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Genmab er snart live på Q&A Spørg løs allerede nu!
      

Genmab: Salg af fabrik+Zalutumumab? Hvornår?


34983 HRmunk 21/10 2010 00:14
Oversigt

Jeg tror at Jan lander en aftale om at sælge zalu+fabrik i en samlet deal. Og jeg tror det er noget, som har været undervejs et stykke tid, og noget som er gået ind i finalen.

Her er hvad vi hørte 18. august i forbindelse med Q2:
Genmab/CEO: Vi er i dialog med mulig køber til fabriksanlæg.
18-08-10 kl. 18-08-10 13:52 | Genmab 70.7 (-0.63)
Genmab-topchef Jan van de Winkel kunne onsdag eftermiddag løfte sløret for, at selskabet er i dialog med en potentiel køber til sin uønskede fabriksfacilitet i Minnesota. Genmab satte fabrikken til salg i november 2009.

- Vi er i aktive diskussioner med en part i forhold til en kombination med at sælge fabriksfaciliteten og give dem adgang til mindst et af vores antistoffer. Vi arbejder på dette scenario, som vi ser som en realistisk mulighed, sagde Jan van de Winkel.

Han vurderede samtidig, at der er en vis sandsynlighed for, at en handel kan komme på plads inden årets udgang.


Jan nævner altså allerede 18. august forhandlinger om salg af fabrik og et stof i samme sætning. I dag ved vi at der er tale om fabrik+zalu som aka og flere andre har gættet på. Forhandlingerne har altså stået på ganske længe, men har helt sikkert afventet den opdatering på zalutumumab som nu er kommet.

Her er hvad vi hørte Jan citeret for 18/10 altså nøjagtig 2 måneder senere, hvor Jan skruer op for retorikken:

“Vi går nu for alvor
videre med vores partnerskabsdrøftelser og har tillid til, at vores potentielle
fremtidige udviklingspartner vil være i stand til at gå videre med en
registreringsansøgning i Europa for zalutumumab.”

Min konklusion er at der kommer en samlet løsning på fabrik+zalu. Og især den gedigne nyhed om at der kan files direkte til 2. line behandling i Europa tror jeg er en garanti for at vi ikke bare får en aftale, men en god aftale.






21/10 2010 09:59 gentogen 234988



Ja, og Jans største bekymring er åbenbart, at han er bange for, at VORES partner ikke nøjes med fabrik og zalu, men køber hele butikken, da det hele jo er alt alt for billigt..... (smil)



21/10 2010 10:06 colombuss 034989



gsk har jo 10% og kan så blokere, mon ikke de er de eneste der reelt kan købe hele molevitten? De giver nok ikke køb på de 10% de har købt til kurs 400.



21/10 2010 10:11 troldmanden 034991



Ja det ligger i kortene at det er en mulighed. Personligt så håber jeg dog ikke på et samlet salg. Og det af 2 årsager.

1. jeg vil meget heller have 2 rigtig gode nyheder end en samlet super nyhed. På den måde underbygges positivt sentiment endnu bedre og vi vil få 2 store kurshop

2. en samlet aftale vil helt sikkert betyde en større rabat på fabrikken end hvis det kun er fabriks salg.

Men det er klart hvis først en potentiel partner for alvor er interesseret i en combo deal så siger Genmab helt sikkert ikke nej



21/10 2010 14:58 gentogen 034999



Lidt om konkurrenten:
monoclonal antibodies
cetuximab.
The best-studied mAb thus far is cetuximab, which is a human–murine chimeric immunoglobulin G1 (IgG1) mAb, which competitively binds to the extracellular domain of the EGFR. Cetuximab has been tested in R/M-SCCHN, either in second-line therapy after failure of platinum-based chemotherapy or in first-line therapy in combination with platinum-based chemotherapy. Moreover, it has been tested as part of the combined modality treatment of locoregionally advanced SCCHN. This latter application is beyond the scope of this article.
cetuximab in second-line therapy.
Three phase II trials examined the role of cetuximab in platinum-refractory or platinum-resistant disease. All patients received cetuximab intravenously (i.v.) at an initial loading dose of 400 mg/m2 followed by weekly 250 mg/m2 [59–61]. In two of these studies cetuximab was added to the platinum compound that was reintroduced [59, 60], in one study cetuximab was given alone [61]. There was a remarkable similarity in outcome in these three studies. Responses were seen in 10%–13% of patients, DC was observed in 46%–55% of patients and median OS was 5.2–6.1 months. This similarity, irrespective of whether cetuximab was administered as a single agent or added to a platinum-based regimen, indicates that the observed responses were attributable to cetuximab alone rather than to the reversal of platinum resistance by cetuximab.
Interestingly, the median survival of 5–6 months achieved with cetuximab in platinum-refractory disease was reaching a level very close to that with first-line therapy in randomized trials and represented an increase in survival of 2.5 months compared with platinum-refractory historical controls [62]. Based on these results and particularly considering the fact that ∼50% of the patients showed DC, cetuximab monotherapy seems to be a good option for patients with R/M-SCCHN who have progressed on platinum-based chemotherapy. It is also approved for that indication in the USA.
cetuximab in first-line therapy.
Table 2 summarizes the data on cetuximab in first-line therapy, showing a remarkable consistency in efficacy in patients with R/M-SCCHN, whether treated with platinum-based chemotherapy [63–65], taxane-based chemotherapy [66] or platinum–taxane-based chemotherapy [67]. Burtness et al. [63] assigned 117 patients to cisplatin 100 mg/m2 every 4 weeks either with weekly cetuximab or with weekly placebo. The primary end point of this study was PFS. The study was designed to detect a difference in median PFS of 2 months i.e. 2 months with cisplatin plus placebo and 4 months with the experimental arm. However, the observed median PFS in the control arm was longer than expected (2.7 months). The median PFS in the cetuximab arm was 4.2 months and that difference did not reach statistical significance (P = 0.09). In fact, the actual power to detect a 2-month difference in this situation was only 50%. The OR rate was 26% in the experimental arm versus 10% in the control arm (P = 0.03). Median OS was not significantly different (9.2 months versus 8 months, P = 0.21). Development of cetuximab-related skin toxicity was associated with an improved OS [hazard ratio (HR) 0.42, P = 0.01]. In the EXTREME study [65] 442 patients were randomized to receive either chemotherapy alone (cisplatin 100 mg/m2 or carboplatin AUC 5 mg/ml/min on day 1 followed by 5-FU 1000 mg/m2/day for 4 days) or the same regimen combined with weekly cetuximab (initial loading dose of 400 mg/m2 followed by weekly doses of 250 mg/m2). Cycles were repeated every 3 weeks for a maximum of six cycles. Thereafter, in the combined arm, cetuximab was continued as a single agent until disease progression or unacceptable toxicity, whichever came first. No crossover was permitted in this study. Excluded were patients who had received prior chemotherapy except when this had been part of their primary treatment provided this chemotherapy was ended at least 6 months before inclusion in the study. The primary end point was OS. The addition of cetuximab to platinum–5-FU significantly prolonged the median OS from 7.4 months in the chemotherapy-alone group to 10.1 months in the group that received chemotherapy plus cetuximab (HR for death, 0.80; 95% CI 0.64–0.99; P = 0.04). The addition of cetuximab also prolonged the median PFS from 3.3 to 5.6 months (HR for progression, 0.54; P < 0.001) and increased the response rate from 20% to 36% (P < 0.001). The beneficial effect was evident in both the patients treated with cisplatin–5-FU and the patients treated with carboplatin–5-FU, although also in this study response rates with carboplatin–5-FU were below those obtained with cisplatin–5-FU independent of the treatment arm. Moreover, protocol-defined subgroup analyses showed that the beneficial effects of adding cetuximab to platinum–fluorouracil chemotherapy on OS and PFS were evident in nearly all subgroups analyzed. The most common grade 3 or 4 adverse events in the chemotherapy-alone and cetuximab groups were anemia (19% and 13%, respectively), neutropenia (23% and 22%) and thrombocytopenia (11% in both groups). Sepsis occurred in nine patients in the cetuximab group and in one patient in the chemotherapy-alone group (P = 0.02). There were 11 cases of grade 3 or 4 hypomagnesemia in the cetuximab group, as compared with three cases in the chemotherapy-alone group (P = 0.05). Of the 219 patients receiving cetuximab, 9% had grade 3 skin reactions and 3% had grade 3 or 4 infusion-related reactions. There were no cetuximab-related deaths.
View this table:
In this windowIn a new windowTable 2.
Cetuximab in first-line therapy of recurrent/metastatic squamous cell carcinoma of the head and neck
This is the first time in >30 years that superiority (in terms of survival) of a new regimen over standard platinum-based combination chemotherapy has been observed. Cetuximab and platinum-based chemotherapy is now considered as a new standard for the treatment of R/M-SCCHN for those who are able to tolerate platinum-based combination chemotherapy regimens [7, 68].
panitumumab.
Panitumumab (ABX-EGF) is a fully human IgG2 antibody which binds very strongly to the receptor [44, 69]. It blocks ligand binding and induces internalization of the receptor but no receptor degradation. Side-effects include pruritus, skin rash, dyspnea, fatigue, abdominal pain, asthenia and diarrhea. Panitumumab at a weekly dose of 2.5 mg/kg has acceptable tolerability and encouraging clinical activity in patients with a variety of tumor types. Its pharmacokinetic profile allows more convenient 3-weekly administration (9 mg/kg). Three studies with panitumumab in the R/M disease setting are of interest, i.e. the PRISM study, the PARTNER study and the SPECTRUM study. The PRISM study is a phase II study with single-agent panitumumab in second-line therapy, the PARTNER study is a randomized phase II study in first-line therapy studying docetaxel plus cisplatin with or without panitumumab and in the SPECTRUM trial, similar patients to those in the EXTREME trial were randomized to receive cisplatin–5-FU with or without panitumumab. Enrolment in this latter trial has been completed. The combination was safe and efficacy data are awaited in 2010 [70].
zalutumumab.
Zalutumumab [44] is also a fully human IgG1 EGFR-directed mAb. The frequency of acneiform rashes with this compound increases with dose. This mAb is currently undergoing phase III testing in patients who failed standard platinum-based chemotherapy versus BSC [71]. However, in this so-called ZALUTE trial a great majority of patients in the BSC arm (78%) received weekly methotrexate as allowed by the protocol. There was a strong trend in favor of the zalutumumab arm for OS (median 6.7 versus 5.2 months, P = 0.0649), which was the primary end point of the study. There was a statistically highly significant difference in PFS in favor of the experimental arm (median 9.9 versus 8.4 weeks; P = 0.0010). The results of this trial confirm the activity of EGFR-directed mAbs in patients with platinum-refractory SCCHN [72].



21/10 2010 16:01 gentogen 035001



Skal vi lige tage fase III ofatumumab listen, som den ser ud på clinical trials pt.

1 Recruiting Ofatumumab Versus Rituximab Salvage Chemoimmunotherapy Followed by Autologous Stem Cell Transplant in Relapsed or Refractory Diffuse Large B Cell Lymphoma Condition: Lymphoma, Large-Cell, Diffuse
Interventions: Drug: OFATUMUMAB + DHAP; Drug: OFATUMUMAB + DVD; Drug: RITUXIMAB + DHAP; Drug: RITUXIMAB + DVD
Phase: Phase III
Primary Completion Date: December 2014

2 Recruiting Ofatumumab Maintenance Treatment vs No Further Treatment in Relapsed CLL Responding to Induction Therapy Condition: Leukaemia, Lymphocytic, Chronic
Interventions: Other: No Intervention; Biological: Ofatumumab
Phase: Phase III
Primary Completion Date: November 2013

3 Not yet recruiting Single Agent Ofatumumab Vs. Single Agent Rituximab in Follicular Lymphoma Relapsed After Rituximab-Containing Therapy Condition: Lymphoma, Follicular
Interventions: Biological: Ofatumumab; Biological: Rituximab
Phase: Phase III
Primary Completion Date: November 2015

4 Recruiting Ofatumumab and Bendamustine Combination Therapy Compared With Bendamustine Monotherapy in Indolent B-cell Non-Hodgkin's Lymphoma (NHL) Unresponsive to Rituximab or a Rituximab-Containing Regimen Conditions: Lymphoma, Non-Hodgkin; Lymphoma, Follicular
Interventions: Drug: Ofatumumab and Bendamustine infusions (Arm A); Drug: Bendamustine infusion (Arm B)
Phase: Phase III
Primary Completion Date: January 2016

5 Recruiting Ofatumumab + Chlorambucil vs. Chlorambucil Monotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia Condition: Chronic Lymphocytic Leukemia
Interventions: Drug: chlorambucil, tablets; Drug: ofatumumab (GSK1841157) infusion
Phase: Phase III
Primary Completion Date: May 2013

6 Recruiting Investigating Clinical Efficacy of Ofatumumab in Adult RA Patients Who Had an Inadequate Response to TNF-α Antagonist Therapy Conditions: Arthritis, Rheumatoid; Rheumatoid Arthritis
Interventions: Drug: Ofatumumab; Drug: Placebo
Phase: Phase III
Primary Completion Date: May 2009

7 Recruiting Ofatumumab Added to Fludarabine-Cyclophosphamide vs. Fludarabine-Cyclophosphamide Combination in Relapsed Subjects With Chronic Lymphocytic Leukemia Condition: Chronic Lymphocytic Leukemia
Interventions: Drug: OFC Infusion; Drug: FC infusion
Phase: Phase III
Primary Completion Date: August 2011




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