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 reported Aspreva's
analysis of the data of an 80 patient investigator initiated trial (IIT)
led by Donald Sanders, M.D of Duke University Medical Center with The
Muscle Study Group, a consortium of academic centers, Durham, North
Carolina. The double-blind, placebo-controlled IIT supported by the Food
and Drug Administration's (FDA's) Office of Orphan Products Development,
Roche and Aspreva, evaluated the effect of the initiation of treatment with
prednisone and CellCept(R) (mycophenolate mofetil or MMF) in comparison to
prednisone alone on the signs and symptoms of myasthenia gravis in patients
who were not on corticosteroids and had not previously received other
immunosuppression.
Aspreva's analysis of the data generated from Dr. Sanders' IIT showed
that after 12 weeks of treatment, the efficacy of MMF and 20mg of
prednisone was no different from the efficacy of 20mg prednisone alone.
This conclusion is based on the Qualitative Myasthenia Gravis (QMG) score,
a questionnaire that evaluates signs and symptoms of myasthenia gravis.
Aspreva's analysis also showed that MMF appeared to be generally well
tolerated by the patients in the study. The most frequent adverse events
were diarrhea, insomnia and muscle spasms. Dr. Sanders and his
co-investigators are preparing a full report of the study and its findings,
which will be submitted for publication to a peer-reviewed medical journal
and presented at an appropriate medical conference.
Aspreva is conducting a multinational, double-blind, placebo-controlled
phase III study. Aspreva's study is designed to evaluate the effects of MMF
on the signs and symptoms of myasthenia gravis in 176 patients who have
been previously treated with corticosteroids.
In contrast to Dr. Sanders' IIT, the primary end point of Aspreva's
phase III study is adequate disease control with steroid sparing.
Steroid-sparing, an important treatment goal of immunosuppression because
of the severe side effects associated with prolonged steroid use, could not
be evaluated in Dr. Sanders' study due to the nature of the design. In
addition, MMF is administered for 36 weeks in Aspreva's study; treatment
duration longer than 12 weeks may be necessary to demonstrate a potential
effect in myasthenia gravis.
Aspreva intends to submit the data from Dr. Sanders' IIT into any
regulatory filings Aspreva and Roche may make seeking approval of CellCept
in the treatment of myasthenia gravis. Database lock on this trial is
anticipated later this month with results from Aspreva's study available
later this quarter.
About Myasthenia Gravis
According to the Myasthenia Gravis Foundation, myasthenia gravis (MG)
affects approximately 70,000 to 100,000 people worldwide, including
approximately 36,000 people in the United States. MG is a debilitating,
chronic autoimmune neuromuscular disease in which the body produces
auto-antibodies which prevent the nerves from sending messages to the
muscles.
Although MG can affect any voluntary muscle, it frequently involves
those controlling eye movements, chewing, swallowing, coughing and facial
expressions, but can be more severe in some of the affected patients.
Complete remission is infrequent and long-term immunosuppression is
usually required. Current treatments of MG include the use of
cholinesterase inhibitors, 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 in the
prevention of organ rejection in adult kidney, heart and liver
transplantation represents 11 years of clinical experience and patient
benefits, including reduced toxicities and prolonged graft and patient
survival.
In July 2003, Aspreva signed a collaboration agreement with Roche for
the exclusive worldwide rights to develop and, upon regulatory approval,
commercialize CellCept for all autoimmune disease applications.
It is important to note that CellCept has not been approved by the FDA
for the treatment of any autoimmune disease.
There are no adequate and well-controlled studies of CellCept 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 hysterectomy.
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 > 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 insomnia.
Patients receiving immunosuppressant regimens are at increased risk of
developing lymphomas and other malignancies, particularly of the skin.
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
patient. For full prescribing information on CellCept, please visit:
rocheusa/products/cellcept.
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".
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 release of full study results from IIT; Aspreva's own
multinational, double-blind, placebo-controlled phase III study; Aspreva's
expectation that its study will evaluate the effect of MMF on
steroid-sparing; Aspreva's expectation that its trial design will show that
MMF addresses the long term need of patients through steroid tapering,
improved disease control and support of the MMF safety profile; Aspreva's
intention to integrate the safety data from Dr. Sanders' IIT with the
results from Aspreva's phase III study when Aspreva and Roche apply for
regulatory approval of CellCept in the treatment of myasthenia gravis in
the second quarter 2007; and Aspreva's expectation that database lock on
this trial is anticipated later this month. Readers are cautioned that the
plans, intentions or expectations disclosed in any forward-looking
statements 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; our ability to attract and retain collaborations
relating to the development and commercialization of new indications;
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; 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. Other risks, uncertainties and factors that our management
believes could cause actual results or events to differ materially from the
forward-looking statements are discussed in our filings with the Securities
and Exchange Commission and securities regulatory authorities in Canada.
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.
Aspreva Pharmaceuticals
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View drug information on CellCept.