AMAG Down Despite Positive Data on Makena Auto-Injector

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AMAG Pharmaceuticals, Inc.AMAG announced positive top-line results from its pharmacokinetic (PK) study on its subcutaneous auto-injector, Makena. However, the company's shares crashed 7.5% due to some data falling outside the bioequivalence range.

A look at AMAG's share price movement over the past one year shows that the stock has underperformed the Zacks classified Medical-Biomedical/Genetics industry. Specifically, AMAG's stock dropped 6.6% during this period, while the industry lost 5.2%.

Coming back to the latest news, the study was designed to demonstrate comparable bioavailability of Makena subcutaneous auto-injector with the current intramuscular (IM) injection form of the product in healthy post-menopausal women (n=120).

Results of the study revealed that subcutaneous administration of Makena demonstrated bioequivalence to the IM injection, with the 90% confidence interval for the ratio of AUC falling within the 80-125% range, which the FDA uses to define bioequivalence. However, the mean maximum or peak plasma concentration (Cmax) for subcutaneous Makena was slightly higher than the IM arm, with the 90% confidence interval for the ratio of Cmax (96.6% to 138.7%) falling outside the bioequivalence range.

AMAG expects to file a supplemental new drug application (sNDA) with the FDA in the second quarter of 2017, with a response anticipated in the fourth quarter of 2017. Approval of the subcutaneous auto-injector will ensure easier administration by healthcare providers and less painful injections for patients.

We remind investors that Makena subcutaneous auto-injector is being developed in partnership with Antares Pharma, Inc. ATRS .

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. Makena's estimated market share expanded to 41% in the third quarter of 2016 with two thirds of Makena sales coming from single-dose vials.

As per the preliminary full-year financial results provided by the company last month, total revenue is expected in the range $529-$534 million, including Makena sales of $333-$336 million.

We note AMAG is focused on expanding Makena's label in a bid to increase its market share. The company anticipates sales of Makena to continue increasing in the upcoming quarters as the company gains further market share from the compounded product due to the availability of its single-dose, preservative-free formulation, and robust growth in the Makena at-home administration program.

AMAG Pharmaceuticals, Inc. Price and Consensus

AMAG Pharmaceuticals, Inc. Price and Consensus | AMAG Pharmaceuticals, Inc. Quote

Zacks Rank & Key Picks

AMAG currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector include Sucampo Pharmaceuticals, Inc. SCMP and Anika Therapeutics Inc. ANIK . Both the stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today's Zacks #1 Rank stocks here .

Sucampo's earnings estimates for 2017 are up 10.12%, while that for Anika are up 0.5% over the last 60 days. Both the companies recorded a positive earnings surprise in each of the last four quarters, the average being 35.33% and 33.14%, respectively.

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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