AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) announced today topline
results from PROLONG (Progestin’s Role in Optimizing Neonatal
Gestation), a randomized, double-blinded, placebo-controlled
clinical trial evaluating Makena® in patients with a history
of a prior spontaneous singleton preterm delivery. The PROLONG
trial was conducted as part of an approval commitment under the
Food & Drug Administration’s (FDA) “Subpart H” accelerated
approval process.
The PROLONG trial did not demonstrate a
statistically significant difference between the treatment and
placebo arms for the co-primary endpoints: the incidence of preterm
delivery at less than 35 weeks (Makena treated group 11.0% vs.
placebo 11.5%, p=.72) and the percentage of patients who met
criteria for the pre-specified neonatal morbidity and mortality
composite index (Makena treated group 5.4% vs 5.2%, p=.84). The
adverse event profile between the two arms was comparable. Adverse
events of special interest, including miscarriage and stillbirth,
were infrequent and similar between the treatment and placebo
groups. The PROLONG trial enrolled approximately 1,700 pregnant
women, over 75 percent of which were enrolled outside the U.S.
“After the initiation of the PROLONG trial and
the approval of Makena in the U.S., Makena became the standard of
care for pregnant women who have had a prior spontaneous preterm
birth. This led to a reluctance by U.S. physicians to enroll their
patients in a placebo-controlled clinical trial and therefore, the
majority of patients in the PROLONG trial were enrolled outside of
the U.S., predominantly from Eastern European countries, with very
different demographics compared to the Meis trial¹,” said Julie
Krop, M.D., AMAG’s Chief Medical Officer. “In light of these recent
findings and the inconsistencies with prior clinical evidence, we
plan to conduct additional sub-group analyses of the PROLONG data,
particularly focusing on patients at the highest risk of preterm
delivery and the subset of patients enrolled in the U.S. We will
work closely with our publications committee to further assess the
data, submit the findings to the FDA, and prepare the data for peer
reviewed publication.”
“As Chair of the PROLONG Publications Committee,
I look forward to working closely with the clinical team to conduct
additional analyses and ensure these data are properly examined
through the scientific peer-review process,” said Sean Blackwell,
M.D., Chair of the Department of Obstetrics, Gynecology, and
Reproductive Sciences at the McGovern Medical School – UTHealth at
Houston and Immediate Past President of the Society for
Maternal-Fetal Medicine (SMFM). “Our committee will be reviewing
the trial data in detail and we will be actively involved in the
analysis and interpretation of the findings. It is clear that the
overall study population of PROLONG is significantly different than
those who participated in the NICHD MFMU² trial with respect
to race, socioeconomic status, and severity of disease. Thus, we
need sufficient time to thoughtfully interpret these findings in
the context of the prior clinical trials.”
_____________________________
¹ See About AMAG section of this press
release for more information on the Meis trial.² National
Institute of Child Health and Human Development (NICHD)
Maternal-Fetal Medicine Units (MFMU) Network.
About Makena® (hydroxyprogesterone
caproate injection)
Makena is a progestin indicated to reduce the
risk of preterm birth in women pregnant with a single baby who have
a history of singleton spontaneous preterm birth. Makena was
approved by the FDA in February 2011 and was granted orphan drug
exclusivity through February 3, 2018. In February of 2018,
AMAG introduced the prefilled Makena auto-injector containing a
short, thin, non-visible needle for subcutaneous use, offering
patients and providers a new administration option.
Makena has certain limitations of use. While
there are many risk factors for preterm birth, safety and efficacy
of Makena has been demonstrated only in women with a prior
spontaneous singleton preterm birth. It is not
intended for use in women with multiple gestations or other risk
factors for preterm birth.
A multicenter, randomized, double-blind, vehicle
(placebo)-controlled clinical trial (the Meis trial), which served
as the basis for the FDA’s approval of Makena, demonstrated a
statistically significant and clinically relevant reduction in the
rate of preterm birth at 37 weeks in the Makena arm (36.3%)
compared to the placebo arm (54.9 %). There are no controlled
trials demonstrating a direct clinical benefit, such as improvement
in neonatal mortality and morbidity.
Makena should not be used in women with any of
the following conditions: blood clots or other blood clotting
problems, breast cancer or other hormone-sensitive cancers, or
history of these conditions; unusual vaginal bleeding not related
to the current pregnancy, yellowing of the skin due to liver
problems during pregnancy, liver problems, including liver tumors,
or uncontrolled high blood pressure. Before patients receive
Makena, they should tell their healthcare provider if they have an
allergy to hydroxyprogesterone caproate, castor oil, or any of the
other ingredients in Makena; diabetes or prediabetes, epilepsy,
migraine headaches, asthma, heart problems, kidney problems,
depression, or high blood pressure.
In one clinical study, certain complications or
events associated with pregnancy occurred more often in women who
received Makena. These included miscarriage (pregnancy loss before
20 weeks of pregnancy), stillbirth (fetal death occurring during or
after the 20th week of pregnancy), hospital admission for preterm
labor, preeclampsia (high blood pressure and too much protein in
the urine), gestational hypertension (high blood pressure caused by
pregnancy), gestational diabetes, and oligohydramnios (low amniotic
fluid levels). Makena may cause serious side effects including
blood clots, allergic reactions, depression, and yellowing of the
skin and the whites of the eyes. The most common side effect
reported with the Makena auto-injector use (and higher than with
the Makena intramuscular injection) was injection site pain.
AMAG developed the Makena auto-injector with its
device partner Antares Pharma, Inc., which holds issued
patents on the auto-injector device and drug-device combination,
the last of which expires in 2034. AMAG also holds a
U.S. patent directed to subcutaneous administration and dosing
of the Makena auto-injector product, which expires in
2036.
For additional product information, including
full prescribing information, please visit www.makena.com.
About AMAG
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 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, statements
regarding AMAG’s beliefs about clinical trial data; beliefs about
the patient-populations involved in the subject trials, including
the challenges with enrollment; plans to analyze and examine data,
including sub-group analyses; the anticipated submission of
findings to the FDA and preparations of the data for peer reviewed
publication; and expectations that the Publications Committee will
review and be actively involved in the findings 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, the risk that the FDA may limit marketing of Makena
and its generic formulation based on the results of the PROLONG
trial, including by withdrawing approval of Makena or imposing
restrictions or requiring warnings on the label; the possibility
that Makena will no longer be the standard of care in the U.S. or
that healthcare providers will be reluctant to prescribe Makena in
light of its efficacy as compared to placebo; the possibility that
further analyses will result in the discovery of data and
experiences that do not support the use of Makena as a viable
treatment option or that further data could negatively impact
Makena’s safety profile, as well as those risks identified in
AMAG’s filings with the U.S. Securities and Exchange Commission
(the SEC), including its Annual Report on Form 10‐K for the year
ended December 31, 2018, and subsequent filings with the SEC, which
are available at the SEC’s website at www.sec.gov. 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. Makena® is a registered
trademark of AMAG Pharma USA, Inc.
AMAG Pharmaceuticals
Contacts:
Investors: Linda Lennox908-627-3424
Media: Sarah Connors 781-296-0722
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