The investigational oral therapy FTY720 (fingolimod) continues to demonstrate
sustained benefits in patients with multiple sclerosis (MS) after three years of
treatment, according to new clinical data presented today from an ongoing Phase
II study extension1.
Results showed that 73% of patients who began the
study on FTY720 5 mg remained free from relapses after three years, and 68% of
those who began the study on FTY720 1.25 mg remained relapse-free1. The figures
after two years of treatment were 77% and 75% respectively3. On the basis of
comparable efficacy and a better safety profile, all patients have been
transferred to FTY720 1.25 mg in the study extension.
The 36-month data
also showed an average annualized relapse rate of 0.201, equivalent to one
relapse in five years, while 89% of patients were free of the active brain
lesions characteristic of MS as measured by magnetic resonance imaging (MRI)1
three years after starting treatment.
The results were presented at the
60th annual meeting of the American Academy of Neurology (AAN) in Chicago, USA.
"These new data demonstrate the exciting potential for FTY720 to reduce
relapse rates in MS patients with a convenient once-daily pill," said Professor
Giancarlo Comi, Professor of Neurology at the University Vita-Salute San
Raffaele in Milan, Italy. "An effective oral treatment would be a significant
breakthrough in the management of MS. That is why these results are encouraging
- because we are seeing substantial benefits of FTY720 maintained over time in
this clinical trial."
FTY720 is a novel, once-daily, oral treatment in
worldwide Phase III clinical development for the treatment of
relapsing-remitting MS, the form of the disease that affects approximately 85%
of people diagnosed with MS4.
More than 2.5 million people worldwide are
affected by MS2, the most common nontraumatic cause of neurological disability
in young people5. Regulatory filings for FTY720 are expected in the US and EU
before the end of 2009.
"The FTY720 Phase III program is the largest
conducted in MS to date, and demonstrates our long-term commitment to the field
of MS therapy," said Trevor Mundel, MD, Head of Global Development Functions at
Novartis Pharma AG. "It is especially encouraging to see that FTY720 continues
to demonstrate sustained efficacy by helping the majority of patients to remain
free of relapses as the study progresses."
FTY720 has the potential to
be the first in a new class of therapies for MS that act on inflammation by
modulating sphingosine-1-phosphate receptors (S1P-R), reducing the number of
inflammatory immune cells, called lymphocytes, from reaching the brain. In
addition, FTY720 reaches the brain and S1P-Rs are present on central nervous
system (CNS) tissue, so FTY720 may have a direct beneficial effect on MS within
the CNS. This additional potential mechanism of action is supported by new
preclinical data being presented at AAN6,7.
The Phase II study presented
at AAN began with a six-month placebo-controlled phase in which 281 patients
with relapsing MS received placebo, FTY720 1.25 mg or FTY720 5 mg once-daily.
This was followed by a long-term extension in which all patients took FTY720. At
the end of three years, 173 patients were in the extension, which is still
ongoing. The study has been conducted in Canada and 10 European countries.
Results from the six-month placebo-controlled trial showed that FTY720
reduced relapse rates by more than 50% compared to placebo5. Current first-line
therapies for MS reduced relapse rates by 30-35% on average in two-year
studies5.
Among patients originally on placebo who converted to active
therapy in the extension, 51% were free of relapses at three years1. The figure
at two years was 57%3.
FTY720 has been generally well tolerated
throughout the three years of the Phase II study and its extension, with the
most common adverse events being nasopharyngitis, headache, fatigue and
influenza1. Increases in alanine aminotransferase (liver enzymes) were observed
in 16% of patients. Dermatological screening of patients was implemented in the
extension after a small number of cases of localized skin malignancies were
reported.
Novartis continues to study FTY720 in an ongoing, blinded
Phase III clinical trial program. This program includes comprehensive monitoring
that will further assess and characterize the safety profile of FTY720.
MS is caused by the destruction of myelin, which helps neurons carry
electrical signals in the brain8. The disease causes problems with muscle
control and strength, vision, balance, sensation and mental function8. MS
typically presents in relapsing forms involving acute self-limiting attacks of
neurological dysfunction (or "relapses") followed by complete or partial
restoration of functions.
Disclaimer
The foregoing release
contains forward-looking statements that can be identified by terminology such
as "planned", "potential", "would", "encouraging", "expected", "commitment",
"may", "continues", "will", or similar expressions, or by express or implied
discussions regarding potential future regulatory filings or marketing approvals
for FTY720 or regarding potential future revenues from FTY720. Such
forward-looking statements reflect the current views of the Company regarding
future events, and involve known and unknown risks, uncertainties and other
factors that may cause actual results with FTY720 to be materially different
from any future results, performance or FTY720 will be submitted to regulatory
authorities for approval, or will be approved for sale in any market. Nor can
there be any guarantee that FTY720 will achieve any particular levels of revenue
in the future. In particular, management's expectations regarding FTY720 could
be affected by, among other things, unexpected clinical trial results, including
unexpected new clinical data and unexpected additional analysis of existing
clinical data; unexpected regulatory actions or delays or government regulation
generally; the company's ability to obtain or maintain patent or other
proprietary intellectual property protection; competition in general;
government, industry and general public pricing pressures, and other risks and
factors referred to in Novartis AG's current Form 20-F on file with the US
Securities and Exchange Commission. Should one or more of these risks or
uncertainties materialize, or should underlying assumptions prove incorrect,
actual results may vary materially from those anticipated, believed, estimated
or expected. Novartis is providing the information in this press release as of
this date and does not undertake any obligation to update any forward-looking
statements contained in this press release as a result of new information,
future events or otherwise.
About Novartis
Novartis AG
provides healthcare solutions that address the evolving needs of patients and
societies. Focused solely on growth areas in healthcare, Novartis offers a
diversified portfolio to best meet these needs: innovative medicines,
cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools,
and consumer health products. Novartis is the only company with leading
positions in these areas. In 2007, the Group's continuing operations (excluding
divestments in 2007) achieved net sales of USD 38.1 billion and net income of
USD 6.5 billion. Approximately USD 6.4 billion was invested in R&D
activities throughout the Group. Headquartered in Basel, Switzerland, Novartis
Group companies employ approximately 98,200 full-time associates and operate in
over 140 countries around the world. For more information, please visit http://www.novartis.com.
References
1.
Comi G et al. Oral FTY720 (fingolimod) in patients with relapsing multiple
sclerosis. 3-year extension shows sustained low relapse rate and MRI activity.
Abstract presented at 60th annual meeting of American Academy of Neurology,
Chicago 12-19 April 2008.
2. National Multiple Sclerosis Society
website. http://www.nationalmssociety.org/about-multiplesclerosis/
who-gets-ms/index.aspx. Accessed March 11, 2008.
3. Kappos L. et al.
Oral fingolimod (FTY720) in relapsing MS: 24-month results of the Phase II
study. ECTRIMS 2006.
4. National Multiple Sclerosis Society website.
http://www.nationalmssociety.org/about-multiplesclerosis/ what-is-ms/index.aspx.
Accessed March 11, 2008.
5. Kappos L et al. Oral Fingolimod (FTY720) for
Relapsing Multiple Sclerosis. N Engl J Med 2006;355, p. 1130.
6. Barske
C et al. FTY720 (Fingolimod) and S1P-Receptor 1 and 5 specific Agonists Increase
the Number of Oligodendrocytes in Vitro. Abstract presented at 60th annual
meeting of American Academy of Neurology, Chicago 12-19 April 2008.
7.
Schubart A et al. FTY720 suppresses ongoing EAE and promotes a remyelinating
environment preventing axonal degeneration within the CNS. Abstract presented at
60th annual meeting of American Academy of Neurology, Chicago 12-19 April 2008.
8. National Multiple Sclerosis Society website.
http://www.nationalmssociety.org/about-multiplesclerosis/ symptoms/index.aspx.
Accessed March 11, 2008.
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