FRIMLEY, England, April 13, 2010 /PRNewswire/ -- Developed for UK consumer and medical journalists
Not intended for media in Republic of Ireland
New Data Presented at the AAN Show That Treatment With Fingolimod:
- Improves Self-Reported Ability to Perform Daily Activities for People With Multiple Sclerosis (MS) - Reduces Severity of Relapses, as Compared to Interferon Beta -1a, With Significantly Less Need for Steroid Intervention and Hospitalisation - Benefits Patients Switched From Interferon Beta -1a to Fingolimod, With Significantly Reduced Relapse Rates and Improved Brain Lesion Measures - Reduces Relapses by 62% in Newly Treated Patients
The recent publication of two pivotal studies (FREEDOMS and TRANSFORMS) in the New England Journal of Medicine (NEJM) confirmed that daily multiple sclerosis pill, fingolimod, was twice as effective as a commonly used injection (interferon Beta -1a) and placebo for the treatment of relapsing-remitting multiple sclerosis (RRMS) - the most common form of the disease.(1,2,3) New data presented this week at the 62nd annual meeting of the American Academy of Neurology (AAN) adds to the growing body of evidence to support fingolimod, showing additional benefits for patients.
New data from a sub-analyses of the TRANSFORMS study demonstrated that patients treated with fingolimod for 12 months experienced significantly less deterioration in their ability to perform daily activities compared with patients taking interferon Beta -1a, thus helping to maintain the independence of people with MS.(4) At month 12, 17.5 - 19.6% of fingolimod-treated patients experienced improvements in PRIMUS-Activities scores from baseline vs. 14.1% of interferon Beta -1a-treated patients.(4) The PRIMUS-Activities Scale, a patient-reported outcome measure of activity limitation, was used to detect changes in the daily functioning of patients.(4)
A further sub-analyses from the TRANSFORMS study showed that patients taking fingolimod 0.5 mg had a 71% reduction in relapses resulting in hospitalisation and a 52% reduction in relapses requiring steroid treatment compared with patients taking interferon Beta -1a, suggesting a better outcome for patients and a reduced burden on hospital resources.(5)
Data presented from the one year extension study for TRANSFORMS confirmed the efficacy of fingolimod in reducing relapses and MRI brain lesions.(6) Of the 1,153 patients who participated in the original one-year study, 1,027 (89%) elected to enter the one-year extension study.(6) Patients who received fingolimod in the original study remained on their original dose (0.5 mg or 1.25 mg) and patients who had received interferon Beta -1a were randomised to receive fingolimod 0.5 mg or 1.25 mg.(6) Patients who received fingolimod 0.5 mg for the full two years of the study experienced a consistently low annualised relapse rate (ARR) in year one (0.16) and year two (0.18).(6)
In the subset of 167 patients who received interferon Beta -1a during the first year and fingolimod 0.5 mg during the second year, the annualised relapse rate was reduced by 31%.(6) The number of new or newly enlarged T2 lesions in the brain, a marker of disease activity, was reduced by 67% after switching to fingolimod.(6) In addition, the percentage of patients free from lesions was significantly higher after switching to fingolimod.(6)
These findings on efficacy are consistent with those of the original one-year core TRANSFORMS study, in which fingolimod significantly reduced annualised relapse rates by 52% (0.5 mg dose) vs. interferon Beta -1a.(1)
In addition, data presented from a sub analyses of the two-year FREEDOMS study showed that fingolimod 0.5 mg reduced the annualised relapse rate (ARR) by 62% for newly treated patients compared to placebo.(7) For patients who had previously received other treatments, the annual relapse rates were reduced by 44%. This new data confirms the effectiveness of fingolimod regardless of treatment history.(7)
In addition to the data presented at the AAN for fingolimod, Novartis is investing in the research and development of an innovative pipeline of MS products:
- BAF312 - a second generation S1-P modulator currently in Phase II clinical trials - PI-2301 - a second generation peptide copolymer from a similar compound class as Copaxone(R) - KRP203 - an S1-P modulator with a differentiated S1-P receptor profile.
Notes to editors: Fingolimod safety information Fingolimod has a well-studied safety profile, with over 5,300 patient years of exposure.(8) The fingolimod MS study programme includes more than 4,000 patient years of exposure, with some patients in the sixth year of therapy, making it the largest Phase III clinical trial programme ever conducted in MS.(8) This robust clinical trial programme strengthens the potential for fingolimod to be the first approved product in a new therapeutic class called S1P receptor modulators.(9)
In TRANSFORMS and FREEDOMS overall, the most commonly reported adverse events for both fingolimod and control groups were nasopharyngitis, headache and fatigue.(1,2)Fingolimod-related adverse events included dose-related, transient, generally asymptomatic heart rate reduction, infrequent transient AV conduction block, 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.(1,2)
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 fingolimod.(1,2) The number of malignancies reported in the two studies was small with comparable rates between the fingolimod and control groups; malignancies were reported more frequently with fingolimod than the control group in the one-year TRANSFORMS study but the opposite pattern was seen in the two-year FREEDOMS study.(1,2)
Extensive clinical trial efficacy and safety data provide evidence of a positive benefit-risk profile for the 0.5 mg dose of fingolimod.(4) Fingolimod was submitted for marketing approval in Europe at the end of 2009.
Novartis in MS: Novartis has been highly active in neuroscience for more than 50 years, having developed treatments for conditions including epilepsy, ADHD, Alzheimer's disease and schizophrenia. Novartis continues to be active in the research and development of new compounds, is committed to addressing unmet medical needs and to supporting patients and their families affected by MS.
Disclaimer: The foregoing release contains forward-looking statements that can be identified by terminology such as planned, future, to focus on, will, potential, potentially, or similar expressions, or by express or implied discussions regarding potential future regulatory submissions or approvals for fingolimod or regarding potential future revenues from fingolimod. 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 fingolimod to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that fingolimod will be submitted or approved for sale in any market. Nor can there be any guarantee that fingolimod will achieve any particular levels of revenue in the future. In particular, management's expectations regarding fingolimod 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; competition in general; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; government, industry and general public pricing pressures; 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 materialise, 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 RD 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.
Please note that fingolimod (FTY720) is an investigational drug and has not been approved or licensed anywhere in the world (April 2010)
References Cohen J. et al. Oral Fingolimod vs. Intramuscular Interferon in Relapsing Multiple Sclerosis. N Eng J Med 2010, 362 (5) 402-415. Kappos L, et al. Placebo-Controlled Study of Oral Fingolimod in Relapsing Multiple Sclerosis. N Eng J Med 2010, 362 (5) 387-401. http://www.mstrust.org.uk/information/aboutms/types.jsp. Last accessed 9 April 2010. Cohen J et al. Oral Fingolimod (FTY720) Treatment Improves the Performance of Daily Activities Compared with Intramuscular Interferon -1a: Patient-Reported Indices for Multiple Sclerosis (PRIMUS ) - Activities Results from a Phase III Study (TRANSFORMS). Poster presented at AAN, Toronto, April 2010. Khatri B et al. Oral Fingolimod (FTY720) Reduces the Rate of Relapses that Require Steroid Intervention or Hospitalization Compared with Intramuscular Interferon Î²-1a: Results from a Phase III study (TRANSFORMS) in Multiple Sclerosis. Poster presented at AAN, Toronto, April 2010. 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. 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. Novartis. Data on file. Foster CA et al. Brain penetration of the oral immunomodulatory drug FTY720 and its phosphorylation in the central nervous system during experimental autoimmune encephalomyelitis: consequences for mode of action in multiple sclerosis. J Pharmacol Exp Ther 2007, 323 (2) 469-76.
SOURCE: Novartis UK Ltd.
CONTACT: Media contacts Claire Eldridge / Aaron Pond, Aurora HealthcareCommunications, Tel: +44-207-424-7940 Mobile: +44-7736-277-196 /+44-7872-812-405, Email: FTYteam@auroracomms.com; Novartis CommunicationsUK Tel: +44-1276-698-691 (Press Office), Email:email@example.com