AMAG Pharmaceuticals, Inc. (AMAG), an in vitro diagnostics company, has reported revenues of $1 million for the first quarter of 2009, compared with the revenues of $0.61 million in the year-ago quarter. It has also reported a net loss of $26.4 million, or $1.55 per share, for the first quarter of 2009, compared with the net loss of $9.3 million, or $0.55 per share, in the year-ago quarter.
As of March 31, 2009, the company’s cash, cash equivalents, investments and settlement rights associated with certain auction rate securities totaled $194.6 million.
Total operating costs and expenses for the first quarter of 2009were $28.9 million as compared to $13.3 million for the same period in 2008, an increase of $15.6 million. The increase in operating costs and expenses was due to increased research and development expenses to expand the company’s clinical development infrastructure, conduct clinical trials, and scale up the company’s manufacturing capabilities, and increased selling, general and administrative expenses to prepare for the planned commercialization of Feraheme.
During the last several months, we worked with the FDA to address the outstanding regulatory issues referenced in the December 2008 Complete Response letter to our Feraheme New Drug Application (NDA). We are delighted that the FDA has informed us that we have satisfactorily addressed the observations made during the inspection of our manufacturing facility. We look forward to bringing the approval process to closure, commented Brian J.G. Pereira, president and chief executive officer of AMAG We believe that we have established the necessary infrastructure to support the successful commercial launch of Feraheme, which we expect to occur shortly after receiving marketing approval, Pereira added.
Recent Corporate Highlights and Accomplishments
The company was recently informed by the FDA that the observations noted during the recent inspection of the company’s manufacturing facility have been adequately addressed, and that a re-inspection of its manufacturing facility will not be required as a condition to approval of Feraheme.
Following discussions with the FDA, 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. Consequently, the company announced that it will neither commence enrollment in its previously planned Phase III clinical development program in abnormal uterine bleeding, nor advance plans for a separate Phase III program in patients with IDA and cancer.
The company presented two posters with positive resultsfrom two randomized, controlled, open-label, multicenter Phase III studies that included 607 patients with CKD stages 1-5 not on dialysis at the National Kidney Foundation’s Spring Clinical Meetings. The first poster, Increases in Hemoglobin and the Effect of Erythropoiesis-Stimulating Agent (ESA) Use in Non-Dialysis Patients with Chronic Kidney Disease Treated with Ferumoxytol, presented results showing that treatment with ferumoxytol increased hemoglobin, both in the presence and absence of concomitant ESA therapy. The second poster, The Relationship Between Hemoglobin Levels, ESA Use, and Adverse Events in Non-Dialysis CKD Patients Treated with Ferumoxytol, showed that neither a higher maximum achieved hemoglobin nor a larger change in hemoglobin was associated with a higher rate of adverse events in patients treated with ferumoxytol.