Janssen Pharmaceutica

Janssen to Showcase New Data Across Broad Rheumatology Portfolio and Immunology Pipeline at EULAR 2018

Beerse, Belgium (ots/PRNewswire) - FOR MEDICAL AND TRADE ONLY

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that ten company-sponsored abstracts will be presented at the Annual European Congress of Rheumatology (EULAR 2018) in Amsterdam, Netherlands being held on 13-16 June.

Data from the rheumatology portfolio includes latest research findings on Stelara® (ustekinumab), an anti-interleukin (IL)-12/23 monoclonal antibody, in the treatment of active systemic lupus erythematosus (SLE)*. Janssen will present two abstracts which evaluate the efficacy and safety as well as the SLE Disease Activity Index 2000 (SLEDAI-2K) and SLEDAI-2K Responder Index-50 (SRI-50) responses of ustekinumab in patients with SLE.[1],[2]

Presentations of note for guselkumab include three abstracts from the Phase 2 study of guselkumab in active psoriatic arthritis patients**. Data on dactylitis and enthesitis, as well as long-term follow-up on efficacy and safety will be presented.[3],[4],[5]

"At Janssen we are committed to addressing the unmet needs of people living with rheumatic diseases today and in the future. We're looking forward to presenting the latest data from our portfolio and pipeline at this prestigious conference," comments Wim Noel, Medical Affairs Director Rheumatology, EMEA at Janssen-Cilag NV.

Abstracts of interest

The following abstracts will be presented at EULAR as an exchange of scientific and clinical information (all times, CEST):



TREMFYA(R) (guselkumab)
Abstract No.            Title                                  
Date/Time

OP0166[6]               Comparative evaluation of cellular     
Oral presentation
and molecular changes associated with  
Thursday June 14;
response to selective IL-23 blockade   
10:15-11:45
vs dual IL-12/23 blockade in          
psoriasis skin

OP0308[5]               Efficacy and safety results of         
Oral presentation
guselkumab in patients with active     
Friday June 15;
psoriatic arthritis over 56 weeks      
10:15-11:45
from a Phase 2a, randomized,
double-blind, placebo-controlled      
study                                 

SAT0322[3]              The effect of guselkumab on            
Poster presentation
dactylitis: results from a Phase 2     
Saturday June 16;
study in patients with active          
10:30-12:00
psoriatic arthritis                   

SAT0344[4]              The effect of guselkumab on            
Poster presentation
enthesitis: results from a Phase 2     
Saturday June 16;
study in patients with active          
10:30-12:00
psoriatic arthritis

AB0912[7]               Two-year efficacy and safety of        
Published in Abstract
guselkumab for treatment of            
Book
moderate-to-severe psoriasis: Phase 3
VOYAGE 1 trial
STELARA (ustekinumab)
Abstract No.            Title                                  
Date/Time

FRI0339[1]              SLEDAI-2K Responder Index-50 is        
Poster presentation
effective in demonstrating partial     
Friday June 15;
response in a Phase 2, randomized      
11.15-13:30
placebo-controlled study of
ustekinumab in patients with active   
systemic lupus erythematosus

FRI0303[2]              Efficacy and safety of ustekinumab in  
Poster presentation and
patients with active systemic lupus    
guided tour
erythematosus: results of a Phase 2,   
Friday June 15;
randomized placebo-controlled study    
11.45-13:30 

About systemic lupus erythematosus (SLE)

Lupus is a chronic, inflammatory autoimmune disease that can affect many different body systems, including joints, skin, heart, lungs, kidneys and brain.[8] SLE can range from mild to severe and is characterised by inflammation of any organ system including kidneys, nervous system and brain.[9] The disease most often affects women and disproportionately affects women of African American, Hispanic, Asian and Native American descent compared to Caucasian women.[10] Incidence rates vary across European countries, ranging from 2.2 cases/100,000 in Spain to 5 cases/100,000 in France.[11] Lupus is estimated to affect at least 5 million people worldwide.[12]

About psoriatic arthritis

Psoriatic arthritis is a chronic immune-mediated inflammatory disease characterised by both joint inflammation and the skin lesions associated with psoriasis.[13] It is estimated that one third of the 125 million people who are living with psoriasis worldwide; over a third of whom will also develop psoriatic arthritis.[14] The disease causes pain, stiffness and swelling in and around the joints and commonly appears between the ages of 30 and 50, but can develop at any time. Though the exact cause of psoriatic arthritis is unknown, genes, the immune system and environmental factors are all believed to play a role in the onset of the disease.[15]

About psoriasis

The most common form of psoriasis is plaque psoriasis, usually resulting in areas of thick, red or inflamed skin covered with silvery scales which are known as plaques.[16] The inconsistent nature of psoriasis means that even when plaques appear to subside, many patients still live in fear of their return.[17]

Psoriasis can cause great physical and psychological burden. A study comparing psoriasis to other prominent conditions found its mental and physical impact comparable to that seen in cancer, heart disease and depression.[18] Psoriasis is also associated with several comorbidities including psoriatic arthritis, cardiovascular diseases, metabolic syndrome, chronic obstructive pulmonary disorder (COPD) and osteoporosis.[19] In addition, many individuals are faced with social exclusion, discrimination, and stigma because of their disease.

About ustekinumab[20]

In the European Union, ustekinumab is approved for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or psoralen plus ultraviolet A (PUVA), and is also indicated for the treatment of moderate to severe plaque psoriasis in adolescent patients from the age of 12 years and older who are inadequately controlled by or are intolerant to other systemic therapies or phototherapies. In addition, ustekinumab is approved alone or in combination with MTX for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying antirheumatic drug (DMARD) therapy has been inadequate. Ustekinumab is approved by the European Commission for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF-alpha antagonist or have medical contraindications to such therapies.

*Ustekinumab is currently under investigation and is not approved for SLE. A Phase 3 program evaluating ustekinumab in the treatment of adults with active SLE is ongoing.

The common (>=1/100) adverse reactions reported in controlled periods of the adult psoriasis, psoriatic arthritis and Crohn's disease clinical studies with ustekinumab as well as post-marketing experience were: upper respiratory tract infection, arthralgia, back pain, diarrhoea, dizziness, fatigue, headache, infection site pain, injection site erythema, myalgia, nasopharyngitis, nausea, oropharyngeal pain, pruritus and vomiting.

The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to ustekinumab, which is currently approved for the treatment of moderate to severe plaque psoriasis in 90 countries, paediatric psoriasis in 43 countries, psoriatic arthritis in 83 countries and Crohn's disease in 54 countries.

Stelara® is a registered trademark of Janssen Biotech, Inc.

Important Safety Information

For complete European Union (EU) prescribing information, please visit: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000958/WC500058513.pdf.

About guselkumab[21]

Guselkumab is a human monoclonal antibody developed by Janssen that selectively blocks the protein interleukin (IL)-23. In May 2018, the National Institute for Health and Care Excellence (NICE) issued its Final Appraisal Determination (FAD) recommending guselkumab for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.[22] Guselkumab received marketing authorization from the European Commission in November 2017 for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.

**Guselkumab is currently under investigation and is not approved for active psoriatic arthritis. A Phase 3 program evaluating guselkumab in the treatment of adults with active psoriatic arthritis is ongoing.

The most common side effects of guselkumab include upper respiratory infections, headache, injection site reactions, joint pain (arthralgia), diarrhoea, stomach flu (gastroenteritis), fungal skin infections, urticaria and herpes simplex infections.

TREMFYA® (guselkumab) is a registered trademark of Janssen Biotech, Inc.

Important Safety Information

For complete European Union (EU) prescribing information, please visit: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004271/WC500239623.pdf.

About the Janssen Pharmaceutical Companies of Johnson & Johnson

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com/EMEA. Follow us on Twitter at https://twitter.com/JanssenEMEA. Janssen Pharmaceutica NV is 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 development of ustekinumab and guselkumab in Europe. 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-Cilag International NV, any of the other Janssen Pharmaceutical Companies 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 or 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 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 December 31, 2017, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in the company's subsequent Quarterly Reports on Form 10-Q and other 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.

References

1. Vollenhoven RV, et al. Efficacy and safety of ustekinumab in patients with active systemic lupus erythematosus: results of a Phase 2, randomized placebo-controlled study. 2018 Annual European Congress of Rheumatology; Abstract no. FRI0303.

2. Touma Z, et al. SLEDAI-2K Responder Index-50 is effective in demonstrating partial response in a Phase 2, randomized placebo-controlled study of ustekinumab in patients with active systemic lupus erythematosus. 2018 Annual European Congress of Rheumatology; Abstract no. FRI0339.

3. Gladman D, et al. The effect of guselkumab on dactylitis: results from a Phase 2 study in patients with active psoriatic arthritis. 2018 Annual European Congress of Rheumatology; Abstract no. SAT0322.

4. Helliwell P, et al. The effect of guselkumab on enthesitis: results from a Phase 2 study in patients with active psoriatic arthritis. 2018 Annual European Congress of Rheumatology; Abstract no. SAT0344.

5. Deodhar A, et al. Efficacy and safety results of guselkumab in patients with active psoriatic arthritis over 56 weeks from a Phase 2a, randomized, double-blind, placebo-controlled study. 2018 Annual European Congress of Rheumatology; Abstract no. OP0308.

6. Li K, et al. Comparative evaluation of cellular and molecular changes associated with response to selective IL-23 blockade vs dual IL-12/23 blockade in psoriasis skin. 2018 Annual European Congress of Rheumatology; Abstract no. OP0166.

7. Griffiths CE, et al. Two-year efficacy and safety of guselkumab for treatment of moderate-to-severe psoriasis: Phase 3 VOYAGE 1 trial. 2018 Annual European Congress of Rheumatology; Abstract no. AB0912.

8. Mayo Clinic. Lupus. Available at: https://www.mayoclinic.org/diseases-conditions/lupus/symptoms-causes/syc-20365789. Accessed May 2018.

9. Arthritis Research UK. Lupus (SLE). Available at: https://www.arthritisresearchuk.org/arthritis-information/conditions/lupus.aspx. Accessed May 2018.

10. Lupus Research Alliance. About Lupus. Available at: http://www.lupusresearch.org/understanding-lupus/what-is-lupus/about-lupus/. Accessed May 2018.

11. Danchenko N, Satia JA and Anthony MS. Epidemiology of systemic lupus erythematosus: a comparison of worldwide disease burden. Lupus 2006;15:308-318.

12. Lupus UK. World Lupus Day 2018 Survey Findings. Available at: https://www.lupusuk.org.uk/wld-survey-2018/. Accessed May 2018.

13. Arthritis Research UK. Psoriatic Arthritis. Available at: https://www.arthritisresearchuk.org/arthritis-information/conditions/psoriatic-arthritis.aspx. Accessed May 2018.

14. International Federation of Psoriasis Associations. Our Cause: Psoriasis. Available at: https://ifpa-pso.com/our-cause/. Accessed May 2018.

15. National Psoriasis Foundation. About Psoriatic Arthritis. Available at: http://www.psoriasis.org/psoriatic-arthritis. Accessed May 2018.

16. British Skin Foundation. Psoriasis. Available at: http://www.britishskinfoundation.org.uk/SkinInformation/AtoZofSkindisease/Psoriasis.aspx. Accessed May 2018.

17. World Health Organization (2016) Global Report on Psoriasis. Available at: http://apps.who.int/iris/bitstream/10665/204417/1/9789241565189_eng.pdf. Accessed May 2018.

18. Rapp S.R, et al. Psoriasis causes as much disability as other major medical diseases. J Am Acad Dermatol. 1999;41(3):401-7.

19. Nijsten T et al. Complexity of the association between psoriasis and comorbidities. J Invest Dermatol. 2009; 129(7):1601-1603.

20. European Medicines Agency. Stelara Summary of Product Characteristics. Janssen-Cilag International NV. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000958/WC500058513.pdf. Accessed May 2018.

21. European Medicines Agency. Tremfya Summary of Product Characteristics. Janssen-Cilaag International NV. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004271/WC500239623.pdf. Accessed May 2018.

22. National Institute of Health and Care Excellence (NICE). Psoriasis (moderate, severe) - guselkumab [ID1075]. Available at: http://www.nice.org.uk/guidance/indevelopment/gid-ta10232/documents. Accessed May 2018.

PHGB/IMM/0518/0029

May 2018

Contact:

Kathleen Provinciael
+32-497-33-26-87
kprovinc@its.jnj.com. Chandni Kerai
+44(0)7896-873321
chandni.kerai@toniclc.com. Investor Contacts: Lesley Fishman
Johnson & Johnson
+1-732-524-3922

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