Acquisition expands AMAG’s maternal health portfolio and commitment to innovative therapies that address unmet medical needs
Conference call scheduled today at
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
“Severe preeclampsia is a global health concern. We are excited about the potential of DIF to significantly benefit mothers and babies around the world who are affected by this serious, and sometimes fatal, medical condition,” said
Approximately 200 antepartum women with severe preeclampsia between 23 and 32 weeks gestation will be enrolled in the multi-center, randomized, double-blind, placebo-controlled, parallel-group Phase 2b/3a study, including the 26 patients who have enrolled in the study since initiation by Velo. To accelerate enrollment, AMAG intends to increase the number of trial sites, including potentially initiating sites outside of the U.S. Participants in the study will receive DIF or placebo intravenously four times a day over four days. The study’s primary endpoint is to demonstrate a reduction in the percentage of babies who develop severe intraventricular hemorrhage, necrotizing enterocolitis or death by 36 weeks corrected gestational age between the DIF and placebo arms. Secondary endpoints include the maternal incidence of pulmonary edema during treatment and the period of time between treatment and delivery.
“The absence of an approved therapy for preeclampsia represents a significant unmet patient need,” said Eleni Tsigas, chief executive officer of the
In addition to the upfront
“Our portfolio expansion strategy is evolving to include innovative development-stage therapeutics, and with our significant presence in women's healthcare, DIF is a natural fit for AMAG,” said
The expected incremental research and development costs associated with advancing AMAG-423 in 2018 does not impact the financial guidance issued on
Conference Call and Webcast Access
International dial-in number: (702) 495-1202
Conference ID: 8488288
Replay dial-in number: (855) 859-2056
Conference ID: 8488288
A telephone replay will be available from approximately
The webcast with slides will be accessible through the Investors section of AMAG’s website at www.amagpharma.com. A replay of the webcast will be archived on the website for 30 days.
About AMAG-423 (digoxin immune Fab)
Elevated levels of endogenous digitalis-like factors (EDLFs) have been found in the placental and maternal circulation of the majority of patients with preeclampsia, and the degree of elevation has been correlated with severity of changes in creatinine clearance (a measure of kidney function).9 DIF is thought to bind to these factors, causing a decrease in available serum EDLFs and inhibition of their activity. The DEEP trial, a smaller, prior placebo-controlled Phase 2 proof-of-concept study in 51 pregnant women with severe preeclampsia, was suggestive of clinical benefit in both mothers and their babies.10
DIF is currently indicated for the treatment of patients with life-threatening or potentially life-threatening digoxin toxicity or overdose.
AMAG is a pharmaceutical company focused on bringing innovative products to patients with unmet medical needs. The company does this by leveraging its development and commercial expertise to invest in and grow its pharmaceutical products across a range of therapeutic areas, including women’s health. For additional company information, please visit www.amagpharma.com.
Forward Looking Statements
This press release contains forward-looking information about AMAG within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein which do not describe historical facts, including, among others, AMAG’s expectation that AMAG will announce topline data from the Phase 2b/3a study in the first half of 2020 and submit a new drug application to the
Such risks and uncertainties include, among others, the risk that DIF will not be approved on the expected timeline or at all, including as a result of the clinical trial design and enrollment, or as a result of any safety issues that may arise as part of such trial; the risk that, even if approved, the market for AMAG-423 may be smaller than expected or AMAG may not be successful in accessing such market or otherwise realize the expected benefits of the acquisition, as well as those risks identified in AMAG’s filings with the
AMAG disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
AMAG Pharmaceuticals® is a registered trademark of
2 Ananth, C. V., Keyes, K. M., & Wapner, R. J. (2013). Pre-eclampsia rates in
3 Society for Maternal-Fetal Medicine,
4 “Premature Birth,”
5 Ananth, C. V., Keyes, K. M., & Wapner, R. J. (2013). Pre-eclampsia rates in
6 AMAG Phase 2b/3a clinical trial population is a subset of the severe preeclampsia population.
7 Buckalew, V.M. (2018). Role of endogenous digitalis-like factors in the clinical manifestations of severe preeclampsia: a systemic review. Clinical Science, 32(12):1215-1242. http:// doi: 10.1042/CS20171499. Print 2018 Jun 29.
8 Stevens, Warren et al. (2017). Short-term costs of preeclampsia to
9 Lam GK et al, a secondary analysis of the DEEP Trial.
10 Adair, David C. et al. (2010). Digoxin Immune Fab Treatment for Severe Preeclampsia.
Source: AMAG Pharmaceuticals, Inc.