AMAG Pharmaceuticals Announces Commercial Availability of Vyleesi™ (Bremelanotide Injection)
27 August 2019 - 10:00PM
AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) announced today that
Vyleesi™ (bremelanotide injection), a melanocortin receptor agonist
indicated for the treatment of acquired, generalized hypoactive
sexual desire disorder (HSDD) in premenopausal women, is now
commercially available through specialty pharmacies, Avella and
BioPlus. Once prescribed, Vyleesi is delivered directly to a
woman’s home. Vyleesi is the first treatment for this patient
population that can be self-administered in anticipation of sexual
activity.
"In my practice I see many women who suffer from HSDD, a medical
condition which impacts approximately 1 in 10 U.S. women," said
Brooke Faught, DNP, WHNP-BC, NCMP, IF, Director of the Women’s
Institute for Sexual Health. "HSDD can significantly impact
self-esteem, body image, and intimate relationships. I’m excited
that I can now offer my patients suffering from this important
condition a treatment option that can be delivered on an as needed
basis."
AMAG is committed to working with payers and healthcare
professionals to help ensure that the millions of eligible
premenopausal women suffering with HSDD have access to
Vyleesi. To help women access
treatment, AMAG is currently offering a copay assistance
program so that eligible patients will be able to obtain their
first four-pack of Vyleesi auto-injectors for $0. Under
the current program, women who choose to refill their prescription
can receive a four-pack of Vyleesi for no more than $99.
Based on usage in clinical trials, a 4-pack is likely to last
patients, on average, 6-8 weeks.
“The team has been working diligently and is excited to make
Vyleesi available to the nearly six million premenopausal women
suffering with HSDD,” said Tony Casciano, chief commercial
officer at AMAG. “We’ve been educating healthcare providers about
Vyleesi with a select group of our sales representatives
across the U.S. over the last few weeks through our early
experience program. We are happy to report that last week we
shipped our very first 4 packs of Vyleesi to patients through our
specialty pharmacy partners. We look forward to launching
nationally with our full sales force in mid-September."
Patients who would like to learn more about HSDD and Vyleesi as
a potential treatment option should speak to a healthcare
professional. One way patients can do that is to schedule a
telemedicine appointment with Plushcare, an independent
telemedicine service. Patients may access Plushcare from the
product website, www.vyleesi.com. Healthcare professionals are
encouraged to visit https://vyleesipro.com/ to learn more.
About Vyleesi™ (bremelanotide
injection)
Vyleesi is approved for the treatment of premenopausal women
with acquired, generalized hypoactive sexual desire disorder
(HSDD). The prefilled Vyleesi autoinjector pen is self-administered
into a woman’s abdomen or thigh at least 45 minutes before
anticipated sexual activity and can be taken at any time of day.
Vyleesi is thought to possess a novel mechanism of action. While
the exact mechanism of action is unknown, Vyleesi is believed to
bind to melanocortin receptors in the central nervous system.
The most common side effects of VYLEESI include nausea,
flushing, injection site reactions, headache and vomiting. Do
not use VYLEESI if you are pregnant, or have uncontrolled
hypertension, known heart disease or are taking oral
naltrexone-containing products intended to treat opioid or alcohol
addiction. Women who can become pregnant should use effective birth
control during treatment with VYLEESI.
For additional product information, including full prescribing
information, please visit www.vyleesi.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
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, beliefs about the size of the potential population for
Vyleesi; statements about AMAG’s ability to make Vyleesi available
to millions of women suffering with HSDD and that its copay program
will help women access Vyleesi; and plans to leverage AMAG’s sales
force 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 ability
of AMAG to successfully execute on its commercialization plans and
the level of market adoption for Vyleesi; the likelihood that
healthcare providers, patients and/or healthcare payers will
support the commercialization and use of Vyleesi; the risk that
AMAG has over-estimated the size of the market for Vyleesi; as well
as 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, 2018, its
Quarterly Report on Form 10-Q for the quarters ended March 31, 2019
and June 30, 2019 and subsequent filings with the U.S. Securities
and Exchange Commission (the “SEC”), 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 the logo are registered trademarks
of AMAG Pharmaceuticals, Inc. Vyleesi™ is a
trademark of AMAG Pharmaceuticals, Inc. and Makena® is a
registered trademark of AMAG Pharma USA, Inc.
AMAG Pharmaceuticals Contacts: Investors: Linda
Lennox908-627-3424
Media: Sarah Connors 781-296-0722
AMAG Pharmaceuticals (NASDAQ:AMAG)
Historical Stock Chart
From Apr 2024 to May 2024
AMAG Pharmaceuticals (NASDAQ:AMAG)
Historical Stock Chart
From May 2023 to May 2024