Supplemental new drug application on track for second quarter 2017 filing
WALTHAM, Mass., Feb. 02, 2017 (GLOBE NEWSWIRE) — AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced results from its definitive pharmacokinetic (PK) study designed to demonstrate comparable bioavailability of the subcutaneous auto-injector product and the current intramuscular (IM) injection form of Makena in approximately 120 healthy post-menopausal women.
Makena administered subcutaneously demonstrated bioequivalence to the IM injection on area under the curve (AUC0-to-inf 2,386 ng/mL compared to 2,086 ng/mL), with the 90 percent confidence interval for the ratio of AUC (105.17 to 124.39) falling within the 80 to 125 percent range, which the FDA uses to define bioequivalence. The mean maximum or peak plasma concentration (Cmax) for Makena subcutaneous was slightly higher than for the IM (7.3 ng/mL compared to 6.3 ng/mL), with the 90 percent confidence interval for the ratio of Cmax (96.6 to 138.7 percent) falling outside of the bioequivalence range of 80 to 125 percent.
“We believe the results from this definitive PK study have demonstrated comparable bioavailability between the subcutaneous and intramuscular injections of Makena, and we are pleased to have met our primary study objective of demonstrating bioequivalence on the measure of AUC,” said Julie Krop, M.D., chief medical officer and senior vice president of clinical development and regulatory affairs at AMAG. “Because hydroxyprogesterone caproate, the active ingredient in Makena, is a long-acting therapy with a proven safety record, we believe AUC is the most clinically relevant PK parameter.”
“Based on the positive findings from this study, we plan to submit a supplemental new drug application to the FDA for the Makena subcutaneous auto-injector in the second quarter of 2017, with an anticipated decision in the fourth quarter of 2017,” added Dr. Krop.
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 products support the health of patients in the areas of maternal 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 beliefs about the study data, including that the primary study objective of the PK study has been met on the measure of area under the curve and that the top line results demonstrate comparable bioavailability between the subcutaneous and intramuscular injections; beliefs that the area under the curve measurement is the most clinically relevant PK parameter for this study; expectations and plans regarding the submission of a supplemental new drug application for the Makena auto-injector product, including expected timing and potential approval 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, 2015, its Quarterly Reports on Form 10-Q for the quarters ended March 31, 2016, June 30, 2016 and September 30, 2016 and subsequent filings with the SEC, including its Current Report on Form 8-K filed with the SEC on January 9, 2017. Any of these 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® is a registered trademark of AMAG Pharmaceuticals, Inc. Makena® is a registered trademark of AMAG Pharmaceuticals IP, Ltd. Cord Blood Registry® and CBR® are registered trademarks of CBR Systems, Inc.
CONTACTS: Investors: Linda Lennox Vice President, Investor Relations 908-627-3424 Media: Katie Payne Vice President, External Affairs 202-669-6786
AMAG Pharmaceuticals, Inc.