Aspreva announces Fast-Track designation granted by the FDA for CellCept in lupus nephritis

    VICTORIA, June 6 /CNW/ - Aspreva Pharmaceuticals Corporation (NASDAQ:  
ASPV; TSX: ASV) today announced that the U.S. Food and Drug Administration
(FDA) has granted Fast Track designation for CellCept (mycophenolate mofetil,
MMF) for the treatment of lupus nephritis. Aspreva is currently evaluating
CellCept for the treatment of lupus nephritis in a global phase III study.
    The FDA's Fast Track designation is designed to expedite the application
and review process for products that have the potential to address a serious
or life-threatening condition. There has been no new approved treatment for
lupus in the United States in over thirty years.
    In granting Fast Track designation, the FDA noted that type III-V lupus
nephritis is a severe inflammation of the kidney associated with systemic
lupus erythematosus, and is a life-threatening disease. They continued stating
that the partnership between Aspreva and Roche shows a commitment to study
clinically important outcomes including death, need of dialysis, or loss of
renal function in this serious disease. Finally the FDA noted that CellCept
received Fast Track designation on the basis that, given the current
development program in lupus nephritis, it may have the potential to address
an unmet medical need in patients with this disease.
    "Lupus nephritis is one of the most serious manifestations of lupus, and
if left untreated can result in progressive kidney failure", said Dr. Usman
Azam, Aspreva's Executive Vice-President and Chief Medical Officer. "We
believe that Fast Track designation from the FDA will be of great assistance
in our efforts to bring an evidence-based treatment option to this patient
population where there is a clear unmet medical need."
    Aspreva's lupus nephritis study is one of the largest phase III studies
ever conducted in this disease. This two-phase induction to maintenance study
was designed as a randomized open-label comparison of MMF with intravenous
cyclophosphamide for the first six months (induction phase), followed by a
double-blind comparison of MMF to azathioprine for up to three years
(maintenance phase). The first patient of this study was treated in July 2005
and patient enrollment was completed at the end of September 2006. Preliminary
results from the induction phase of this trial are expected towards the end of
June 2007. Re-randomization into maintenance phase is complete and this phase
of the study is ongoing.

    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.
    It is important to note that MMF is not currently approved by the FDA for
the treatment of any autoimmune disease.

    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 a global pharmaceutical company focused on identifying,
developing, and, upon approval, commercializing evidence-based medicines for
patients living with less common diseases. Aspreva common stock is traded on
the NASDAQ Global Select Market under the trading symbol "ASPV" and on the
Toronto Stock Exchange under the trading symbol "ASV". Learn more at

    This news release contains forward-looking statements within the meaning
of the United States Private Securities Litigation Reform Act of 1995 and
forward-looking information within the meaning of applicable securities laws
in Canada (collectively, "forward-looking statements"). The words
"anticipates", "believes", "budgets", "could", "estimates", "expects",
"forecasts", "intends", "may", "might", "plans", "projects", "schedule",
"should", "will", "would" and similar expressions are intended to identify
forward-looking statements, although not all forward-looking statements
contain these identifying words. Forward-looking statements in this news
release include, but are not limited to, statements about: our expectations
with respect to the Fast Track designation; our strategy, future operations,
clinical trials, prospects and plans of management; the effects of CellCept on
patients; our expectations with respect to our existing collaboration
agreement with Roche for the development of CellCept in autoimmune
indications; and our phase III clinical program underway with CellCept: for
the treatment of lupus nephritis.
    With respect to the forward-looking statements contained in this news
release, we have made numerous assumptions regarding, among other things: our
ability to predict the effects of CellCept on patients; our ability to
continue our phase III clinical program underway with CellCept: for the
treatment of lupus nephritis; our ability to protect our intellectual property
rights and to not infringe on the intellectual property rights of others; our
ability to comply with applicable governmental regulations and standards; and
our ability to succeed at establishing a successful commercialization program
for any of our potential products. Readers are cautioned that the plans,
intentions or expectations disclosed in any forward-looking statements and
underlying assumptions may not be achieved and that they should not place
undue reliance on any forward-looking statement. Actual results or events
could differ materially from the plans, intentions, expectations, and
assumptions expressed or implied in any forward-looking statements as a result
of numerous risks, uncertainties and other factors, including those relating
to: difficulties or delays in the progress, timing and results of clinical
trials and studies; difficulties or delays in obtaining regulatory approvals;
the FDA may determine that the design and planned analysis of our clinical
trials do not adequately address the trial objectives in support of our
regulatory submission; future sales of CellCept may be less than expected; our
future operating results are uncertain and likely to fluctuate; we may not be
able to develop and obtain regulatory approval for CellCept in the treatment
of autoimmune indications and any future products in our targeted indications;
we may not be able to establish marketing and sales capabilities and the costs
of launching CellCept in the treatment of autoimmune indications and any
future products for our targeting indications may be greater than anticipated;
the risk that we may not sustain our profitability; our ability to attract and
retain collaborations relating to the development and commercialization of new
indications; competition from other pharmaceutical or biotechnology companies;
our ability to raise additional financing required to fund further research
and development, clinical studies, and obtain regulatory approvals, on
commercially acceptable terms or at all; economic and capital market
conditions; our ability to obtain and protect patents and other intellectual
property rights; our ability to operate without infringing the intellectual
property rights of others; our ability to comply with applicable governmental
regulations and standards; currency exchange rates; and our ability to
successfully attract and retain skilled and experienced personnel.
    For a more thorough discussion of the risks associated with Aspreva's
business, see the "Risk Factors" section in Aspreva's Quarterly Report on Form
10-Q for the quarter ended March 31, 2007, filed with the U.S. Securities and
Exchange Commission at and with securities regulatory authorities
in Canada at Although we have attempted to identify important
risks, uncertainties and other factors that could cause actual results or
events to differ materially from those expressed or implied in the
forward-looking statements, there may be other factors that cause actual
results or events to differ from those expressed or implied in the
forward-looking statements. All forward-looking statements are qualified in
their entirety by this cautionary statement and Aspreva undertakes no
obligation to revise or update any forward-looking statements as a result of
new information, future events or otherwise after the date hereof.
    %SEDAR: 00021534E

For further information:

For further information: Sage Baker, VP, Investor Relations & Corporate
Communications, Aspreva Pharmaceuticals, (250) 744-2488 ext. 84270,

Organization Profile


More on this organization

Custom Packages

Browse our custom packages or build your own to meet your unique communications needs.

Start today.

CNW Membership

Fill out a CNW membership form or contact us at 1 (877) 269-7890

Learn about CNW services

Request more information about CNW products and services or call us at 1 (877) 269-7890