Genmab — Februar 2024
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AMGEN: TEPEZZA
(teprotumumab-trbw) generated $448 million of sales for the period. TEPEZZA is the first and only FDA-approved treatment for thyroid eye disease (TED). -Sales figures reflect only sales in the period from Oct. 6 2023 through the end of the year, and not the full quarter. https://investors.amgen.com/news-releases/news-release-details/amgen-reports-fourth-quarter-and-full-year-2023-financial -
In December 2023, TEPEZZA received orphan drug designation in Japan for patients with moderate to severe active thyroid eye disease (TED).
A New Drug Application was submitted for TEPEZZA in Japan based on the results from the OPTIC-J study evaluating TEPEZZA in patients with active TED.
A Phase 3 study of TEPEZZA in Japan for chronic or low clinical activity score (CAS) TED continues to enroll patients. -
Lundbeck igangsætter fase 3-studie med CNS-kandidat
På trods af de umiddelbart ufordelagtige statistiske resultater fra et tidligere studie igangsætter Lundbeck nu et fase 3-studie med Lu AF82422.
(medwatch.dk)
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we'll see how that works out for Tepezza SC, we don't know if the contracts are similar, but at at least Genmab now knows how to proceed with a potential arbitrage
The news in itself is not real news in that Horizon was looking at SC already in 2020 with Halozyme, but i imagine Xeris Biopharma will run with the deal after this
https://finance.yahoo.com/news/xeris-xers-licensing-deal-amgen-133000124.html -
the Ph3 EPCORE FL-2 trials started recruiting https://classic.clinicaltrials.gov/ct2/history/NCT06191744?B=3&A=2&C=merged#StudyPageTop
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Nice - full steam ahead. Any ideas as to how easy/difficult recruitment will be?
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incidence US = 15k/year
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@gentogen some antibodies may not need an addition to be admistered SC and then genmab can do it itself, depends also on how potent the drug is and how much you will need to dose (like epco, and possibly HexaCD38). But for others i think outside technology will be used, i mean large pharmas also do that
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Primary outcome measured as % of CRs at 30 months. Will take some time before we get there
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Amgen makes progress with its Horizon prize Tepezza, but there's much work left to do https://www.fiercepharma.com/pharma/amgen-expects-revenue-bump-its-acquisition-horizon-between-324b-and-338b
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