AMAG Sees High Feraheme Sales, To Sell Women Healthcare Drugs

We issued an updated report on AMAG Pharmaceuticals (NASDAQ:AMAG) on Mar 6.

AMAG Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of drugs related to maternal health, anemia management and cancer supportive care.

The company achieved record revenues from Feraheme in 2019. The drug’s sales increased 24.4% in 2019 to $167.9 million.

Makena subcutaneous auto-injector recorded sales of $122.1 million in 2019, reflecting a decrease of 62.1% year over year.

Notably, in second-quarter 2019, AMAG took a mutual decision with Prasco to exit the generic intramuscular (IM) market due to the ongoing supply issues and increased generic competition. As a result, Makena IM generated negative revenues, which resulted in a significant loss of market share for the IM brand.

In October 2019, AMAG announced that the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee analyzed data from the PROLONG trial on Makena. The drug is approved to reduce preterm birth in pregnant women, who have had a prior spontaneous preterm delivery. Nine of 16 advisory committee members voted to recommend the FDA to pursue the withdrawal of Makena from the market, while the rest voted in favor of keeping the product in the market under an accelerated approval and requested a new confirmatory trial. The regulatory agency will consider the advisory committee's recommendation when making its decision but is not bound by the same.

Following the advisory committee meeting, the company saw some market contraction and additional net price pressure on Makena in the fourth quarter. The company remains committed to working with the FDA to find the path that could allow at-risk women to have continued access to Makena and to manage Makena-related expenses so that the product is cash flow positive.

The company acknowledged the Makena challenges during its strategic review, which led to the decision of divesting Intrarosa and Vyleesi. This decision is expected to position the company well to continue the development of its pipeline candidates, ciraparantag and AMAG-423; see continued growth of Feraheme; and carry on with its work to retain patient access to Makena.

In January 2019, AMAG completed the previously announced acquisition of Perosphere Pharmaceuticals Inc., a private biopharmaceutical company. Through this acquisition, AMAG added ciraparantag to its development portfolio. Ciraparantag is in development as a single dose, ready-to-use solution for use in patients treated with novel oral anticoagulants (NOACs) or low molecular weight heparin (LMWH) when reversal of the anticoagulant effect of these products is needed for emergency surgery, urgent procedures or due to life-threatening or uncontrolled bleeding.

AMAG also faces intense competition from Sanofi (NASDAQ:SNY) , Novartis’ (NYSE:NVS) generic arm, Sandoz, and ANI Pharmaceuticals (NASDAQ:ANIP) .

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