AMAG Pharmaceuticals, Inc. Announces Presentation of Positive Results from Phase III Studies of Ferumoxytol as an Intravenous Iron Replacement Therapy in Kidney Transplant Recipients at the American Transplant Congress
CAMBRIDGE, Mass.--(Business Wire)--
AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG), a biopharmaceutical
company that utilizes its proprietary nanoparticle technology for the
development and commercialization of therapeutic iron compounds to
treat anemia, and novel imaging agents to aid in the diagnosis of
cancer and cardiovascular disease, today announced positive results
from pooled data from two open-label, multicenter, randomized Phase
III studies of ferumoxytol as an intravenous iron replacement
therapeutic agent. The data are being presented at approximately 5:30
pm ET as a poster at the 8th American Transplant Congress in Toronto,
Canada. The poster is available on the Company's website at
www.amagpharma.com.
The poster, "Ferumoxytol as an Intravenous Iron Replacement
Therapy: Efficacy and Safety in Subjects with Functioning Kidney
Transplants" presents results from 31 patients with chronic kidney
disease (CKD) stages 1-5 with functioning kidney transplants. Patients
received either two doses of 510 mg of intravenous (IV) ferumoxytol
within one week or 200 mg of oral iron daily for three weeks and were
followed for 35 days. The pooled, post-hoc data demonstrated a
statistically significant achievement of the primary endpoint in
patients treated with ferumoxytol compared to those treated with oral
iron. The primary endpoint was the mean change in hemoglobin from
baseline at Day 35.
"We are very pleased to present these positive ferumoxytol results
in CKD patients with functioning kidney transplants and iron
deficiency anemia," stated Brian J.G. Pereira, MD, President and CEO
of AMAG Pharmaceuticals Inc. "The treatment of iron deficiency anemia
with IV iron has not been extensively studied in kidney transplant
recipients. These data are consistent with previously reported
ferumoxytol clinical results and suggest that ferumoxytol may also be
useful in this patient subgroup."
Efficacy and Safety Information Included in Poster
The poster presents pooled results from two Phase III trials
(ClinicalTrials.gov identifiers NCT00255437 and NCT00255424). Efficacy
results from this post-hoc kidney transplant subset analysis showed:
-- For the primary endpoint, the mean change in hemoglobin from
baseline at Day 35, there was a statistically significant
greater mean (+/- standard deviation) increase in hemoglobin
in patients receiving ferumoxytol compared with patients
receiving oral iron (ferumoxytol 1.45 +/- 1.27 g/dl vs. oral
iron -0.09 +/- 1.47 g/dl, p=0.035). There was also a
statistically significantly greater mean increase in
hemoglobin from baseline at Day 21 in patients receiving
ferumoxytol compared with patients receiving oral iron
(ferumoxytol 1.04 +/- 0.97 g/dl vs. oral iron 0.23 +/- 0.52
g/dl; p=0.035).
-- A higher proportion of ferumoxytol-treated patients compared
with oral iron-treated patients achieved a 1.0 g/dL or greater
rise in hemoglobin at Day 21 (47.8% vs. 12.5%; p=0.108) and
Day 35 (60.9% vs. 25.0%; p=0.113).
The incidence of adverse events was lower in patients following
ferumoxytol administration than after oral iron (47.8% vs. 75.0%), as
was the incidence of serious adverse events (13.0% vs. 37.5%).
About AMAG Pharmaceuticals, Inc.
AMAG Pharmaceuticals, Inc. is a biopharmaceutical company that
utilizes its proprietary nanoparticle technology for the development
and commercialization of therapeutic iron compounds to treat anemia
and novel imaging agents to aid in the diagnosis of cancer and
cardiovascular disease.
Ferumoxytol, the Company's key product candidate, is being
developed for use as an intravenous iron replacement therapeutic agent
for the treatment of iron deficiency anemia in chronic kidney disease
patients. The Company has released data on all four planned Phase III
clinical trials of ferumoxytol as an intravenous iron replacement
therapeutic agent in chronic kidney disease patients. The Company
submitted a New Drug Application for marketing approval of ferumoxytol
with the U.S. Food and Drug Administration (FDA) in December 2007,
which was accepted for filing by the FDA in February 2008.
AMAG Pharmaceuticals, Inc.
Kristen Galfetti, 617-498-3362
kgalfetti@amagpharma.com
Copyright Business Wire 2008
