Aspreva Announces Fast-Track Designation Granted By The FDA For CellCept In Lupus Nephritis
July 10, 2017
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 aspreva.
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 sec and with securities
regulatory authorities in Canada at sedar. 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
aspreva
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