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AMAG Pharmaceuticals Acquires Orphan Drug Candidate for Treatment of Severe Preeclampsia
Sep. 26, 2018 09:07AM PST
Pharmaceutical InvestingAMAG Pharmaceuticals (NASDAQ:AMAG) today announced it has acquired global rights to develop and market digoxin immune Fab (ovine) (DIF), a polyclonal antibody in development for the treatment of severe preeclampsia in pregnant women. AMAG and Velo Bio, LLC, a privately held life sciences company located in the Research Triangle Park region of North Carolina, entered into …
AMAG Pharmaceuticals (NASDAQ:AMAG) today announced it has acquired global rights to develop and market digoxin immune Fab (ovine) (DIF), a polyclonal antibody in development for the treatment of severe preeclampsia in pregnant women. AMAG and Velo Bio, LLC, a privately held life sciences company located in the Research Triangle Park region of North Carolina, entered into an option agreement in July 2015 to develop DIF.
As quoted in the press release:
The companies have amended the agreement, enabling AMAG to exercise its option to acquire the program (now referred to as AMAG-423) for an upfront fee of $12.5 million. AMAG will now manage and complete the Phase 2b/3a study that Velo initiated in mid-2017. The company expects to announce topline data in the first half of 2020 and to submit a new drug application to the U.S. Food and Drug Administration (FDA) in the second half of 2020. DIF has been granted both orphan drug and fast-track designations by the FDA for use in the treatment of severe preeclampsia.
Preeclampsia results in adverse neonatal outcomes, and is a leading cause of maternal morbidity and mortality, affecting approximately 140,000 pregnant women in the U.S. annually.1,2 The condition typically develops in women after 20 weeks of pregnancy and is characterized by elevated blood pressure, as well as vascular abnormalities, that can lead to end organ damage, intrauterine growth restriction and premature delivery.3 Premature delivery can lead to a number of serious health consequences for the infant, including intraventricular hemorrhage (bleeding in the brain) or necrotizing enterocolitis (severe inflammation of the infant bowels).4 Severe preeclampsia, a more serious form of the condition that can be life threatening to both the woman and infant, impacts approximately 50,000 women per year.5,6 Currently, there are no FDA-approved treatments for preeclampsia or severe preeclampsia.
