AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) announced today that it
has submitted a supplemental new drug application (sNDA) to the
U.S. Food and Drug Administration (FDA) for the Makena®
subcutaneous auto-injector, a drug-device combination product. The
current Makena intramuscular (IM) injection is the only
FDA-approved treatment indicated to reduce the risk of preterm
birth in women who are pregnant with one baby and who spontaneously
delivered one preterm baby in the past.
In October 2016, the company initiated a definitive
pharmacokinetic (PK) study which AMAG believes demonstrated
comparable bioavailability between the subcutaneous auto-injector
product and the current IM injection form of Makena in 120 healthy
post-menopausal women. Notably, Makena administered subcutaneously
via the auto-injector demonstrated bioequivalence for area under
the curve (AUC0-to-inf 2,386 ng/mL compared to 2,086 ng/mL for
the IM injection), a key PK parameter, with the 90 percent
confidence interval for the ratio of AUC (105.17 to 124.39) falling
within the 80 to 125 percent range.
“The Makena auto-injector has the potential to meet the needs of
providers by offering the convenience of a ready-to-administer
subcutaneous auto-injector while at the same time providing
patients with an alternative option to an IM injection,” said Julie
Krop, MD, chief medical officer and senior vice president of
clinical development and regulatory affairs at AMAG. “We look
forward to working with the FDA to help bring this drug-device
combination product to market as a demonstration of our commitment
to advancing treatment options for the patients and providers we
serve.”
AMAG recently conducted a survey of treatment preferences of the
administration of Makena via subcutaneous auto-injector compared to
IM administration among 183 women, including some women who are
currently receiving, or previously received, IM hydroxyprogesterone
caproate (HPC) injections, or who are eligible to receive future
therapy based on their obstetric history.1 The analysis
indicated that based on product descriptions, patients would prefer
the Makena subcutaneous auto-injector due to the decreased time
needed to administer the injection, the shorter needle and the lack
of visibility of the needle during the injection process. Further,
it showed that the women also perceived these attributes,
particularly the limited visibility of a subcutaneous needle, as
important drivers of adherence to the therapeutic regimen. These
data were included in the sNDA submission.
AMAG anticipates a six-month FDA review timeline with the
potential for approval and launch in the fourth quarter of 2017.
AMAG developed the Makena auto-injector with its device partner
Antares Pharma, Inc., (NASDAQ:ATRS) which holds issued patents
on the auto-injector. If the Makena auto-injector is approved, AMAG
will request Orange Book listing of the eligible Antares patents,
the last of which expires in 2026.
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.
About Makena® (hydroxyprogesterone caproate injection)
Intramuscular 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.
The effectiveness of Makena is based on improvement in the
proportion of women who delivered <37 weeks of gestation. There
are no controlled trials demonstrating a direct clinical benefit,
such as improvement in neonatal mortality and morbidity.
Limitation 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.
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 effects of Makena include
injection site reactions (pain, swelling, itching, bruising, or a
hard bump), hives, itching, nausea, and diarrhea.
For additional product information, including full prescribing
information, please visit www.makena.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, AMAG’s beliefs about the study data, including that
the PK study demonstrate comparable bioavailability between
the subcutaneous auto-injector and the current IM injections and
that the PK study demonstrated bioequivalence on a key PK parameter
of area under the curve; beliefs that the area under the curve
measurement is a key PK parameter for this study; beliefs that the
auto-injector has the potential to meet the needs of providers by
offering the convenience of a ready-to-administer subcutaneous
auto-injector while providing patients with an alternative option
to an IM injection; AMAG’s ability to bring the drug-device
combination product to market; expectations regarding the approval
timeline of the supplemental new drug application for the Makena
auto-injector product and the timing of launch of the Makena
auto-injector; beliefs about whether women will prefer the Makena
subcutaneous auto-injector and whether certain attributes of the
auto-injector will drive greater adherence to the therapeutic
regimen; the ability to list eligible auto-injector patents in the
Orange Book, 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 of these 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
Pharmaceuticals IP, Ltd. CBR® is a registered trademark of
CBR Systems, Inc.
1 Study conducted by Trinity Healthcare (sponsored by AMAG
Pharmaceuticals, Inc.)
CONTACT:
Investors:
Linda Lennox
Vice President, Investor Relations
908-627-3424
Media:
Katie Payne
Vice President, External Affairs
202-669-6786
AMAG Pharmaceuticals (NASDAQ:AMAG)
Historical Stock Chart
From Mar 2024 to Apr 2024
AMAG Pharmaceuticals (NASDAQ:AMAG)
Historical Stock Chart
From Apr 2023 to Apr 2024