BRIEF—AMAG exercises option on orphan drug candidate

AMAG Pharmaceutical has acquired global rights to develop and market an orphan drug candidate for the treatment of severe preeclampsia.

Digoxin immune Fab (DIF), a polyclonal antibody, has been granted both orphan drug and fast-track designations by the US FDA.

AMAG bought the rights from Velo Bio, acting on a 2015 option agreement and acquiring the candidate for an upfront fee of $12.5 million. AMAG will now take over a Phase IIb/IIIa study that Velo initiated in mid-2017.

Topline data is expected in 2020, and the firm says it will submit a new drug application in the US in the same year.

Velo is also due a $35 million milestone payment upon FDA approval, as well as sales milestone payments of up to $240 million, and mid-single digit royalties based on net sales.