WALTHAM, Mass. May 3, 2019 – AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) announced today that it will present new data related to investigational drug bremelanotide for the treatment of hypoactive sexual desire disorder (HSDD) and Feraheme® (ferumoxytol) related to iron deficiency anemia (IDA) resulting from abnormal uterine bleeding (AUB) at the American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting taking place in Nashville, Tennessee from May 3-5.
“At ACOG this year we will share new subgroup analyses from our pivotal bremelanotide trials as well as data looking at ferumoxytol in women with AUB,” said Julie Krop, M.D., chief medical officer and executive vice president of development at AMAG. “AMAG has a long history of commitment to women’s health, as demonstrated by our broad women’s health portfolio including Intrarosa® and Makena®.”
Bremelanotide Research Podium Session
“Bremelanotide for Hypoactive Sexual Desire Disorder: Contraceptive Subgroups Efficacy Analysis,” Anita Clayton, M.D., University of Virginia; Session M, Friday May 3, 10:40-10:50 am CT
Bremelanotide Research Poster Session “Efficacy of Bremelanotide Across Hypoactive Sexual Desire Disorder Duration Subgroups,” Sheryl A Kingsberg, PhD, University Hospitals Cleveland Medical Center; Session M, Saturday, May 4, 3-4 pm CT
Bremelanotide is an investigational drug in development for the treatment of HSDD in pre-menopausal women. HSDD is a condition characterized by low sexual desire that causes marked distress or interpersonal difficulty. Approximately 1 in 10 pre-menopausal women in the United States have HSDD.
Feraheme Research Poster Session
“Sustained Improvements in Anemia and Fatigue of AUB after a Single Course of Ferumoxytol: 6-month Follow-up,” Naomi V. Dahl, Pharm D, AMAG Pharmaceuticals, Inc. and Anne Moore, DNP, WHNP-BC, FAANP, AMAG Pharmaceuticals, Inc.; Saturday, May 4, 11:30-12:30 pm CT
In February of 2018, the U.S. Food and Drug Administration broadened the existing label for ferumoxytol to include all eligible adult IDA patients who have intolerance to oral iron or have had unsatisfactory response to oral iron. Iron deficiency anemia is a common, treatable condition that occurs when iron stores are depleted due to an imbalance between iron uptake and iron utilization. IDA affects an estimated 5 million adults in the United States. Women are generally at greater risk for IDA than men and there are several causes of heavy uterine bleeding that result in low iron levels.
About bremelanotide injection
Bremelanotide, an investigational product candidate, is being developed for the treatment of hypoactive sexual desire disorder (HSDD) in pre-menopausal women. The PDUFA date for bremelanotide is June 23, 2019. Bremelanotide is designed to be used in anticipation of a sexual encounter, and is thought to possess a novel mechanism of action that impacts the excitatory neural pathways in the brain to restore sexual desire.
Bremelanotide has been studied in more than 30 clinical trials with over 2,500 women. AMAG’s New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) was supported by clinical data from two identical large double-blind placebo-controlled Phase 3 studies in which bremelanotide met the pre-specified co-primary efficacy endpoints of improvement in desire and decrease in distress associated with low sexual desire as measured by validated patient-reported outcomes. Women in the trials had the option, after completion of the trial, to continue in an 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 received bremelanotide.
The most common adverse events were nausea, flushing, injection site reactions and headache. The majority of events were reported to be transient and mild-to-moderate in intensity.
Bremelanotide is protected by a number of U.S. and foreign patents and applications that are owned by Palatin Technologies, Inc. Certain of the patents include claims directed to the bremelanotide drug composition and methods of use thereof with terms expiring in 2020, and other patents include claims directed to methods of treating female sexual dysfunction by subcutaneous administration of compositions that include bremelanotide with terms expiring in 2033.
About Feraheme® (ferumoxytol injection)
Feraheme received marketing approval from the U.S. Food and Drug Administration (FDA) in June 2009 for the treatment of iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD). In February 2018, the FDA approved the supplemental New Drug Application (NDA) to expand the label beyond the CKD indication to include all eligible adult IDA patients who have intolerance to oral iron or have had unsatisfactory response to oral iron in addition to patients who have CKD.
Fatal and serious hypersensitivity reactions including anaphylaxis have occurred in patients receiving Feraheme. Initial symptoms may include hypotension, syncope, unresponsiveness, cardiac/cardiorespiratory arrest. Hypersensitivity reactions have occurred in patients in whom a previous Feraheme dose was tolerated. Patients with a history of multiple drug allergies may have a greater risk of anaphylaxis with parenteral iron products.
Feraheme is contraindicated in patients with known hypersensitivity to Feraheme or any of its components, or a history of allergic reaction to any intravenous iron product. Feraheme may cause clinically significant hypotension. Excessive therapy with parenteral iron can lead to excess storage of iron and possible hemosiderosis. Administration of Feraheme may transiently affect the diagnostic ability of magnetic resonance imaging. The most common adverse reactions (≥ 2%) are diarrhea, headache, nausea, dizziness, hypotension, constipation, and peripheral edema.
Feraheme is protected in the U.S. by seven issued patents covering the composition and dosage form of the product, the last of which expires in June 2023. Certain of these patents are the subject of a settlement agreement with Sandoz Inc.
For additional product information, including full prescribing information and the boxed warning, please visit www.feraheme.com.
AMAG is a pharmaceutical 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, including women’s health. 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 the prevalence of HSDD and IDA in the U.S. and beliefs about the mechanism of action of bremelanotide 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, the risk that bremelanotide will not be approved on a timely basis, or at all and those risks identified in AMAG’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including its Annual Report on Form 10‐K for the year ended December 31, 2018 and subsequent filings with the SEC, including Current Reports on Form 8-K, 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® and Feraheme are registered trademarks of AMAG Pharmaceuticals, Inc. Makena® is a registered trademark of AMAG Pharma USA, Inc. Intrarosa is a registered trademark of Endoceutics, Inc.
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