WALTHAM, Mass., Dec. 21, 2017 (GLOBE NEWSWIRE) — As part of the company’s ongoing support of maternal and neonatal health, AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced it has awarded four grants totaling $300,000 to independent researchers in the field.
“While there are therapeutic options like Makena® (hydroxyprogesterone caproate injection), the only FDA-approved medicine indicated to reduce the risk of recurrent preterm birth in certain at-risk pregnant women, we must better understand the complexities of prematurity,” said Rob Kaper, MD, senior vice president of medical and scientific affairs at AMAG. “The March of Dimes recently reported that preterm birth rates in our country rose for a second year in a rowi, further underscoring the importance of supporting this research through AMAG’s annual prematurity research grants program.”
The 2017 grant recipients were selected by an independent external review panel of several maternal fetal medicine (MFM) specialists. The panel was chaired by George Saade, MD, Professor, Obstetrics/Gynecology and Cell Biology at The University of Texas Medical Branch.
“Research is an important way to advance our understanding of preterm birth, which we hope will ultimately lead to the reduction of babies born too early in our country,” said Dr. Saade. “The review committee was extremely pleased with the number, quality and novelty of the applications this year. Support from organizations like AMAG is critical, enabling these researchers to continue their work and expand our knowledge about preterm birth.”
The following four investigators and studies have been awarded grants:
- Akila Subramaniam, MD, MPH, an associate professor at the University of Alabama at Birmingham Department of Obstetrics and Gynecology, who is researching the relationship of the cervicovaginal microbiome to local inflammation, cervical length shortening and ultrasound-indicated cerclage success;
- Cynthia Gyamfi-Bannerman, MD, MSc, the Ellen Jacobson Levine and Eugene Jacobson Associate Professor of Obstetrics and Gynecology and Co-Director of the Preterm Birth Prevention Center, and Whitney A. Booker, MD, Maternal-Fetal Medicine Fellow at New York-Presbyterian/Columbia University Medical Center, who are researching quantitative activity levels and the possible relationship to gestational age at delivery among nulliparous women;
- Jacqueline Parchem, MD, an assistant professor at the McGovern Medical School, University of Texas Health Science Center at Houston in the Department of Obstetrics, Gynecology & Reproductive Sciences who is researching the role of amniotic fluid exosomes in fetal development and placental membrane health; and
- Kaylon Bruner-Tran, PhD, an associate professor in the Department of Obstetrics and Gynecology at Vanderbilt University School of Medical and co-director of the Women’s Reproductive Health Research Center at Vanderbilt University Medical Center, who is examining mechanisms to eliminate the paternal-derived risks of preterm birth.
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.
About Makena® (hydroxyprogesterone caproate injection)
Makena is a progestin indicated to reduce the risk of preterm birth in women pregnant with a single baby who have a history of singleton spontaneous preterm birth.
The effectiveness of Makena is based on improvement in the proportion of women who delivered <37 weeks of gestation. There are no controlled trials demonstrating a direct clinical benefit, such as improvement in neonatal mortality and morbidity.
Limitation of use: While there are many risk factors for preterm birth, safety and efficacy of Makena has been demonstrated only in women with a prior spontaneous singleton preterm birth. It is not intended for use in women with multiple gestations or other risk factors for preterm birth.
Makena should not be used in women with any of the following conditions: blood clots or other blood clotting problems, breast cancer or other hormone-sensitive cancers, or history of these conditions; unusual vaginal bleeding not related to the current pregnancy, yellowing of the skin due to liver problems during pregnancy, liver problems, including liver tumors, or uncontrolled high blood pressure. Before patients receive Makena, they should tell their healthcare provider if they have an allergy to hydroxyprogesterone caproate, castor oil, or any of the other ingredients in Makena; diabetes or prediabetes, epilepsy, migraine headaches, asthma, heart problems, kidney problems, depression, or high blood pressure.
In one clinical study, certain complications or events associated with pregnancy occurred more often in women who received Makena. These included miscarriage (pregnancy loss before 20 weeks of pregnancy), stillbirth (fetal death occurring during or after the 20th week of pregnancy), hospital admission for preterm labor, preeclampsia (high blood pressure and too much protein in the urine), gestational hypertension (high blood pressure caused by pregnancy), gestational diabetes, and oligohydramnios (low amniotic fluid levels).
Makena may cause serious side effects including blood clots, allergic reactions, depression, and yellowing of the skin and the whites of the eyes. The most common side effects of Makena include injection site reactions (pain, swelling, itching, bruising, or a hard bump), hives, itching, nausea, and diarrhea.
For additional product information, including full prescribing information, please visit www.makena.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, AMAG’s belief that certain research will advance the understanding of preterm birth and neonatal health 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 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, 2016, its Quarterly Reports on Form 10-Q for the quarters ending March 31, 2017, June 30, 2017 and September 30, 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. MuGard® is a registered trademark of Abeona Therapeutics, Inc. Makena® is a registered trademark of AMAG Pharmaceuticals IP, Ltd. Cord Blood Registry® and CBR® are registered trademarks of Cbr Systems, Inc. Intrarosa® is a registered trademark of Endoceutics, Inc.
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