Two-year Phase III study shows Novartis oral MS therapy FTY720
significantly reduces relapses and di
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ * FREEDOMS study shows FTY720 reduced relapse rates by 54-60% compared to placebo, and disability progression by 30-32%[1] * Results build on Phase III TRANSFORMS one-year study showing FTY720 reduced relapses significantly more than interferon beta-1a, a standard of care[2] * Phase III efficacy and safety data confirm positive benefit-risk profile for lower 0.5 mg dose[1] and support planned submissions in US and EU at end of 2009 * Future development of FTY720 in relapsing forms of MS to focus on lower 0.5 mg doseBasel, September 30, 2009 - Initial results from the two-year PhaseIII FREEDOMS study show that oral FTY720 (fingolimod) wassignificantly superior to placebo in reducing both relapses anddisability progression in patients with relapsing-remitting multiplesclerosis (MS)[1] - one of the leading causes of neurologicaldisability in young adults[3].The FREEDOMS study met its primary and secondary endpoints for boththe 0.5 mg and 1.25 mg doses, with no significant difference inefficacy between doses. This result builds on previous data showingsuperior efficacy to interferon beta-1a[2] in TRANSFORMS, the largesthead-to-head Phase III study against a standard of care treatment inMS.In FREEDOMS, FTY720 was generally well tolerated with a lowerincidence of adverse events at the 0.5 mg dose than 1.25 mg[1].Regulatory submissions for FTY720, planned in the US and EU at theend of 2009, will seek approval for the lower 0.5 mg dose based oncomprehensive Phase III results establishing its positivebenefit-risk profile. Future development of FTY720 in relapsing formsof MS will focus on the 0.5 mg dose."We are proud to have reached this critical milestone in thedevelopment of FTY720, a novel oral therapy that has the potential totransform the treatment of this ultimately disabling disease," saidTrevor Mundel, MD, Global Head of Development at Novartis Pharma AG."FTY720 0.5 mg therapy offers compelling efficacy on all relevantendpoints compared to both placebo and a standard of care,complemented by extensive safety data."Results from the placebo-controlled FREEDOMS study show that FTY720reduced the relapse rate by 54% for the 0.5 mg dose and 60% for the1.25 mg dose compared to placebo (both p<0.001)[1]. In addition,FTY720 reduced the progression of disability by 30% for patients on0.5 mg (p=0.024) and 32% for those on 1.25 mg (p=0.017) compared toplacebo over two years[1]. These findings were supported by positiveeffects on brain lesions as measured by magnetic resonance imaging(MRI) scans.FREEDOMS is the second of three Phase III studies to report resultsin the largest development program ever conducted in MS, involvingmore than 4,000 patients worldwide. Previously reported results fromthe one-year TRANSFORMS study showed a reduction in relapse rates of52% and 38% for FTY720 0.5 mg and 1.25 mg respectively compared tointerferon beta-1a (both p<0.001)[2]. FREEDOMS II, currently underway, is a two-year placebo-controlled Phase III study, similar indesign to FREEDOMS."The positive results from the FREEDOMS study confirm the efficacyand safety of fingolimod, and provide important evidence of itseffect on disability," said Professor Ludwig Kappos, Chair ofNeurology and Research Group Leader in the Department of Biomedicineat the University Hospital in Basel, Switzerland, and the principalinvestigator of the FREEDOMS study. "As an oral therapy, it is clearthat fingolimod potentially represents a significant advance in thetreatment of MS."FTY720 has a well-studied safety profile with more than 5,300patient-years of exposure, including patients now in their sixth yearof treatment. Previous data from the development program raisedquestions about potential side effects including macular edema,melanoma, liver injury, infections, and increased blood pressure. Inthe FREEDOMS study, at the 0.5 mg dose there were no cases of macularedema or melanoma[1]. Reversible and generally asymptomatic liverenzyme elevations were observed more frequently with FTY720 thanplacebo, and lung infections were also slightly more common[1]. Mildelevation in blood pressure was observed with FTY720. No new safetysignals were seen in FREEDOMS compared to previous clinical trials.Three patients died during the FREEDOMS study, one on FTY720 1.25 mgand two on placebo. None of the deaths was assessed as being relatedto the study drug[1].FREEDOMS (FTY720 Research Evaluating Effects of Daily Oral therapy inMultiple Sclerosis) was a double-blind, placebo-controlled studyinvolving 1,272 patients in 22 countries to assess the efficacy,safety and tolerability of FTY720. The primary endpoint was reductionin annual relapse rate and the key secondary endpoint was reductionin disability progression, defined as an increase from baseline inExpanded Disability Status Scale (EDSS) scores confirmed at threemonths[1].FTY720 has the potential to be the first in a new class of MStherapies called sphingosine 1-phosphate (S1-P) receptor modulators.Comprehensive analyses of the FREEDOMS data are ongoing, and detailedresults are planned to be presented at a leading scientific congressin 2010.DisclaimerThe foregoing release contains forward-looking statements that can beidentified by terminology such as "planned," "future," "to focus on,""will," "potential," "potentially," or similar expressions, or byexpress or implied discussions regarding potential future regulatorysubmissions or approvals for FTY720 or regarding potential futurerevenues from FTY720. You should not place undue reliance on thesestatements. Such forward-looking statements reflect the current viewsof management regarding future events, and involve known and unknownrisks, uncertainties and other factors that may cause actual resultswith 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 or approvedfor sale in any market. Nor can there be any guarantee that FTY720will achieve any particular levels of revenue in the future. Inparticular, management's expectations regarding FTY720 could beaffected by, among other things, unexpected clinical trial results,including unexpected new clinical data and unexpected additionalanalysis of existing clinical data; unexpected regulatory actions ordelays or government regulation generally; competition in general;the company's ability to obtain or maintain patent or otherproprietary intellectual property protection; government, industryand general public pricing pressures; the impact that the foregoingfactors could have on the values attributed to the Novartis Group'sassets and liabilities as recorded in the Group's consolidatedbalance sheet, and other risks and factors referred to in NovartisAG's current Form 20-F on file with the US Securities and ExchangeCommission. Should one or more of these risks or uncertaintiesmaterialize, or should underlying assumptions prove incorrect, actualresults may vary materially from those anticipated, believed,estimated or expected. Novartis is providing the information in thispress release as of this date and does not undertake any obligationto update any forward-looking statements contained in this pressrelease as a result of new information, future events or otherwise.About NovartisNovartis provides healthcare solutions that address the evolvingneeds of patients and societies. Focused solely on healthcare,Novartis offers a diversified portfolio to best meet these needs:innovative medicines, cost-saving generic pharmaceuticals, preventivevaccines, diagnostic tools and consumer health products. Novartis isthe only company with leading positions in each of these areas. In2008, the Group's continuing operations achieved net sales of USD41.5 billion and net income of USD 8.2 billion. Approximately USD 7.2billion was invested in R&D activities throughout the Group.Headquartered in Basel, Switzerland, Novartis Group companies employapproximately 99,000 full-time-equivalent associates and operate inmore than 140 countries around the world. For more information,please visit http://www.novartis.com.References[1] Novartis. Data on file.[2] Cohen J. et al. Oral Fingolimod (FTY720) Versus InterferonBeta-1a in Relapsing-Remitting Multiple Sclerosis: Results from aPhase III Study (TRANSFORMS). Slide deck associated with OralPresentation at the American Academy of Neurology Annual Meeting2009. [S21.004].[3] Cochrane Database of Systematic Reviews 2001, Issue 4.http://mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD002002/frame.html (Accessed29 September 2009). # # #Novartis Media RelationsCentral media line: +41 61 324 2200Eric Althoff ÿsa JosefssonNovartis Global Media Novartis Pharma CommunicationsRelations +41 61 324 0161 (direct)+41 61 324 7999 (direct) +41 79 515 2253 (mobile)+41 79 593 4202 (mobile) asa.josefsson(at)novartis.comeric.althoff(at)novartis.come-mail: media.relations(at)novartis.comNovartis Investor RelationsCentral phone: +41 61 324 7944Ruth Metzler-Arnold +41 61 324 North America: 9980Pierre-Michel +41 61 324 Richard Jarvis +1 212 830 2433Bringer 1065John Gilardi +41 61 324 Jill Pozarek +1 212 830 2445 3018Thomas +41 61 324 Edwin Valeriano +1 212 830 2456Hungerbuehler 8425Isabella Zinck +41 61 324 7188e-mail: e-mail:investor.relations(at)novartis.com investor.relations(at)novartis.comhttp://hugin.info/134323/R/1344775/322562.pdf --- End of Message ---Novartis International AGPosfach Basel WKN: 904278; ISIN: CH0012005267; Index: SPI, SLCI, SMI, SLIFE;Listed: ZLS in BX Berne eXchange, Main Market in SIX Swiss Exchange;
Datum: 30.09.2009 - 07:15 Uhr
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