AMAG expands maternal health pipeline, bags late-stage orphan drug for $12.5M
AMAG Pharma has had three years to study Velo Bio’s one and only maternal health drug up close as a development partner for the past few years. And now that a Phase IIb/IIIa is underway, AMAG has decided it wants the whole program for itself.
The drug, which treats severe preeclampsia in pregnant women, only costs $12.5 million upfront. The price tag on it starts shooting up depending on performance: add $35 million for an FDA approval, up to $240 million in aggregate sales milestone, plus an additional $10 million fee to a previous licensor contingent on those sales. All of this is on top of the $10 million AMAG handed over in 2015 for the option to acquire the program in the first place.
Waltham, MA-based AMAG estimates that preeclampsia — a condition characterized by high blood pressure and could lead to organ damage in the baby — affects around 140,000 pregnant women in the US, and that digoxin immune Fab (now AMAG-423) can be a billion-dollar addition to their women’s health portfolio.
“In a recently published review article, data was summarized that strongly support a potential role of EDLFs in the pathogenesis of preeclampsia,” said Julie Krop, AMAG’s chief medical officer and EVP of development. “DIF is a polyvalent antibody intended to bind to EDLFs and remove them from circulation. We believe that decreasing EDLFs may improve vascular function and lead to better post-delivery outcomes in affected mothers and babies.”
AMAG will now take over the pivotal trial from Vela Bio, which is based in Research Park Triangle, NC, with an eye to accelerating patient recruitment. Assuming that’s successful, the company says they are on track to unveil topline data in 2020 and file an NDA in the same year.