WALTHAM, Mass., June 26, 2017 (GLOBE NEWSWIRE) — AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that the U.S. Food and Drug Administration (FDA) accepted the supplemental new drug application (sNDA) for the Makena® subcutaneous auto-injector, a drug-device combination product. The agency has established a Prescription Drug User Fee Act (PDUFA) target action date of February 14, 2018. The FDA acknowledged that it had previously communicated a 6-month review to the company for this sNDA, but it has now determined that the filing is subject to a standard 10-month review.
“The FDA’s acceptance of our Makena subcutaneous auto-injector sNDA filing is an important milestone for this product and for pregnant women who have experienced a prior singleton, spontaneous preterm birth,” said Julie Krop, MD, chief medical officer and senior vice president of clinical development and regulatory affairs at AMAG. “We believe that, if approved, this drug-device combination product can help meet the needs of providers by offering the convenience of a ready-to-administer subcutaneous auto-injector while providing patients with an alternative option to an intramuscular injection.”
The current Makena intramuscular injection is the only FDA-approved treatment indicated to reduce the risk of preterm birth in women who are pregnant with one baby and who spontaneously delivered one preterm baby in the past. AMAG developed the Makena auto-injector with its device partner Antares Pharma, Inc. (NASDAQ:ATRS), which holds issued patents on the auto-injector device. If the Makena auto-injector is approved, AMAG will request Orange Book listing of the eligible Antares patents, the last of which expires in 2026.
”We are progressing our plans to bring the Makena subcutaneous auto-injector to market as well as refining our plans to address any potential future competitive threats to the Makena franchise. Our market research indicates that physicians would prescribe the subcutaneous auto-injector form of Makena when available to more than 80% of their patients,” said Nik Grund, chief commercial officer of AMAG. “Today we are continuing to focus our efforts on helping more at-risk women get treated with Makena, and we are reaffirming our 2017 financial guidance, including Makena revenue guidance of $410 million to $440 million.”
About Makena® (hydroxyprogesterone caproate injection) Intramuscular 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.
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, AMAG’s beliefs that, if approved, the Makena auto-injector has the potential to meet the needs of providers by offering the convenience of a ready-to-administer subcutaneous auto-injector while providing patients with an alternative option to an intramuscular injection; the ability to list eligible auto-injector patents in the Orange Book; AMAG’s ability to bring the Makena subcutaneous auto-injector to market and to address potential future competitive threats to the Makena franchise; expectations that physicians might prescribe the auto-injector form of Makena when available to more than 80% of their patients; AMAG’s ability to help more at-risk women get treated with Makena; expectations for 2017 revenue guidance, including Makena revenue guidance 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 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® is a registered trademark of AMAG Pharmaceuticals, Inc. Makena® is a registered trademark of AMAG Pharmaceuticals IP, Ltd. CBR® is a registered trademark of CBR Systems, Inc.
AMAG Pharmaceuticals, Inc. Contacts: Investors: Linda Lennox Vice President, Investor Relations 908-627-3424 Media: Rushmie Nofsinger Executive Director, Corporate Communications 617-498-3332
AMAG Pharmaceuticals, Inc.