AMAG Announces First Patient Enrolled in Phase 2b/3a Digoxin Immune Fab Study Conducted by Velo Bio
June 01 2017 - 8:00AM
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 FabElevated 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.
About AMAGAMAG 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.
Forward-Looking StatementsThis 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.
AMAG Pharmaceuticals, Inc. Contacts:
Investors:
Linda Lennox
Vice President, Investor Relations
908-627-3424
Media:
Katie Payne
Vice President, External Affairs
202-669-6786
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