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Label Expansion of Ferahame Bodes Well for AMAG Pharmaceuticals

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Feb. 16 2018, Updated 12:00 p.m. ET

Antares Pharma

AMAG Pharmaceuticals (AMAG) acquired Lumara Health in November 2014. In September 2014, Lumara entered into a development and licensing agreement with Antares Pharma (ATRS). Under the agreement, AMAG received an exclusive, worldwide, royalty-bearing license for the Makena auto-injector.

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Product sales

AMAG Pharmaceuticals’ key products are Makena, Ferahame, MuGard, and Intrarosa. In 3Q17, the Makena injection contributed $97.6 million to AMAG’s total revenues compared with $93.3 million in 3Q16. Revenues from Ferahame rose to $26 million in 3Q17 from $22.2 million in 3Q16. MuGard and Intrarosa contributed $241,000 and $360,000, respectively, in 3Q17.

FDA approval for Ferahame

On February 5, 2018, AMAG Pharmaceuticals announced that it has received FDA (U.S. Food & Drug Administration) approval for its sNDA (supplemental new drug application) for Ferahame. It allows label expansion of Ferahame from its current chronic kidney disease (or CKD) indication to include patients with iron deficiency anemia (or IDA). According to the company, that means doubling the product’s potential market by a million patients per year.

The approval came on the back of two positive Phase 3 trials evaluating Ferahame against iron sucrose or a placebo in a population of patients with IDA.

Stock performance

Since January 5, 2018, AMAG stock has risen 21%. After the label expansion of Makena, the performance of AMAG stock was even more significant. From February 9–15, 2018, the stock rose 46%.

In comparison, Pfizer (PFE), Amgen (AMGN), and Merck & Co. (MRK) stocks have returned -3%, 2.2%, and -9.2%, respectively, in the same period.

In the next part of this series, we’ll take a look at AMAG Pharmaceuticals’ financial performance.

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