WALTHAM, Mass., October 14, 2020 – AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) announced today that it has formally requested a public hearing in response to the U.S. Food and Drug Administration’s (FDA) proposal to withdraw its approval of Makena®, the only FDA-approved treatment, along with its equivalent generics, to reduce preterm birth. Makena was approved in 2011, based on the landmark NICHD MFMU trial by Meis et al. A second, FDA-required trial (PROLONG) predominantly enrolled women outside of the U.S., in countries with markedly lower rates of preterm birth. The PROLONG trial did not show a difference between treatment and vehicle arms with respect to preterm birth or neonatal outcome. However, maternal and fetal safety was re-affirmed.
Today’s hearing request will be followed by a submission of supporting documentation to the FDA. That submission will provide further detail on the company’s reasoning for a hearing, recognizing clinicians’ decade-long use of this treatment and the public health implications of withdrawing its approval. At this time, it is important to note that Makena remains approved and available and the product label remains unchanged.
“We believe it is in the best interest of these high-risk pregnant patients to allow their obstetrical provider to determine whether to use Makena, following the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) guidelines, as well as their own long-standing clinical experience. The continued widening of maternal and infant health disparities among minority and disadvantaged communities, and the potential return to compounded versions of Makena are concerning,” said AMAG CEO Scott Myers. “We remain committed to preserving access to the FDA-approved therapy, as there are no other evidence-based options for these vulnerable patients.”
AMAG submitted a proposal earlier this year to the FDA, requesting to meet and discuss two studies intended to define the patient population who would most benefit from therapy: a retrospective study using real world evidence, and a prospective, primary data collection study. FDA declined the request to meet, stating it was premature. AMAG announced in August that it was beginning the first part of the retrospective study.
Covis Pharma has entered into a transaction to acquire AMAG, which is subject to customary closing conditions including the tender offering and is expected to close in November.
Commenting on AMAG’s hearing request, Covis Pharma CEO Michael Porter said, “We support the efforts by AMAG to preserve patient access to this important treatment option. AMAG and Covis believe in Makena’s efficacy for those at risk for recurrent preterm birth, which are often vulnerable patient groups. We respectfully believe that further study is necessary before precipitously withdrawing the product from the market and are prepared to help formulate and implement appropriate study parameters for additional review of its efficacy.”
ACOG issued a statement in response to FDA’s proposed withdrawal, noting that the need for an effective preterm birth treatment is great. As ACOG further recognized, Makena and its associated generics represent the only treatment currently available to obstetrician-gynecologists to help prevent this condition. ACOG states that their treatment recommendations remain unchanged at this time.
AMAG is a commercial-stage biopharmaceutical company focused on bringing innovative products to patients with unmet medical needs. The company does this by leveraging its development and commercial expertise to invest in and grow its pharmaceutical products across a range of therapeutic areas. For additional company information, please visit www.amagpharma.com.
Forward Looking Statements
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, statements regarding plans to submit, and expectations for, supporting documentation to the FDA; beliefs that it is in the best interest of patients to allow access to Makena; beliefs about maternal and infant health disparities among minority communities and the return to compounded versions of Makena, and that there are no other evidence-based options; beliefs, including beliefs attributed to other groups, in Makena’s efficacy for those at risk, including that further study should be undertaken into the efficacy of Makena before taking action to withdraw the product from the market and the ability of AMAG’s efforts to preserve patient access to Makena; expectations for working towards formulating and implementing appropriate study parameters to be undertaken to confirm Makena’s efficacy after the tender offer and merger transaction between Covis and AMAG closes, and expectations for the recently announced tender offer and merger transaction are based on management’s current expectations and beliefs and 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, risks and uncertainties related to the path forward for Makena and our ability to successfully and timely secure a hearing and compile information that might be helpful to the FDA; the possibility that our request for a hearing could be denied, or that the FDA will withdraw marketing approval for Makena even following such a hearing (or before or during the pendency of the hearing and deliberation), the pursuit and planning of which could be costly and distracting to management, the risks related to the pending tender offer and merger transaction (including as described in our Current Report on Form 8-K filed with the U.S. Securities and Exchange Commission (SEC) on October 1, 2020), and those other risks identified in AMAG’s filings with the SEC, including its Annual Report on Form 10-K for the year ended December 31, 2019 (as amended), its Current Reports on Form 8-K, its Quarterly Reports on Form 10-Q, including for the quarters ended March 31, 2020 and June 30, 2020, and in any subsequent filings with the SEC, which are available at the SEC’s website at www.sec.gov. 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®, the logo and designs, are registered trademarks of AMAG Pharmaceuticals, Inc. Makena® is a registered trademark of AMAG Pharma USA, Inc.
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