Biotech Values

[AlpineBV_Miller]

SGEN - ALCL and EMEA and ODAC

Management said on the conference call Millenium was taking this trial to the EMEa and had already spoken with them about design and potential approvability. That said, I'd be a little surprised if the EMEA approved based on one uncontrolled Phase II trial.

In ALCL, the company said if the data were of comparable strength to the HL data AND the FDA agreed it was OK, they would file for both indications jointly. 55 patient is enough size for that population. In the Phase I, 7/8 r/r pts had a CR. If they can duplicate that or even the 75% rate in HL I think the FDA will entertain a dual indication application.

I was surprised to hear SGEN mgmt describe ODAC as optional. Apparently the new code has an out for the agency where they can waive the requirement for a panel for a first-in-class drug. I either forgot about that or missed that in the code. I don't think an ODAC would be a worry for SGEN, but no requirement to have one might quicken approval.