ex99-1
Exhibit
99.1
FOR
IMMEDIATE RELEASE
Contacts:
Kristen
Galfetti (investors)
kgalfetti@advancedmagnetics.com
(617)
498-3362
Lynn
Kettleson (media)
lkettleson@clarkecommgroup.com
(978)
463-7952
ADVANCED
MAGNETICS ANNOUNCES POSITIVE RESULTS FROM TWO ADDITIONAL PHASE III
STUDIES
OF FERUMOXYTOL AS AN INTRAVENOUS IRON REPLACEMENT
THERAPEUTIC
CAMBRIDGE,
MA
(April
11, 2007) - Advanced Magnetics (NASDAQ: AMAG) today announced positive results
from two additional Phase III clinical trials of ferumoxytol as an intravenous
(IV) iron replacement therapeutic that are being presented today at
approximately 6:00 pm EDT as posters at the National Kidney Foundation’s Spring
Clinical Meeting in Orlando, Florida. These posters are available in the
investor section on the company’s web site at www.advancedmagnetics.com.
The
first
poster, “Evaluation
of the Efficacy and Safety of Ferumoxytol as an Intravenous Iron Replacement
Therapy in Chronic Kidney Disease (CKD) Patients Not on Dialysis”
shows
results from 303 non-dialysis
dependent CKD patients who
were
randomized to receive either two 510 mg doses of ferumoxytol within one week
or
200 mg of oral iron daily for three weeks. This Phase III study demonstrated
a
statistically significant achievement of all primary and secondary endpoints.
Additionally, all primary and secondary endpoints were achieved with statistical
significance in both patients on erythropoiesis stimulating proteins (ESP)
and
those not on ESPs. These new results are consistent with the results previously
presented at the American Society of Nephrology’s Renal Week in San Diego, CA in
November 2006 from another study in non-dialysis dependent CKD patients with
an
identical protocol.
The
second poster, “Evaluation of the Safety of Intravenous Ferumoxytol for Iron
Replacement Therapy in Chronic Kidney Disease (CKD)” shows results from a
double-blind, placebo-controlled, crossover Phase III study which enrolled
a
total of 750 patients, including both dialysis-dependent CKD patients and
non-dialysis dependent CKD patients, who received either one 510 mg dose of
ferumoxytol or IV placebo (saline) at day zero and received the other treatment
at day seven. The primary safety analysis was the descriptive comparison of
adverse events (AEs) experienced during ferumoxytol and placebo administration.
Treatment related AEs occurred in 37 patients (5.2%) after ferumoxytol treatment
and in 30 patients (4.2%) after placebo treatment. Treatment related serious
adverse events (SAEs), as determined by the investigator, occurred in one
patient (0.1%) after ferumoxytol treatment and in one patient (0.1%) after
placebo treatment.
“The
data
from these studies are very promising because they demonstrate a statistically
significant improvement in hemoglobin levels for non-dialysis dependent CKD
patients undergoing ferumoxytol therapy as compared to oral iron therapy. In
my
opinion, the results from these two new studies, in conjunction with previous
clinical trials, support an attractive profile for ferumoxytol,” stated Allen
Nissenson, MD, Professor of Medicine and Director of the Dialysis Program at
David Geffen School of Medicine at UCLA and Chair of the Ferumoxytol Scientific
Advisory Board.
“We
are
very pleased with the results that we are presenting today at the National
Kidney Foundation meeting,” stated Brian J.G. Pereira, MD, President and CEO of
Advanced Magnetics. “We have now presented data from three of the four studies
in the pivotal program for ferumoxytol. These new results are encouraging,
and
we remain on track to file our NDA for ferumoxytol in the fourth calendar
quarter of 2007.”
Efficacy
and Safety Study in Non-Dialysis Dependent CKD
Poster
The
first
poster shows results from the second of two efficacy and safety studies in
non-dialysis dependent CKD patients (Protocol 62,745-7; ClinicalTrials.gov
identifier NCT00255437). Efficacy results in the intent to treat (ITT) and
efficacy evaluable populations were similar. Efficacy results from the ITT
analysis showed:
| · |
For
the primary endpoint, which is change in hemoglobin from baseline
at Day
35, patients receiving ferumoxytol had a significantly greater mean
increase in hemoglobin compared to patients receiving oral iron
(ferumoxytol 1.24 ± 1.25 g/dl vs. oral iron 0.50 ± 0.98 g/dl,
p<0.0001).
|
| · |
Ferumoxytol
was more likely to increase baseline hemoglobin by ≥ 1 g/dl compared to
oral iron (52.9% of ferumoxytol patients vs. 18.2% of oral iron patients,
p<0.0001).
|
| · |
Mean
increase in serum ferritin from baseline was significantly greater
in the
ferumoxytol group compared to the oral iron group at Day 21 (ferumoxytol
416.0 ± 249.0 ng/ml vs. oral iron 4.3 ± 48.2 ng/ml,
p<0.0001).
|
| · |
Stratifying
by ESP use, there was a significantly greater increase in hemoglobin
at
Day 35 for ferumoxytol compared to oral iron in both patients who
were on
ESPs and those who were not on
ESPs.
|
| · |
In
patients on a stable ESP dose, mean hemoglobin increase at Day 35
was 1.66
± 1.38 g/dl for ferumoxytol compared to 0.82 ± 1.28 g/dl for oral iron
(p=0.0024). In addition, 66.3% of patients treated with ferumoxytol
experienced an increase of ≥ 1 g/dl in hemoglobin compared to 35.3% of
patients treated with oral iron
(p=0.0017).
|
| · |
Similarly,
in patients not treated with ESPs, mean hemoglobin increase at Day
35 was
0.93 ± 1.05 g/dl for ferumoxytol compared to 0.25 ± 0.56 g/dl for oral
iron (p<0.0001). In addition, 43.1% of patients treated with
ferumoxytol alone experienced an increase of ≥ 1 g/dl in hemoglobin
compared to 4.7% of patients treated with oral iron alone
(p<0.0001).
|
Ferumoxytol
was well tolerated with repeated dosing (2 x 510 mg). Adverse events occurred
in
55.5% of ferumoxytol patients compared to 59.5% of oral iron patients.
Drug-related adverse events occurred in 21.4% of ferumoxytol patients compared
to 16.2% of oral iron patients. Serious adverse events occurred in 7.7% of
ferumoxytol patients compared to 13.5% of oral iron
patients.
There were no drug-related SAEs in ferumoxytol treated patients. There was
one
drug-related SAE in one oral iron treated patient (1.4%); a case of severe
gastritis which led to discontinuation of the study drug.
Safety
Study in CKD Poster
The
second poster shows results from a double-blind, placebo-controlled, crossover
safety study in dialysis- dependent CKD and non-dialysis dependent CKD patients
(Protocol 62,745-8; ClinicalTrials.gov identifier NCT00255450). Complete safety
data was available for 360 patients randomized to the ferumoxytol to placebo
sequence and for 362 patients randomized to the placebo to ferumoxytol sequence.
For the ferumoxytol to placebo sequence, 40.3% of patients had
dialysis-dependent CKD, and for the placebo to ferumoxytol sequence 43.6% of
patients had dialysis-dependent CKD. The results from this safety study
showed:
| · |
There
were no meaningful mean changes in vital signs on laboratory values
from
baseline for patients after either ferumoxytol or placebo
administration.
|
| · |
AEs
occurred in 21.3% of patients after ferumoxytol administration and
in
16.3% of patients after placebo administration. On a blinded basis,
these
were deemed to be related to treatment by the investigator in 5.2%
of
patients after ferumoxytol and in 4.2% of patients after placebo.
|
| · |
SAEs
occurred in 2.9% of patients after ferumoxytol administration and
in 1.8%
of patients after placebo administration. On a blinded basis, these
SAEs
were deemed to be related to treatment by the investigator in one
patient
(0.1%) after ferumoxytol and in one patient (0.1%) after
placebo.
|
| · |
The
single SAE attributed to the drug after ferumoxytol administration
occurred in an 85 year-old male, with non-dialysis dependent CKD,
hypertension, coronary artery disease, cerebrovascular disease and
a
history of multiple drug allergies to ciprofloxacin, levofloxacin,
and
percocet. The patient experienced an anaphylactoid reaction with
severe
hypotension a few minutes after ferumoxytol administration, was treated
with subcutaneous epinephrine and recovered without sequelae.
|
| · |
The
single SAE attributed to the drug after placebo administration occurred
in
an 81 year-old female, with non-dialysis dependent CKD, hypertension,
atrial fibrillation, oxygen-dependent chronic obstructive pulmonary
disease, hypothryroidism and gout. The patient developed a petechial
rash
one day after placebo administration, was withdrawn from the study
and did
not receive ferumoxytol.
|
The
combined data from three of the four Phase III studies for which results are
now
available represent a total of approximately 1,588 administrations of 510 mg
of
ferumoxytol in 1,151 patients (protocols 62,745-6; 62,745-7; and 62,745-8).
One
of 1,151 patients (0.09%) experienced a drug related SAE after ferumoxytol
treatment compared to one of 149 patients (0.67%) treated with oral iron and
one
of 716 patients (0.14%) treated with IV saline (placebo).
Conference
Call Information
The
company will host a conference call at 4:30 pm EDT today to discuss and answer
questions regarding the data from the completed ferumoxytol studies and the
status of the ferumoxytol clinical development program.
To
listen
to this conference call via audio webcast, please visit the Investors
section
of the Advanced Magnetics website at www.advancedmagnetics.com.
The web
cast will also be
available
as a replay starting approximately one hour after the call is finished through
July 11, 2007. Alternatively, to access the
call
via live telephone, please dial (800) 909-5202. Internationally, the call may
be
accessed by dialing (785) 830-7975. The confirmation call for this call is
2603141.
Replay
information will be published by the company following this call.
About
Ferumoxytol
Ferumoxytol,
the
company’s key product candidate, is being developed for use as an intravenous
iron replacement therapeutic for the treatment of iron deficiency anemia in
chronic kidney disease. The company plans to file a New Drug Application for
marketing approval of ferumoxytol with the U.S. Food and Drug Administration
during the fourth calendar quarter of 2007.
About
Advanced Magnetics
Advanced
Magnetics, Inc. is a developer of superparamagnetic iron oxide nanoparticles
used in pharmaceutical products. As a leader in our field, we are dedicated
to
the development and commercialization of our proprietary nanoparticle technology
for use in therapeutic iron compounds to treat anemia, as well as novel imaging
agents to aid in the diagnosis of cancer and cardiovascular disease. For more
information about Advanced Magnetics, please visit our website at
http://www.advancedmagnetics.com, the content of which is not part of this
press
release.
Forward-looking
Statement
This
document contains forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995 and federal securities laws. Any
statements contained in this press release that do not describe historical
facts, including but not limited to, statements regarding the promising nature
of the ferumoxytol data presented in this press release, the opinion that these
results support an attractive profile for ferumoxytol, the encouraging nature
of
these results and the timing of the planned submission of the NDA for
ferumoxytol in the fourth quarter of calendar 2007 are forward-looking
statements that involve risks and uncertainties that could cause actual results
to differ materially from those discussed in such forward-looking statements.
Such risks and uncertainties include the following: (1) the possibility that
we
may not be able to successfully complete the development of ferumoxytol, or
may
not be able to complete the development in a timely or cost-effective manner,
due to deficiencies in the design or oversight by us of these trials, the
failure of our trials to demonstrate that ferumoxytol is safe and efficacious,
unexpected results from our clinical sites, inadequate performance by
third-party service providers, or any other factor causing an increase in
expenses, a delay and/or a negative effect on the results of the clinical
studies for ferumoxytol; (2) uncertainties surrounding our ability to obtain
regulatory approval for ferumoxytol from the FDA; (3) the possibility that
the
results of past ferumoxytol studies may not be replicated in future studies;
(4)
the fact that we have limited sales and marketing expertise; (5) the possibility
that we may not be able to raise additional capital on terms and on a timeframe
acceptable to us, if at all; (6) uncertainties relating to our patents and
proprietary rights; and (7) other risks identified in our Securities and
Exchange Commission filings. We caution readers not to place undue reliance
on
any forward-looking statements which speak only as of the date they are made.
We
disclaim any obligation to publicly update or revise any such statements to
reflect any change in expectations or in events, conditions or circumstances
on
which any such statements may be based, or that may affect the likelihood that
actual results will differ from those set forth in the forward-looking
statements.
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