Share price of AMAG Pharmaceuticals, Inc. AMAG has increased 37.9% year to date, against the industry 's decline of 19.0%.
AMAG has three marketed products, namely Feraheme (ferumoxytol), which is approved for intravenous (IV) as iron replacement therapy for the treatment of iron-deficiency anemia (IDA) in adults with chronic kidney disease (CKD); Makena (hydroxyprogesterone caproate injection), which is a progestin approved to reduce the risk of preterm birth in women pregnant with a single baby who have a history of singleton spontaneous preterm birth; and MuGard for the management of oral mucositis and stomatitis.
The company made efforts towards the label expansion of its marketed drugs. In February 2018, the company received FDA approval for the label expansion of Feraheme and Makena. The FDA approved label expansion of Feraheme (ferumoxytol injection) beyond the current CKD indication.
The new approval includes all eligible adult Iron Deficiency Anemia ("IDA") patients who have intolerance to or have had unsatisfactory response to oral iron. The company launched Feraheme with broad IV IDA label during the first quarter of 2018 and the drug is already capturing additional market share.
In February 2018, the FDA also approved a new administration option for Makena- subcutaneous autoinjector drug-device combination product to reduce the risk of preterm birth in certain at-risk women. The company has developed an auto-injector device for subcutaneous administration of Makena (Makena SQ), including chemistry, manufacturing and controls development, in partnership with Antares Pharma. AMAG also launched it in the first quarter of 2018.
Makena SQ auto-injector will ensure easier administration by healthcare providers and less painful injections for patients. This might lead to better sales of the drug. Revenues for the Makena-subcutaneous autoinjector grew three fold in the third quarter of 2018 versus that in the second quarter, and made up 57% of the total Makena brand revenues. The company is optimistic about the Makena subcutaneous autoinjector.
Further, AMAG bought exclusive U.S. rights to develop and commercialize Palatin Technologies' Vyleesi (bremelanotide) this year. Vyleesi is designed for the on-demand treatment of HSDD in pre-menopausal women. In March 2018, AMAG submitted a new drug application (NDA) for bremelanotide to treat hypoactive sexual desire disorder (HSDD), which was accepted by the FDA in June.
Vyleesi is currently under review with the FDA and the company is preparing for the upcoming FDA advisory committee meeting in January 2019 and a PDUFA date of Mar 23, 2019. A potential approval of this candidate will be a big boost for the company as it caters to a huge unmet medical need for women.
To further boost its maternal health portfolio, in September 2018, AMAG exercised its option to acquire the global rights to an orphan drug candidate, AMAG-423. The move was in accordance with an option agreement entered into in July 2015 with Velo Bio, LLC, a privately-held life-sciences company, the terms of which were amended at the time of exercise.
AMAG-423 is a polyclonal antibody, currently in clinical development for the treatment of severe preeclampsia in pregnant women. The candidate has been granted both orphan drug and fast-track review designations by the FDA. AMAG will now complete the phase IIb/IIIa study that Velo initiated in the second quarter of 2017. AMAG expects to report top-line data from the study in the first half of 2020 and plans to submit a new drug application (NDA) to the FDA soon.
Meanwhile, the company completed the divestiture of Cord Blood Registry (CBR) in August 2018 and this sale will allow AMAG to strengthen its balance sheet significantly by paying off its $475-million high-yield notes. The deal also underscores the company's commitment to focus on the development and commercialization of medicines that address unmet medical needs.
However, we note that Feraheme currently competes with IV iron replacement therapies like Venofer, Injectafer, Ferrlecit and their generic versions, among others. Feraheme may also face competition from generic IV iron replacement products that could further limit sales.
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