Genmab — Juli 2020

[E_L]

Q- Vas, you mentioned that you were in final labeling discussions with FDA on ofatumumab. Given it was filed as an sBLA and Arzerra has a black box warning, should we be expecting a black box warning for ofa?

[E_L]

A- Yes. So on Arzerra, I think the black box warning specifically refers to both PML cases and HBV reactivation. And looking at the mechanism of ofatumumab, if you think about the overall approach, what we've actually looked at for ofatumumab is the fastest B cell repletion. So when patients are actually receiving subcu injections,

[E_L]

they have very low and very quick recovery of their B cells. So in return, in the studies for ASCLEPIOS I and II, we did not see any cases of PML and we also did not see any cases of HBV reactivation. So you can -- I think the FDA will accurately reflect what was in our ASCLEPIOS I and II studies. And I believe that will be the readthrough in terms of how we will have the label moving forward.

[E_L]

And we expect to get a new trade name, which will actually reflect both the efficacy and safety of the label. So we will get a new brand name associated with this. So I think this would be a different overall label and brand name for ofatumumab.

[E_L]

So- a lot of attention in that call on Ofa.

[E_L]

Kiadis announces publication in Blood highlighting proof-of-concept to enhance potency of anti-CD38 antibodies with Kiadis’ K-NK004, recently licensed by Sanofi https://www.globenewswire.com/news-release/2020/07/22/2065517/0/en/Kiadis-announces-publication-in-Blood-highlighting-proof-of-concept-to-enhance-potency-of-anti-CD38-antibodies-with-Kiadis-K-NK004-recently-licensed-by-Sanofi.html

[E_L]

we saw this article before, and the funny thing is that it is using Dara instead of Isa

[GeorgeBest]

Thanks for All the info E L

[Helge_LarsenPI-redaktør]

Ditto from me.

[E_L]

i had no choice GB, I was forced

[gentogen]

Thanks EL

[E_L]

New Teprotumumab trial - A Randomized, Double-Blind Multicenter Study With TEPEZZA in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) - https://clinicaltrials.gov/ct2/show/NCT04478994?term=genmab+OR+daratumumab+OR+darzalex+OR+ofatumumab+OR+Teprotumumab+OR+Tisotumab+OR+camidanlumab+OR+Enapotamab+OR+ADCT-301+OR+duobody&lupd_s=07%2F20%2F2020&draw=2&rank=12

[Helge_LarsenPI-redaktør]

US Darzalex salg fra Symphony Health for juni USD 219.8M. Juni 22 arbejsdage, mod 20 i maj. Stigning på dagsbasis ca. 8%

[bikube]

Hvis man kan holde den stigningstakt, ser det da smukt ud.

[nohope]

"Problemet" er nok ROW.

[bikube]

Der var det jo en reduktion på prisen, der fik et negativt udslag. Det skulle jo nødigt gentage sig. Jeg blev da noget skuffet over, at ROW blev sat tilbage ift. U S salg.

[Helge_LarsenPI-redaktør]

De tidlige nedlukninger i Q2 i Europa må have påvirket ROW kraftigt i negativ retning.

[nohope]

Yep. Det kan også sagtens tænkes at der er en mindre effektueringsprocent af Symphony tallene end ellers pga corona.

[AaBforever]

Patienter med cancer får vel ikke mindre behov for medicin og behandling, selv under en coronakrise?

[gdn55]

Hvis der under en krise ikke er personale nok til at udfører behandlingerne, må der jo vælges. Hvad der udsættes kan bliver udsat.