Full Press Release Details
(Monday, January 9 @ 8
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
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
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
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
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
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
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
1 U.S Census Bureau,
2014; Shifren et all, Sexual Problems and Distress in United States
Women; Obstetrics & Gynecology, Vol. 112, No. 5, November
2 U.S. Census Bureau,
2015 American Community Survey 1-Year Estimates
Proceedings: Hypoactive Sexual Desire Disorder:
International Society for the Study of Women's Sexual Health
(ISSWSH) Expert Consensus Panel Review, Volume 92, Issue 1,
Patient and Economic Flow Study, April 2016
Patient Segmentation Insights, August 2016
Patient and Economic Flow Study, April 2016
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
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
Rekynda (bremelanotide), an investigational product, is thought to
possess a novel mechanism of action, activating endogenous
melanocortin pathways involved in sexual desire and
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.