WALTHAM, Mass., June 01, 2017 (GLOBE NEWSWIRE) — AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that Velo Bio, LLC has enrolled the first patient in a Phase 2b/3a study designed to evaluate the efficacy and safety of digoxin immune fab (DIF), a polyclonal antibody in development for the treatment of severe preeclampsia in pregnant women. Following completion of the study, AMAG has the exclusive option to acquire the worldwide rights to the DIF program from Velo Bio, a privately held life sciences company, based on the terms of the July 2015 agreement between the two companies. AMAG believes the results of the DIF study may form the basis for a new drug application (NDA) with potential approval of DIF by the U.S. Food and Drug Administration (FDA) in 2020, assuming a submission in 2019.
“Severe preeclampsia can be a life-threatening condition and is a contributing factor in a significant number of preterm births in the U.S., yet no FDA-approved treatment options currently exist,” said Julie Krop, M.D., chief medical officer and senior vice president, clinical development and regulatory affairs at AMAG. “The development and potential approval of DIF for the treatment of severe preeclampsia could have a significant impact on the lives of high-risk pregnant women and their babies, and the therapy would nicely complement AMAG’s existing portfolio of maternal health products.”
Approximately 200 antepartum women with severe preeclampsia will be enrolled in the multi-center, randomized, double-blind, placebo-controlled, parallel-group Phase 2b/3a study. The primary endpoint is a composite endpoint comparing the incidence of babies who develop severe intraventricular hemorrhage, necrotizing enterocolitis or death at 36 weeks post-menstrual age between the DIF and placebo arms.
A 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. DIF has been granted both orphan drug and fast-track review designations by the FDA for use in the treatment of severe preeclampsia and has four issued patents, the last of which expires in 2024.
Severe preeclampsia is characterized by difficult-to-control hypertension with evidence of end organ damage in the mother and/or the baby and often requires immediate delivery to stop disease progression. Severe preeclampsia is one of the leading causes of maternal death and is responsible for 15% of premature births in the U.S. each year, often resulting in morbidity and mortality.
Under the terms of the July 2015 agreement, AMAG may exercise, extend or terminate the acquisition option following completion of the Phase 2b/3a study. The costs associated with the Phase 2b/3a trial are to be incurred by Velo. If AMAG exercises its option to acquire DIF, the company will pay an option fee and a potential U.S. approval milestone, totaling up to $65 million.
About 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 is positively correlated with disease severity. DIF is thought to bind to these factors, causing a decrease in available serum EDLFs and inhibition of their activity.
AMAG is a biopharmaceutical company focused on developing and delivering important therapeutics, conducting clinical research in areas of unmet need and creating education and support programs for the patients and families we serve. Our currently marketed products support the health of patients in the areas of maternal and women’s health, anemia management and cancer supportive care. Through CBR®, we also help families to preserve newborn stem cells, which are used today in transplant medicine for certain cancers and blood, immune and metabolic disorders, and have the potential to play a valuable role in the ongoing development of regenerative medicine. For additional company information, please visit www.amagpharma.com.
This press release contains forward-looking information about AMAG Pharmaceuticals, Inc. 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 beliefs that the results of the Phase 2b/3a study may form the basis for a new drug application (NDA) and potential approval of DIF in 2020; the assumption that an NDA will be submitted in 2019; statements that the development and potential approval of DIF could have a significant impact on the lives of high-risk pregnant women and their babies and would nicely complement AMAG’s existing portfolio of maternal health products; expectations of the size and design of the Phase 2b/3a study; beliefs that DIF study data suggests a clinical benefit in both mothers and their babies; expectations regarding patent protection; beliefs about the efficacy and behavior of DIF; and beliefs that newborn stem cells have the potential to play a valuable role in the development of regenerative medicine are forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements.
Such risks and uncertainties include, among others, those risks identified in AMAG’s filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2016 and subsequent filings with the SEC. Any such risks and uncertainties could materially and adversely affect AMAG’s results of operations, its profitability and its cash flows, which would, in turn, have a significant and adverse impact on AMAG’s stock price. AMAG cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made.
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 AMAG Pharmaceuticals, Inc. CBR® is a registered trademark of CBR Systems, Inc.
CONTACT: AMAG Pharmaceuticals, Inc. Contacts: Investors: Linda Lennox Vice President, Investor Relations 908-627-3424 Media: Katie Payne Vice President, External Affairs 202-669-6786