Novartis oral MS therapy FTY720 shows reduced risk of confirmed disability progression as published
(Thomson Reuters ONE) - NOVARTIS AG CHF0.50(REGD) / Novartis oral MS therapy FTY720 shows reduced risk of confirmed disability progression as published in New England Journal of Medicine processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement. * Combined data from TRANSFORMS and FREEDOMS studies show significant efficacy in reducing relapses, disability progression and MRI lesions in MS * In FREEDOMS, FTY720 0.5 mg dose reduced the risk of 3-month and 6-month confirmed disability progression by 30% and 37% over two years versus placebo * FTY720 clinical program provides safety experience in over 2,300 MS patients, including some patients in their sixth year of therapy * Robust clinical trial program strengthens potential for oral FTY720 to be the first approved product in new therapeutic class called S1P receptor modulators * FTY720 0.5 mg dose submitted for regulatory approval in US and EU in December 2009Basel, January 20, 2010 - Results of the TRANSFORMS[1] and FREEDOMS[2] studies,the two pivotal Phase III clinical trials with oral FTY720 (fingolimod), havebeen published in The New England Journal of Medicine, providing comprehensiveevidence to support the efficacy and safety profile of this first-in-classtherapy for multiple sclerosis (MS).The data, from one of the largest Phase III programs conducted in MS, wereincluded in the applications for regulatory approval submitted to the US Foodand Drug Administration (FDA) and European Medicines Agency (EMEA) in December2009. In both studies, two doses of FTY720 were examined (0.5 mg and 1.25 mg).Approval is sought for the lower 0.5 mg dose as the results from the studiesindicate that this dose has the most positive benefit-risk profile."Innovative science leading to new medicines for MS patients is greatly needed,"said John Richert, MD, Executive Vice President for Research and ClinicalPrograms at the US National Multiple Sclerosis Society. "The positive resultspublished in The New England Journal of Medicine showing benefit of fingolimodon the clinical and MRI outcomes assessed is very encouraging for MS patients,their families and their physicians."The one-year TRANSFORMS study involving 1,292 patients showed that oral FTY7200.5 mg reduced relapses by 52% compared to interferon beta-1a (Avonex(®))? givenby intramuscular injection, while the reduction with FTY720 1.25 mg was 38%(both p<0.001). The two-year FREEDOMS study, involving 1,272 patients, showedthat FTY720 reduced 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). Patients on FTY720 0.5 mg alsohad a 30% lower risk of disability progression, three-month confirmed (p=0.02)and a 37% lower risk of disability progression, six-month confirmed (p=0.01)over two years compared to placebo. Similarly, the FTY720 1.25 mg dose reducedthe risk of three-month and six-month confirmed disability progression by 32%(p=0.02) and 40% (p=0.006) respectively.In both studies, treatment with FTY720 also resulted in statisticallysignificant reductions in brain lesion activity and reduced loss of brain volumeas measured by magnetic resonance imaging (MRI)."The TRANSFORMS data demonstrate the efficacy of fingolimod compared to acurrent standard of care. These findings may represent a real step forward inthe fight against MS," said Jeffrey Cohen, MD, TRANSFORMS study leadinvestigator and staff physician at the Cleveland Clinic Mellen Center forMultiple Sclerosis Treatment and Research in Cleveland, Ohio, USA. "Currentdisease-modifying therapies for relapsing-remittingMS are administered byinjection or infusion, which may negatively affect tolerability, convenience,and compliance for patients on these therapies."Professor Ludwig Kappos, MD, principal investigator for the FREEDOMS clinicaltrial and Chair of Neurology and Research Group Leader in the Department ofBiomedicine at the University Hospital in Basel, Switzerland, said: "FTY720demonstrated clear clinical superiority over placebo in terms of reducingrelapse rates and disability progression. The positive findings of TRANSFORMSand FREEDOMS give an increasingly complete understanding of the efficacy andsafety of FTY720."Up to 2.5 million people worldwide are affected by MS, an inflammatory and neurodegenerative condition that often begins when patients are in the prime oftheir lives[3].FTY720 has the potential to be the first approved therapy in a new class ofdrugs called sphingosine 1-phosphate (S1P) receptor modulators. These medicinesreduce inflammation and may also have a direct beneficial effect on cells in thecentral nervous system (CNS). FTY720 acts selectively by retaining certainlymphocytes (a sub-group of white blood cells) in the lymph nodes, reducing thenumber of lymphocytes that reach the brain where they can cause inflammatorydestruction. This lymphocyte retention is reversible, allowing circulatinglymphocytes to regain normal levels if treatment is stopped."These data demonstrate that oral FTY720 has the potential to offer an importantnew treatment option for patients with MS," said Trevor Mundel, MD, Global Headof Development at Novartis Pharma AG. "We have a long-term commitment to the MScommunity, and trust that FTY720, once approved, will prove to be a valuabletreatment option for many people who live with this disease."In both TRANSFORMS and FREEDOMS, adherence to therapy was best for the FTY7200.5 mg and control groups compared to the 1.25 mg group. The mostcommonlyreported adverse events for both FTY720 and control groups were nasopharyngitis,headache and fatigue. FTY720-related adverse events included dose-related,transient, generally asymptomatic heart rate reduction, infrequent transient AVconduction block, mild (1-3 mm Hg) blood pressure increase, macular edema (morecommon with 1.25 mg than the 0.5 mg target dose), and asymptomatic, reversibleelevation of liver enzymes.The rates of infections overall, including serious infections, were comparablebetween treatment groups, although a slight increase in lung infections(primarily bronchitis) was seen in patients treated with FTY720. The number ofmalignancies reported in the two studies was small with comparable rates betweenthe FTY720 and control groups; malignancies were reported more frequently withFTY720 than the control group in the one-year TRANSFORMS study but the oppositepattern was seen in the two-year FREEDOMS study.Serious adverse events were comparable between treatment groups, thoughgenerally slightly higher with the 1.25 mg than 0.5 mg dose. Overall rates ofdrug-related adverse events, particularly those related to the mechanism ofaction, as well as discontinuations due to adverse events, were more common with1.25 mg than 0.5 mg.The completed MS FTY720 studies and their extensions include more than 2,300patients with approximately 4,000 patient-years of exposure, including somepatients now in their sixth year of treatment. Safety is also being monitored inapproximately 1,000 additional patients in ongoing MS studies.The publication in The New England Journal of Medicine marks the firstpresentation of full results from the two studies. Top line results of FREEDOMSand TRANSFORMS have been disclosed in Novartis press releases, and theTRANSFORMS study has also been presented at scientific congresses[4].?Avonex(®) is a registered trademark of Biogen Idec.Dr. Jeffrey Cohen conducts research and is a paid consultant for Novartis.DisclaimerThe foregoing release contains forward-looking statements that can be identifiedby terminology such as "risk," "potential," "encouraging," "may," "can,""commitment," "will," or similar expressions, or by express or implieddiscussions regarding marketing approvals for FTY720 or regarding potentialfuture revenues from FTY720. You should not place undue reliance on thesestatements. Such forward-looking statements reflect the current views ofmanagement regarding future events, and involve known and unknown risks,uncertainties and other factors that may cause actual results with FTY720 to bematerially different from any future results, performance or achievementsexpressed or implied by such statements. There can be no guarantee that FTY720will be approved for sale in any market. Nor can there be any guarantee thatFTY720 will achieve any particular levels of revenue in the future. Inparticular, management's expectations regarding FTY720 could be affected by,among other things, unexpected regulatory actions or delays or governmentregulation generally; unexpected clinical trial results, including unexpectednew clinical data and unexpected additional analysis of existing clinical data;the company's ability to obtain or maintain patent or other proprietaryintellectual property protection; competition in general; government, industryand general public pricing pressures; the impact that the foregoing factorscould have on the values attributed to the Novartis Group's assets andliabilities as recorded in the Group's consolidated balance sheet, and otherrisks and factors referred to in Novartis AG's current Form 20-F on file withthe US Securities and Exchange Commission. Should one or more of these risks oruncertainties materialize, or should underlying assumptions prove incorrect,actual results may vary materially from those anticipated, believed, estimatedor expected. Novartis is providing the information in this press release as ofthis date and does not undertake any obligation to update any forward-lookingstatements contained in this press release as a result of new information,future events or otherwise.About NovartisNovartis provides healthcare solutions that address the evolving needs ofpatients and societies. Focused solely on healthcare, Novartis offers adiversified portfolio to best meet these needs: innovative medicines,cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools andconsumer health products. Novartis is the only company with leading positions ineach of these areas. In 2008, the Group's continuing operations achieved netsales of USD 41.5 billion and net income of USD 8.2 billion. Approximately USD7.2 billion was invested in R&D activities throughout the Group. Headquarteredin Basel, Switzerland, Novartis Group companies employ approximately 99,000full-time-equivalent associates and operate in more than 140 countries aroundthe world. For more information, please visit http://www.novartis.com
Themen in dieser Pressemitteilung:
Unternehmensinformation / Kurzprofil:
Datum: 20.01.2010 - 17:06 Uhr
Sprache: Deutsch
News-ID 1009172
Anzahl Zeichen: 0
contact information:
Contact person:
Town:
Basel
Phone:
Kategorie:
Business News
Anmerkungen:
Diese Pressemitteilung wurde bisher 121 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Novartis oral MS therapy FTY720 shows reduced risk of confirmed disability progression as published
"
steht unter der journalistisch-redaktionellen Verantwortung von
NOVARTIS AG CHF0.50(REGD) (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
