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Johnson & Johnson : JANSSEN DEMONSTRATES STRONG COMMITMENT TO RESEARCH AND DEVELOPMENT OF THERAPIES FOR INFLAMMATORY BOWEL DISEASES WITH NINE DATA PRESENTATIONS AT ACG 2020

10/19/2020 | 10:30am EST

News Release

Media contact:

Ania DiAntonio

Mobile: +1 (215) 620-9717

Investor contacts:

Chris DelOrefice

Office: +1 (732) 524-2955

Jennifer McIntyre

Office: +1 (731) 524-3922

JANSSEN DEMONSTRATES STRONG COMMITMENT TO RESEARCH AND

DEVELOPMENT OF THERAPIES FOR INFLAMMATORY BOWEL DISEASES WITH

NINE DATA PRESENTATIONS AT ACG 2020

Final, Five-Year Results of Long-Term Extension Study of Clinical Response and Remission of STELARA® (ustekinumab) in Patients with Moderate-to-Severe Crohn's Disease to be Featured in Oral Presentation

HORSHAM, PENNSYLVANIA, October 19, 2020 - The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that data from nine company- sponsored abstracts will be presented at the 2020 American College of Gastroenterology (ACG) Annual Meeting, being held virtually this year from October 23

  • October 28. Featured among the eight poster presentations and one oral presentation are final five-year data from the IM-UNITIopen-labellong-term extension (LTE) study evaluating the efficacy and safety of STELARA® (ustekinumab) therapy in adult patients with moderately to severely active Crohn's disease, which will be presented via a pre- recorded, on-demand session available to registered attendees.

"While this year's meeting may look different in its virtual setting, our commitment to advancing the science and addressing unmet needs for people living with IBD is unchanged," said Jan Wehkamp, M.D., Vice President, Gastroenterology Disease Area

Page 1 of 9

Leader, Janssen Research & Development, LLC. "Patients with a chronic condition like Crohn's disease require long-term treatment, so it is critical to conduct studies like the IM-UNITIlong-term extension study to gather important data on durability of treatment response and long-term outcomes. We look forward to sharing findings of this STELARA research with the medical community during this year's congress."

Other notable presentations at ACG include data from the Phase 3 UNIFI study evaluating the safety and efficacy of STELARA as a maintenance therapy in patients with moderately to severely active ulcerative colitis who previously failed biologic or conventional therapy. Data will be presented from the long-term extension study out to two years, including an abstract showing the effect of the treatment on stool frequency and rectal bleeding.

A listing of all abstracts to be featured at the congress, each available on-demand via the congress' virtual platform, are provided in the table below.

Abstract No.

Title

P1650

Pharmacokinetics and Immunogenicity of Maintenance Therapy with Ustekinumab: 2-Year Results

from the UNIFI Long-Term Extension Study

P1692

Fecal Calprotectin as a Surrogate Marker of Clinical Remission, Clinical Response, Endoscopic

Improvement, and Histo-endoscopic Mucosal Healing: UNIFI Induction Study

P1584

Effect of Ustekinumab Maintenance Therapy on Stool Frequency and Rectal Bleeding Through 2

Years in the UNIFI Phase 3 Study in Ulcerative Colitis

OP42

Efficacy and Safety of Ustekinumab for Crohn's Disease Through 5 Years: Final Results from the IM-

UNITI Long-term Extension

P1677

Healthcare Cost Offsets from Reductions in Ulcerative Colitis-Related Hospitalizations and Surgeries

in Patients Treated with Ustekinumab in the UNIFI Study

Page 2 of 9

Abstract No.

Title

P1567

Nonbiologic Drug Use One Year Before and Two Years After Initiation of Ustekinumab or Adalimumab

for Crohn's Disease Patients

P1676

Costs of Inflammatory Bowel Disease-Related Hospitalizations and Surgeries: A Retrospective

Analysis in a Commercially Insured Population

P1100

Economic Costs Associated with Reduction in Work Productivity Loss for Ulcerative Colitis Patients

Receiving Ustekinumab Using Results from the UNIFI Clinical Trial

P1101

Cost Reduction Associated With Improvement In Work Productivity Loss From Ustekinumab

Treatment By Disease Severity States: Results From The IM-UNITI Clinical Trial

About Inflammatory Bowel Diseases

More than five million people worldwide are living with Crohn's disease and ulcerative colitis-collectively known as IBD.1 Crohn's disease most commonly affects the end of the small bowel (the ileum) and the beginning of the colon, but it may affect any part of the gastrointestinal (GI) tract, from the mouth to the anus. Ulcerative colitis is limited to the colon, also called the large intestine. Symptoms of Crohn's disease can vary but may include abdominal cramps and pain, frequent diarrhea, rectal bleeding, weight loss and fever. There is currently no cure for Crohn's disease.2 Symptoms of ulcerative colitis can vary but may include looser and more urgent bowel movements, bloody stool, crampy abdominal pain, loss of appetite and fatigue. There is currently no cure for ulcerative colitis.3

About STELARA® (ustekinumab)

STELARA® (ustekinumab), a human IL-12 and IL-23 antagonist, is approved in the United States for the treatment of: 1) adults and children 6 years and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; 2) adult patients (18 years or older) with active psoriatic arthritis, used alone or in combination with methotrexate (MTX); 3) adult patients (18 years and older) with moderately to severely active Crohn's disease who have failed or were intolerant to

Page 3 of 9

immunomodulators or corticosteroids; or failed or were intolerant to anti-TNF therapies;

  1. adult patients (18 years and older) with moderately to severely active ulcerative colitis.

The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to STELARA®.

Important Safety Information

STELARA® is a prescription medicine that affects your immune system. STELARA® can increase your chance of having serious side effects including:

Serious Infections

STELARA® may lower your ability to fight infections and may increase your risk of infections. While taking STELARA®, some people have serious infections, which may require hospitalization, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses.

  • Your doctor should check you for TB before starting STELARA® and watch you closely for signs and symptoms of TB during treatment with STELARA®.
  • If your doctor feels that you are at risk for TB, you may be treated for TB before and during treatment with STELARA®.

You should not start taking STELARA® if you have any kind of infection unless your doctor says it is okay.

Before starting STELARA®, tell your doctor if you:

  • think you have an infection or have symptoms of an infection such as: o fever, sweats, or chills
    o muscle aches o cough
    o shortness of breath o blood in phlegm
    o weight loss
    o warm, red, or painful skin or sores on your body o diarrhea or stomach pain

Page 4 of 9

This is an excerpt of the original content. To continue reading it, access the original document here.

Disclaimer

Johnson & Johnson published this content on 19 October 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 19 October 2020 14:29:04 UTC


© Publicnow 2020
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