AMAG Drug Nears Approval

AMAG Pharmaceutical’s Feraheme Close to Approval

AMAG Pharmaceuticals, Inc. (AMAG - Analyst Report) reported first quarter 2009 financial resorts and recent accomplishments Thursday after market close.

Apparently, investors are not interested in its financial results; instead, they are more focused on the approval status of the company’s lead anti-anemia drug Feraheme. In the news release and the conference call, the company disclosed that all outstanding issues pertaining to the manufacturing of Feraheme have been settled to the satisfaction of the FDA, and that a re-inspection of its manufacturing facility will not be required as a condition to approval of Feraheme.

Put another way -- the approval of Feraheme is very close. We estimate a final decision from the FDA by the middle of this year.

As a reminder, Feraheme (formerly called Ferumoxytol) is AMAG’s lead anti-anemia drug candidate. 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 by the FDA in February 2008 and the company received a complete response letter from the FDA in late October 2008.

The finalization of labeling discussion should be an easy one for the company. Therefore, we believe final approval of Feraheme may come as early as this summer.

AMAG also disclosed in the news release, following discussions with the FDA, that the company has decided to pursue a broad phase III clinical development program to treat iron deficiency anemia (IDA) in a wide range of patient populations and in multiple disease states rather than pursue individual indications. This will greatly broaden Feraheme’s utility for anemia.

AMAG plans to launch Feraheme promptly after approval. Sales force of approximately 80 renal sales specialists and managers has been hired and has been out in the field, interacting with physicians on disease state awareness, profiling of accounts and similar activities. The sales team is targeting over 5,000 nephrologists and hematologists in the US.

We reiterate our Buy rating for AMAG.