Genmab — November 2017
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Regnskabet er nok i sig selv en non-event, men tror Jan får en del spørgsmål angående salget..........og hvis ikke han er klar i spyttet her, så tænker jeg også ned i morgen. Af dårlige ting i regnskabet kunne være fase III data for ofatumumab i FL. Desuden skal vi også snart have de to IND´er på banen - ville være noget af en bet, hvis en af dem forsinkes betydeligt eller helt udebliver
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From the Halozyme Therapeutics Q3 Results - Earnings Call Transcript:
https://seekingalpha.com/article/4122004-halozyme-therapeutics-halo-ceo-dr-helen-torley-q3-2017-results-earnings-call-transcript?part=single -
Based on these results, Janssen has finalized a 15 ml injection of co-formulated daratumumab plus rHuPH20 to be delivered in five minutes or less and the dose of first amyloidosis patient in the Phase 3 trial. This is the first of three Phase 3 studies Janssen plans to initiate in the near-term. The others will be in multiple myeloma and in smaller in myeloma patients. Upon the dosing of the third patient, Halozyme will earn a $15 million milestone payment.
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As we’ve been demonstrated previously, once the partner begins the Phase 3 study using our technology, approval has been ultimately granted by the applicable regulatory agency in all cases whereof three for three, and therefore view the star of the daratumumab Phase 3 trial as a meaningful de-risking event for the combination. To finish in DARZALEX, market receptions to the IV formulation remain strong.
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Q: So first, any idea how quickly Janssen can move into Phase 3 for multiple myeloma and smouldering myeloma?
Dr. Helen Torley
Well, certainly for multiple myeloma, the previously made comments that it will happen before the end of this year. So I do think absolutely in the next weeks for the multiple myeloma study. I don’t think this given the specific from the smouldering myeloma, but we know they’re working all three of the studies in parallel. So, it will begin soon as well.
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