AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that it
has submitted a New Drug Application (NDA) to the U.S. Food and
Drug Administration (FDA) for bremelanotide, which AMAG in-licensed
from Palatin Technologies, Inc. in February 2017. Bremelanotide is
a first-in-class melanocortin 4 receptor agonist developed to treat
acquired, generalized hypoactive sexual desire disorder (HSDD) in
premenopausal women. It has a novel mechanism of action that
activates the endogenous melanocortin pathways in the brain
involved in the body’s normal sexual desire and arousal responses.
If approved, this new treatment will be available as a subcutaneous
self-injection in a prefilled disposable auto-injector pen for use
in anticipation of a sexual encounter.
“Today’s NDA submission represents a continuation of AMAG’s
commitment to support patients with unmet medical needs, and in
particular it underscores our commitment to women’s health,” said
Julie Krop, M.D., chief medical officer and executive vice
president of clinical development and regulatory affairs at AMAG.
“We are excited by the prospect of introducing a new treatment
option to premenopausal women who suffer from HSDD.”
HSDD is the most common type of Female Sexual Dysfunction
affecting an estimated 12 million women in the United States.1 The
condition is characterized by low sexual desire and marked distress
which are not attributable to existing medical, pharmacologic,
psychiatric, or relationship issues. Approximately 6 million
premenopausal women meet the diagnosis for acquired, generalized
HSDD.2 Patient awareness and understanding of this condition
remains low, and few women currently seek or receive treatment.
Recent industry-sponsored market research indicates that up to 95
percent of premenopausal women suffering from HSDD are unaware that
HSDD is a treatable medical condition.3
AMAG’s NDA submission is supported by clinical data from two
Phase 3 trials in which bremelanotide met the pre-specified
co-primary endpoints of improvement in desire and decrease in
distress as measured by validated patient-reported outcomes. The
most common adverse events were nausea, flushing and headache. The
majority of events were reported to be mild-to-moderate in
intensity and transient.
This submission marks another milestone for AMAG in 2018,
following the FDA approvals of the Makena® (hydroxyprogesterone
caproate injection) subcutaneous auto-injector and the expanded
indication for Feraheme® (ferumoxytol injection) in February.
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 RECONNECT studies for HSDD in premenopausal women
consisted of two double-blind placebo-controlled, randomized
parallel group studies comparing as desired 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 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.
In the Phase 3 clinical trials, the most frequent adverse events
were nausea, flushing, and headache, which were generally
mild-to-moderate in intensity and transient.
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 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 the timing and outcome of the
bremelanotide NDA filing and the results of clinical trials; AMAG’s
beliefs regarding the target product profile for bremelanotide,
including the presumed mode of administration, indication, safety
profile and presumed mechanism of action; the breadth of the HSDD
premenopausal market; AMAG’s beliefs related to condition awareness
of HSDD; and beliefs that newborn stem cells have the potential to
play a valuable role in the development of regenerative medicine
beliefs regarding AMAG’s development capabilities 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 other
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, 2017 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 Pharma USA, Inc. Cord Blood Registry® and
CBR® are registered trademarks of Cbr Systems, Inc.
CONTACTS: Investors: Linda Lennox
908-627-3424
Media: Sarah Connors 781-296-0722
1 Shifren et al, Sexual Problems and Distress in United States
Women; Obstetrics & Gynecology, Vol. 112, No. 5, November
2008; 2014 U.S. Census data
2 Patient & Economic Flow Study sponsored by Palatin
Technologies, Inc. and conducted by Burke Institute, April 2016
3 Patient & Economic Flow Study sponsored by Palatin
Technologies, Inc. and conducted by Burke Institute, April 2016
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