Halozyme Therapeutics Inc (HALO)

[rod5247]

From Genmab transcript.

"Then the second real key presentation will be on subcu data with the daratumumab formulation and multiple myeloma."

"All right, thanks Michael for the questions. I’ll let David think a little bit more about questions one to three and take the last one myself right now on the subcu data at ASH. You will indeed see data from the first study, the powerful study Michael. There we will show detailed data from a number of cohorts. And that is indeed what we call mix and deliver. So, we actually mix the daratumumab in different doses because we want to test the different dose levels with the Halozyme enzyme and that’s then infused 20 to 30 minutes actually into the patients. We see that there is a working study just to estimate the optimal dose. We now noted those, I can tell you. And the final formulation will be a co-formulation of the enzyme with the optimal dose for subcu daratumumab, and that will then be able to be infused in a much shorter time, probably closer to 5 minutes than to 10 minutes. And we will intend to do the next studies, which will be a number of studies where we’re likely to get final formulation dose. And you will get further clarity of that in a new year. That’s probably all I can say at this time. Probably you will run a little bit more from abstract tomorrow."

"Then second question on the subcu formulation, it will likely start not at the beginning of 2017 because formulation is now being made; now we know what the concentration, if you want to use. There is intense debate at the regulators between Janssen and the European and U.S. regulators. So, I would say probably closer to the middle of 2017 that it will start. And question associated with that is yes we think we have data in 2019 that is still unscheduled. And the launch, we haven’t given feedback on but the data will come in 2019. That’s all I can say at this time before the trials have been started."

"Then the smoldering, the trial is complete. And next a study likely be initiated next year. So, it’s a subcu formulation of daratumumab, probably closer towards the middle of the year than beginning, and data potentially at a medical conference. I haven’t heard Sarah, which medical conference, either going to be in the summer timeframe with ASCO or at ASH but that has not been decided yet, as I already said in response to Scahin’s question. There are so much data now coming out of that and Janssen is orchestrating the news in a very precise way to focus the attention of the doctors and of the analysts and another stakeholders very precisely on different data, the data sets. And I haven’t heard yet when the smoldering data is going to be presented in full. But I can tell you that we are pretty excited about that data and we will plan next studies with the subcu formulation also."

http://seekingalpha.com/article/4018495-genmabs-gnmsf-ceo-jan-van-de-winkel-q3-2016-results-earnings-call-transcript