Attached files
file | filename |
---|---|
8-K - CURRENT REPORT - PALATIN TECHNOLOGIES INC | ptn_8k.htm |
Exhibit 99.1
|
FOR IMMEDIATE RELEASE
(Monday, January 9 @ 8
a.m.)
AMAG PHARMACEUTICALS AND PALATIN
TECHNOLOGIES ENTER INTO EXCLUSIVE LICENSING AGREEMENT FOR NORTH
AMERICAN RIGHTS TO REKYNDATM
(BREMELANOTIDE), A POTENTIAL TREATMENT
FOR A COMMON FEMALE SEXUAL DISORDER
Two Phase 3 trials completed for Rekynda; co-primary endpoints
met
Will address underserved medical condition with significant
untapped market potential
Broadens AMAG’s presence in women’s health and
leverages AMAG’s commercial capabilities and customer
relationships
WALTHAM, Mass. and CRANBURY, NJ, January 9, 2017 - AMAG
Pharmaceuticals, Inc. (Nasdaq: AMAG) together with Palatin
Technologies, Inc. (NYSE MKT: PTN) today announced they have
entered into an agreement for exclusive North American rights to
develop and commercialize RekyndaTM
(bremelanotide), an investigational
product designed for on-demand treatment of hypoactive sexual
desire disorder (HSDD) in pre-menopausal women, that has
successfully completed two Phase 3 trials. The anticipated filing
date in the U.S. for a new drug application (NDA) for Rekynda is in
early 2018, with an anticipated approval and launch by early
2019.
“AMAG is excited to expand its women’s health portfolio
with a product that could address a compelling medical problem that
currently is under-addressed,” said William Heiden, chief
executive officer of AMAG. “Rekynda is a natural extension of
our existing women’s health platform and offers us a
compelling opportunity to create awareness and educate patients and
providers about this condition. HSDD can significantly impact
self-image, relationships and the general well-being of millions of
women.”
HSDD, the most common type of female sexual
dysfunction (FSD), is characterized by low sexual desire that
causes marked distress or interpersonal difficulties. HSDD affects
approximately 15 million women in the United
States.1 Approximately 5.8 million of these women are
pre-menopausal and have a primary diagnosis of
HSDD.2,3,4 Despite
one HSDD therapy on the market today for pre-menopausal women,
patient awareness and understanding of the condition remain
extremely low, and few women currently seek
treatment.5 Recent
market research indicates that 95 percent of pre-menopausal women
suffering from HSDD are unaware that it is a treatable medical
condition and that the majority of these women would try a product
like Rekynda, if recommended by their doctor.6
“As a potentially safe, on-demand treatment with a fast onset
of action, Rekynda could offer an important therapeutic alternative
for pre-menopausal women suffering from HSDD,” said Carl
Spana, Ph.D., chief executive officer of Palatin Technologies.
“AMAG’s commercial capabilities are uniquely suited to
raise awareness and understanding of HSDD and the potential
benefits of Rekynda to both providers and patients. I am confident
that AMAG will drive a successful approval and launch of Rekynda in
early 2019.”
Under the terms of the license agreement, AMAG will pay to Palatin
$60 million of total upfront consideration, up to $80 million
contingent upon achieving certain regulatory milestones and up to
$300 million contingent upon meeting certain sales milestones. The
first sales milestone is $25 million and would be triggered when
Rekynda annual net sales in North America exceed $250 million.
Additionally, AMAG expects to reimburse Palatin for up to $25
million of ongoing development expenses incurred by Palatin in
connection with the remaining development of Rekynda in 2017. AMAG
will also pay Palatin tiered royalties on net sales ranging from
high single-digit to low double-digit percentages. AMAG expects the
transaction to close in the first quarter of 2017.
"We are excited about the potential value Rekynda will create for
shareholders as we diversify our women’s health
portfolio,” said Frank Thomas, president and chief operating
officer of AMAG. “HSDD is an under-diagnosed medical
condition with significant untapped market potential, and we
believe our experience in raising awareness and building patient
education programs that directly engage women creates a unique
opportunity for AMAG and for millions of women across the
country.”
About RekyndaTM
(bremelanotide)
Rekynda (bremelanotide), an investigational product, is thought to
possess a novel mechanism of action, activating endogenous
melanocortin pathways involved in sexual desire and
response.
The two Phase 3 studies for HSDD in pre-menopausal women consisted
of double-blind placebo-controlled, randomized parallel group
studies comparing a subcutaneous dose of 1.75 mg Rekynda delivered
via an auto-injector pen to placebo. 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, Rekynda met the pre-specified co-primary efficacy endpoints
of 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 ongoing open-label safety extension study for an
additional 12 months. Nearly 80% of patients elected to remain in
the open-label portion of the study, and all of these patients will
continue to receive Rekynda.
In both Phase 2 and Phase 3 clinical trials, the most frequent
adverse events were nausea, flushing, and headache (generally mild
in nature).
Rekynda has no known alcohol interactions.
Advisors
Leerink Partners LLC served as financial advisor to AMAG on
the transaction. AMAG's legal advisor was Ropes & Gray
LLP. Palatin’s financial advisor for the transaction was
Greenhill & Co., LLC and its legal advisor was Thompson Hine
LLP.
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 products support the health
of patients in the areas of maternal 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 Palatin Technologies
Palatin Technologies, Inc. is a biopharmaceutical company
developing targeted, receptor-specific peptide therapeutics for the
treatment of diseases with significant unmet medical need and
commercial potential. Palatin's strategy is to develop products and
then form marketing collaborations with industry leaders in order
to maximize their commercial potential. For additional
information regarding Palatin, please visit Palatin's website
at www.Palatin.com.
Forward-Looking Statements
This press release contains forward-looking statements 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 but not limited
to statements regarding: AMAG’s anticipated expansion in
women’s health through the licensing transaction with Palatin
Technologies, Inc. and plans regarding the development activity of
Rekynda; the structure of planned and pending Rekynda clinical
trials; the expected timeline, indications and expenditures for
clinical development and commercialization of Rekynda, including
the timing for the new drug application (NDA), subsequent
regulatory action by the Food and Drug Administration and
commercial launch; Rekynda’s strategic fit for AMAG’s
women’s health business, the competitive landscape and the
breadth of the female sexual dysfunction (FSD) and hypoactive
sexual desire disorder (HSDD) markets and Rekynda’s potential
benefits and market potential, the expected timing for the closing
of the transaction, and the potential value Rekynda will create for
AMAG’s shareholders 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: (1) the possibility that the
closing conditions set forth in the license agreement, including
and any required filings under Rule 3-05 of Regulation S-X, will
not be met and that the parties will be unable to consummate the
proposed transactions, (2) uncertainties regarding AMAG’s and
Palatin’s ability to successfully and timely complete
clinical development programs and obtain regulatory approval
for Rekynda in North America, (3) the possibility that
significant safety or drug interaction problems could arise with
respect to Rekynda, (4) the ability of AMAG to raise awareness
and understanding of HSDD and the potential benefits of Rekynda (5)
uncertainties regarding the manufacture of Rekynda, (6)
uncertainties relating to AMAG’s and Palatin’s patents
and proprietary rights in North America, (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
Palatin will fail to fully perform under the license agreement, (9)
uncertainty regarding AMAG’s ability to compete in the FSD
market in North America, and (10) other risks identified in
AMAG’s and Palatin’s Securities and Exchange
Commission filings, including AMAG’s and Palatin’s
Quarterly Report on Form 10-Q for the quarter ended September
30, 2016 and subsequent filings with the SEC. AMAG and Palatin
caution you not to place undue reliance on any forward-looking
statements, which speak only as of the date they are
made.
AMAG and Palatin disclaim 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. RekyndaTM is
a trademark of Palatin Technologies, Inc.
CONTACTS:
Investors for AMAG:
Linda Lennox
Vice President, Investor Relations
908-627-3424
Media for AMAG:
Katie Payne
Vice President, External Affairs
202-669-6786
Investors for Palatin:
Stephen
T. Wills, CPA, MST
Chief
Operating Officer / Chief Financial Officer
609-495-2200
/ info@palatin.com
Media for Palatin:
Paul
Arndt, MBA, LifeSci Advisors, LLC
Managing
Director
646-597-6992
/ paul@lifesciadvisors.com