Double Blessing Or Double Whammy - What Awaits AMAG?

(RTTNews) - Shares of AMAG Pharmaceuticals Inc. (AMAG) are nearly 43% down from its 52-week high of $25.20 that was recorded on March 8, 2017. With two of the Company's drugs awaiting FDA decision for label expansion, there could be some sharp movement in the level of its stock price in February, depending upon the outcomes.

AMAG Pharma's drugs seeking label expansion are Feraheme, an iron replacement therapy, given by injection, and Makena, the only FDA-approved therapy to reduce recurrent preterm birth in certain at-risk women.

Currently, Feraheme is approved for the treatment of iron deficiency anemia in adult patients only with chronic kidney disease. The Company has sought FDA approval to expand the drug's use in all eligible adult patients with iron deficiency anemia who have failed or cannot tolerate oral iron treatment. The decision on the expanded use of Feraheme is expected on February 2, 2018.

This is the Company's second attempt to get FDA approval for Feraheme for the broader iron deficiency anemia (IDA) indication. The U.S regulatory agency had turned down the Company's request to approve the expanded use of Feraheme in January 2014, and additional clinical trial data in the proposed broad IDA patient population with a primary composite safety endpoint of serious hypersensitivity/anaphylaxis, cardiovascular events, and death were sought.

The Company conducted a phase III non-inferiority clinical trial evaluating Feraheme against FDA-approved Injectafer in approximately 2,000 adults with iron deficiency anemia, which achieved all primary and secondary safety and efficacy endpoints, before seeking FDA approval for the expanded use again.

According to IMS data, the current addressable IV iron market is valued at $390 million. Feraheme notched up revenue of $26.1 million in Q3, 2017, compared to $22.3 million in Q3, 2016. If approved for the expanded use, the addressable market of Feraheme would be doubled, according to the Company.

Makena, the other drug of AMAG Pharma at the FDA altar, is currently available as intramuscular injection formulation. The Company has sought FDA approval for the subcutaneous auto-injector form of the drug, and the FDA decision is expected on February 14, 2018. AMAG developed the Makena auto-injector with its device partner Antares Pharma Inc. (ATRS).

Makena's market share has increased over the years. Sales of Makena were $251 million in 2015, $334 million in 2016, and it is expected to be $385 million to $395 million in 2017. The Company is expected to report fourth quarter and full year 2017 financial results on February 28, 2018.

Will the FDA give AMAG a double blessing?

AMAG is currently trading at $14.55, up 0.69%. The stock has traded in a range of $11.93 to $25.20 in the last 1 year.