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New, Subgroup

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced results from a new subgroup analysis of the pivotal Phase 3 OPTIMUM trial.

13.10.2021 - 12:12:33

New Subgroup Analysis of the Phase 3 OPTIMUM Study Demonstrates the Benefits of PONVORYTM? Over teriflunomide in Early Disease Multiple Sclerosis

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Janssen-Cilag International NV, the marketing authorisation holder for PONVORY™ (ponesimod) in the EU, Janssen Global Services, LLC, and Janssen Cilag GmBH are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding ponesimod. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Janssen-Cilag International NV, Actelion Pharmaceuticals Ltd, Janssen Pharmaceutica NV and/or any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 3, 2021, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

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References

DiBernardo A, Turkoz I et al. Ponesimod demonstrated increased clinical benefit over teriflunomide in early disease subgroup compared with overall population. E-poster at the Congress of the European Committee for Treatment Research in Multiple Sclerosis (ECTRIMS) 13-15 October 2021.DiBernardo A, Turkoz I et al. Ponesimod demonstrated increased clinical benefit over teriflunomide in early disease subgroup compared with overall population. Abstract at the Congress of the European Committee for Treatment Research in Multiple Sclerosis (ECTRIMS) 13-15 October 2021.National Multiple Sclerosis Society. Definition of MS. Available at: https://www.nationalmssociety.org/What-is-MS/Definition-of-MS. Last accessed: October 2021.National Multiple Sclerosis Society. Symptoms and Diagnosis. Available at: https://www.nationalmssociety.org/Symptoms-Diagnosis. Last accessed: October 2021.Giovannoni G, Butzkueven H, Dhib-Jalbut S, et al. Brain health: time matters in multiple sclerosis. Mult Scler Relat Disord. 2016;9(1):5-48.National Multiple Sclerosis Society. Cognitive Changes. Available at: https://www.nationalmssociety.org/Symptoms-Diagnosis/MSSymptoms/Cognitive-Changes Last accessed: October 2021.D'Ambrosio D, Freedman MS, Prinz J. Ponesimod, a selective S1P1 receptor modulator: a potential treatment for multiple sclerosis and other immune-mediated diseases. Ther Adv Chronic Dis. 2016;7(1):18-33. doi:10.1177/2040622315617354.Ponvory summary of product characteristics, June 2021. Available at: https://www.ema.europa.eu/en/documents/product-information/ponvory-epar-product-information_en.pdf Last accessed: October 2021.Johnson & Johnson. European Commission approves PONVORYTM? (ponesimod), a Once Daily, Oral Therapy for the Treatment of Adults with Relapsing Forms of Multiple Sclerosis with Active Disease Defined by Clinical or Imaging Features. Available at:https://www.janssen.com/emea/sites/www_janssen_com_emea/files/european_commission_approves_ponvorytm_ponesimod_a_once_daily_oral_therapy_for_the_treatment_of_adults_with_relapsing_forms_of_multiple_sclerosis_with_active_disease_defined_by_clinical_or_imaging_features.pdf. Last accessed: October 2021.Kappos L, Fox RJ, Burcklen M, et al. Ponesimod compared with teriflunomide in patients with relapsing multiple sclerosis in the active-comparator phase 3 OPTIMUM study: a Randomized clinical trial. JAMA Neurol. 2021.

CP-266001

Date prepared: October 2021

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