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AMAG Pharmaceuticals Announces the U.S. Commercial Launch of New Single-Dose, Preservative-Free Makena® (hydroxyprogesterone caproate injection)

WALTHAM, Mass., April 04, 2016 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that the new single-dose, preservative-free Makena® is now available for prescribing. Makena 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.

The single-dose formulation is an expansion of the Makena product line and provides the convenience of a single-use vial for once-weekly dosing, without the need for storage of a multi-dose vial. Available in trays of four, the single-dose formulation provides an alternative package, which allows pharmacists to dispense a month’s supply of four single-dose Makena vials or individual single-dose vials for women who are nearing the end of their course of therapy.

“Single-dose, preservative-free Makena underscores our company’s commitment to listening and responding to requests from healthcare providers and patients,” said Nik Grund, executive vice president and chief commercial officer at AMAG. “Prior to the approval and commercialization of the new single-dose, preservative-free Makena, healthcare providers and patients who wanted a preservative-free formulation of hydroxyprogesterone caproate had to use non-FDA-approved, compounded versions. According to our latest estimates, we believe that approximately 38 percent of pregnant women at risk for recurrent preterm birth are treated with compounded product. This launch now offers our customers and their patients an FDA-approved single-dose, preservative-free version of Makena, manufactured to rigorous FDA standards.”

AMAG has also expanded the operations of its customer support center, Makena Care Connection, which provides comprehensive assistance from start to finish of processing the Makena prescription to include a new feature, “Makena @Home.” This new program offering facilitates home administration of Makena by a trained healthcare professional through the payer-preferred home health agency. Market research indicates that nearly one-third of clinically indicated patients currently receive hydroxyprogesterone caproate injections in the home setting. The Makena Care Connection also has established expertise in supporting patients during their pregnancy by connecting eligible patients to a variety of support services, including a financial assistance program and a maternal health nurse counseling service that coaches patients on the risks of preterm birth and the importance of adhering to weekly Makena injections.

“The launch of single-dose Makena is an important step in our next generation development program for Makena and demonstrates our company’s dedication to improving the options available to prescribers and patients,” said Dr. Rob Kaper, senior vice president of medical and scientific affairs at AMAG. “We are also developing a subcutaneous auto-injector for Makena with a targeted regulatory filing in the first quarter of 2017.”

About Makena® (hydroxyprogesterone caproate injection)

Makena® is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy 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.

Important Safety Information for Makena (hydroxyprogesterone caproate injection)

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 U.S. product information, including full prescribing information, please visit www.makena.com.

About AMAG

AMAG is a biopharmaceutical company focused on bringing therapeutics to market that provide clear benefits and help improve people’s lives. Headquartered in Waltham, MA, AMAG possesses a diverse portfolio of products to support the health of patients in the areas of maternal health, anemia management and cancer supportive care. Through CBR®, the company also helps families to preserve newborn stem cells, which are used today in transplant medicine for certain cancers and blood conditions 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 (PSLRA) and other federal securities laws. Any statements contained herein which do not describe historical facts, including, among others, the expected benefits of the single-dose vial of Makena to healthcare providers and patients; expectations for the next generation development program for Makena, including the targeted timing of a regulatory filing for a subcutaneous auto-injector for Makena; estimates for the population being treated with compounded product and the potential market for the single-dose vial of Makena; the expected benefits of the Makena Care Connection and Makena@Home; AMAG’s ability to provide clear benefits and help improve people’s lives; and the potential role of newborn stem cells in 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 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 Lumara Health IP Ltd. CBR® is a registered trademark of CBR Systems, Inc.


Media Contact: Katie Payne Vice President, External Affairs 617-498-3303 Investor Contact: Linda Lennox Vice President, Investor Relations 617-498-2846

Source:AMAG Pharmaceuticals, Inc.