AMAG Pharmaceuticals Completes Divestment of Women’s Health Assets
27 Juli 2020 - 01:30PM
AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG)
today announced AMAG and Palatin Technologies, Inc. have
mutually terminated the January 2017 license agreement pursuant to
which AMAG was granted exclusive rights to develop and
commercialize Vyleesi® (bremelanotide), a melanocortin receptor
agonist indicated for the treatment of acquired, generalized
hypoactive sexual desire disorder (HSDD) in premenopausal women, in
North America.
“Coupled with the recent sale of Intrarosa®, the return of
Vyleesi to Palatin allows us to reduce operating expenses and
prioritize the company’s future value drivers – developing
ciraparantag, maximizing Feraheme’s value to address significant
unmet medical needs, exploring portfolio partnering opportunities
for our established brands and our pipeline, as well as retaining
patient access to Makena,” said Scott Myers AMAG’s president and
chief executive officer. “Palatin’s long-standing commitment to the
melanocortin platform enabled Vyleesi to be developed as the first
as-needed treatment option for HSDD and under their leadership of
the product, premenopausal women suffering from the condition will
have continued access to the therapy.”
Under the terms of the termination agreement, all of AMAG’s
rights and obligations to develop and commercialize Vyleesi under
the license agreement will terminate, and full ownership of Vyleesi
will transfer back to Palatin. AMAG will pay Palatin $12 million at
closing and $4.3 million on March 31, 2021. In exchange for such
payments, Palatin will assume all Vyleesi manufacturing agreements
and associated minimum commitments and AMAG will transfer to
Palatin all data and assets related exclusively to Vyleesi. Under
the agreement, Palatin has agreed to compensate AMAG to provide
certain transitional services to Palatin for a period of time to
ensure continued patient access to Vyleesi during the transition
back to Palatin.
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 AMAG AMAG is a commercial stage
biopharmaceutical 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. 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, expectations about the benefits of the sale of
Intrarosa and Vyleesi to AMAG’s strategy, including AMAG’s ability
to reduce operating expenses, optimize its marketed asset, maximize
Feraheme’s value, retain patient access to Makena or execute on
partnering opportunities are based on management’s current
expectations and beliefs and 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, risks and
uncertainties related to the scale and scope of the COVID-19
pandemic and its impact on AMAG’s revenues and operations, as well
as COVID-19’s impact on AMAG’s business partners, healthcare
providers, patients, employees and the health care industry and
worldwide economies generally, risks related to the divestiture of
Intrarosa and Vyleesi, including any unintended consequences from
such efforts and AMAG’s ability to successfully achieve the
expected benefits of such initiatives in a timely manner, or at
all, risks that Feraheme could face increased competition in the
near term, including as a result of the recent approval of
Monoferric® or if Sandoz’s ANDA is approved 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, 2019, its Current Reports on Form
8-K, its Quarterly Reports on Form 10-Q, including for the quarter
ended March 31, 2020, and in any subsequent filings with 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®, the logo and designs, are registered
trademarks of AMAG Pharmaceuticals, Inc. Any other trademarks
referred to in this report are the property of their respective
owners.
AMAG CONTACTS:Media: Rushmie Nofsinger(781)
530-6838
Investors: Loraine Spreen617-866-0303
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