WALTHAM, Mass., May 16, 2017 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced the appointment of Helen Milton, Ph.D., to the role of vice president of regulatory affairs. Dr. Milton will have responsibility for AMAG’s regulatory activities, including leading the strategic direction and regulatory approach for all products. She will also oversee the company’s upcoming regulatory filings, which include a supplemental new drug application submission in mid-2017 to potentially broaden the Feraheme® (ferumoxytol) label beyond its current indication, as well as the submission of a new drug application in early 2018 for bremelanotide, an investigational product for the treatment of hypoactive sexual desire disorder.
“We are delighted to have Helen join the AMAG team. She has more than two decades of senior-level experience in clinical drug development and global regulatory affairs and has supported the advancement of products across a broad array of therapeutic areas, including renal, central nervous system, respiratory and oncology,” said Julie Krop, MD, chief medical officer and senior vice president of clinical development and regulatory affairs at AMAG. “Helen’s deep knowledge of the regulatory and pharmaceutical landscape will be extremely valuable to AMAG as we continue to make progress with our product and lifecycle development strategies.”
Dr. Milton has significant experience filing a broad array of regulatory submissions, and has led drug safety and risk management activities both from a US and global perspective. Prior to joining AMAG, she served in leadership roles at Keryx Biopharmaceuticals, Sunovion Pharmaceuticals and Pfizer. Dr. Milton received her doctorate in pharmacology from the University of Liverpool.
Inducement Equity Awards
In connection with Dr. Milton’s entering into employment with AMAG, the Board of Directors of AMAG approved awards to Dr. Milton of (i) an option to purchase 15,000 shares of common stock and (ii) 5,000 restricted stock units. The option will have an exercise price equal to the closing price of AMAG's common stock on the grant date and will be exercisable in four equal annual installments beginning on the first anniversary of the grant date. The option will have a ten-year term and be subject to the terms and conditions of the stock option agreement pursuant to which the option will be granted. The restricted stock units will vest in three equal annual installments beginning on the first anniversary of the grant date and will be subject to the restricted stock unit agreement pursuant to which the restricted stock units will be granted. These equity awards will be granted without stockholder approval as inducements material to Dr. Milton entering into employment with AMAG in accordance with NASDAQ Listing Rule 5635(c)(4).
About Feraheme® (ferumoxytol)
Feraheme received marketing approval from the FDA on June 30, 2009 for the treatment of IDA in adult CKD patients and was commercially launched by AMAG in the U.S. shortly thereafter. Ferumoxytol is protected in the U.S. by seven issued patents covering the composition and dosage form of the product. Six of the issued patents are listed in the FDA’s Orange Book, the last of which expires in June 2023.
Fatal and serious hypersensitivity reactions including anaphylaxis have occurred in patients receiving Feraheme. Initial symptoms may include hypotension, syncope, unresponsiveness, cardiac/cardiorespiratory arrest. Feraheme is contraindicated in patients with a known hypersensitivity to Feraheme or any of its components, or a history of allergic reaction to any intravenous iron product.
For additional product information, please see full Prescribing Information, including Boxed Warning, available at www.feraheme.com.
About Bremelanotide
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 hypoactive sexual desire disorder (HSDD) in pre-menopausal women consisted of double-blind placebo-controlled, randomized parallel group studies comparing a subcutaneous dose of 1.75 mg of bremelanotide 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, bremelanotide 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 bremelanotide.
In both Phase 2 and Phase 3 clinical trials, the most frequent adverse events were nausea, flushing, and headache, which were generally mild-to-moderate in severity.
Bremelanotide has no known alcohol interactions.
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 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.
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 Dr. Milton’s responsibilities at AMAG, including AMAG’s expectations to file an sNDA to broaden the Feraheme label in mid-2017 and to file a new drug application in early 2018 for bremelanotide, AMAG’s belief that Dr. Milton’s deep knowledge of the regulatory and pharmaceutical landscape will be extremely valuable to AMAG to make progress with its product and lifecycle development strategies, 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, those identified in AMAG’s Securities and Exchange Commission (SEC) filings, including AMAG’s Annual Report on Form 10-K for the year ended December 31, 2016, its Quarterly Report on Form 10-Q for the three months ended March 31, 2017 and subsequent filings with the SEC. We caution 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. CBR® is a registered trademark of CBR Systems, Inc.