Aspreva and Roche announce preliminary results for phase III study evaluating CellCept in lupus nephritis

    VICTORIA, BC, Canada and BASEL, Switzerland, June 27 /CNW/ - Aspreva
Pharmaceuticals Corporation (NASDAQ:   ASPV; TSX: ASV) and Roche today released
preliminary results for a clinical trial comparing CellCept (oral
mycophenolate mofetil, MMF) to intravenous cyclophosphamide (IVC), which is
the current standard of care, for inducing treatment response in the induction
phase of patients suffering from lupus nephritis.
    Although response rates were similar in both arms, the trial did not meet
its primary objective of demonstrating that MMF was superior to IVC in
inducing treatment response in this disease. The results relate to the
induction phase of this study, which was designed to measure treatment
response in patients after 24 weeks of induction therapy with 185 patients in
the MMF arm and 185 in the IVC arm. The results indicate similar treatment
responses with 56.2% in the MMF arm and 53% in the IVC arm were observed.
Additional analyses are ongoing to determine the potential for a regulatory
submission and Aspreva plans to present the final results at an appropriate
scientific forum.
    Based on preliminary analysis, it appears that, in general, the adverse
events experienced by patients in both arms of the study are consistent with
those observed in lupus nephritis patients receiving immunosuppressive
therapy. Overall incidence of adverse events was comparable in both treatment
    Aspreva will host a conference call today at 9:30 a.m. ET (6:30 a.m. PT)
to discuss these preliminary results.

    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, considered life-threatening, but rare, is the most
serious manifestation of SLE. If left untreated, it can lead to kidney
failure, need of dialysis, and potentially death. It is a complicated disease
as patients typically fluctuate between periods of intense disease activity,
during which the patient's own immune system is actively attacking and causing
damage in their kidney, and periods of remission. Aspreva estimates that there
are about 600,000 diagnosed lupus nephritis patients worldwide.
    There have been no new approved treatment options for SLE or lupus
nephritis in the United States in over forty years. Current induction
treatments involve the off-label use of existing cancer drugs such as
cyclophosphamide, steroids, and immunosuppressants such as azathioprine. These
treatments can also have life-threatening side effects that can be worse than
the disease itself. Since the disease is more prevalent in women and tends to
manifest itself when they are of child-bearing age, drugs that adversely
affect fertility can also compound the negative impact of the disease on a
patient's quality of life.

    More About the Aspreva Lupus Nephritis Study

    Aspreva's lupus nephritis study is one of the largest phase III studies
ever conducted in lupus nephritis. This two-phase induction to maintenance
study was designed as a randomized open label comparison of mycophenolate
mofetil (MMF) with 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). Treatment response in the induction phase of
this trial was defined as a decrease in proteinuria and the stabilization or
improvement of serum creatinine. The first patient of this study was treated
in July 2005 and patient enrollment was completed at the end of September,
2006. Re-randomization to the maintenance phase is complete and this phase of
the study is ongoing.
    It is important to note that MMF is not currently approved by the FDA for
the treatment of any autoimmune disease.

    Conference Call

    Aspreva will host a conference call to discuss results on Wednesday, June
27, 2007 at 9:30 a.m. ET (6:30 a.m. PT).

    Dial-in information:
    North America (toll free): 1-866-713-8310
    International: 1-617-597-5308
    Enter passcode: 82004406

    The call will be available for replay until Wednesday, July 5, 2007 by
calling 1-888-286-8010 (North America) or 1-617-801-6888 (International) and
entering the pass code 55009709.
    A live webcast will also be available to all interested parties on
Aspreva's website: Please click on the "Webcasts and Events"
link under the Investors section of Aspreva's website. A replay of the webcast
will be available until the Company's second quarter 2007 conference call.

    About CellCept

    CellCept (mycophenolate mofetil, MMF) is an immunosuppressant or
anti-rejection drug approved for use in combination with other
immunosuppressive drugs (cyclosporine and corticosteroids) for the prevention
of rejection in patients receiving kidney, heart and liver transplants.
    There are no adequate and well-controlled studies in pregnant women. As
CellCept has been shown to have teratogenic effects in animals at subclinical
doses on a body surface area basis, it may cause fetal harm when administered
to a pregnant woman. CellCept should not be used in pregnant women unless the
potential benefit justifies the potential risk to the fetus. Women of
childbearing potential should have a negative serum or urine pregnancy test
with a sensitivity of at least 50 mIU/mL within one week prior to beginning
therapy even where there has been a history of infertility, unless due to
    Women of childbearing potential must use effective contraception before
beginning CellCept therapy, during therapy and for six weeks following
discontinuation of therapy. Two reliable forms of contraception must be used
simultaneously unless abstinence is the chosen method. If pregnancy occurs
during treatment, the physician and patient should discuss the desirability of
continuing the pregnancy (see complete product information).
    Adverse events reported in more than 30% of renal, cardiac or liver
transplant patients receiving CellCept (in combination with cyclosporine and
corticosteroids) were pain, fever, headache, asthenia, anemia, leucopenia
(patients should be monitored for neutropenia; dosing should be interrupted or
the dose reduced if neutropenia develops), thrombocytopenia, leukocytosis,
urinary tract infection, hypertension, hypotension, peripheral edema,
hypercholesteremia, hypokalemia, hyperglycemia, creatinine, BUN and cough
increased, hypomagnesemia, diarrhea, constipation, nausea, vomiting,
respiratory infection, dyspnea, lung disorder, pleural effusion, tremor and
    Patients receiving immunosuppressant regimens are at increased risk of
developing lymphomas and other malignancies, particularly of the skin.

    Warning: Increased susceptibility to infection and the possible
development of lymphoma may result from immunosuppression. Only physicians
experienced in immunosuppressive therapy and management of renal, cardiac or
hepatic transplant patients should use CellCept. Patients receiving the drug
should be managed in facilities equipped and staffed with adequate laboratory
and supportive medical resources. The physician responsible for maintenance
therapy should have complete information requisite for the follow-up of the

    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

    About Roche

    Headquartered in Basel, Switzerland, Roche is one of the world's leading
research-focused healthcare groups in the fields of pharmaceuticals and
diagnostics. As a supplier of innovative products and services for the early
detection, prevention, diagnosis and treatment of disease, the Group
contributes on a broad range of fronts to improving people's health and
quality of life. Roche is a world leader in diagnostics, the leading supplier
of drugs for cancer and transplantation and a market leader in virology. In
2006, sales by the Pharmaceuticals Division totaled 33.3 billion Swiss franc
($26.6 billion US), and the Diagnostics Division posted sales of 8.7 billion
Swiss franc ($6.96 billion US). Roche employs roughly 75,000 people in 150
countries and has R&D agreements and strategic alliances with numerous
partners, including majority ownership interests in Genentech and Chugai.
Additional information, about the Roche Group is available on the Internet at

    All trademarks used or mentioned in this release are protected by law.

    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 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 two phase III clinical programs underway with
CellCept: lupus nephritis and pemphigus vulgaris.
    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 two phase III clinical programs underway with CellCept: lupus
nephritis and pemphigus vulgaris; 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, Vice President, IR & Corporate
Communications, Aspreva Pharmaceuticals, (250) 744-2488 ext. 84270,; Roche Group Media Office: Phone: +41 61 688 8888, e-mail: - Daniel Piller (Head of Roche Group Media Office)
- Katja Prowald (Head of Science Communications) - Martina Rupp - Baschi

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