WALTHAM, Mass., March 26, 2018 (GLOBE NEWSWIRE) — AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for bremelanotide, which AMAG in-licensed from Palatin Technologies, Inc. in February 2017. Bremelanotide is a first-in-class melanocortin 4 receptor agonist developed to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. It has a novel mechanism of action that activates the endogenous melanocortin pathways in the brain involved in the body’s normal sexual desire and arousal responses. If approved, this new treatment will be available as a subcutaneous self-injection in a prefilled disposable auto-injector pen for use in anticipation of a sexual encounter.
“Today’s NDA submission represents a continuation of AMAG’s commitment to support patients with unmet medical needs, and in particular it underscores our commitment to women’s health,” said Julie Krop, M.D., chief medical officer and executive vice president of clinical development and regulatory affairs at AMAG. “We are excited by the prospect of introducing a new treatment option to premenopausal women who suffer from HSDD.”
HSDD is the most common type of Female Sexual Dysfunction affecting an estimated 12 million women in the United States.1 The condition is characterized by low sexual desire and marked distress which are not attributable to existing medical, pharmacologic, psychiatric, or relationship issues. Approximately 6 million premenopausal women meet the diagnosis for acquired, generalized HSDD.2 Patient awareness and understanding of this condition remains low, and few women currently seek or receive treatment. Recent industry-sponsored market research indicates that up to 95 percent of premenopausal women suffering from HSDD are unaware that HSDD is a treatable medical condition.3
AMAG’s NDA submission is supported by clinical data from two Phase 3 trials in which bremelanotide met the pre-specified co-primary endpoints of improvement in desire and decrease in distress as measured by validated patient-reported outcomes. The most common adverse events were nausea, flushing and headache. The majority of events were reported to be mild-to-moderate in intensity and transient.
This submission marks another milestone for AMAG in 2018, following the FDA approvals of the Makena® (hydroxyprogesterone caproate injection) subcutaneous auto-injector and the expanded indication for Feraheme® (ferumoxytol injection) in February.
Bremelanotide, an investigational product, is thought to possess a novel mechanism of action, activating endogenous melanocortin pathways involved in sexual desire and response.
The Phase 3 RECONNECT studies for HSDD in premenopausal women consisted of two double-blind placebo-controlled, randomized parallel group studies comparing as desired use of 1.75 mg of bremelanotide versus placebo, in each case, delivered via a subcutaneous auto-injector. 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, bremelanotide met the pre-specified co-primary efficacy endpoints of median 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 open-label safety extension study for an additional 52 weeks. Nearly 80% of patients who completed the randomized portion of the study elected to remain in the open-label portion of the study.
In the Phase 3 clinical trials, the most frequent adverse events were nausea, flushing, and headache, which were generally mild-to-moderate in intensity and transient.
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 currently marketed products support the health of patients in the areas of maternal and 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.
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 beliefs about the timing and outcome of the bremelanotide NDA filing and the results of clinical trials; AMAG’s beliefs regarding the target product profile for bremelanotide, including the presumed mode of administration, indication, safety profile and presumed mechanism of action; the breadth of the HSDD premenopausal market; AMAG’s beliefs related to condition awareness of HSDD; and beliefs that newborn stem cells have the potential to play a valuable role in the development of regenerative medicine beliefs regarding AMAG’s development capabilities 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, those other 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, 2017 and subsequent filings with the SEC. 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 Feraheme® are registered trademark of AMAG Pharmaceuticals, Inc. Makena® is a registered trademark of AMAG Pharma USA, Inc. Cord Blood Registry® and CBR® are registered trademarks of Cbr Systems, Inc.
1 Shifren et al, Sexual Problems and Distress in United States Women; Obstetrics & Gynecology, Vol. 112, No. 5, November 2008; 2014 U.S. Census data
2 Patient & Economic Flow Study sponsored by Palatin Technologies, Inc. and conducted by Burke Institute, April 2016
3 Patient & Economic Flow Study sponsored by Palatin Technologies, Inc. and conducted by Burke Institute, April 2016