Novartis International AG /New data at AAN to confirm efficacy of Novartis' Gilenya® across four key measures of MS disease activity, including brain volume loss . Processed and transmitted by NASDAQ OMX Corporate Solutions.The issuer is solely responsible for the content of this announcement. Gilenya reduced relapse rates, new MRI lesion counts, brain volume loss and disability progression in previously-treated MS patients with high disease activity. Data at AAN showed significantly more Gilenya-treated patients (vs. patients on placebo) had brain volume loss rates comparable to people without MS Generation of scientifically meaningful data, highlighted by 38 abstracts at AAN, is central to Novartis' commitment to address the unmet needs of MS community Basel, April 23, 2014 - New analyses of pooled data from the FREEDOMS and FREEDOMS II trials will be presented at the 66th American Academy of Neurology (AAN) Annual Meeting in Philadelphia, Pennsylvania[1], and will show the consistent efficacy of Gilenya® (fingolimod) on four key measures of multiple sclerosis (MS) disease activity - reducing relapses, new MRI lesion counts, brain volume loss and disability progression. Demonstrating benefit on these four measures is important in order to improve the course of MS and ultimately address the loss of function (e.g. problems walking or difficulty with mental tasks) experienced by patients with MS. An additional analysis of FREEDOMS and FREEDOMS II will show that significantly more Gilenya-treated patients (vs. patients on placebo) had brain volume loss rates comparable to people without MS[2]. Given that brain volume loss, measured by Magnetic Resonance Imaging (MRI), starts early in the disease course and is correlated with long-term disability (both physical and cognitive)[3]-[8], a treatment benefit on this measure will be important for patients with MS. "These new analyses provide further evidence of how Gilenya impacts four key measures of MS disease activity," said David Epstein, Division Head, Novartis Pharmaceuticals. "Additionally, new data reinforcing Gilenya's positive effect on brain volume loss are of significant interest to the MS community. People with MS lose brain volume up to three to five times faster than people without MS and these data will highlight the importance of a treatment that can minimize brain volume loss in patients." Novartis is also presenting trial design information on PARADIGMS, the first controlled clinical trial investigating a disease-modifying therapy (DMT) in pediatric MS patients[9]. In collaboration with regulatory agencies and international leaders in pediatric MS, Novartis has developed the PARADIGMS study to evaluate the efficacy and safety of fingolimod versus an injectable interferon beta 1-a treatment in pediatric patients treated for 24 months[9]. Pediatric MS is uncommon, given that only 3-5% of all MS cases start in this age range[10]-[14]. There are currently no approved treatments for pediatric MS, and no controlled studies of MS therapies have been conducted in this population. Novartis MS portfolio highlights at AAN include: Gilenya® (fingolimod) in relapsing-remitting MS Proportion of patients with brain volume loss comparable to healthy adults in fingolimod phase 3 multiple sclerosis studies - Platform presentation S13.006, De Stefano: April 29, 14:15 EST Efficacy of fingolimod in pre-treated patients with disease activity: pooled analyses of FREEDOMS and FREEDOMS II - Poster P3.174, Bergvall: April 29, 15:00 EST Consistent reduction in the annualized rate of brain volume loss across phase 3 core and extension trials of fingolimod in relapsing multiple sclerosis - Poster P3.180, Radue: April 29, 15:00 EST Efficacy benefits of fingolimod 0.5 mg once daily in patients previously treated with glatiramer acetate: pooled analysis of the phase 3, placebo-controlled FREEDOMS and FREEDOMS II studies in relapsing multiple sclerosis - Poster P3.193, Jeffrey: April 29, 15:00 EST Four-year Expanded Disability Status Scale (EDSS) outcomes in patients treated with fingolimod in the phase 3 and extension trial program - Poster P3.185, Cree: April 29, 15:00 EST Long-term safety of fingolimod: interim evaluation of data from the LONGTERMS trial - Poster P2.210, Cohen: April 29, 07:30 EST Relapse rates among patients with multiple sclerosis who switch from interferon therapy to fingolimod or glatiramer acetate: a retrospective US claims database analysis - Poster P7.211, Lahoz: May 1, 15:00 EST Fingolimod in pediatric MS Fingolimod in pediatric MS: design of a double-blind study versus interferon beta-1a IM (PARADIGMS) - Poster P2.238, Chitnis: April 29, 07:30 EST BAF312 (siponimod) in relapsing-remitting MS Safety and efficacy of siponimod (BAF312) in patients with relapsing-remitting multiple sclerosis: Results from dose-blinded extension phase of BOLD study - Poster P3.151, Kappos: April 29, 15:00 EST Story Source: The above story is based on materials provided by ANDHRANEWS Note: Materials may be edited for content and length Click here to read

Novartis International AG /New data at AAN to confirm efficacy of Novartis' Gilenya® across four key measures of MS disease activity, including brain volume loss . Processed and transmitted by NASDAQ OMX Corporate Solutions.The issuer is solely responsible for the content of this announcement.

Gilenya reduced relapse rates, new MRI lesion counts, brain volume loss and disability progression in previously-treated MS patients with high disease activity.

Data at AAN showed significantly more Gilenya-treated patients (vs. patients on placebo) had brain volume loss rates comparable to people without MS
Generation of scientifically meaningful data, highlighted by 38 abstracts at AAN, is central to Novartis' commitment to address the unmet needs of MS community
           
Basel, April 23, 2014 - New analyses of pooled data from the FREEDOMS and FREEDOMS II trials will be presented at the 66th American Academy of Neurology (AAN) Annual Meeting in Philadelphia, Pennsylvania[1], and will show the consistent efficacy of Gilenya® (fingolimod) on four key measures of multiple sclerosis (MS) disease activity - reducing relapses, new MRI lesion counts, brain volume loss and disability progression.

Demonstrating benefit on these four measures is important in order to improve the course of MS and ultimately address the loss of function (e.g. problems walking or difficulty with mental tasks) experienced by patients with MS. An additional analysis of FREEDOMS and FREEDOMS II will show that significantly more Gilenya-treated patients (vs. patients on placebo) had brain volume loss rates comparable to people without MS[2]. Given that brain volume loss, measured by Magnetic Resonance Imaging (MRI), starts early in the disease course and is correlated with long-term disability (both physical and cognitive)[3]-[8], a treatment benefit on this measure will be important for patients with MS.

"These new analyses provide further evidence of how Gilenya impacts four key measures of MS disease activity," said David Epstein, Division Head, Novartis Pharmaceuticals. "Additionally, new data reinforcing Gilenya's positive effect on brain volume loss are of significant interest to the MS community. People with MS lose brain volume up to three to five times faster than people without MS and these data will highlight the importance of a treatment that can minimize brain volume loss in patients."

Novartis is also presenting trial design information on PARADIGMS, the first controlled clinical trial investigating a disease-modifying therapy (DMT) in pediatric MS patients[9]. In collaboration with regulatory agencies and international leaders in pediatric MS, Novartis has developed the PARADIGMS study to evaluate the efficacy and safety of fingolimod versus an injectable interferon beta 1-a treatment in pediatric patients treated for 24 months[9]. Pediatric MS is uncommon, given that only 3-5% of all MS cases start in this age range[10]-[14]. There are currently no approved treatments for pediatric MS, and no controlled studies of MS therapies have been conducted in this population.

Novartis MS portfolio highlights at AAN include:

Gilenya® (fingolimod) in relapsing-remitting MS

Proportion of patients with brain volume loss comparable to healthy adults in fingolimod phase 3 multiple sclerosis studies - Platform presentation S13.006, De Stefano:  April 29, 14:15 EST

Efficacy of fingolimod in pre-treated patients with disease activity: pooled analyses of FREEDOMS and FREEDOMS II - Poster P3.174, Bergvall: April 29, 15:00 EST

Consistent reduction in the annualized rate of brain volume loss across phase 3 core and extension trials of fingolimod in relapsing multiple sclerosis - Poster P3.180, Radue: April 29, 15:00 EST

Efficacy benefits of fingolimod 0.5 mg once daily in patients previously treated with glatiramer acetate: pooled analysis of the phase 3, placebo-controlled FREEDOMS and FREEDOMS II studies in relapsing multiple sclerosis - Poster P3.193, Jeffrey: April 29, 15:00 EST

Four-year Expanded Disability Status Scale (EDSS) outcomes in patients treated with fingolimod in the phase 3 and extension trial program - Poster P3.185, Cree: April 29, 15:00 EST

Long-term safety of fingolimod: interim evaluation of data from the LONGTERMS trial - Poster P2.210, Cohen: April 29, 07:30 EST
Relapse rates among patients with multiple sclerosis who switch from interferon therapy to fingolimod or glatiramer acetate: a retrospective US claims database analysis - Poster P7.211, Lahoz: May 1, 15:00 EST
Fingolimod in pediatric MS

Fingolimod in pediatric MS: design of a double-blind study versus interferon beta-1a IM (PARADIGMS) - Poster P2.238, Chitnis: April 29, 07:30 EST
BAF312 (siponimod) in relapsing-remitting MS

Safety and efficacy of siponimod (BAF312) in patients with relapsing-remitting multiple sclerosis: Results from dose-blinded extension phase of BOLD study - Poster P3.151, Kappos: April 29, 15:00 EST

Story Source: The above story is based on materials provided by ANDHRANEWS

Note: Materials may be edited for content and length

Click here to read