Friday, July 31, 2015

AstraZeneca suggests that it will be proceeding with brodalumab development

  • AstraZeneca held its Q2 results call yesterday and hinted at continued development of brodalumab
  • The future of brodalumab had been put in doubt earlier this year with Amgen announcing that it was no longer going to develop brodalumab in the US [see our earlier post]
  • Amgen consequently transitioned rights to AstraZeneca
  • Amgen stated its decision was due to reported suicidality and ideation of suicide in brodalumab trials
  • While Amgen has yet to disclose the level of risk, it commented that there was a fear of labelled monitoring requirements diminishing the competitiveness of brodalumab
  • During the company's comments AstraZeneca commented that an initial evaluation of data suggested that suicidality was likely unrelated to brodalumab
  • It was also commented that it had received multiple partnering offers but that it was completing data analysis prior to selecting a partner
  • On the slide deck accompanying the results call, brodalumab filing continues to be listed as 2015

Comments: The full reasons behind Amgen's decision to abandon brodalumab continue to be elusive.  The fact that AstraZeneca is muting possible licensing suggests others are less concerned that FDA requirements will reduce the competitiveness of brodalumab however a 2015 filing would seem unlikely in the US unless AstraZeneca opts for a commercial license handling  submission itself

Call quotes:  As for brodalumab we have conducted an initial evaluation of the data, which confirms that broda demonstrated strong efficacy in psoriasis and indicates that the observations of suicide or ideation are unlikely to be causally related to brodalumab therapy....we've actually had several expression of [partnering] interest. In fact we've already received offers, and we are considering those and engaging in discussions with potential partners. But it was really encouraging to see that we didn't get one, we got several expressions of interest from a variety of partners...But the key is really first of all to go through the data in more details, and that's what we are still doing. And secondly decide how we progress this together with the partner that we would select.

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