AMAG Pharmaceuticals, Inc. AMAG announced the achievement of key milestones with respect to its next-generation development programs on Makena and Feraheme.
The company announced that it has initiated a randomized, open-label, parallel definitive pharmacokinetic and the comparative pain study on the Makena subcutaneous auto-injector program (Makena SQ) and has already dosed the first patient in the study.
The definitive pharmacokinetic portion of the study will evaluate the comparable bioavailability between the subcutaneous and intramuscular formulations of Makena. The comparative pain arm, on the other hand, would compare the average pain related to four weekly injections of the subcutaneous and intramuscular injections of Makena using a validated pain scale. The company plans to use the data from the open-label study to determine superiority of Makena SQ auto-injector over the intramuscular injection for a regulatory filing in the U.S. as well as for orphan drug exclusivity for Makena SQ auto-injector.
AMAG intends to file a supplemental new drug application for Makena SQ auto-injector in the second quarter of 2017. A decision should be out in the first quarter of 2018. If approved, Makena SQ auto-injector will ensure easier administration by healthcare providers and less painful injections for patients.
We note that Makena is approved for reducing the risk of preterm birth in women pregnant with a single baby who have a history of singleton, spontaneous, preterm birth.
AMAG launched a single-dose, preservative-free formulation of Makena in the second quarter of 2016. The drug became part of the company’s portfolio following its Nov 2014 Lumara Health acquisition.
AMAG also announced that patient enrollment in the phase III study evaluating the incidence of moderate-to-severe hypersensitivity reactions (including anaphylaxis), and moderate-to-severe hypotension with Feraheme, compared to Injectafer, in adults with iron deficiency anemia (IDA) has exceeded about two-thirds of the total target enrollment of 2,000 patients ahead of schedule. Considering this latest development, the company now plans to file for an sNDA in mid 2017, with a decision on the approval status anticipated in the first half of 2018.
Feraheme is currently approved for the treatment IDA in adult chronic kidney disease (CKD) patients. The company is looking to expand the use of Feraheme beyond the CKD indication to include adult IDA patients who have failed or cannot tolerate oral iron treatment, or in whom oral iron was contraindicated. A potential label expansion will significantly increase the addressable patient population eligible for treatment with Feraheme, upon approval.
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Zacks Rank & Key Picks
AMAG currently sports a Zacks Rank #3 (Hold). Some better-ranked stocks in health care sector include Amarin Corporation plc AMRN, BioMarin Pharmaceutical Inc. BMRN and Exelixis, Inc. EXEL. All the three stocks sport a Zacks Rank #1. You can see the complete list of today’s Zacks #1 Rank stocks here.
Amarin’s loss estimates have narrowed from 53 cents to 40 cents for 2016 and from 36 cents to 27 cents for 2017 over the last 60 days. The company’s share price has soared 65.1% year to date.
BioMarin’s loss estimates narrowed from 28 cents to 27 cents for 2016 and from $1.16 to $1.12 for 2017 over the last 60 days. The company had recorded a positive earnings surprise in three of the four trailing quarters.
Exelixis’ loss estimates narrowed from 76 cents to 63 cents for 2016 and from 22 cents to 3 cents for 2017 over the last 60 days. The company has posted a positive earnings surprise twice in the four trailing quarters with an average beat of 9.1%. Its share price has skyrocketed 117.3% year to date.
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