Definitive pharmacokinetic and comparative pain
studies initiated for Makena subcutaneous auto-injector program
AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that it
has achieved two key milestones in its next generation development
programs. The definitive pharmacokinetic study and the comparative
pain study for the Makena® (hydroxyprogesterone caproate injection)
subcutaneous auto-injector program (Makena SQ) have been initiated
with the first patient dosed. The enrollment of patients in the
Feraheme Phase 3 label expansion trial for the treatment of iron
deficiency anemia (IDA) has surpassed approximately two-thirds of
the total target enrollment of 2,000 patients, resulting in the
acceleration of the estimated supplemental new drug application
(sNDA) filing date to mid-2017.
“We are pleased to announce significant progress on these two
next generation development programs,” said William Heiden, chief
executive officer of AMAG. “The Makena subcutaneous auto-injector
is designed for easier administration by healthcare providers and
potentially less painful injections for patients, and we are
focused on completing the development of this product and bringing
it to market as quickly as possible. With an earlier sNDA filing
for Feraheme, we hope to receive FDA approval for a broader label
sooner than previously forecasted, which if approved, could
significantly expand the number of patients who could benefit from
Feraheme therapy in the future.”
Makena subcutaneous auto-injector development
programThe definitive pharmacokinetic study for the Makena
SQ program is a randomized open label parallel study designed to
demonstrate comparable bioavailability between subcutaneous and
intramuscular injections of Makena. The study is expected to enroll
120 healthy post-menopausal women with a 1:1 randomization.
The comparative pain study is also a randomized open label
parallel study designed to compare the average injection pain of
four weekly injections between the subcutaneous and intramuscular
injections of Makena using a validated pain scale. The study is
expected to enroll 60 healthy, post-menopausal women with a 1:1
randomization. The company intends to use the results from the pain
study to establish clinical superiority of the SQ auto-injector
over the intramuscular injection to support a submission to the FDA
for orphan drug exclusivity for the Makena SQ auto-injector.
AMAG plans to file the sNDA for the Makena SQ auto-injector in
the second quarter of 2017 and anticipates a decision on approval
in the first quarter of 2018.
Phase 3 clinical trial evaluating the safety of Feraheme
compared to InjectaferThis is the final trial that the
company plans to conduct in preparation for filing the sNDA to
broaden the use of Feraheme beyond the current chronic kidney
disease (CKD) indication to include all adult IDA patients who have
failed or cannot tolerate oral iron treatment or in whom oral iron
was contraindicated. Patient enrollment in the clinical trial has
surpassed two-thirds of the total target enrollment mark ahead of
schedule. Based on the rapid pace of enrollment, AMAG now expects
to file the sNDA in mid-2017, with a decision on approval expected
in the first half of 2018. Approval of the broader IDA label would
double the addressable patient population eligible for
Feraheme.
The non-inferiority, randomized, double-blind, multicenter
clinical trial is evaluating the incidence of moderate-to-severe
hypersensitivity reactions (including anaphylaxis), and
moderate-to-severe hypotension with Feraheme compared to Injectafer
in adults with IDA. A total of approximately 2,000 patients will be
randomized in a 1:1 ratio into one of two treatment groups—Feraheme
IV infusion or Injectafer IV infusion. While the trial’s primary
endpoint is safety, the trial will also assess efficacy.
“This clinical trial is progressing well and if the current pace
of enrollment continues, we believe that the trial could be
completed in early 2017,” said Dr. Julie Krop, chief medical
officer and senior vice president of clinical development and
regulatory affairs at AMAG. “We are grateful to the investigators
participating in the trial whose enthusiasm and commitment have
allowed us to enroll the trial much faster than anticipated,
potentially allowing a broader population of patients suffering
from IDA to benefit from Feraheme earlier than previously expected.
We are also pleased that the Makena next generation subcutaneous
auto-injector program is progressing well and we remain on track
for our sNDA filing next year.”
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. 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 the full
prescribing information, please visit www.makena.com.
About Feraheme® (ferumoxytol) InjectionFeraheme
received marketing approval from the FDA on June 30,
2009 for the treatment of IDA in adult CKD patients and was
commercially launched by AMAG in the U.S. shortly thereafter.
Ferumoxytol is protected in the U.S. by six issued patents covering
the composition and dosage form of the product. Each issued patent
is listed in the FDA's Orange Book, the last of which expires
in June 2023.
Fatal and serious hypersensitivity reactions including
anaphylaxis have occurred in patients receiving Feraheme. Initial
symptoms may include hypotension, syncope, unresponsiveness, and
cardiac/cardiorespiratory arrest. Feraheme is contraindicated in
patients with a known hypersensitivity to Feraheme or any of its
components, or a history of allergic reaction to any intravenous
iron product.
For additional product information, please see the full
prescribing information, including Boxed Warning, available
at www.feraheme.com.
About Iron Deficiency AnemiaApproximately 4.5
million Americans suffer from IDA and many IDA patients fail
treatment with oral iron due to intolerability or side effects.
In 2015, an estimated 776,000 patients were treated with IV iron
outside the dialysis setting, approximately half of whom were
estimated to have CKD, with the other half suffering from IDA
caused by conditions other than CKD, including abnormal uterine
bleeding, gastrointestinal disorders, inflammatory diseases and
chemotherapy-induced anemia.
Forward Looking StatementsThis press release
contains forward-looking statements 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, expectations
for the Makena subcutaneous auto-injector program, including design
and size of the definitive pharmacokinetic study and the
comparative pain study, AMAG’s intention to establish clinical
superiority over the intramuscular injection by demonstrating a
reduction in pain, the expected timing of an sNDA submission and
related decision from the FDA; expectations for AMAG’s Phase 3
clinical trial for the broader indication for Feraheme, including
its design and size, the expected timing of an sNDA submission and
related decision from the FDA, the estimated timing of completion
of the trial and the impact of approval of the broader IDA label on
the addressable patient population eligible for Feraheme; 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, 2015, its Quarterly Reports on Form 10-Q
for the quarters ended March 31, 2016 and June 30, 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® and Feraheme® are registered trademark of
AMAG Pharmaceuticals, Inc. Makena® is a registered trademark of
AMAG Pharmaceuticals IP, Ltd. Cord Blood Registry® and CBR®
are registered trademarks of CBR Systems, Inc.
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 products support the health of patients in the areas of
maternal 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.
AMAG Pharmaceuticals Contact Information:
Media
Rushmie Nofsinger
Senior Director, External Affairs
617-498-3332
Investors
Linda Lennox
Vice President, Investor Relations
908-627-3424
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