AMAG Pharmaceuticals Inc. (NASDAQ: AMAG) saw its shares skyrocket early on Thursday after the company announced that it received an FDA approval. Specifically, the company said that the FDA approved its supplemental New Drug Application (NDA) for Makena, which was designed as a treatment to reduce the risk of preterm birth in women who are pregnant with one baby and who spontaneously delivered one preterm baby in the past.
This drug-device combination is used in conjunction with the Antares Pharma Inc. (NASDAQ: ATRS) QuickShot device.
Under this arrangement, AMAG will manufacture and supply the drug product to Antares. And in turn, Antares will manufacture the device and be responsible for the assembly and packaging of the final product, which will be sold to AMAG at cost plus margin.
AMAG is also responsible for commercialization and distribution of the final product. Antares will receive high single-digit to low double-digit royalties on net sales as well as sales milestones.
Robert F. Apple, president and CEO of Antares, commented:
Today’s announcement represents the first FDA approval of a drug-device combination product utilizing our QuickShot auto injector. This first pass approval was made possible through an excellent working collaboration with our device team and the development group at AMAG. The Makena QuickShot device was designed to enhance performance on the attributes we believe are most critical to healthcare providers and patient acceptance, including decreased time to administer and use of a shorter, thinner nonvisible needle for subcutaneous injection, while potentially providing an alternative to the existing intramuscular methods of administration. We look forward to our continuing partnership with AMAG as it transitions from development to a commercial supply relationship.
And according to a recent report by Janney Capital:
AMAG received FDA approval yesterday for a new subcutaneous version of Makena, slamming the door on the worst case scenario for its outlook. This dramatically increases the likelihood AMAG can protect the majority the nearly $400 million Makena franchise. Thus far there is no generic to the intramuscular form of Makena despite the expiration of Orphan Drug Exclusivity, which occurred on Feb. 3, 2018. Additionally the FDA approved an expansion of Ferhame’s label to include iron deficiency anemia on Feb. 2. This is likely to lead to acceleration in revenue growth for this franchise that currently accounts for about 20% of AMAG’s revenues
Shares of AMAG were last seen up about 24% at $17.25, with a consensus analyst price target of $17.90 and a 52-week trading range of $11.93 to $25.20.
Antares shares were up roughly 9% at $2.15, with a 52-week range of $1.58 to $4.09 and a consensus price target of $3.73.