FDA Approves AMAG’s Feraheme

After a series of delay, late yesterday (June 30) the FDA finally granted marketing approval for AMAG Pharmaceuticals, Inc.'s (AMAG - Snapshot Report) Feraheme (ferumoxytol) Injection for intravenous (IV) use as an iron replacement therapy for the treatment of iron deficiency anemia in adult patients with chronic kidney disease.

The FDA recommended an initial dose of 510 mg IV injection followed by a second 510 mg IV injection three to eight days later. Feraheme should be administered as an undiluted IV injection delivered at a rate of up to 1 mL/sec (30 mg/sec). The recommended Feraheme dose may be readministered to patients with persistent or recurrent iron deficiency anemia.

AMAG plans to launch Feraheme in the U.S. during the second half of this month. Feraheme will be distributed primarily through wholesalers and specialty distributors. The Company will market and sell Feraheme through its commercial organization consisting of approximately 150 seasoned professionals, including an 80-person specialized sales force, an experienced account management and reimbursement team, and a contract nurse team.

The Feraheme label is expected to treat chronic kidney disease, including patients not on dialysis and patients on dialysis. Iron deficiency anemia is a significant problem in patients with chronic kidney disease, and is frequently underdiagnosed and undertreated. Peak sales of Feraheme could reach $500 million.

As a reminder, Feraheme is AMAG’s lead anti-anemia drug candidate. Feraheme, formerly called ferumoxytol, is an iron oxide nanoparticle which is highly bioavailable. Feraheme can be easily incorporated into hemoglobin with minimal detectable and releasable free iron. The drug candidate is intended to treat iron deficient anemia in chronic kidney disease (CKD) patients.

The company filed a New Drug Application (NDA) with the FDA for the marketing approval of Feraheme on December 19, 2007. The NDA filing was accepted in February 2008 and the company received a complete response letter from the FDA in late October 2008. In Nov 2008, AMAG responded to the complete response letter and the FDA designated the company's resubmission for its NDA as a complete, Class 1 response.

The FDA established a December 30, 2008 Prescription Drug User Fee Act (PDUFA) target action date. However, On Dec 22, 2008, AMAG received a second Complete Response letter from the FDA, requiring additional information. The company responded to the issues raised in the December 2008 complete response letter and the FDA accepted the response in May 12, 2009 and established a PDUFA date of June 29, 2009.

We reiterate our Buy rating for AMAG with a price target of $62.