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Press release_bg 12 ectrims_biogen_idec

PRESS RELEASE
NEW DATA FROM PHASE 3 STUDIES PROVIDE ADDITIONAL EVIDENCE
SUPPORTING TREATMENT EFFECT FOR ORAL BG-12 (DIMETHYL FUMARATE)
IN MULTIPLE SCLEROSIS
Interim Results from ENDORSE Extension Study Further Support Safety Profile from
Weston, Mass. – October 12, 2012 – Today Biogen Idec (NASDAQ: BIIB) announced
new data from studies evaluating oral BG-12 (dimethyl fumarate), which provide
further evidence supporting its strong clinical and radiological effects in people with
relapsing-remitting multiple sclerosis (RRMS) and reinforce its favorable safety profile
seen to date. These data were presented at the 28th Congress of the European
Committee for the Treatment and Research of Multiple Sclerosis (ECTRIMS) in Lyon,
France.1

In a pre-specified analysis of integrated, or pooled, data from the Phase 3 DEFINE and
CONFIRM studies, dimethyl fumarate showed statistically significant and clinically
relevant effects in reducing multiple sclerosis (MS) relapses and progression of
disability, as well as reductions in magnetic resonance imaging (MRI) measures of
disease activity. In addition, interim safety data from a Phase 3 extension study
indicate that continued exposure to dimethyl fumarate did not result in any new or
worsening safety signals, and that its safety and tolerability profiles were consistent
with previous studies.1
“These data provide additional insight into the positive efficacy and safety results from
our Phase 3 studies, showing there is a consistent beneficial effect with dimethyl
fumarate in reducing MS relapses, brain lesions and disability,” said Alfred Sandrock,
M.D., Ph.D., senior vice president, Development Sciences and chief medical officer of
Biogen Idec. “If approved, dimethyl fumarate may provide a broad range of MS
patients with an effective therapy that offers the ease of oral administration and an
acceptable tolerability profile.”1
Analyses of Pooled Phase 3 Efficacy Results1,2,3
DEFINE and CONFIRM were randomized, double-blind studies that compared the
efficacy and safety of dimethyl fumarate 240 mg, administered twice daily (BID) or
three times daily (TID), to placebo over two years. CONFIRM also included a reference
comparator of glatiramer acetate (GA; 20 mg subcutaneous daily injection). A pooled
analysis of the efficacy data from more than 2,300 patients in these two studies was
performed in order to provide the medical community with a more precise estimate of
dimethyl fumarate’s treatment effects versus placebo on relapse, progression and MRI
outcomes.

Analyses of the pooled clinical efficacy results of DEFINE and CONFIRM show that
treatment with dimethyl fumarate led to significant reductions in MS relapses and
disease progression. At two years compared to placebo, dimethyl fumarate
significantly reduced:
• Annualized relapse rate (ARR) by 49 percent for both BID and TID (p<0.0001 for
• Proportion of patients who relapsed by 43 percent for BID and 47 percent for TID • Risk of 12-week confirmed disability progression, as measured by the Expanded Disability Status Scale (EDSS), by 32 percent for BID (p=0.0034) and 30 percent for TID (p=0.0059) In MRI cohorts from DEFINE and CONFIRM, treatment with dimethyl fumarate significantly improved MRI outcomes over two years compared to placebo by reducing: • Mean number of new or newly enlarging T2-hyperintense lesions by 78 percent for BID and 73 percent for TID (p<0.0001 for both) • Mean number of new non-enhancing T1-hypointense lesions by 65 percent for BID and 64 percent for TID (p<0.0001 for both) • Odds of having a greater number of gadolinium-enhancing (Gd+) lesions by 83 percent for BID and 70 percent for TID (p<0.0001 for both) “These pooled results demonstrate that dimethyl fumarate had a significant effect on measures that MS patients are acutely aware of – the frequency of the relapses they experience and the progression of disability,” said Ralf Gold, Ph.D., professor/chair of the Department of Neurology at St. Josef-Hospital/Ruhr-University in Bochum, Germany. Pooled DEFINE and CONFIRM efficacy data are included in one platform and two poster presentations: • Clinical Effects of BG-12 in Subgroups of Patients with Relapsing-Remitting Multiple Sclerosis: An Integrated Analysis of the Phase 3 DEFINE and CONFIRM Studies was available for viewing on Thursday, Oct. 11, 2012 from 3:30-5:00 p.m. CEST Clinical Efficacy of BG-12 in Relapsing-Remitting Multiple Sclerosis: An Integrated Analysis of the Phase 3 DEFINE and CONFIRM Studies will be presented by Prof. Ralf Gold on Friday, Oct. 12, 2012 at 2:40 p.m. CEST • Effects of BG-12 on Magnetic Resonance Imaging Outcomes in Relapsing-Remitting Multiple Sclerosis: An Integrated Analysis of the Phase 3 DEFINE and CONFIRM Studies will be available for viewing on Friday, Oct. 12, 2012 from 3:30-5:00 p.m. CEST
Pooled Safety Results1,2,3
Safety and tolerability results were pooled from three placebo-controlled studies
(DEFINE; CONFIRM; and a Phase 2 dose-ranging study) involving more than 2,400
patients who had received placebo or 240 mg of dimethyl fumarate twice or three
times a day. These pooled data were consistent with results presented at previous
medical conferences. The overall incidence of adverse events (AEs: 92% placebo, 95%
BID, 93% TID) and serious adverse events (SAEs: 21% placebo, 18% BID, 15% TID) was
similar for all treatment groups. The most common AEs associated with dimethyl
fumarate treatment were flushing and gastrointestinal (GI) events; the incidence of
these events was highest during the first month and decreased thereafter.

Mean lymphocyte counts decreased during the first year of dimethyl fumarate
treatment and then plateaued, staying within normal limits throughout the entire
treatment period. The incidence of hepatic and renal events was comparable among
all study groups. The incidence of serious infections (≤2%) and malignancies (<1%) was
low and balanced across the study groups. There were no opportunistic infections.
Pooled DEFINE and CONFIRM safety data are included in one poster presentation:
Safety and Tolerability of BG-12 in Patients with Relapsing-Remitting Multiple
An Integrated Analysis of the Placebo-Controlled Studies was available for viewing on
Thursday, Oct. 11 from 3:30-5:00 p.m. CEST
Interim Extension Study Safety Results4
Positive interim safety data from ENDORSE, a dose-blind, multi-center, Phase 3
extension study evaluating the long-term safety and efficacy of dimethyl fumarate 240
mg BID and TID, will also be presented at the congress. At the time of analysis, 1,736
patients with RRMS who completed the DEFINE study or the CONFIRM study had been
dosed in ENDORSE.
Patients who received two years of dimethyl fumarate in DEFINE and CONFIRM
continued on the same dimethyl fumarate dose (BID or TID) in ENDORSE. Patients who
had previously received placebo or GA (CONFIRM only) were randomized 1:1 to
dimethyl fumarate 240 mg BID or TID.
At the time of analysis, more than half of the patients in ENDORSE had been followed
for more than one year. Overall, the safety profile for those first exposed to dimethyl
fumarate in ENDORSE was consistent with the safety results established in the DEFINE
and CONFIRM studies. There were no new safety signals observed in patients who had
previously been on dimethyl fumarate.
In ENDORSE, the incidence of serious infections was low (≤2%) in all treatment groups
and there were no opportunistic infections. There was no increased risk of infection in
patients treated long-term with dimethyl fumarate. The overall incidence of
malignancies was low (<1%).
The types and frequency of malignancies that were observed in the treatment groups were expected in the population under study, and no specific pattern of malignancies was observed. These data are included in one poster presentation: • Long-Term Safety and Tolerability of Oral BG-12 (Dimethyl Fumarate) in Relapsing- Remitting Multiple Sclerosis: Interim Results from ENDORSE will be available for viewing on Friday, Oct. 12 from 3:30-5:00 p.m. CEST (late-breaking news)
The data presented at ECTRIMS were included in Biogen Idec’s regulatory submissions
for dimethyl fumarate around the world.
About DEFINE
DEFINE (Determination of the Efficacy and safety of oral Fumarate IN rElapsing-
remitting MS) was a global, randomized, double-blind, placebo-controlled, dose-
comparison study to determine the efficacy and safety of dimethyl fumarate (240 mg,
BID or TID) and enrolled 1,237 people with RRMS. The primary objective was to
determine if dimethyl fumarate was effective in reducing the proportion of relapsing
patients at two years. Secondary endpoints included reduction in the number of new
or newly enlarging T2-hyperintense lesions and Gd+ lesions as measured by MRI,
reduction in ARR, and reduction of disability progression as measured by EDSS.
Additional endpoints included the safety and tolerability of dimethyl fumarate.
Detailed results from DEFINE were presented at the 5th Joint Triennial Congress of the
European and Americas Committees on Treatment and Research in Multiple Sclerosis
(ECTRIMS and ACTRIMS) in October 2011.
About CONFIRM
CONFIRM (COmparator and aN oral Fumarate In Relapsing-remitting MS) was a global,
randomized, double-blind, placebo-controlled, dose-comparison study to determine
the efficacy and safety of dimethyl fumarate and enrolled 1,430 people with RRMS.
The study evaluated two dose regimens of dimethyl fumarate, 240 mg BID and 240 mg
TID, as well as a reference comparator of GA (20 mg subcutaneous daily injection).
Both dimethyl fumarate and GA groups were evaluated versus placebo. The primary
objective was to determine whether dimethyl fumarate was effective in reducing the
rate of clinical relapses at two years. Secondary endpoints at two years included
reduction in: the number of new or newly enlarging T2-hyperintense lesions and the
number of new non-enhancing T1-hypointense lesions (MRI scans were obtained at a
cohort of sites); the proportion of patients who relapsed; and in progression of
disability as measured by EDSS. Safety and tolerability of dimethyl fumarate were also
assessed. Detailed results from CONFIRM were presented at the 64th Annual Meeting
of the American Academy of Neurology (AAN) in April 2012.

About ENDORSE
ENDORSE is an ongoing global, dose-blind extension study to determine the long-term
safety and efficacy of dimethyl fumarate (240 mg, BID or TID). The study has enrolled
1,738 patients with RRMS who completed the DEFINE study or the CONFIRM study.
Patients participating in ENDORSE will be followed for up to five years. The primary
objective is to evaluate the longterm safety profile of dimethyl fumarate. Secondary
objectives include: long-term efficacy of dimethyl fumarate on clinical outcomes and
MS brain lesions on MRI scans; and effects of dimethyl fumarate on quality of life
measurements. It is estimated that the ENDORSE study will be completed in 2016.
About Dimethyl Fumarate
Dimethyl fumarate, also known as BG-12, is an investigational oral therapy in late-
stage clinical development for the treatment of RRMS, the most common form of MS.
Dimethyl fumarate is the only currently known investigational compound for the
treatment of RRMS that has experimentally demonstrated activation of the Nrf-2
pathway. Dimethyl fumarate is currently under review by regulatory authorities in the
United States, European Union, Australia, Canada and Switzerland.
About Biogen Idec
Through cutting-edge science and medicine, Biogen Idec discovers, develops and
delivers to patients worldwide innovative therapies for the treatment of
neurodegenerative diseases, hemophilia and autoimmune disorders. Founded in 1978,
Biogen Idec is the world’s oldest independent biotechnology company. Patients
worldwide benefit from its leading multiple sclerosis therapies, and the company
generates more than $5 billion in annual revenues. For product labeling, press releases
and additional information about the company, please visit www.biogenidec.com .
1. Gold R. et al, Clinical efficacy of BG-12 in relapsing–remitting multiple sclerosis: an integrated analysis of the phase 3 DEFINE and CONFIRM studies. Apresentado na sessão paralela 12 do 28º ECTRIMS. Lyon, França; 10-13 Outubro 2012 2. Miller DH et al, P445 do 28º ECTRIMS. Lyon, França; 10-13 Outubro 2012 3. Bar-Or A et al, P445 do 28º ECTRIMS. Lyon, França; 10-13 Outubro 2012 4. Selmaj K et al, P445 do 28º ECTRIMS. Lyon, França; 10-13 Outubro 2012 Para mais informações/contactos médicos:
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