AMAG Pharmaceuticals provides update on the commercial launch of Feraheme Injection

Jan 10 2010

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today provided an update on the commercial launch of Feraheme® (ferumoxytol) Injection for intravenous (IV) use, including preliminary fourth quarter 2009 Feraheme net product revenues estimates, as well as an update on the Company’s international and label expansion efforts. The Company will present further details at the 28^th Annual J.P. Morgan Healthcare Conference in San Francisco on January 11, 2010 at 11:00 a.m. Pacific time.

“Although we are still in the early days of the launch of Feraheme, we are pleased with the results to date, having ended 2009 with Feraheme being the number one intravenous iron utilized in nephrology offices”

Commercial Launch of Feraheme

• AMAG expects to report fourth quarter 2009 Feraheme net product revenues of between $12 and $13 million (unaudited), including approximately $1 million of the $11.5 million in previously deferred product revenues. The Company expects that utilization of the remaining deferred product revenues from the launch incentive program, which were recorded during the third quarter of 2009, will increase going forward as each launch incentive program customer has now initiated a pilot program and begun to use Feraheme. These deferred revenues will be recognized when the purchases are utilized by these customers; no new deferred revenues are expected to be recorded during the fourth quarter of 2009. The Company continues to expect that total operating expenses for the fourth quarter of 2009 will be higher than those reported for the third quarter of 2009, due primarily to increases in both research and development expenses and commercial spending.
• More than 1,000 customers have purchased Feraheme; collectively, these customers have used 200,000 grams of all forms of IV iron over the past 52 weeks¹. Approximately 60 percent of customers have purchased Feraheme on a repeat basis.
• AMAG estimates that approximately 60 percent of Feraheme provider demand through the first five months of launch was outside of the dialysis setting.

International Expansion

• AMAG has made progress with the international registrational program for Feraheme. In December 2009, the Company filed a New Drug Submission with the Therapeutic Products Directorate of Health Canada, the regulatory authority in Canada, for Feraheme to treat iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD).
• AMAG’s partner in China, 3SBio Inc., filed an application for a registrational trial with the Chinese regulatory agency during the fourth quarter of 2009. The approval of the application will allow 3SBio to begin a bridging study of Feraheme in CKD patients, which is necessary to file for marketing approval in that country.
• AMAG has met with European health authorities and expects to file a Marketing Authorization Application (MAA) for Feraheme for the treatment of IDA in patients with CKD with the European Medicines Agency (EMEA) by mid-2010. To support the MAA, AMAG plans to conduct one additional clinical study evaluating Feraheme treatment compared to treatment with another IV iron. The Company plans to conduct this study concurrent with the EMEA’s review of the Feraheme MAA. AMAG has already received approval for its Pediatric Investigation Plan, which is a prerequisite for the submission of the Feraheme MAA.
• AMAG is in active discussions with potential commercial partners for Feraheme in the E.U.

Label Expansion

• AMAG is working to finalize the protocols with global regulatory authorities for the registrational clinical program of Feraheme for the treatment of iron deficiency anemia regardless of the underlying cause, and intends to initiate the phase III program by mid-2010.
• The Company has finalized and submitted the pediatric protocols to meet its U.S. Food and Drug Administration post-approval Pediatric Research Equity Act requirement to support pediatric labeling, and intends to initiate these studies in 2010.
• AMAG is also advancing the development of ferumoxytol as an imaging agent for vascular enhanced magnetic resonance imaging (VE-MRI), with its phase II trial for patients with suspected peripheral arterial disease now more than 50 percent enrolled.

“Although we are still in the early days of the launch of Feraheme, we are pleased with the results to date, having ended 2009 with Feraheme being the number one intravenous iron utilized in nephrology offices,” said Brian J.G. Pereira, MD, President and Chief Executive Officer of AMAG Pharmaceuticals, Inc. “As we enter 2010, we will have to overcome several challenges to gain market share with dialysis organizations, expand the market for IV iron in non-dialysis CKD patients and make Feraheme the IV iron of choice for CKD patients treated in the hospital setting.”

Dr. Pereira continued, “As we seek to make Feraheme a commercial success for the treatment of iron deficiency anemia in chronic kidney disease patients in the U.S., we remain focused on our other near-term objectives, which include expanding our Feraheme development programs around the world for patients with iron deficiency anemia, with or without chronic kidney disease, and advancing our phase II ferumoxytol imaging program.”