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DANMARKS STØRSTE INVESTORSITE MED DEBAT, CHAT OG NYHEDER
9/11 17:43
af Helge Larsen/PI-redaktør
This session have ended.
9/11 17:43
af Jan Van de Winkel
Thank you very much. Another energizing session and look forward to the next one!
9/11 17:43
af Helge Larsen/PI-redaktør
Jan and David. Thank You for joining us and thank you for the many fullfilling answers to our questions. We wish you a very good presentation at ASH. We look forward to to seeing you back here on ProInvestor after Q4.
9/11 17:42
af Jan Van de Winkel
There is a total market which exceeds 20 bn USD and our partner Novartis has put ofa on a list of potential blockbusters and we need to see the landscape in MS will be impacted by the eventual data from Ofa and other agents in the coming years.
9/11 17:41
af GeorgeBest
How much do you estimate Ofatumumab peaksales in MS can reach? I see some analysts with 2 billion USD forecast. But it seems low when they on the other hand forecast + USD 5 billion for ocrelizumab in MS. Is there really so much difference because Roche was first mover?
9/11 17:41
af Jan Van de Winkel
We will first study the safety and efficacy of this exciting DuoBody in the clinic and we believe we can continue to run this program.
9/11 17:39
af Solsen
Mr. Winkel. I assume that the bispecific CD3 x CD20 potential i so huge that Genmab cant take the duobody all way. At which point do you think you will find a partner in the developement ?
9/11 17:39
af Jan Van de Winkel
Looking forward.
9/11 17:39
af Helge Larsen/PI-redaktør
Great. We have 2 questions more left for you.
9/11 17:39
af Jan Van de Winkel
I have been very pleased with the quality of the cervical cancer data in these difficult to treat patient population.
9/11 17:38
af Thomas
Tisotumab Vedotin is named the next winner by you in Børsen this morning - can you share what makes you confident enough to say that already?
9/11 17:38
af Jan Van de Winkel
This is too premature to speculate on timelines on RA and daratumumab - we don't have clinical data yet.
9/11 17:37
af Thomas
What is a realistic timeline for daratumuma b potentially obtaining approval for RA?
9/11 17:37
af Jan Van de Winkel
We think that the toxicity observed with CAR-T approaches is inherent to that technology and therefore may limit the use of that type of technology. We are very confident that daratumumab will become the future backbone for future treatment in all lines of MM.
9/11 17:36
af GeorgeBest
Do you ever see the possibility that Juno/Bluebird/Kite can get rid of the serious side effects in CAR-T, and thereby become a serious risk for reaching the peaksales estimates for Darzalex?
9/11 17:35
af Jan Van de Winkel
We have included it within our Q3 report.
9/11 17:35
af Legolas23
Mr. Winkel - why did Genmab not announce IND for RA?
9/11 17:34
af Jan Van de Winkel
As you say, it is Janssen responsible for commercialization of daratumumab, as well as interactions with the local NL regulatory bodies.
9/11 17:34
af E L
I know JNJ is responsible for Dara sales; but since you know the Dutch market so well; can you give us your comments on the recent advice of the Dutch Health Care Institute (zorginstituut) on Dara? Do you feel you can contribute anything to this proces?
9/11 17:33
af Jan Van de Winkel
We would hope to see data from these other studies but it is in the hands of BMS who's running these studies.
9/11 17:32
af GeorgeBest
You have announced that we can expect to see data in solid cancers from the CALLISTO study in 2018. What about the 3 Dara + Opdivo studies. Do you also expect announcements on these in 2018?
9/11 17:31
af Jan Van de Winkel
We anticipate that due to the large dose of dara SC, administration will have to take place in a hospital or clinic.
9/11 17:31
af Bulder
In abstract 4676 it says in the conclusion: "Currently, home administration of SC rituximab but also brentuximab vedotin, eculizumab and more recently daratumumab is part of our standard of care." Does this mean that sc dara at home is a possibility?
9/11 17:30
af Jan Van de Winkel
This is not something we are exploring at this moment.
9/11 17:28
af DevOp
share your view on the Dara + PEGPH20 + ... combi in solids?
9/11 17:28
af DevOp
As Halozyme’s ENHANZE (rHuPH20) is already used for Dara SC, and the polymer spun edition of the ENHANZE enzyme, PEGPH20, seems to have a major overlap with Dara in targeted solid cancers (PEGPH20 targets pancreatic, breast, lung, colon and prostate), PEGPH20 appears to be an obvious match for combi treatment with Dara in the overlapping solid cancer types to make the tumour cells even more exposed to both Dara, other combi agents and the immune system response triggeded by Dara. Can you please
9/11 17:28
af Jan Van de Winkel
It's Cellimmune running AMG-714 so further development is in their control.
9/11 17:27
af MrEbbe
Mr Winkel when can we expect phase II studies completed om AMG-174?
9/11 17:26
af Jan Van de Winkel
The FDA had put a partial clinical hold on all combinations PD1s/PDL1s in MM and this may well be connected to suspending locations.
9/11 17:25
af bibob
Mr. Winkel. Why is there so many Withdrawn and suspended locations on the Dara/Atezo study ??. Especially all the German locations are suspended. !!
9/11 17:25
af Jan Van de Winkel
Janssen is currently planning a Phase 3 study in D-RVd, and the Phase 2 data if positive could be included in a compendium listing.
9/11 17:24
af Bulder
The MMY2004 (D-RVd) phase 2 study: Can it become a potential registrational study even though it is "only" phase 2?
9/11 17:24
af Jan Van de Winkel
This is a topic under active discussions with the regulators.
9/11 17:23
af Bulder
Do you think that MRD-testing will substitute PFS as endpoint in future MM-trials?
9/11 17:23
af Jan Van de Winkel
We understand that 2022 in the US is correct, it becomes generic in EU in 2019. Data has shown that Dvd is an efficacious treatment option.
9/11 17:21
af Bulder
Can you confirm that the Velcade patent has been prolonged until 2022? And in that case will it have any impact on the marketing of the dara-combo?
9/11 17:21
af Jan Van de Winkel
Tisotumab has anti cancer efficacy in itself (ADCC) but the capacity to kill tumors is greatly enhanced by combining it with MMAE.
9/11 17:20
af Bulder
Has Tisotumab any anti-cancer efficacy in itself, or is it only a carrier for the vedotin?
9/11 17:20
af Jan Van de Winkel
We believe that a combination between daratumumab and ADCs is supported by preclinical data but it is too premature to comment on that specific combination.
9/11 17:19
af Bulder
A recent study indicated that CD38 enhances the proliferation and inhibits the apoptosis of cervical cancer cells. Do you see a future for a combo between dara and Tv in cervical cancer or other solid cancers?
9/11 17:19
af Jan Van de Winkel
We will have to see the data and it depends on the quality of the data - so it is too premature to speculate on next steps for HuMax-AXL-ADC.
9/11 17:18
af Bulder
Can the ongoing phase I/II AXL-ADC study - in the event of strong data - be followed by a registrational study, or will another phase II study be needed?
9/11 17:17
af Jan Van de Winkel
We regularly look at the issue of a share split but don't have any plans to do one at this time.
9/11 17:16
af jkj
Some days trading with Genmab shares is low, and it is easy for foreign players to control the share price. A share split will be shareholder friendly and create greater turnover and less volatility, is it something that is in your consideration
9/11 17:15
af Jan Van de Winkel
As usual we have busy business development, and we are confident of hitting our goal of further partnerships with our technology.
9/11 17:14
af Solsen
Mr Winkel Thanks for another good quater. Still some milestones to achieve for the full year. Could you say something about the tech deal we are waiting on ?
9/11 17:13
af Jan Van de Winkel
Unfortunately we are not able to comment on future milestones.
9/11 17:12
af Legolas23
Can you please specify - not amount of money, but what milestones can we expect from the Alcyone study. Is there for submission to FDA, EMA, first sale, etc?
9/11 17:11
af Jan Van de Winkel
We usually have around 7 dates a year and they are often timed around financial reports. This issue will become of less importance in the future, as we switch to partly using Restricted Stock Units (RSUs).
9/11 17:09
af E L
Would it be possible for Genmab to publish a schedule of future dates of possible warrant exercises? It could soften the market impact. I think there is 1 next week?
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