Genmab/CEO: Risikerer købstilbud
14-Oct-2010
KØBENHAVN (Direkt) Den lave børskurs på Genmab betyder, at det er en reel risiko, at der kan komme et købstilbud på selskabet.
Det konstaterede administrerende direktør i Genmab, Jan van de Winkel, torsdag på et pressemøde.
Med den nuværende prissætning af aktien værdisættes selskabets pipeline til nul, hvilket ifølge Jan van de Winkel ikke giver meget mening.
Han hæfter sig desuden ved, at der ikke tillægges meget værdi til selskabets lægemiddel Arzerra, samtidig med at partneren GlaxoSmithKline og Genmab selv investerer hundredvis af millioner af dollar i midlet.
Genmab har desuden en stor kontantbeholdning efter at have genforhandlet sin partneraftale med GlaxoSmithKline om Arzerra tidligere i år, og så arbejder man på et salg af selskabets antistoffabrik i Minnesota, som også vil spytte kontanter i kassen.
"Vi snakker fortsat med potentielle købere. Det er en fortløbende proces," sagde Jan van de Winkel.
Han konstaterede, at det ikke er nemt at sælge faciliteten, men han er dog optimistisk. Der arbejdes blandt andet på en kombinationsaftale, så man kombinerer en partneraftale for Zalutumumab med en aftale for antistoffabrikken.
Jakob Dalskov +45 33 300 600
Nyhedsbureauet Direkt
14/10 2010 10:42 ornso 0
34760 Genmab/CEO: Opdatering om Zalutumumab nærmer sig
14-Oct-2010
KØBENHAVN (Direkt) Genmab regner med i løbet af de kommende uger at kunne annoncere en plan for lægemiddelkandidaten Zalutumumabs videre vej til markedet. De afsluttende fase 3 studier i hoved- og halskræftpatienter nåede ikke det primære effektmål, og man diskuterer i øjeblikket den videre vej frem med de regulatoriske myndigheder.
Ligegyldigt hvordan samtalerne falder ud, og om der kræves nye studier, går Genmab efter en partner til midlet, fastslog administrerende direktør i Genmab, Jan van de Winkel, torsdag på et pressemøde.
Markedet kan desuden se frem til en opdatering vedrørende Genmabs pipeline i januar, og derudover kommer der yderligere opdateringer i forbindelse med kvartalsregnskabet i november.
Jakob Dalskov +45 33 300 600
Nyhedsbureauet Direkt
Så er der igen et ny studie med ofatumumab!
Dexamethasone, Ofatumumab and Bendamustine (DOT) First-line in Mantle-cell Lymphoma(MCL)
This study is currently recruiting participants.
Verified by Southern Europe New Drug Organization, October 2010
First Received: October 13, 2010
Dexamethasone, Ofatumumab and Bendamustine (DOT) First-line in Mantle-cell Lymphoma(MCL)
This study is currently recruiting participants.
Verified by Southern Europe New Drug Organization, October 2010
First Received: October 13, 2010
Det kunne godt ligne et forsøg på at skabe en ny guldstandard hvor man inkluderer bendamustine.
Fra Wiki:
Mantle cell lymphoma (MCL) is one of the rarest of the non-Hodgkin's lymphomas (NHLs), comprising about 6% of NHL cases.[1] There are only about 15,000 patients presently in the U.S. (The prevalence seems to be somewhat higher in Europe.) While it is difficult to treat and seldom considered cured, investigations into better treatments are actively pursued worldwide. Median survival times were about 3 years, but are now estimated as approaching 6 years for new patients.
Mantle cell lymphoma (MCL) is one of the rarest of the non-Hodgkin's lymphomas (NHLs), comprising about 6% of NHL cases.[1] There are only about 15,000 patients presently in the U.S. (The prevalence seems to be somewhat higher in Europe.) While it is difficult to treat and seldom considered cured, investigations into better treatments are actively pursued worldwide. Median survival times were about 3 years, but are now estimated as approaching 6 years for new patients.
Der er efterhånden ret mange, der tror på Ofatumumab... Listen ud over GSK og Genmab selv over sponsorer på clinical trials omfatter efterhånden følgende;
Chronic Lymphocytic Leukemia Research Consortium;
Georgetown University og Cephalon
Nevada Cancer Institute og Cephalon;
Mayo Clinic
University of Oxford; Oxford Radcliffe Hospitals NHS Trust; NCRI CLL Subgroup
Southern Europe New Drug Organization
National Heart, Lung, and Blood Institute (NHLBI); University of Virginia;
M.D. Anderson Cancer Center; Celgene Corporation
Cancer and Leukemia Group B; National Cancer Institute (NCI)
Oncology Specialists, S.C.
Sarah Cannon Research Institute
Cephalon
Medical University of South Carolina; Celgene Corporation
University of Nebraska; Celgene Corporation
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
University of Cologne
Brown University; Rhode Island Hospital; The Miriam Hospital, Memorial Hospital of Rhode Island
Groupe d'Etude des Lymphomes de l'Adulte - Recherche Clinique
Pharmacyclics
Calistoga Pharmaceuticals, Inc.
Chronic Lymphocytic Leukemia Research Consortium;
Georgetown University og Cephalon
Nevada Cancer Institute og Cephalon;
Mayo Clinic
University of Oxford; Oxford Radcliffe Hospitals NHS Trust; NCRI CLL Subgroup
Southern Europe New Drug Organization
National Heart, Lung, and Blood Institute (NHLBI); University of Virginia;
M.D. Anderson Cancer Center; Celgene Corporation
Cancer and Leukemia Group B; National Cancer Institute (NCI)
Oncology Specialists, S.C.
Sarah Cannon Research Institute
Cephalon
Medical University of South Carolina; Celgene Corporation
University of Nebraska; Celgene Corporation
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
University of Cologne
Brown University; Rhode Island Hospital; The Miriam Hospital, Memorial Hospital of Rhode Island
Groupe d'Etude des Lymphomes de l'Adulte - Recherche Clinique
Pharmacyclics
Calistoga Pharmaceuticals, Inc.
18/10 2010 14:09 gentogen 034843 I øvrigt havde Genmab jo gode resultater i O-FC på ASCO. Jeg kan faktisk ikke huske, om det udvidede abstract hat været vist her før, men det kan godt tåles at ses igen i givet fald....ORR 92% i høje dosis er da meget pænt;
Authors
William G. Wierda1, Thomas J. Kipps2, Jan Dürig3, Laimonas Griskevicius4, Stephan Stilgenbauer5, Jiri Mayer6, Lukas Smolej7, Georg Hess8, Rasa Griniute9, Francisco J. Hernandez-Ilizaliturri10, Swaminathan Padmanabhan11, Michele Gorczyca12, Ira Gupta12, Tina G. Nielsen13, Charlotte A. Russell13
1 M. D. Anderson Cancer Center, The University of Texas, Houston, TX
2 UCSD Moores Cancer Center, La Jolla, CA
3 Klinik für Hämatologie Huflandstr, Universitätsklinikum Essen, Essen, Germany
4 Vilnius University Hospital Santariskiu Clinics, Vilnius, Lithuania
5Department of Internal Medicine III, Universitätsklinikum Ulm, Ulm, Germany
6Dept of Internal Medicine/Hemato-Oncology, Faculty Hospital Brno, Brno, Czech Republic
72nd Department of Internal Medicine, Dept of Clinical Hematology, University Hospital and Faculty of Medicine, Hradec Kralove, Czech Republic
8 Johannes Gutenberg-University, Mainz, Germany
9 Kaunas Medical University Hospital, Kaunas, Lithuania
10 Roswell Park Cancer Center, Buffalo, NY
11Roswell Park Cancer Institute, Cancer Therapy Research Center, San Antonio, Texas, Buffalo, NY
12 GlaxoSmithKline, Collegeville, PA
13 Genmab, Copenhagen, Denmark
Abstract
Introduction: Chemoimmunotherapy regimens are the treatment standard for fit patients with chronic lymphocytic leukemia (CLL). Ofatumumab is a human monoclonal antibody that binds to a unique membrane-proximal epitope composed of both the large- and small-loop domains of CD20. Overall response rates (ORRs) of 47%-58% have been observed with single-agent ofatumumab in patients with fludarabine-refractory CLL. We evaluated the efficacy and tolerability of 2 doses of ofatumumab combined with fludarabine and cyclophosphamide (O-FC) in previously untreated patients with CLL in an international, randomized, parallel-group phase II trial. Patients and Methods: Patients with active CLL were randomized to ofatumumab 500 mg (group A) or 1000 mg (group B) day 1, with fludarabine 25 mg/m2 and cyclophosphamide 250 mg/m2 days 2-4, course 1; days 1-3, courses 2-6; administered every 4 weeks for 6 courses. For both groups, first dose of ofatumumab was 300 mg. The primary endpoint was complete response (CR) rate (1996 NCI-WG criteria) assessed by an Independent Review Committee (IRC), measured from the start of treatment up to 3 months after the last course. Results: There were 61 patients enrolled and randomized on this study (Table 1). Seventy-one percent and 57% of patients in groups A (n = 31) and B (n = 30), respectively, completed all 6 courses of O-FC treatment. The CR rate by IRC evaluation was 32% (95% CI, 17%-51%) for group A and 50% (95% CI, 31%-69%) for group B; the ORR was 77% (95% CI, 59%-90%) and 73% (95% CI, 54%-88%), respectively (Table 1). The CR rate and ORR for patients who received all 6 courses of O-FC were 56% and 92%, respectively. Follow-up is ongoing for progression-free and overall survival. No grade 3-4 infusion-related reactions on the day of ofatumumab infusion were reported. During treatment and up to 30 days following the last dose, the most common (> 10% of patients) grade 3-4 adverse events (AEs) reported by investigators were infections in 11 patients (group A, n = 4; group B, n = 7), including febrile neutropenia in 3 patients in each group, and hematologic AEs, including neutropenia in 29 patients (group A, n = 11; group B, n = 18), anemia in 8 patients (group A, n = 2; group B, n = 6), and thrombocytopenia in 9 patients (group A, n = 2; group B, n = 7). Grade 3-4 hemolytic anemia occurred in 2 patients in group A and 1 in group B. In group A, a patient died 50 days from last dose during follow-up (febrile neutropenia). In group B, a patient died 19 days from last dose during treatment (dyspnea; etiology unknown), and another patient died 186 days from last dose (neutropenia following alternative treatment for progressive CLL). Conclusions: The O-FC regimen is active in previously untreated patients with CLL at the ofatumumab doses investigated. AEs with the O-FC regimen were manageable with no unexpected toxicities. The 1000 mg dose of ofatumumab is currently being evaluated in combination with chemotherapy in other studies for patients with CLL.
Authors
William G. Wierda1, Thomas J. Kipps2, Jan Dürig3, Laimonas Griskevicius4, Stephan Stilgenbauer5, Jiri Mayer6, Lukas Smolej7, Georg Hess8, Rasa Griniute9, Francisco J. Hernandez-Ilizaliturri10, Swaminathan Padmanabhan11, Michele Gorczyca12, Ira Gupta12, Tina G. Nielsen13, Charlotte A. Russell13
1 M. D. Anderson Cancer Center, The University of Texas, Houston, TX
2 UCSD Moores Cancer Center, La Jolla, CA
3 Klinik für Hämatologie Huflandstr, Universitätsklinikum Essen, Essen, Germany
4 Vilnius University Hospital Santariskiu Clinics, Vilnius, Lithuania
5Department of Internal Medicine III, Universitätsklinikum Ulm, Ulm, Germany
6Dept of Internal Medicine/Hemato-Oncology, Faculty Hospital Brno, Brno, Czech Republic
72nd Department of Internal Medicine, Dept of Clinical Hematology, University Hospital and Faculty of Medicine, Hradec Kralove, Czech Republic
8 Johannes Gutenberg-University, Mainz, Germany
9 Kaunas Medical University Hospital, Kaunas, Lithuania
10 Roswell Park Cancer Center, Buffalo, NY
11Roswell Park Cancer Institute, Cancer Therapy Research Center, San Antonio, Texas, Buffalo, NY
12 GlaxoSmithKline, Collegeville, PA
13 Genmab, Copenhagen, Denmark
Abstract
Introduction: Chemoimmunotherapy regimens are the treatment standard for fit patients with chronic lymphocytic leukemia (CLL). Ofatumumab is a human monoclonal antibody that binds to a unique membrane-proximal epitope composed of both the large- and small-loop domains of CD20. Overall response rates (ORRs) of 47%-58% have been observed with single-agent ofatumumab in patients with fludarabine-refractory CLL. We evaluated the efficacy and tolerability of 2 doses of ofatumumab combined with fludarabine and cyclophosphamide (O-FC) in previously untreated patients with CLL in an international, randomized, parallel-group phase II trial. Patients and Methods: Patients with active CLL were randomized to ofatumumab 500 mg (group A) or 1000 mg (group B) day 1, with fludarabine 25 mg/m2 and cyclophosphamide 250 mg/m2 days 2-4, course 1; days 1-3, courses 2-6; administered every 4 weeks for 6 courses. For both groups, first dose of ofatumumab was 300 mg. The primary endpoint was complete response (CR) rate (1996 NCI-WG criteria) assessed by an Independent Review Committee (IRC), measured from the start of treatment up to 3 months after the last course. Results: There were 61 patients enrolled and randomized on this study (Table 1). Seventy-one percent and 57% of patients in groups A (n = 31) and B (n = 30), respectively, completed all 6 courses of O-FC treatment. The CR rate by IRC evaluation was 32% (95% CI, 17%-51%) for group A and 50% (95% CI, 31%-69%) for group B; the ORR was 77% (95% CI, 59%-90%) and 73% (95% CI, 54%-88%), respectively (Table 1). The CR rate and ORR for patients who received all 6 courses of O-FC were 56% and 92%, respectively. Follow-up is ongoing for progression-free and overall survival. No grade 3-4 infusion-related reactions on the day of ofatumumab infusion were reported. During treatment and up to 30 days following the last dose, the most common (> 10% of patients) grade 3-4 adverse events (AEs) reported by investigators were infections in 11 patients (group A, n = 4; group B, n = 7), including febrile neutropenia in 3 patients in each group, and hematologic AEs, including neutropenia in 29 patients (group A, n = 11; group B, n = 18), anemia in 8 patients (group A, n = 2; group B, n = 6), and thrombocytopenia in 9 patients (group A, n = 2; group B, n = 7). Grade 3-4 hemolytic anemia occurred in 2 patients in group A and 1 in group B. In group A, a patient died 50 days from last dose during follow-up (febrile neutropenia). In group B, a patient died 19 days from last dose during treatment (dyspnea; etiology unknown), and another patient died 186 days from last dose (neutropenia following alternative treatment for progressive CLL). Conclusions: The O-FC regimen is active in previously untreated patients with CLL at the ofatumumab doses investigated. AEs with the O-FC regimen were manageable with no unexpected toxicities. The 1000 mg dose of ofatumumab is currently being evaluated in combination with chemotherapy in other studies for patients with CLL.
Ja men det virkeligt imponerende er da Complete Response på 56%. Det er da vildt og det er netop denne der skal op mod FCR, som er den nuværende "Guld-Standard". 56% - der er sku da kræft kurering der vil noget!
Det er denne formulering og kombinationsbehandling hvor de rigtigt store penge for Arzerra ligger. Og med en god bivirkningsprofil synes man godt at lægerne kan tage et offlabel bet på OFC.
Det er denne formulering og kombinationsbehandling hvor de rigtigt store penge for Arzerra ligger. Og med en god bivirkningsprofil synes man godt at lægerne kan tage et offlabel bet på OFC.
