Proven efficacy with PONVORY™1

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PRIMARY
ENDPOINT1

30.5% greater
reduction in ARR vs Aubagio®
(teriflunomide)
(P = 0.0003)

SECONDARY
ENDPOINT1

59% greater reduction in the number of new GdE T1 lesions
(P < 0.0001)

SECONDARY
ENDPOINT1

56% greater reduction in the number of new or enlarging T2 hyperintense lesions
(P < 0.0001)

SECONDARY
ENDPOINT1

As measured by time to 3-month CDP, ~9 out of 10 patients taking PONVORY™ did not experience disability progression over 2 years*

EXPLORATORY
ENDPOINTS1,2

ARR = annualized relapse rate; CDP = confirmed disability progression; GdE = gadolinium-enhancing; MS = multiple sclerosis.

*There was no statistically significant difference between the PONVORY™ and Aubagio® groups.1

30.5% greater relapse reduction vs Aubagio®1

  • In a phase 3 study, PONVORY™ was proven superior to Aubagio® in reducing ARR by 30.5% (P = 0.0003)1‡
30.5% greater relapse reduction with PONVORY™ vs an established oral comparator1

CL = confidence limit.

ARR was defined as confirmed relapses per year through the study period (negative binomial regression model with stratification variables, including EDSS ≤3.5 vs EDSS >3.5; use of non-steroid treatment for MS within the last 2 years prior to randomization [Yes vs No]; and the number of relapses in the year prior to study entry [≤1 vs ≥2] as covariates).1

Over the study period of ~108 weeks.1

71% of patients taking PONVORY™ were relapse-free during the OPTIMUM study1

  • Over the study period of ~108 weeks:
    • ~7 out of 10 patients taking PONVORY™ did not experience a relapse1
    • ~6 out of 10 patients taking Aubagio® did not experience a relapse1
  • This endpoint was not adjusted for multiple comparisons and statistical significance has not been established
71% of PONVORY™ patients were relapse-free during the OPTIMUM study1

59% greater reduction in the number of new GdE T1 lesions vs Aubagio®1

  • PONVORY™ demonstrated a superior reduction in the number of new GdE T1 lesions vs Aubagio® over the study period1
59% greater reduction in the number of new GdE T1 lesions vs Aubagio®1

GdE = gadolinium-enhancing.

§Over the study period of ~108 weeks.1

This endpoint is based on the cumulative number of combined unique active lesions (CUALs) as a prespecified secondary endpoint.1

56% greater reduction in the number of new or enlarging T2 lesions vs Aubagio®

  • PONVORY™ demonstrated a superior reduction in the number of new or enlarging T2 hyperintense lesions vs Aubagio® over the study period1
56% greater reduction in the number of new or enlarging T2 lesions vs Aubagio®

#Over the study period of ~108 weeks, lesions measured included number of new or enlarging T2 lesions (without double counting).1

||This endpoint is based on the cumulative number of combined unique active lesions (CUALs) as a prespecified secondary endpoint.1

As measured by time to 3-month CDP

~9 out of 10 patients taking PONVORY™ did not experience disability progression over 2 years1

  • Most patients taking PONVORY™ or Aubagio® showed no 3-month CDP over 108 weeks**
  • PONVORY™ reduced the relative risk of 3-month CDP by 17% (hazard ratio: 0.83; P = 0.29)‡‡ vs Aubagio®, a DMT which has previously demonstrated statistically significant reduction in relative risk of 3-month CDP across multiple studies1,3,5
~9 out of 10 patients taking PONVORY™ did not experience disability progression over 2 years1

CDP = confirmed disability progression; DMT = disease-modifying therapy; EDSS = Expanded Disability Status Scale.

**Based on proportion of patients with 3-month CDP (Kaplan-Meier estimates at Week 108).1

††A 3-month CDP was defined as an increase in EDSS score of at least 1.5 if baseline was 0, an increase of at least 1.0 if baseline was 1.0 to 5.0, or an increase of at least 0.5 if baseline was ≥5.5, which was confirmed 3 months later.1

‡‡Defined as time to 3-month CDP through the study period (stratified Cox proportional hazard model, P value based on the stratified log-rank test). Not statistically significant.1

~9 out of 10 patients taking PONVORY™ did not experience disability progression over 2 years1,3

  • Most patients taking PONVORY™ or Aubagio® showed no 3- or 6-month CDP over 108 weeks1,3§§
  • The 6-month CDP endpoint was not adjusted for multiple comparisons and statistical significance has not been established3
~9 out of 10 patients taking PONVORY™ did not experience disability progression over 2 years1,3

CDP = confirmed disability progression; DMT = disease-modifying therapy; EDSS = Expanded Disability Status Scale.

§§Based on proportion of patients with 3- and 6-month CDP (Kaplan-Meier estimates at Week 108).1

¶¶CDP was defined as an increase in EDSS score of at least 1.5 if baseline was 0, an increase of at least 1.0 if baseline was 1.0 to 5.0, or an increase of at least 0.5 if baseline was ≥5.5, which was confirmed 3 and 6 months later.1

##Defined as time to 3-month CDP through the study period (stratified Cox proportional hazard model, P value based on the stratified log-rank test). Not statistically significant.1

MRI exploratory endpoint: change in brain volume during the OPTIMUM study2

  • This endpoint was not adjusted for multiple comparisons and statistical significance has not been established
  • Longitudinal brain volume measurements were derived from MRI scans by using Structural Image Evaluation, using Normalization, of Atrophy (SIENA) methodology2
30.5% greater relapse reduction with PONVORY™ vs an established oral comparator1

The OPTIMUM Study

A phase 3, multicenter, randomized, double-blind, parallel-group, active-controlled superiority study1,3

In the OPTIMUM study, patients underwent a 14-day titration or mock titration at the start of treatment, followed by a once-daily maintenance dose up to Week 108. An accelerated elimination procedure was needed to accelerate the reduction of teriflunomide plasma concentrations. To maintain blinding, nearly all patients (~93%), including those who had received PONVORY™, underwent this procedure.1,4

OPTIMUM study design_PONVORY™ 20 mg (567) patients compared to teriflunomide, (566) patients

A 14-day up-titration schedule was used when initiating PONVORY™ to help reduce cardiac effects.1 The primary endpoint of the OPTIMUM study was the annualized relapse rate (ARR) over the study period. Secondary endpoints included the number of new gadolinium-enhancing (GdE) T1 lesions from baseline to Week 108, the number of new or enlarging T2 lesions from baseline to Week 108,*** and time to 3-month confirmed disability progression (CDP).1

***Without double counting of lesions.1