Novartis investigational multiple sclerosis therapy Gilenia®* (FTY720) shown to reduce relapse rates regardless of treatment history
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Novartis International AG / Novartis investigational multiple sclerosis therapy Gilenia®* (FTY720) shown to reduce relapse rates regardless of treatment history processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.
* Data presented at the American Academy of Neurology show annual relapse
rates reduced by 62% in newly treated patients
* Relapse rates reduced by 44% in previously treated patients
* New extension data show Gilenia effect sustained over two years; also
highlights potential benefits of switching from interferon beta-1a
* US and EU regulatory reviews underway for 0.5 mg once-daily dose of Gilenia
Basel, April 13, 2010 - Data presented at the American Academy of Neurology
(AAN) annual meeting add to the accumulating evidence of the positive
benefit/risk profile of Gilenia, a potential first-in-class, once-daily oral
therapy for relapsing forms of multiple sclerosis (MS).
Data from the two-year FREEDOMS study showed that Gilenia 0.5 mg reduced annual
relapse rates (ARR) by 62% for treatment naïve patients compared to placebo. For
patients previously receiving other treatments, the annual relapse rates were
reduced by 44%. In addition, at two years Gilenia delayed the progression of
disability by 30% for patients on 0.5 mg compared to placebo[1].
"These findings reinforce the potential for Gilenia to be a breakthrough therapy
option for physicians and people with relapsing forms of MS," said Trevor
Mundel, MD, Global Head of Development at Novartis Pharma AG. "The data
demonstrate the effectiveness of Gilenia irrespective of treatment history, and
further support both the sustained efficacy of Gilenia over two years and the
potential benefits of switching from interferon beta-1a, a currently approved MS
therapy, to Gilenia."
Of the 1153 patients who participated in the one-year TRANSFORMS study, 1027
(89%) elected to enter the one-year extension study. Patients in the extension
study who also received Gilenia in the core study remained on their original
dose (0.5 mg or 1.25 mg), while patients who had received intramuscular
interferon beta-1a (Avonex(®)) were randomized to receive Gilenia 0.5 mg or
1.25 mg[2].
Patients who received Gilenia 0.5 mg for two years experienced a consistently
low ARR at year one (0.16) and at year two (0.18). These patients also retained
a significant reduction in relapses and MRI brain lesions over two years
compared to the group originally randomized to intramuscular interferon beta-1a
and later switched to Gilenia[2].
In the subset of patients who received intramuscular interferon beta-1a during
year one and Gilenia 0.5 mg during year two, the annual relapse rate in year two
was reduced by 31% and the number of new or newly enlarged T2 lesions in the
brain, a marker of disease activity, was reduced by 67% in the second year[2].()
These findings on efficacy are consistent with those of the one-year core
TRANSFORMS study demonstrating Gilenia significantly reduced annualized relapse
rates by 52% (0.5 mg dose) vs. intramuscular interferon beta-1a[3].
Additional data presented at AAN showed that patients in the core TRANSFORMS
study taking Gilenia 0.5 mg had a 71% reduction in relapses resulting in
hospitalization, and a 52% reduction in relapses requiring steroid treatment
compared with patients taking intramuscular interferon beta-1a[4].()
The safety profile of Gilenia has been well studied in one of the largest-ever
Phase III clinical trial programs conducted in MS. The full program, including
completed as well as on-going studies in MS, now has more than 6600 patient
years of experience, with some patients now in their sixth year of treatment.
In the TRANSFORMS and FREEDOMS studies the most commonly reported adverse events
for both Gilenia and control groups were nasopharyngitis, headache and fatigue.
Gilenia-related adverse events included transient, dose-related, generally
asymptomatic heart rate reduction and infrequent transient AV conduction block
at treatment initiation, mild (1-3 mm Hg) blood pressure increase, macular edema
(more common with 1.25 mg than the 0.5 mg target dose), and asymptomatic,
reversible elevation of liver enzymes.
The rates of infections overall, including serious infections, were comparable
between treatment groups, although a slight increase in lung infections
(primarily bronchitis) was seen in patients treated with Gilenia. The number of
malignancies reported across the two studies was small with comparable rates
between the Gilenia and control groups.
Novartis has submitted the 0.5 mg dose for regulatory approval in the US and EU
as results from the studies indicate that this dose has the most favorable
benefit/risk profile. Applications for regulatory approval for Gilenia 0.5 mg
were submitted to the US Food and Drug Administration (FDA) and European
Medicines Agency (EMA) in December 2009. In February 2010, the FDA granted
Gilenia priority review status. Since Gilenia involves a new active ingredient
(New Molecular Entity), the FDA has required an Advisory Committee meeting on
June 10 and will evaluate the risk management program, which could result in the
FDA extending its review at the end of the designated six-month period in June
2010.
* The brand name Gilenia has been provisionally approved by the FDA for use in
connection with the product, but the product itself has not received marketing
authorization or NDA approval from any regulatory authorities.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "potential," "priority review," "could," or similar
expressions, or by express or implied discussions regarding potential marketing
approvals for Gilenia, or the potential timing of such approvals, or regarding
potential future revenues from Gilenia. You should not place undue reliance on
these statements. Such forward-looking statements reflect the current views of
management regarding future events, and involve known and unknown risks,
uncertainties and other factors that may cause actual results with Gilenia to be
materially different from any future results, performance or achievements
expressed or implied by such statements. There can be no guarantee that Gilenia
will be approved for sale in any market, or at any particular time. Nor can
there be any guarantee that Gilenia will achieve any particular levels of
revenue in the future. In particular, management's expectations regarding
Gilenia could be affected by, among other things, unexpected regulatory actions
or delays or government regulation generally; unexpected clinical trial results,
including unexpected new clinical data and unexpected additional analysis of
existing clinical data; competition in general; government, industry and general
public pricing pressures; the company's ability to obtain or maintain patent or
other proprietary intellectual property protection; the impact that the
foregoing factors could have on the values attributed to the Novartis Group's
assets and liabilities as recorded in the Group's consolidated balance sheet,
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 provides healthcare solutions that address the evolving needs of
patients and societies. Focused solely on healthcare, Novartis offers a
diversified portfolio to best meet these needs: innovative medicines,
cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools and
consumer health products. Novartis is the only company with leading positions in
these areas. In 2009, the Group's continuing operations achieved net sales of
USD 44.3 billion, while approximately USD 7.5 billion was invested in R&D
activities throughout the Group. Headquartered in Basel, Switzerland, Novartis
Group companies employ approximately 100,000 full-time-equivalent associates and
operate in more than 140 countries around the world. For more information,
please visit http://www.novartis.com.
References
[1] Kappos L. et al. Oral Fingolimod (FTY720) vs Placebo in Relapsing-Remitting
Multiple Sclerosis: 24-month Clinical Efficacy Results from a Randomized,
Double-Blind, Multicenter Phase III Study (FREEDOMS). Slide deck associated with
Oral Presentation at the American Academy of Neurology (AAN) Annual Meeting
2010 in Toronto.
[2] Khatri B. et al. 24-Month Efficacy and Safety Outcomes from the TRANSFORMS
Extension Study of Oral Fingolimod (FTY720) in Patients with Relapsing-Remitting
Multiple Sclerosis. Poster presented at AAN, Toronto, April 2010.
[3] Cohen J. et al. Oral Fingolimod vs. Intramuscular Interferon in Relapsing
Multiple Sclerosis. N Eng J Med 2010; 362:402-415.
[4] Khatri B et al. Oral Fingolimod (FTY720) Reduces the Rate of Relapses that
Require Steroid Intervention or Hospitalization Compared with Intramuscular
Interferon ?-1a: Results from a Phase III study (TRANSFORMS) in Multiple
Sclerosis. Poster presented at AAN, Toronto, April 2010.
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