 2558(USA)
Enter the ID 17725 followed by the # sign
Webcast
The live conference call can also be accessed via http://www.roche.com/home/investors.htm." title="http://www.roche.com/home/investors.htm." target="_new111">http://www.roche.com/home/investors.htm. Following the event, an MP3 file will be made available for download.
Presentation slides
At the time of the conference call, the accompanying presentation will be available from the IR website at http://www.roche.com/home/investors.htm." title="http://www.roche.com/home/investors.htm." target="_new111">http://www.roche.com/home/investors.htm.
ASH Sessions
Oral Presentation December 7 at 7:30 AM EST - Ofatumumab Combined with Fludarabine and Cyclophosphamide (O-FC) Shows High Activity in Patients with Previously Untreated Chronic Lymphocytic Leukemia (CLL): Results From a Randomized, Multicenter, International, Two-Dose, Parallel Group, Phase II Trial
Oral Presentation December 7 at 3:00 PM EST - Daratumumab, a Novel Potent Human Anti-CD38 Monoclonal Antibody, Induces Significant Killing of Human Multiple Myeloma Cells: Therapeutic Implication
Oral Presentation December 8 at 8:30AM EST - Evaluation of Ofatumumab, a Novel Human CD20 Monoclonal Antibody, as Single Agent Therapy in Rituximab-Refractory Follicular Lymphoma
Poster Session: CLL - Therapy, Excluding Transplantation II, December 7 between 6:00PM - 8:00 PM EST, Poster III-182 - Correlation Between Serum Ofatumumab Concentrations, Baseline Patient Characteristics and Clinical Outcomes in Patients with Fludarabine-Refractory Chronic Lymphocytic Leukemia (CLL) Treated with Single-Agent Ofatumumab
Poster Session: Molecular Pharmacology, Drug Resistance I, December 5 between 5:30PM - 7:30 PM EST, Poster I-747 - Ofatumumab, a human mAb targeting a membrane-proximal small-loop epitope on CD20, induces potent NK cell-mediated ADCC
Poster - The humanized Multiple Myeloma mouse model: opportunities for studying the pathogenesis of MM in its natural environment
Oral Presentation December 7 at 7:30 AM EST - Ofatumumab Combined with Fludarabine and Cyclophosphamide (O-FC) Shows High Activity in Patients with Previously Untreated Chronic Lymphocytic Leukemia (CLL): Results From a Randomized, Multicenter, International, Two-Dose, Parallel Group, Phase II Trial
Oral Presentation December 7 at 3:00 PM EST - Daratumumab, a Novel Potent Human Anti-CD38 Monoclonal Antibody, Induces Significant Killing of Human Multiple Myeloma Cells: Therapeutic Implication
Oral Presentation December 8 at 8:30AM EST - Evaluation of Ofatumumab, a Novel Human CD20 Monoclonal Antibody, as Single Agent Therapy in Rituximab-Refractory Follicular Lymphoma
Poster Session: CLL - Therapy, Excluding Transplantation II, December 7 between 6:00PM - 8:00 PM EST, Poster III-182 - Correlation Between Serum Ofatumumab Concentrations, Baseline Patient Characteristics and Clinical Outcomes in Patients with Fludarabine-Refractory Chronic Lymphocytic Leukemia (CLL) Treated with Single-Agent Ofatumumab
Poster Session: Molecular Pharmacology, Drug Resistance I, December 5 between 5:30PM - 7:30 PM EST, Poster I-747 - Ofatumumab, a human mAb targeting a membrane-proximal small-loop epitope on CD20, induces potent NK cell-mediated ADCC
Poster - The humanized Multiple Myeloma mouse model: opportunities for studying the pathogenesis of MM in its natural environment
Desuden har medicinalgiganten Roches blockbuster Rituxan, der ligesom Arzerra er et CD20-antistof, ikke opnået godkendelse i USA som førstelinjebehandling af kronisk lymfatisk leukæmi. Roche mener dog ikke, at det har nogen betydning, da Rituxan allerede bruges som behandling af kronisk lymfatisk leukæmi alligevel.
20/11 2009 19:58 collersteen 022395 Det ser ud til at være nogle label-discussions der forårsager forsinkelsen. Her er en ret god artikel, såvidt jeg lægmand lige kan vurdere. Der står lidt om offlabel-salg og Genmab nævnes sågar også.
http://www.biovalley.ch/content.cfm?nav=4&content=10&command=details&id=12127
http://www.biovalley.ch/content.cfm?nav=4&content=10&command=details&id=12127
Altså det er enten GREAT news og STINKING news. Men det er ihvertfald en helt afgørende udvikling i CLL i mine øjne.
Kan Arzerra så IKKE blive godkendt eller kan de NETOP blive godkendt og så fjerne hele salget af
Kan Arzerra så IKKE blive godkendt eller kan de NETOP blive godkendt og så fjerne hele salget af
