Intrarosa addresses an unmet need for women with
moderate to severe dyspareunia, a common symptom of vulvar and
vaginal atrophy, due to menopause
AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced the
commercial availability of Intrarosa™ (prasterone) at pharmacies
nationwide, supported by a newly created 137-person women’s health
sales force. Intrarosa is the first and only FDA-approved, local
non-estrogen product for the treatment of moderate to severe
dyspareunia (pain during intercourse), a symptom of vulvar and
vaginal atrophy (VVA), due to menopause. Intrarosa contains
prasterone, an inactive precursor that is converted locally into
estrogens and androgens with minimal systemic
exposure.1,2 Intrarosa does not carry a boxed warning in its
label and has no restrictions on duration of use.
Nearly 32 million women (approximately half of all
post-menopausal women in the United States) suffer from symptoms of
VVA.3 Of those women, between 44 percent and 78 percent report
symptoms of dyspareunia (pain during
intercourse).4,5 According to patient survey data, more than
half of women who report symptoms of dyspareunia are not currently
being treated with a prescription therapy or seeking
treatment.6,7
“Intrarosa addresses an important unmet medical need for the
millions of women suffering from moderate to severe dyspareunia,
many of whom are dissatisfied with their current treatment or are
untreated due either to lack of awareness of the condition or
safety concerns with current treatment options,”8 said Nik
Grund, executive vice president and chief commercial officer at
AMAG. “Ensuring the immediate accessibility and affordability of
Intrarosa for patients who have been prescribed the therapy is a
top priority for us at AMAG. Today we are also launching a
comprehensive commercial copay savings program to help ensure that
patients can gain immediate access to this novel therapy.”
Through the Intrarosa Copay Savings Program, qualified
commercially insured patients will receive their first prescription
with a $0 copay and will pay no more than a $25 copay for each
refill for the duration of the program.
“The launch of Intrarosa demonstrates the rapid progress we are
making in executing our corporate strategy to expand AMAG’s product
portfolio with the development and commercialization of products
with significant, long-term growth potential. Intrarosa extends our
commitment to innovation in women’s healthcare and provides us with
a unique opportunity to impact the lives of millions of women,”
said William Heiden, president and chief executive officer at
AMAG.
About IntrarosaTM
(prasterone)Intrarosa is a steroid indicated
for the treatment of moderate to severe dyspareunia, a symptom of
vulvar and vaginal atrophy, due to menopause. Intrarosa contains
prasterone, also known as dehydroepiandrosterone (DHEA). Prasterone
is an inactive endogenous steroid, which is converted locally in
the vagina into androgens and estrogens to help restore the vaginal
tissue as indicated by improvements in the percentage of
superficial cells, parabasal cells, pH and pain with intercourse.
The mechanism of action is not fully established.
Intrarosa is contraindicated in women with undiagnosed abnormal
genital bleeding. Estrogen is a metabolite of prasterone. Use of
exogenous estrogen is contraindicated in women with a known or
suspected history of breast cancer. Intrarosa has not been studied
in women with a history of breast cancer.
In four 12-week randomized, placebo-controlled clinical trials,
the most common adverse reaction with an incidence ≥ 2 percent was
vaginal discharge. In one 52-week open-label clinical trial, the
most common adverse reactions with an incidence ≥ 2 percent were
vaginal discharge and abnormal Pap smear.
Please see full Prescribing Information available
at INTRAROSA.com
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.
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, the belief
that our copay savings program is best-in-class; the belief the
prasterone is converted to androgens and estrogens locally with
minimal systemic exposure; beliefs regarding Intrarosa’s market
opportunity and the ability of Intrarosa to address an important
unmet medical need, including for women who are dissatisfied with
their current treatment or are untreated due to lack of awareness
of the condition or safety concerns; AMAG’s ability to ensure
immediate accessibility and affordability of Intrarosa for patients
who have been prescribed the therapy; the ability of AMAG’s
commercial copay savings program to ensure that patients can gain
immediate access to Intrarosa; beliefs that Intrarosa is a novel
therapy; AMAG’s ability to expand its product portfolio with the
development and commercialization of products with significant,
long-term growth potential; the ability of Intrarosa to impact the
lives of millions of women; 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 quarter ended March 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® is a registered trademark of AMAG
Pharmaceuticals, Inc. CBR® is a registered trademark of Cbr
Systems, Inc. IntrarosaTM is a trademark of Endoceutics,
Inc.
___________________________________1 Intrarosa [package
insert]. Waltham, MA: AMAG Pharmaceuticals, Inc.; 2017.2 The
mechanism of action is not fully established.3 Wysocki et
al. Management of Vaginal Atrophy: Implications from
the REVIVE Survey. Clinical Medicine Insights:
Reproductive Health 2014:8 23–30.4 Ibid.5 F.
Palma et al: Vaginal atrophy of women in postmenopause. Results
from a multicentric observational study: The AGATA
study.6 Wysocki et al. Management of Vaginal Atrophy:
Implications from the REVIVE Survey. Clinical Medicine
Insights: Reproductive Health 2014:8 25.7 Multiple
publications based on patient surveys.8 Kingsberg et al.
Vulvar and Vaginal Atrophy in Postmenopausal Women: Findings from
the REVIVE (REal Women's Views of Treatment Options for Menopausal
Vaginal ChangEs) Survey. J Sex Med 2013; 10: 1795.
CONTACT:
Investors:
Linda Lennox
Vice President, Investor Relations
O: 617-498-2846
M: 908-627-3424
Media:
Rushmie Nofsinger
Executive Director, External Affairs
rnofsinger@amagpharma.com
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