Recently approved first-of-its-kind, non-estrogen
prescription therapy for a common symptom of menopause
AMAG Pharmaceuticals, Inc. (Nasdaq:AMAG) and Endoceutics, Inc.
today announced that they have entered into an exclusive license
agreement that provides AMAG with U.S. commercial rights to
Intrarosa™ (prasterone). Intrarosa is the only FDA-approved,
locally administered, daily, non-estrogen product for the treatment
of moderate-to-severe dyspareunia (pain during intercourse), a
common symptom of vulvar and vaginal atrophy (VVA), due to
menopause. Unlike conventional pharmacological estrogen-containing
medications, Intrarosa does not carry a boxed safety warning in its
label.
“AMAG is pleased to add another product to its expanding women’s
health portfolio and to work with Endoceutics founder Dr. Fernand
Labrie, a world-renowned endocrinologist who led the development of
this innovative treatment approach,” said William Heiden, chief
executive officer of AMAG. “Intrarosa will address a compelling
unmet medical need for post-menopausal women suffering today from
moderate-to-severe dyspareunia who are interested in alternatives
to their current treatment or most of whom choose to go untreated
due to safety concerns about conventional synthetic
estrogen-containing therapies. We look forward to introducing this
new, differentiated therapy to women and their healthcare
providers.”
The transaction represents a further expansion into women’s
health and is an important step in continuing to execute AMAG’s
growth strategy. Earlier this month, AMAG announced the closing of
a license agreement with Palatin Technologies, Inc., for the
exclusive North American rights to develop and commercialize
Rekynda™ (bremelanotide), a potential novel treatment for
hypoactive sexual desire disorder, the most common form of female
sexual dysfunction (FSD). The addition of these two products will
allow AMAG to address key needs across the continuum of women’s
healthcare, with three potential new product launches over the next
two years, starting with Intrarosa in 2017, followed by the Makena
subcutaneous auto-injector and Rekynda, if approved.
Intrarosa enters an existing billion dollar-plus market for
intravaginal prescription therapies that treat VVA symptoms. There
are an estimated 64 million post-menopausal women in the U.S., and
as many as 32 million women suffer from VVA symptoms.1 Studies
suggest that between 44 percent and 78 percent of women with VVA
suffer from dyspareunia.2,3 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.4
Intrarosa contains prasterone, a precursor of hormones that is
converted locally inside the vaginal cells into androgens and
estrogens with no meaningful increases detected in the blood.
Intrarosa does not carry the boxed warnings currently included in
the labels of conventional estrogen-containing medications which
highlight the increased risk of certain types of cancers, such as
endometrial cancer, as well as cardiovascular disorders and
probable dementia. While Intrarosa is currently approved for the
treatment of moderate-to-severe dyspareunia, Endoceutics and AMAG
have agreed to co-develop the product as a potential treatment for
FSD in post-menopausal women.
“As a non-estrogen containing treatment, Intrarosa is a novel
vaginal prescription therapy that provides an important alternative
for patients with moderate-to-severe dyspareunia, a common symptom
of post-menopausal VVA,” said Dr. Fernand Labrie, founder and chief
executive officer of Endoceutics. “Intrarosa stimulates the body’s
natural ability to produce hormones locally and thus significantly
reduces pain during intercourse. Because Intrarosa does not contain
estrogen, patients may feel more comfortable seeking treatment than
with synthetic traditional estrogen-containing hormone
therapies.”
“Endoceutics is committed to ensuring that Intrarosa becomes the
standard of care for the treatment of VVA. In addition to AMAG’s
investments in the success of Intrarosa, Endoceutics plans to put
an additional $20 million toward supporting educational programs in
2017,” Dr. Labrie continued.
AMAG will be expanding its women’s health sales force beyond the
current 100-person Makena- and CBR-focused team with
approximately 150 additional sales representatives dedicated to the
commercialization of Intrarosa. This expanded sales force will
allow AMAG to call on a larger number of OB/GYNs, as well as
provide AMAG with future sales force deployment flexibility in
women’s health, such as the potential launch of Rekynda in early
2019. AMAG expects to launch Intrarosa in the U.S. in mid-2017.
“Three Orange Book-listed patents with terms out to 2031, a
sizeable untapped market and overlap with our current physician
call points make Intrarosa an excellent strategic opportunity for
AMAG that will help drive growth and sustained shareholder value,”
said Frank Thomas, president and chief operating officer of AMAG.
“The additions of FDA-approved Intrarosa and recently licensed
Rekynda will meaningfully add to our expanding women’s health
portfolio. AMAG’s strong cash position, combined with the
cash-generating potential of our current businesses, puts us in an
excellent position to continue to pursue additional acquisition and
licensing opportunities.”
Transaction DetailsUnder the terms of the
license agreement, AMAG will receive the right to commercialize and
develop Intrarosa in the U.S. for the treatment of VVA and FSD. At
closing, AMAG will pay Endoceutics $50 million of total upfront
consideration and issue Endoceutics 600,000 unregistered shares of
AMAG common stock. In addition, AMAG will pay Endoceutics up to $10
million upon delivery of adequate launch quantities of Intrarosa
and $10 million upon the first anniversary of the effective date of
the agreement. Endoceutics will be entitled to certain sales
milestone payments, including a first sales milestone payment of
$15 million, which would be triggered when Intrarosa annual net
U.S. sales exceed $150 million, and a second milestone payment of
$30 million, which would be triggered when annual net U.S. sales
exceed $300 million. Should annual net U.S. sales exceed $500
million, there are additional sales milestone payments of up to
$850 million, which would be triggered at various sales thresholds.
AMAG will also pay Endoceutics tiered royalties as a percent of
Intrarosa net sales ranging from the mid-teens (for calendar year
net sales up to $150 million) to the mid-twenties (for any calendar
year net sales that exceed $1 billion). At closing, AMAG and
Endoceutics will also enter into a supply agreement, under which
Endoceutics will supply Intrarosa to AMAG.
AMAG has also committed to co-fund a Phase 3 clinical program,
which would be conducted by Endoceutics to support regulatory
approval of Intrarosa for the treatment of certain types of FSD in
post-menopausal women. The direct costs of the potential FSD label
expansion study will be shared equally by the parties and capped at
up to $20 million for AMAG. The transaction does not include the
transfer of any Endoceutics employees or facilities.
The license transaction is expected to close in the first half
of 2017 and is subject to customary closing conditions, including
U.S. antitrust approval.
AdvisorsEVOLUTION Life Science Partners LLC, a
division of Gordian Investments, LLC acted as advisor to
Endoceutics. Goodwin Procter LLP served as AMAG’s legal advisor on
the transaction and Cooley LLP served as legal advisor to
Endoceutics.
Conference Call and Webcast AccessAMAG
Pharmaceuticals, Inc. will host a conference call and webcast today
at 8:00 a.m. ET to discuss the Intrarosa license agreement, as well
as the company's 2016 financial results announced today in a
separate news release.
Dial-in NumberU.S./Canada Dial-in Number: (877)
412-6083International Dial-in Number: (702) 495-1202Conference ID:
65936323
Replay Dial-in Number: (855) 859-2056Replay International
Dial-in Number: (404) 537-3406Conference ID: 65936323
A telephone replay will be available from approximately 11:00
a.m. ET on February 14, 2017 through midnight on February 21,
2017.
The webcast with slides will be accessible through the Investors
section of AMAG’s website at www.amagpharma.com. A replay of the
webcast will be archived on the website for 30 days.
About
Intrarosa™ (Prasterone)Intrarosa is
the only FDA-approved, locally administered, daily non-estrogen
steroid 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, also known as
dehydroepiandrosterone (DHEA). Prasterone is an inactive endogenous
steroid, which is converted locally into androgens and estrogens to
help restore the vaginal tissue as indicated by improvements in the
percentage of superficial cells, parabasal cells, and pH. The
mechanism of action is not fully established.
In two primary 12-week placebo-controlled efficacy trials, women
taking Intrarosa experienced a significant reduction in
dyspareunia, as well as significant improvements in the percentage
of vaginal superficial cells and parabasal cells, as well as
vaginal pH. In clinical trials, the most common adverse reactions
were vaginal discharge and abnormal pap smear. Intrarosa has not
been studied in women with a history of breast cancer.
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 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.
About EndoceuticsEndoceutics is a private
pharmaceutical company operating in the field of women’s health and
hormone-sensitive cancer prevention and treatment. Endoceutics
research focuses on developing non estrogen-based therapies for
vulvar and vaginal atrophy, sexual dysfunction and the other
symptoms of menopause, including hot flashes, osteoporosis, muscle
loss and type 2 diabetes. Hormonal therapies for breast, uterine
and prostate cancer, male hypogonadism as well as endometriosis are
also under development.
Endoceutics has five Phase 3 product candidates addressing large
market opportunities and two Phase 1/2 product candidates.
Endoceutics has exclusive worldwide rights to patents, patent
applications, technology and know-how related to all its
products.
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 anticipated further
expansion in and commitment to women’s health through the licensing
transaction with Endoceutics, Inc., including beliefs that AMAG
will serve key needs across the continuum of women’s healthcare;
the ability of Intrarosa to treat moderate-to-severe dyspareunia;
beliefs as to the timing of the commercial launch of Intrarosa, the
Makena subcutaneous auto-injector and Rekynda; beliefs regarding
Intrarosa’s potential benefits and market opportunity; whether
patients may feel more comfortable seeking treatment with Intrarosa
than with traditional estrogen-containing hormone therapies; AMAG’s
commercialization launch strategy of Intrarosa, including its plans
to invest significantly and expand its existing sales force; the
ability of patents covering Intrarosa and AMAG’s current physician
call points to make Intrarosa a growth opportunity that drives
shareholder value; expected investments by Endoceutics in education
programs in 2017; the ability to execute future acquisition and
licensing opportunities; anticipated clinical development plans and
costs for Intrarosa to support regulatory approval of FSD; expected
timing for the closing of the transaction; the timing and amounts
of future milestone payments; expected investment amounts by AMAG
in the potential FSD label expansion 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, (1) the
possibility that the closing conditions set forth in the License
Agreement, including, those related to antitrust clearance, will
not be met and that the parties will be unable to consummate the
proposed transactions; (2) the possibility that AMAG will not
realize the expected benefits of the transaction, including the
anticipated market opportunity and the ability of its current or
expanded sales force to successfully commercialize Intrarosa; (3)
the possibility that significant safety or drug interaction
problems could arise with respect to Intrarosa; (4) the ability of
AMAG to drive awareness of dyspareunia and the potential benefits
of Intrarosa; (5) uncertainties regarding the manufacture of
Intrarosa; (6) uncertainties relating to patents and proprietary
rights associated with Intrarosa in the United States; (7) that the
cost of the transaction to AMAG will be more than planned and/or
will not provide the intended positive financial results; (8) that
AMAG or Endoceutics will fail to fully perform their respective
obligations under the License Agreement or the Supply Agreement;
(9) uncertainty regarding AMAG’s ability to compete in the
dyspareunia market in the United States; and (10) other risks
identified in AMAG’s Securities and Exchange Commission (“SEC”)
filings, including its Annual Report on Form 10-K for the year
ended December 31, 2015, its Quarterly Reports on Form 10-Q for the
quarters ended March 31, 2016, June 30, 2016 and September 30, 2016
and subsequent filings with the SEC, including its Current Reports
on Form 8-K filed with the SEC on January 9, 2017
and February 3, 2017, as well as in its upcoming Annual Report on
Form 10-K for the year ended December 31, 2016. AMAG cautions you
not to place undue reliance on any forward-looking statements,
which speak only as of the date they are made.
1 Wysocki et al. Management of Vaginal Atrophy:
Implications from the REVIVE Survey. Clinical Medicine
Insights: Reproductive Health 2014:8 23–30.
2 Ibid.
3 F. Palma et al: Vaginal atrophy of women in
postmenopause. Results from a multicentric observational study: The
AGATA study.
4 Multiple publications based on patient surveys.
CONTACT:
Investors:
Linda Lennox
Vice President, Investor Relations
908-627-3424
Media:
Katie Payne
Vice President, External Affairs
202-669-6786
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