AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that the
U.S. Food and Drug Administration (FDA) approved the Makena®
subcutaneous auto-injector drug-device combination product as a
ready-to-administer treatment to reduce the risk of preterm birth
in women pregnant with one baby and who spontaneously delivered one
preterm baby in the past. The prefilled Makena auto-injector offers
a new administration option for patients and providers and contains
a shorter, thinner non-visible needle compared to the intramuscular
(IM) Makena injection.
“We are proud to deliver on back-to-back FDA approvals of our
next-generation programs for both Makena and Feraheme, and look
forward to maximizing the impact that these innovative products can
deliver for patients and providers,” said William Heiden,
AMAG’s president and chief executive officer. “Today’s
approval provides a significant opportunity for us to extend the
Makena franchise in 2018 and beyond. We have been preparing for
this approval for months and are poised to execute on our
aggressive launch plans, leveraging deep relationships with
providers and payers in the maternal health space to bring this
important therapy to at-risk pregnant women.”
Makena was approved by the FDA in February 2011 and remains the
first and only FDA-approved treatment option currently available
for pregnant women who have had a prior spontaneous preterm birth.
Makena revenues grew to nearly $400 million in 2017, and the
company estimates that approximately half of all eligible patients
are currently treated with Makena. While the product’s 7-year
orphan drug exclusivity expired earlier this month, the company
does not anticipate a generic version of the IM formulation of
Makena to enter the market until mid-year. AMAG expects the
subcutaneous auto-injector to be available in the second half of
March, and the company will continue to offer the IM formulation of
Makena in both single-dose and multi-dose vials. The auto-injector
will be priced at parity with the IM formulation to help ensure
timely and affordable access.
“About one in 10 babies in the U.S. are born prematurely. The
consequences of preterm birth are a significant public health
issue, and Makena has served an important medical need for
appropriate at-risk pregnant mothers over the past several years,”
said Sean Blackwell, M.D., Chair of the Department of Obstetrics,
Gynecology, and Reproductive Sciences at the University of Texas
Medical School and President of the Society for Maternal-Fetal
Medicine (SMFM). “The Makena subcutaneous auto-injector
offers healthcare providers an important alternative mode of
delivery for patients at risk of recurrent preterm birth.”
“Our recent regulatory successes are important steps toward
achieving AMAG’s growth strategy, which includes broadening the
company’s focus on product development and bringing new therapies
to market that address important unmet medical needs,” said Julie
Krop, M.D., chief medical officer and executive vice president of
clinical development and regulatory affairs at AMAG. “The
introduction of our next-generation Makena auto-injector
underscores our continued commitment to maternal and women’s
health. This drug-device combination product, which features a
smaller, non-visible needle, was designed to address some of the
known barriers to treatment of recurrent preterm birth, including
lack of patient acceptance and adherence.”
The majority of Makena IM prescriptions flow through the Makena
Care Connection, which provides patient support and helps ensure
timely and affordable access to Makena therapy. Makena Care
Connection services will be extended to assist providers and
patients with access to the new Makena auto-injector. These
services include prescription support, financial assistance,
connecting mothers to home healthcare services and an education and
adherence program.
AMAG developed the Makena auto-injector with its device partner
Antares Pharma, Inc. (NASDAQ:ATRS), 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. AMAG
will request Orange Book listing of the eligible AMAG and Antares
patents.
Today's approval marks the second sNDA approval this month for
AMAG. In addition, the company expects to file a new drug
application (NDA) this quarter for a new chemical entity
(bremelanotide) to treat hypoactive sexual desire disorder (HSDD),
a common sexual health condition affecting an estimated 15 million
American women. Later this month AMAG plans to report full-year
2017 financial results and provide a company update. The company
anticipates providing an update to its financial revenue and
earnings guidance on its first quarter earnings call in May.
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. The most common
side effects reported with the Makena auto-injector use (and higher
than with the Makena intramuscular injection) was injection site
pain.
For additional product information, including full prescribing
information, please visit www.makena.com.
About Bremelanotide
Bremelanotide, an investigational product, is thought to possess
a novel mechanism of action, activating endogenous melanocortin
pathways involved in sexual desire and response.
The Phase 3 studies for HSDD in pre-menopausal women consisted
of two double-blind placebo-controlled, randomized parallel group
studies comparing on desire use of 1.75 mg of bremelanotide versus
placebo, in each case, delivered via a subcutaneous auto-injector.
Each trial consisted of more than 600 patients randomized in a 1:1
ratio to either the treatment arm or placebo with a 24 week
evaluation period. In both clinical trials, bremelanotide met the
pre-specified co-primary efficacy endpoints of median improvement
in desire and decrease in distress associated with low sexual
desire as measured using validated patient-reported outcome
instruments.
Women in the trials had the option, after completion of the
trial, to continue in an ongoing open-label safety extension study
for an additional 52 weeks. Nearly 80% of patients who completed
the randomized portion of the study elected to remain in the
open-label portion of the study, and all of these patients will
continue to receive bremelanotide.
In both Phase 2 and Phase 3 clinical trials, the most frequent
adverse events were nausea, flushing, and headache, which were
generally mild-to-moderate in severity.
About AMAG 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.
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 expectations about the impact of recent
approvals for Makena and Feraheme next generation programs; AMAG’s
expectations regarding the launch timing for the Makena
subcutaneous auto-injector and AMAG’s ability to execute on
aggressive launch plans for the auto-injector and bring the therapy
to at-risk pregnant women; AMAG’s plans and expected impact
regarding leveraging provider and payer relationships; estimates
regarding the Makena patient population; beliefs about the
auto-injector’s ability to extend the Makena franchise in 2018 and
beyond; AMAG’s expectations about the pricing of the auto-injector
compared to the IM formulation; beliefs about barriers to treatment
for recurrent preterm birth and the ability of the Makena
auto-injector to address those barriers; AMAG’s beliefs that an
authorized generic to the Makena intramuscular product will not
enter the market until the middle of 2018; AMAG’s ability to grow
its business and bring new therapies to market that address
important unmet medical needs; AMAG’s expectations regarding the
submission of a new drug application for bremelanotide in March
2018 and whether the product will be novel and beliefs about the
market opportunity for bremelanotide; AMAG’s belief that the Makena
Care Connection helps ensure timely access to Makena; the ability
to list eligible AMAG and Antares patents for the Makena
auto-injector in the Orange Book; statements about AMAG’s plans to
update its financial revenue and earnings guidance 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, its Quarterly
Report on Form 10-Q for the quarters ended March 31, 2017, June 30,
2017 and September 30, 2017 and subsequent filings with
the SEC, as well as AMAG’s upcoming Annual Report on Form 10-K
for the year ended December 31, 2017. 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,® Feraheme® and Makena Care
Connection® are registered trademarks of AMAG Pharmaceuticals, Inc.
CBR® is a registered trademark of Cbr Systems, Inc.
CONTACTS: Investors: Linda Lennox
908-627-3424
Media: Sarah Connors 781-296-0722
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