Janssen Submits Application To EMA Seeking Approval Of Anti-Interleukin-23 Monoclonal Antibody Guselkumab For The Treatment Of Moderate To Severe Plaque Psoriasis

BEERSE, Belgium, Nov. 25, 2016 /PRNewswire/ -- Janssen-Cilag International NV (Janssen) announced today the submission of a Marketing Authorisation Application to the European Medicines Agency (EMA) seeking approval of guselkumab for the treatment of adults living with moderate to severe plaque psoriasis. Guselkumab is a human monoclonal antibody that targets the protein interleukin (IL)-23, which has been shown to play a key role in the development of immune-mediated inflammatory diseases.¹  Psoriasis is a chronic, autoimmune inflammatory disorder that results in the overproduction of skin cells, characterised by raised, inflamed, scaly, red lesions, or plaques, which can cause itching, discomfort and pain.² It is estimated that 14 million Europeans have psoriasis³, which can range from mild to severe and disabling, and can often significantly impair quality of life.⁴

Logo - http://photos.prnewswire.com/prnh/20161123/442474LOGO

"We are committed to the discovery and development of innovative therapies to address the continued unmet medical needs of people living with psoriasis," said Newman Yeilding, MD, Head of Immunology Development, Janssen Research & Development, LLC.  "We look forward to working with the EMA during the agency's review of the application as we seek approval of guselkumab for the treatment of adults living with moderate to severe plaque psoriasis in the European Union."  

Data from four studies evaluating the efficacy and safety of guselkumab when administered by subcutaneous injection in the treatment of adults living with moderate to severe plaque psoriasis served as the basis for the submission: the VOYAGE 1⁵ , VOYAGE 2⁶ and NAVIGATE⁷ Phase 3 studies, and the X-PLORE⁸ Phase 2 study, which appeared in The New England Journal of Medicine in July 2015. Results from the VOYAGE 1 study were recently presented at the European Academy of Dermatology and Venereology (EADV) congress, and results from the VOYAGE 2 and NAVIGATE studies are planned for presentation at upcoming scientific congresses.

About Guselkumab
Guselkumab is a human monoclonal antibody with a novel mechanism of action that targets the protein interleukin (IL)-23 and is in Phase 3 development as a subcutaneously administered therapy for the treatment of moderate to severe plaque psoriasis.  On 17^th November, Janssen Biotech, Inc. announced the submission of a Biologics License Application to the United States Food and Drug Administration seeking approval of guselkumab for the treatment of adults living with moderate to severe plaque psoriasis.  Additionally, findings from a Phase 2 study evaluating guselkumab in the treatment of patients with active psoriatic arthritis were recently presented at the American College of Rheumatology meeting and a Phase 3 program for this indication is planned.

About Psoriasis
Psoriasis is a chronic, autoimmune inflammatory disorder that results in the overproduction of skin cells, characterised by raised, inflamed, scaly, red lesions, or plaques, which can cause itching and physical pain.² It is estimated that as many as 125 million people worldwide have psoriasis⁹, including 14 million Europeans³, and approximately 20% of people affected have cases that are considered moderate to severe.¹⁰

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 at Twitter.com/JanssenEMEA.

Janssen-Cilag International NV, Janssen Research & Development, LLC and Janssen Biotech, Inc. 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 new product development. 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, Janssen Research & Development, LLC, Janssen Biotech, Inc. 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; competition, including technological advances, new products and patents attained by competitors; challenges to patents; manufacturing difficulties or delays; product efficacy or safety concerns resulting in product recalls or regulatory action; 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, 2016, including in Exhibit 99 thereto, 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 or Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

References

1. Sofen H, et al. Guselkumab (an IL-23–specific mAb) demonstrates clinical and molecular response in patients with moderate-to-severe psoriasis. J Allergy Clin Immunol 2014;133:1032–40.
2. National Psoriasis Foundation. Psoriasis Fact Sheet. https://www.psoriasis.org/sites/default/files/psoriasis_fact_sheet.pdf. Accessed November 2016.
3. Ortonne J, et al. Alefacept: a novel and selective biologic agent for the treatment of chronic plaque psoriasis. Eur J Dermatol 2004;14:41–45.
4. World Health Organization, Global Report on Psoriasis. http://apps.who.int/iris/bitstream/10665/204417/1/9789241565189_eng.pdf?ua=1. Accessed November 2016.
5. A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis (VOYAGE 1). https://clinicaltrials.gov/ct2/show/NCT02207231. Accessed November 2016.
6. A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis With Randomized Withdrawal and Retreatment (VOYAGE 2). https://clinicaltrials.gov/ct2/show/NCT02207244. Accessed November 2016.
7.  A Study of Guselkumab in Participants With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab (NAVIGATE). https://clinicaltrials.gov/ct2/show/NCT02203032. Accessed November 2016.
8. A Study to Evaluate CNTO 1959 in the Treatment of Patients With Moderate to Severe Plaque-type Psoriasis (X-PLORE). https://clinicaltrials.gov/ct2/show/NCT01483599. Accessed November 2016.
9. National Psoriasis Foundation. People of All Races Overcome Psoriatic Disease. https://www.psoriasis.org/advance/features/people-of-all-races-overcome-the-challenge-of-psoriatic-diseases. Accessed November 2016.
10. The Psoriasis and Psoriatic Arthritis Alliance (PAPAA). About Psoriasis. http://www.papaa.org/resources/about-psoriasis. Accessed November 2016.