| September
29 , 2005
FOR IMMEDIATE RELEASE
Aspreva Announces Achievement
of Targeted Patient Enrolment in Phase
III Clinical Trial for CellCept in
Lupus Nephritis
Victoria, B.C., Canada; September
29, 2006 – Aspreva Pharmaceuticals
Corporation (NASDAQ: ASPV; TSX: ASV),
an emerging pharmaceutical company
focused on increasing the pool of
evidence-based medicines available
for patients living with less common
diseases, today announced the completion
of the targeted enrolment of 358 patients
in its global phase III clinical trial
for CellCept® (mycophenolate mofetil)
in the treatment of lupus nephritis.
The study is assessing the safety
and efficacy of CellCept in inducing
response and maintaining remission
in patients with biopsy-proven lupus
nephritis.
The two-phase induction and maintenance
study is a randomized open-label comparison
of mycophenolate mofetil with the
current standard of care, intravenous
cyclophosphamide, for the first six
months or induction phase, followed
by a double-blind comparison of mycophenolate
mofetil with azathioprine for up to
three years or maintenance phase.
The primary end point for the induction
phase is an improvement in proteinuria
and stabilization of serum creatinine.
The Company expects database lock
on the induction phase of the study
in the second quarter of 2007 with
submission of an sNDA to the United
States Food and Drug Administration
(FDA) in the fourth quarter of 2007.
Dr. Richard Jones, Senior Vice President,
Clinical and Regulatory Affairs at
Aspreva, said, “Our clinical
trial in lupus nephritis is our largest
phase III study currently underway,
and we are very pleased with our rapid
development in this challenging clinical
area. The successful completion of
targeted patient enrolment reflects
the cooperation between Aspreva, key
opinion leaders, advocacy groups and
the medical community, which together
enabled us to attract patients and
physicians to our clinical trial in
this complex disease area. We couldn’t
achieve this success without the global
support of our employees, our partner,
Roche, and the patients and physicians
represented by the 117 global clinical
sites. We look forward to sharing
clinical results upon completion of
this trial and the associated regulatory
filings to follow.”
About Lupus Nephritis
Systemic lupus erythematosus (SLE),
commonly called lupus, is a chronic
autoimmune disease that causes the
body to attack its own tissues and
joints.
Lupus nephritis is the most serious
manifestation of the disease, which,
if left untreated, can lead to kidney
failure, requiring dialysis. It is
a complicated disease as patients
typically fluctuate between periods
of intense disease activity when the
patient’s own immune system
is actively attacking and causing
damage in their kidney, interspersed
with periods of remission. Clinicians
estimate that one third to one half
of lupus patients have lupus nephritis.
There has been no new approved treatment
for SLE or lupus nephritis in the
United States in over thirty years.
Current treatments involve the off-label
use of existing cancer drugs such
as cyclophosphamide, steroids, and
other immunosuppressant drugs such
as azathioprine.
About CellCept
CellCept is Roche’s leading
immunosuppressant or "anti-rejection"
drug used in combination with other
immunosuppressive drugs (cyclosporine
and corticosteroids) for the prevention
of rejection in patients receiving
heart, kidney and liver transplants.
CellCept was first approved for use
in combination therapy for the prevention
of acute organ rejection in kidney
transplantation in 1995 and has since
been approved worldwide for prevention
of organ rejection in adult kidney,
heart and liver transplantation. In
some countries, it has also been approved
for paediatric kidney transplantation.
This therapeutic success represents
11 years of clinical experience and
patient benefits, including reduced
toxicities and prolonged graft and
patient survival. Over the last decade,
CellCept has become the world's most
widely studied immunosuppressant and
research is ongoing both in organ
transplantation and related areas,
such as autoimmune disease, to help
provide clinical benefit to a wider
range of patients.
In July 2003, Aspreva signed a collaboration
agreement with Roche for the exclusive
worldwide rights (excluding Japan)
to develop and, upon regulatory approval,
commercialize CellCept for all autoimmune
disease applications.
About Aspreva Pharmaceuticals
Aspreva is an emerging pharmaceutical
company focused on identifying, developing
and, upon regulatory approval, commercializing
new indications for approved drugs
and late stage drug candidates for
patients living with less common diseases.
Aspreva is listed on the Nasdaq Global
Select Market under the trading symbol
"ASPV" and on the Toronto
Stock Exchange under the trading symbol
"ASV".
For further information please
contact:
Sage Baker
Vice President, Investor Relations
and Corporate Communications
Aspreva Pharmaceuticals
250-744-2488 ext. 270
sbaker@aspreva.com
This press release contains forward-looking
statements or information within the
meaning of the Private Securities
Litigation Act of 1995 and applicable
Canadian Securities Legislation. These
include, without limitation, statements
or information related to our strategy,
future operations, clinical trials,
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Words such as "anticipates,"
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Our actual results and the timing
of events could differ materially
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of these risks and uncertainties,
which include, without limitation,
risks related to difficulties or delays
in the progress, timing and results
of our clinical trials, our ability
to attract and retain collaborations
relating to the development and commercialization
of new indications, difficulties or
delays in obtaining regulatory approval,
the FDA may finally determine that
the design and planned analysis of
our clinical trials do not adequately
address the trial objectives in support
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from other pharmaceutical or biotechnology
companies, and other risks detailed
in our filings with the Securities
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You are cautioned not to place undue
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