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AMAG Pharmaceuticals Inc.

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AMAG Pharmaceuticals Announces Completion of Enrollment in its Phase III Program Evaluating Feraheme for a Broader Iron Deficiency Anemia Indication

LEXINGTON, Mass.--(BUSINESS WIRE)--Jan. 30, 2012-- AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced the completion of patient enrollment in the second of the company’s two phase III studies that comprise its global registrational program for Feraheme® (ferumoxytol) in patients with iron-deficiency anemia (IDA) who are not candidates for oral iron, regardless of the underlying cause. The two phase III studies include one comparing treatment with Feraheme to placebo and one comparing treatment with Feraheme to treatment with intravenous iron sucrose. Both studies have now completed enrollment, with more than 1,400 patients enrolled through 210 study sites globally.

“The completion of enrollment in this program is an important step forward in AMAG’s goal to expand Feraheme’s reach to a much larger number of patients who suffer from IDA,” said Lee F. Allen, M.D., Ph.D., executive vice president and chief medical officer of AMAG. “As we complete data collection and analysis over the next few months, the results of these studies will form the basis for global regulatory submissions, which will seek to expand the indication of Feraheme for the treatment of IDA beyond the current indication for adult patients with chronic kidney disease.”
Source: press release, 1/30/12. http://ir.amagpharma.com/phoenix.zhtml?c=61596&p=irol-newsArticle&ID=165...

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AMAG Pharmaceuticals Announces Preliminary Data Regarding the Safety and Efficacy of a Single Infusion of 1020 mg Ferumoxytol (Feraheme®) in Patients with Iron Deficiency Anemia

~Data were presented at the American Society of Hematology Annual Meeting~

LEXINGTON, Mass.--(BUSINESS WIRE)--Dec. 12, 2011-- AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced new clinical data for ferumoxytol (Feraheme®), the company’s treatment for iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD). These data were presented on Saturday, December 10, 2011, at a poster session at the American Society of Hematology annual meeting in San Diego, CA.
Source: press release, 12/12/11. http://ir.amagpharma.com/phoenix.zhtml?c=61596&p=irol-newsArticle&ID=163...

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Brian J.G. Pereira, MD, President and CEO, commented on the progress being made with the phase III Fermoxytol program. He stated, "In additional the global registrational program for the broad IDA indication is now 65% enrolled, so we are making strong progress here as well."
Source: Q2 2011 earnings conference call, 7/26/11.

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Brian J.G. Pereira, MD, President and CEO, commented on the progress being made in enrolling the IDA trial. He stated, "Enrollment continues in the global IDA registrational program and we expect to complete enrollment this year."
Source: Q1 2011 earnings conference call, 5/3/11.

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Complete enrollment in the Company's global registrational program for iron deficiency anemia by the end of 2011;
Source: press release, 2/25/11. http://ir.amagpharma.com/phoenix.zhtml?c=61596&p=irol-newsArticle&ID=153...

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AMAG is currently enrolling patients in its global registrational program for Feraheme for the treatment of iron deficiency anemia, regardless of the underlying cause. The estimated 1,400-patient program consists of two phase III studies, one comparing treatment with Feraheme to placebo, and the other comparing treatment with Feraheme to treatment with intravenous iron sucrose. The Company plans to complete enrollment in this program by year-end 2011.
Source: press release, 1/09/11. http://ir.amagpharma.com/phoenix.zhtml?c=61596&p=irol-newsArticle&ID=151...

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Brian J.G. Pereira, MD, President and CEO, commented on how the safety issues have effected clinical trial enrollment. He stated, "We have not seen any change in the enrollment rate. They are on track."
Source: Q3 2010 earnings conference call, 10/28/10.

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Brian J.G. Pereira, MD, President and CEO, gave guidance for the enrollment completion of Feraheme in iron deficiency anemia regardless of underlying cause. He stated, "The major objective for us in 2010 is to expand the global reach and the label of Feraheme during the quarter we made important strides toward this goal. We filed our marketing authorization application with the European Medicines Agency for Feraheme for the treatment of iron deficiency anemia in adult CKD patients and we initiated enrollment in the global registrational program for Feraheme for the treatment of iron deficiency anemia regardless of the underlying cause. We expect to complete enrollment in these trials by the end of 2011."
Source: Q2 2010 earnings conference call, 7/28/10.

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During the second quarter, AMAG initiated enrollment in its global registrational program for Feraheme for the treatment of iron deficiency anemia, regardless of the underlying cause. The estimated 1,400-patient program consists of two phase III studies, one comparing treatment with Feraheme to placebo, and the other comparing treatment with Feraheme to treatment with intravenous iron sucrose. The company plans to complete enrollment in this program by year end 2011.
Source: press release, 7/28/10. http://ir.amagpharma.com/phoenix.zhtml?c=61596&p=irol-newsArticle&ID=145...

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302 - A Phase III, Randomized, Open-label, Active-Controlled, Trial Comparing Ferumoxytol With Iron Sucrose for the Treatment of Iron Deficiency Anemia
Estimated Enrollment: 600
Study Start Date: June 2010
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Source: clinical trials.gov. http://clinicaltrials.gov/ct2/show/NCT01114204?term=amag&rank=1

Mechanism of action: Ferumoxytol, a nanoparticle (coated super paramagnetic iron oxide), raises the hemoglobin level by an increase in bio-available iron.

Phase of Development: III

Event Type: Data: Phase III trial results

Dates: 2012-04-01 - 2012-06-30

Results:

AMAG Pharmaceuticals Announces New Data from Ferumoxytol Pivotal Phase III Broad Iron Deficiency Anemia Program Presented at ASH

New Data from an Additional Study Exploring 1 Gram Total Dose Infusion of Ferumoxytol also Presented

LEXINGTON, Mass.--(BUSINESS WIRE)--Dec. 10, 2012-- AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that new data from two pivotal phase III clinical trials were presented at the American Society of Hematology’s (ASH) annual meeting in Atlanta, Georgia. The phase III trials evaluated the use of ferumoxytol in subjects with iron deficiency anemia (IDA), regardless of the underlying cause of the anemia, who had failed or could not tolerate oral iron treatment. New data from an investigator-initiated study evaluating a one gram 15-minute infusion of ferumoxytol are also being presented at ASH; the current approved dosing of ferumoxytol is two 510 mg injections, three to eight days apart.

Two poster sessions highlighted the safety and efficacy data from each of the phase III clinical trials: IDA-301 and IDA-302. In addition, an oral presentation contained patient-reported outcome data from IDA-301, which demonstrated a direct correlation between the rise in hemoglobin and improvement in patient-reported measures of fatigue. Data from these two clinical trials will be the foundation for AMAG’s supplemental new drug application (sNDA) in the United States.

More than 4 million Americans have iron deficiency anemia; 1.6 million of whom are estimated to have chronic kidney disease (CKD), while the other 2.4 million suffer from anemia due to other causes.1 For these patients with anemia due to other causes, the underlying diseases or conditions causing IDA include abnormal uterine bleeding, gastrointestinal disorders, inflammatory diseases and chemotherapy-induced anemia. Many IDA patients fail treatment with oral iron due to intolerability or side effects.2

AMAG's sNDA will seek to expand the use of Feraheme® (ferumoxytol) for all adult iron deficiency anemia patients with a history of unsatisfactory use of oral iron. The company expects to submit the sNDA to the U.S. Food and Drug Administration (FDA) this month. In the United States, Feraheme is currently indicated only for the treatment of iron deficiency anemia in adult CKD patients.
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Source: press release, 12/10/12. http://ir.amagpharma.com/phoenix.zhtml?c=61596&p=irol-newsArticle&ID=176...

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AMAG Pharmaceuticals Announces Preliminary Results from its Phase III Study Evaluating Feraheme Compared to IV Iron Sucrose in Patients with Iron Deficiency Anemia

Study Meets Primary Efficacy Endpoints

LEXINGTON, Mass.--(BUSINESS WIRE)--Mar. 7, 2012-- AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today reported preliminary results from the first of two phase III studies that comprise its global registrational program for Feraheme® (ferumoxytol) in patients with iron-deficiency anemia (IDA) regardless of the underlying cause. The study being reported today compared treatment with Feraheme to treatment with intravenous (IV) iron sucrose, and enrolled 605 patients at 74 sites in Europe, Asia Pacific and Australia. The patients enrolled in the study had a history of unsatisfactory oral iron therapy, and had IDA associated with various conditions including abnormal uterine bleeding, cancer, gastrointestinal disorders or other causes.
Source: press release, 3/07/12. http://ir.amagpharma.com/phoenix.zhtml?c=61596&p=irol-newsArticle&ID=167...