- Phase II study extension shows 68-73% of patients with multiple sclerosis
remained relapse-free after three years of treatment with oral FTY720
- New data demonstrate 89% of patients free from active brain lesions - the
injury caused by MS - three years after starting treatment
- MS, a devastating disease causing progressive disability, affects 2.5
million people worldwide including many young adults
- FTY720 regulatory filings planned before end of 2009 in US and EU
EAST HANOVER, N.J., April 15 /PRNewswire-FirstCall/ -- 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 extension.
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-free. The figures after two
years of treatment were 77% and 75% respectively. 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
0.20, 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) 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 MS.
More than 2.5 million people worldwide are affected by MS, the most
common non-traumatic cause of neurological disability in young people.
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 AAN.
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 placebo. Current
first-line therapies for MS reduced relapse rates by 30-35% on average in
two-year studies.
Among patients originally on placebo who converted to active therapy in
the extension, 51% were free of relapses at three years. The figure at two
years was 57%.
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 influenza. 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. For more
information about the clinical trial program, including eligibility
criteria and location of U.S. study sites, patients can call the following
toll-free number: 866-788-3930, or visit http://www.MSClinicalTrials.com.
MS is caused by the destruction of myelin, which helps neurons carry
electrical signals in the brain. The disease causes problems with muscle
control and strength, vision, balance, sensation and mental function. 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 achievements expressed or
implied by such statements. There can be no guarantee that 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 Pharmaceuticals Corporation researches, develops, manufactures
and markets leading innovative prescription drugs used to treat a number of
diseases and conditions, including those in the cardiovascular, metabolic,
cancer, organ transplantation, central nervous system, dermatological, GI
and respiratory areas. The company's mission is to improve people's lives
by pioneering novel healthcare solutions.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals
Corporation is an affiliate of Novartis AG (NYSE: NVS), which 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.
Novartis Media Relations
Beatrix Benz
Novartis Global Media Relations
+41 61 324 7999 (direct)
+41 79 618 7748 (mobile)
beatrix.benz@novartis.com
e-mail: media.relations@novartis.com
Gina Moran
Novartis Pharmaceutical Corporation
973-476-3643 (cell)
862-778-5567 (office)
gina.moran@novartis.com
Novartis Investor Relations
Ruth Metzler-Arnold +41 61 324 9980
Katharina Ambuehl +41 61 324 5316
Pierre-Michel Bringer +41 61 324 1065
John Gilardi +41 61 324 3018
Jason Hannon +41 61 324 2152
Thomas Hungerbuehler +41 61 324 8425
Isabella Zinck +41 61 324 7188
Central phone no: +41 61 324 7944
Fax no: +41 61 324 8444
e-mail: investor.relations@novartis.com
North America Office
Richard Jarvis +1 212 830 2433
Jill Pozarek +1 212 830 2445
Edwin Valeriano +1 212 830 2456
Fax no: +1 212 830 2405
e-mail: investor.relations@novartis.com
SOURCE Novartis Pharmaceuticals Corporation
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Related links:
http://www.novartis.com
http://www.MSClinicalTrials.com
CONTACT:
Beatrix Benz, Novartis Global Media
Relations, +41-61-324-7999, direct, +41-79-618-7748, mobile,
beatrix.benz@novartis.com, or Gina Moran, Novartis Pharmaceutical
Corporation, +1-973-476-3643, cell, +1-862-778-5567, office,
gina.moran@novartis.com, both for Novartis Media Relations,
media.relations@novartis.com; or Ruth Metzler-Arnold,
+41-61-324-9980, Katharina Ambuehl, +41-61-324-5316,
Pierre-Michel Bringer, +41-61-324-1065, John Gilardi,
+41-61-324-3018, Jason Hannon, +41-61-324-2152, Thomas
Hungerbuehler, +41-61-324-8425, or Isabella Zinck,
+41-61-324-7188, Central phone, +41-61-324-7944, Fax,
+41-61-324-8444, or North America Office, Richard Jarvis,
+1-212-830-2433, Jill Pozarek, +1-212-830-2445, or Edwin
Valeriano, +1-212-830-2456, Fax, +1-212-830-2405, all of Novartis
Investor Relations, investor.relations@novartis.com
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