AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) announced today that it
will present new data related to investigational drug bremelanotide
for the treatment of hypoactive sexual desire disorder (HSDD) and
Feraheme® (ferumoxytol) related to iron deficiency
anemia (IDA) resulting from abnormal uterine bleeding (AUB) at the
American College of Obstetricians and Gynecologists (ACOG) Annual
Clinical and Scientific Meeting taking place in Nashville,
Tennessee from May 3-5.
"At ACOG this year we will share new subgroup analyses from our
pivotal bremelanotide trials as well as data looking at ferumoxytol
in women with AUB," said Julie Krop, M.D., chief medical
officer and executive vice president of development at
AMAG. “AMAG has a long history of commitment to women’s
health, as demonstrated by our broad women’s health portfolio
including Intrarosa® and Makena®.”
Bremelanotide Research Podium
Session “Bremelanotide for Hypoactive Sexual Desire
Disorder: Contraceptive Subgroups Efficacy Analysis,” Anita
Clayton, M.D., University of Virginia; Session M, Friday May
3, 10:40-10:50 am CT
Bremelanotide Research Poster Session “Efficacy
of Bremelanotide Across Hypoactive Sexual Desire Disorder
Duration Subgroups,” Sheryl A Kingsberg, PhD, University Hospitals
Cleveland Medical Center; Session M, Saturday, May 4, 3-4 pm CT
Bremelanotide is an investigational drug in development for the
treatment of HSDD in pre-menopausal women. HSDD is a condition
characterized by low sexual desire that causes marked distress or
interpersonal difficulty. Approximately 1 in 10
pre-menopausal women in the United States have HSDD.
Feraheme Research Poster Session“Sustained
Improvements in Anemia and Fatigue of AUB after a Single Course of
Ferumoxytol: 6-month Follow-up,” Naomi V. Dahl, Pharm D, AMAG
Pharmaceuticals, Inc. and Anne Moore, DNP, WHNP-BC, FAANP, AMAG
Pharmaceuticals, Inc.; Saturday, May 4, 11:30-12:30 pm CT
In February of 2018, the U.S. Food and Drug Administration
broadened the existing label for ferumoxytol to include all
eligible adult IDA patients who have intolerance to oral iron or
have had unsatisfactory response to oral iron. Iron deficiency
anemia is a common, treatable condition that occurs when iron
stores are depleted due to an imbalance between iron uptake and
iron utilization. IDA affects an estimated 5 million adults in the
United States. Women are generally at greater risk for IDA than men
and there are several causes of heavy uterine bleeding that result
in low iron levels.
About bremelanotide injection
Bremelanotide, an investigational product candidate, is being
developed for the treatment of hypoactive sexual desire disorder
(HSDD) in pre-menopausal women. The PDUFA date for
bremelanotide is June 23, 2019. Bremelanotide is designed to
be used in anticipation of a sexual encounter, and is thought to
possess a novel mechanism of action that impacts the excitatory
neural pathways in the brain to restore sexual desire.
Bremelanotide has been studied in more than 30 clinical trials
with over 2,500 women. AMAG’s New Drug Application
(NDA) to the U.S. Food and Drug Administration (FDA) was
supported by clinical data from two identical large double-blind
placebo-controlled Phase 3 studies in which bremelanotide met the
pre-specified co-primary efficacy endpoints of improvement in
desire and decrease in distress associated with low sexual desire
as measured by validated patient-reported outcomes. Women in the
trials had the option, after completion of the trial, to continue
in an open-label safety extension study for an additional 12
months. Nearly 80% of patients elected to remain in the open-label
portion of the study, and all of these patients received
bremelanotide.
The most common adverse events were nausea, flushing, injection
site reactions and headache. The majority of events were reported
to be transient and mild-to-moderate in intensity.
Bremelanotide is protected by a number of U.S. and foreign
patents and applications that are owned by Palatin Technologies,
Inc. Certain of the patents include claims directed to the
bremelanotide drug composition and methods of use thereof with
terms expiring in 2020, and other patents include claims directed
to methods of treating female sexual dysfunction by subcutaneous
administration of compositions that include bremelanotide with
terms expiring in 2033.
About Feraheme® (ferumoxytol injection)
Feraheme received marketing approval from the U.S. Food and Drug
Administration (FDA) in June 2009 for the treatment of iron
deficiency anemia (IDA) in adult patients with chronic kidney
disease (CKD). In February 2018, the FDA approved the supplemental
New Drug Application (NDA) to expand the label beyond the CKD
indication to include all eligible adult IDA patients who have
intolerance to oral iron or have had unsatisfactory response to
oral iron in addition to patients who have CKD.
Fatal and serious hypersensitivity reactions including
anaphylaxis have occurred in patients receiving Feraheme. Initial
symptoms may include hypotension, syncope, unresponsiveness,
cardiac/cardiorespiratory arrest. Hypersensitivity reactions have
occurred in patients in whom a previous Feraheme dose was
tolerated. Patients with a history of multiple drug allergies may
have a greater risk of anaphylaxis with parenteral iron
products.
Feraheme is contraindicated in patients with known
hypersensitivity to Feraheme or any of its components, or a history
of allergic reaction to any intravenous iron product. Feraheme
may cause clinically significant hypotension. Excessive
therapy with parenteral iron can lead to excess storage of iron and
possible hemosiderosis. Administration of Feraheme may
transiently affect the diagnostic ability of magnetic resonance
imaging. The most common adverse reactions (≥ 2%) are
diarrhea, headache, nausea, dizziness, hypotension, constipation,
and peripheral edema.
Feraheme is protected in the U.S. by seven issued patents
covering the composition and dosage form of the product, the last
of which expires in June 2023. Certain of these patents are the
subject of a settlement agreement with Sandoz Inc.
For additional product information, including full prescribing
information and the boxed warning, please visit
www.feraheme.com.
About AMAGAMAG 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 the prevalence
of HSDD and IDA in the U.S. and beliefs about the mechanism of
action of bremelanotide 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 bremelanotide will not be approved on a timely basis, or at
all and 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, including
Current Reports on Form 8-K, 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® and Feraheme are registered trademarks
of AMAG Pharmaceuticals, Inc. Makena® is a registered
trademark of AMAG Pharma USA, Inc. Intrarosa is a
registered trademark of Endoceutics, Inc.
AMAG Pharmaceuticals Contacts: Investors: Linda
Lennox908-627-3424
Media: Sarah Connors 781-296-0722
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