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26/2 16:05
af Helge Larsen/PI-redaktør
This session have ended
26/2 16:04
af Jan Van de Winkel
We have truly enjoyed the interaction and can not wait to chat again. Have a nice day.
26/2 16:03
af Helge Larsen/PI-redaktør
Jan and Andrew. This was all we had for you this time. Thank you for joining us and thank you for the many fulfilling answers to the broad range of interested questions from our investors here at ProInvestor. com. We look very much forward to having you back again here for a Q&A in the near future after Q1.
26/2 16:02
af Jan Van de Winkel
We anticipate a broad label based on the submissions by Janssen of the COLUMBA and PLEIADES data.
26/2 16:01
af chaitea
Which lines of treatment do you anticipate SC dara being used upon approval? Can it be used in newly diagnosed?
26/2 16:00
af Jan Van de Winkel
recent surveys show high levels of enthusiasm in both the US and the EU.
26/2 15:59
af Jan Van de Winkel
Dara subQ will be an advantage for patients and doctors...
26/2 15:59
af Jan Van de Winkel
initially we will test it in MM and DLBCL.
26/2 15:58
af Akshay1976
What is the value proposition for Dara SC? Will it be economically beneficial to patients? Or looking at just the convenience of patients? It would be great if we can get answer from both US and EU persepective?
26/2 15:58
af Jan Van de Winkel
We feel that HexaBody CD38 is one of the most exciting molecules in development for treatment of MM...
26/2 15:57
af Solsen
Mr Winkel How do you see Takedas new products in development in the anti-CD38 landscape. And do Genmab pursue solid tumours in their first hexa-cd38 trials.
26/2 15:57
af Jan Van de Winkel
and especially early signs of clinical activity with patients that do not respond to check point inhibitors.
26/2 15:56
af Jan Van de Winkel
We are very excited about the preclinical validation and the early clinical data in solid cancers...
26/2 15:55
af Solsen
Mr Winkel Thanks for one more good year ! GEN1046 is one of the “winners” Could you tell us what you have seen since you are so optimistic. And when could it potentially hit the market.
26/2 15:54
af Jan Van de Winkel
Our scientists are continuously exploring novel and better ways for ADC approaches.
26/2 15:53
af Sukkeralf
Jan how do you see Genmabs future in the ADC space - are you considering newer linker and payloads technologies or something like site specific conjugation?
26/2 15:53
af Jan Van de Winkel
.
26/2 15:53
af Jan Van de Winkel
We have not flagged up a maintenance data readout for 2020
26/2 15:52
af Sukkeralf
Will there be any daratumumab maintenance readout i 2020?
26/2 15:52
af Jan Van de Winkel
We see rapid progress in the 372 clinical development and are enthusiastic about a potential subQ formulation to create an even more viable product candidate.
26/2 15:50
af Sukkeralf
Halozymes mentioned that Janssen has selected the ENHANCE technology for JNJ61186372 in december. 2019. Do you consider that a setback (IV not good enough) or further validation of Janssens interest in JNJ61186372?
26/2 15:49
af Jan Van de Winkel
It is too early to detail strategy for regulatory filings. But we continue highly energized and enthusiastic the rapid progress in the expanding epcoritamab clinical program.
26/2 15:48
af Raffles
If, or when, it eventually comes to the approval process of Epcoritamab do you see any chances of a Priority Review from FDA or would you consider buying a PR-voucher in order to shorten the approval process and thereby catch up with the competing products?
26/2 15:48
af Jan Van de Winkel
No comment.
26/2 15:47
af Bulder
Do you know if Janssen has submitted a placeholder for Andromeda as late breaker at ASCO?
26/2 15:47
af Jan Van de Winkel
Lundbeck will message progress of this clinical program.
26/2 15:46
af Raffles
Concrats with the 2019 results and thanks for spending time with us. In relation to the Lundbeck study (Lu AF82422 – Parkinson) – this study had primary completion in January 2020 with study completion in June 2020. Do you expect the results from the phase 1-study to be published in the near future? Do you have any expectations to the results and further development and is there any dialogue between Lundbeck and Genmab?
26/2 15:45
af Jan Van de Winkel
Well the trial is in active recruitment mode and clinical data is anticipated for H2 2020.
26/2 15:44
af E L
I noted a big increase in the anticipated patient enrollment number for GEN1029 (HexaBody-DR5/DR5) –from 188 to 520- in clinicaltrials.gov. Could you confirm this and would it then be fair to assume this trial is going really well…?
26/2 15:44
af Jan Van de Winkel
Yes the list price was increased by 4.9% in end of January.
26/2 15:43
af E L
Dara list prices were raised early 2018 and 2019. Can you update us as to whether this also happened this year and if so by how much?
26/2 15:43
af Jan Van de Winkel
Yes, both in the US and EU, the 90 min dosing is very actively used in hospitals.
26/2 15:42
af E L
Can you tell us if the split dosing for Darzalex and the 90-minute dosing regimen have been usefull so far in practice?
26/2 15:42
af Jan Van de Winkel
The actual injection takes 3-5 min as you know.
26/2 15:42
af Jan Van de Winkel
There will be some pre and post medication observation but there are development efforts to shorten these..
26/2 15:41
af Bulder
Is total treatment time for dara sc a few minutes? Or will there also be pre- and post-medication and observation?
26/2 15:40
af Jan Van de Winkel
For Janssen, the company is fully ready to commercialise Dara and has a pre-approval access program active.
26/2 15:40
af Jan Van de Winkel
We know from our partners that they intend to very rapidly bring the subQ formulations to the market...
26/2 15:39
af Bulder
Will sc dara be on the market as soon as it is approved? Or do we have to await price negotiations? And the same question on ofa in RMS.
26/2 15:39
af Jan Van de Winkel
It is to early to estimate marketshare for epcoritamab as that will be determined by the clinical data.
26/2 15:38
af Jan Van de Winkel
The market is estimated to be larger than USD 8bn..
26/2 15:38
af Bulder
How big is the market for B-cell malignancies? And how big a market share do you expect Epcoritamab to get - if successful?
26/2 15:38
af Jan Van de Winkel
We actually spend 50/50 with BioNTech and in our financials we will be reimbursed and book under revenue.
26/2 15:37
af troldmanden
Is it Genmab who front all the cost for PD-L1X4-1BB in 2020 and then get 50% reimbursed?
26/2 15:36
af Jan Van de Winkel
Well, as a public company you are always at risk.
26/2 15:36
af troldmanden
With an unpartnered antibody like CD3xCD20, do you then see an increased risk of a potential hostile takeover from a big pharma?
26/2 15:35
af Jan Van de Winkel
We currently anticipate a massive clinical development program for epcoritamab, its too early to attach numbers.
26/2 15:34
af troldmanden
When looking at Janssens development plans for DARA they have now spent around 2 billion dollars (exclusive milestones to Genmab) and within the next 2-3 years they will probably have spent 1 billion dollars more. Do you see a clinical program of equal size for CD3XCD20 for the coming 5-7 years?
26/2 15:34
af Jan Van de Winkel
Further details on clinical development of epcoritamab will follow during 2020.
26/2 15:34
af Jan Van de Winkel
At this time we cannot provide further color for the exact plan for epcoritamab or PDL1-41BB for competitive reasons...
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