Janssen to Highlight Latest Research on Multiple Sclerosis at ACTRIMS Forum 2021

February 24, 2021 7:00 AM EST

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TITUSVILLE, N.J., Feb. 24, 2021 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that its latest multiple sclerosis (MS) research will be presented at the 2021 Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum from February 25-27. Nine Janssen-sponsored data abstracts on MS research will be presented, including real-world evidence highlighting the impact of fatigue in U.S. adults with relapsing MS (RMS); a study assessing the impact of MS fatigue on work productivity and activity impairment; and cross-sectional analyses of both the economic and humanistic burden associated with fatigue in relapsing-remitting MS.

"We are pleased to present findings from our continued research in MS at ACTRIMS Forum 2021, which highlight data demonstrating the efficacy of our investigational treatment, ponesimod, in addressing various symptoms of relapsing MS, including fatigue," said Bill Martin, Ph.D., Global Therapeutic Area Head, Neuroscience, Janssen Research & Development, LLC. "These data further reinforce our commitment to supporting research and development programs for people living with MS as we expand our innovative research portfolio in neuroscience."

Janssen Data Presentations Include:

Changes in Fatigue Status on the FSIQ-RMS Symptoms Domain in the Phase 3 OPTIMUM StudyThis study evaluated the likelihood of patient fatigue symptoms improving or remaining stable with investigational ponesimod vs. Aubagio® (teriflunomide) on a novel, patient-reported outcome measure used to assess the impact of MS fatigue by tracking related symptoms in people with relapsing MS.

Assessing the Impact of Disease Activity and Fatigue Symptom on Work Productivity and Activity Impairment in Patients with Relapsing Multiple SclerosisThis analysis aimed to estimate the impact of MS disease activity and worsening of fatigue on work productivity and activity impairment (WPAI), as assessed by the WPAI:MS, using data from the Phase 3 OPTIMUM study.

Measuring the Symptoms and Impacts of Fatigue in Adults with Relapsing Multiple Sclerosis Using a Novel Disease-Specific Scale: A Real-World Study in U.S. PopulationThis ongoing noninterventional prospective study of RMS patients measures MS fatigue and its impact on daily life in a real-world population using a survey including the FSIQ-RMS instrument.

The Economic Burden Associated with Fatigue in Relapsing-Remitting Multiple SclerosisThis cross-sectional study used data from the 2017 and 2019 U.S. National Health and Wellness Survey to characterize associations between fatigue and economic burden in relapsing-remitting MS (RRMS).

A complete listing of Janssen-sponsored abstracts is provided below. Abstracts can also be viewed on the ACTRIMS Forum 2021 website.

Presentation #

Title

P163

Identifying and Characterizing Fatigue in Patients Diagnosed with Multiple Sclerosis on Disease-Modifying Therapies Using Real World Evidence

P034

MS Fatigue: Treatment Effect of Ponesimod in RMS Patients with and without Disease Activity

P202

Changes in Fatigue Status on the FSIQ-RMS Symptoms Domain in the Phase 3 OPTIMUM Study

P191

A Central Effect of Ponesimod on Neuroinflammation in a Pre-Clinical Model of Multiple Sclerosis

P201

Assessing the Impact of Disease Activity and Fatigue Symptom on Work Productivity and Activity Impairment in Patients with Relapsing Multiple Sclerosis

P206

Measuring the Symptoms and Impacts of Fatigue in Adults with Relapsing Multiple Sclerosis Using a Novel Disease- Specific Scale: A Real-World Study in U.S. Population

P213

The Economic Burden Associated with Fatigue in Relapsing-Remitting Multiple Sclerosis

P214

The Humanistic Burden Associated with Fatigue in Relapsing-Remitting Multiple Sclerosis

P204

Evaluating the Impact of Fatigue Symptoms on Work Productivity and Activity Impairment Using Longitudinal Data from the Phase 3 OPTIMUM Study

About PonesimodPonesimod is an investigational highly selective sphingosine-1-phosphate receptor 1 (S1P1) modulator that is believed to functionally inhibit S1P1 receptor activity and, in so doing, reduces the number of circulating lymphocytes that can cross the blood-brain barrier. In patients with MS, the penetration of autoreactive immune cells into the brain damages myelin, the protective sheath that insulates nerve cells. Damage to myelin slows or halts nerve conduction, producing the neurologic signs and symptoms of MS.i

Ponesimod has been submitted to the U.S. Food and Drug Administration, the European Medicines Agency and several other regulatory agencies around the world for approval for the treatment of adult patients with relapsing MS and is currently under review by health authorities.

Actelion Pharmaceuticals Ltd, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, is party to a revenue-sharing agreement with Idorsia Pharmaceuticals Ltd, which provides for certain payments to Idorsia related to the sales of ponesimod.

About Multiple Sclerosis (MS)MS is a chronic autoimmune inflammatory disease in which the body attacks and damages the central nervous system (CNS), which includes the brain, spinal cord, and optic nerves. It is caused by the movement of immune cells into the CNS, which damages myelin (the protective casing that insulates nerve cells).ii This slows or prevents nerves from communicating with the rest of the body, causing the neurologic signs and symptoms of MS. Relapsing forms of MS, which make up 85 percent of all MS cases at disease onset, include clinically isolated syndrome, relapsing-remitting MS and active secondary progressive MS.iii

Relapses are defined as new, worsening, or recurrent neurological symptoms that last for more than 24 hours with the absence of fever or infections. Relapses may be fully resolved over days or weeks or lead to persistent residual deficits and accumulation of disability.iv

About the Janssen Pharmaceutical Companies of Johnson & JohnsonAt Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenGlobal. Janssen Research & Development, LLC and Actelion Pharmaceuticals Ltd are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

*Aubagio® (teriflunomide) is a registered trademark of Sanofi Société Anonyme France.

Cautions Concerning Forward-Looking StatementsThis 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 materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, 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; changes in behavior 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.

______________________________i National Multiple Sclerosis Society. What is Myelin? Available at: https://www.nationalmssociety.org/What-is-MS/Definition-of-MS/Myelin. Accessed July 22, 2019.ii National Multiple Sclerosis Society. Definition of MS. Available at: https://www.nationalmssociety.org/What-is-MS/Definition-of-MS. Accessed January 21, 2021.iii National Multiple Sclerosis Society. Types of MS. Available at: https://www.nationalmssociety.org/What-is-MS/Types-of-MS. Accessed July 22, 2019. iv Multiple Sclerosis Association of America. What is an MS relapse? Available at: https://mymsaa.org/publications/ms-relapse-toolkit/what-relapse/. Accessed July 22, 2019.

Media contact:Stela Meirelles+1 (732) 258-1540

Investor contacts:Chris DelOrefice +1 (732) 524-2955

Jennifer McIntyre+1 (732) 524-3922

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SOURCE The Janssen Pharmaceutical Companies of Johnson & Johnson



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