JANSSEN

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the United Kingdom’s National Institute for Health and Care Excellence (NICE) has published positive guidance for Tremfya^® (guselkumab), following its positive Final Appraisal Determination delivered on 2 May 2018.^1,2 This means that adults with moderate to severe plaque psoriasis will now have access to guselkumab through the National Health Service (NHS) in England and Wales.

Additionally, on 17 May 2018, Germany’s drug reimbursement body, The Federal Joint Committee (Gemeinsamer Bundesausschuss; G-BA) published its decision stating that guselkumab offered “substantial additional therapeutic benefits” compared to treatment with comparators for all patient populations assessed.³ This is the first time a biologic treatment for psoriasis has been awarded this level of benefit.

Dr Jaime Oliver, Medical Lead for Janssen Immunology, EMEA said: “The swift decision by two of Europe’s key Health Technology Assessment bodies reflects the positive results demonstrated in clinical studies of guselkumab for the treatment of moderate to severe plaque psoriasis. Psoriasis can be a painful, debilitating condition with severe psychological repercussions, often causing patients to feel self-conscious, isolated and depressed. Providing a new therapeutic option may help to alleviate some of the physical and emotional burden of this disease. We are therefore working hard to ensure that eligible patients in Europe can access guselkumab as quickly as possible. ”

These announcements mark the first two positive Health Technology Assessments (HTAs) in Europe for guselkumab after its Marketing Authorisation was granted by the European Commission in November 2017.⁴ Further assessments of guselkumab are currently underway in a number of other countries in the European Union, with decisions anticipated later in the year.

Guselkumab is the first biologic to selectively target interleukin (IL)-23, a key protein that initiates a specific immune inflammatory response in psoriasis.^5,6,7,8 Guselkumab may offer patients both effective and sustained control of this debilitating disease which affects approximately 14 million people across Europe.⁹

The NICE guidance and the G-BA endorsement for guselkumab are based on data from Phase 3 clinical studies. The VOYAGE 1 and 2 trials compared guselkumab with placebo and Humira^® (adalimumab), and showed high levels of skin clearance after 16 weeks, with a PASI 90 score in around 7 out of 10 patients receiving guselkumab, compared with approximately 5 out of 10 patients receiving adalimumab, respectively (P<0.001).^5,6 Longer term data also demonstrated consistent rates of skin clearance in patients with moderate to severe psoriasis who received treatment with guselkumab for almost two years.¹⁰

During the clinical development for guselkumab in psoriasis, there were no signals of increased risk of malignancy, major cardiovascular events or serious infections.^5,6,7 Adverse events reported in at least 1 out of 20 of guselkumab-treated patients during the first 16 weeks in the VOYAGE 1 and 2 trials included: nasopharyngitis, upper respiratory tract infection, injection site erythema, headache, arthralgia, pruritus and back pain. The types of adverse events reported remained generally consistent through 48 weeks of treatment.^5,6

Guselkumab is a subcutaneous injectable treatment for psoriasis and can be self-administered following training. Treatment requires two starter doses, one initially and the other four weeks later, followed by a maintenance dose once every eight weeks (q8w) thereafter.^5,6,11

Information for Editors

About guselkumab

VOYAGE 1, VOYAGE 2 and NAVIGATE studies

• VOYAGE 1 is a Phase III, multicentre, randomised, double-blind, placebo- and active comparator-controlled study, including 837 patients. It included a placebo-controlled period (weeks 0–16), after which patients taking placebo crossed over to receive guselkumab through week 48, and an active comparator-controlled period comparing guselkumab with adalimumab (week 0-48).⁵ Patients randomised to guselkumab at week 0 and those who crossed over from placebo to guselkumab at week 16 continued to receive guselkumab q8w at week 48.¹⁰ Beginning at week 52, all patients began receiving open-label guselkumab. This study will continue for a total of 5 years.
• VOYAGE 2 is a Phase III, multicentre, randomised, double-blind, placebo- and active comparator-controlled study, including 992 patients. It consisted of a placebo-controlled period (weeks 0-16), an active comparator-controlled period (weeks 0–28), and a randomised withdrawal and retreatment period (weeks 28–72).⁶ Beginning at week 76, all patients began receiving open-label guselkumab.
• A third phase III study was included as part of the regulatory submission, the NAVIGATE study. NAVIGATE was a Phase III, multicentre, randomised, double-blind study, including 871 patients. All patients received open-label ustekinumab treatment (patients weighing ≤100 kg: 45 mg, patients weighing >100 kg: 90 mg) at weeks 0 and 4. At week 16, patients with an inadequate response to ustekinumab (IGA score ≥2) were randomised in a double-blinded fashion to receive guselkumab at weeks 16, 20, and every 8 weeks thereafter through week 44, or to continue ustekinumab at week 16 and every 12 weeks thereafter through week 40. The final safety follow-up visit was at week 60.⁷

Clinical development programme

Phase III studies are being undertaken to evaluate the efficacy and safety of guselkumab for patients with psoriatic arthritis.¹² A Phase III comparator study (the ECLIPSE study) is underway to evaluate the efficacy of guselkumab versus Cosentyx^® (secukinumab), an IL-17A inhibitor, in patients with moderate to severe plaque psoriasis.¹¹

Prescribing and safety information

On 10 November 2017, guselkumab was granted market authorisation in Europe for the treatment of adult patients with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy).⁴

Guselkumab is the first psoriasis treatment licensed in the European Union to selectively target IL-23, a key driver of the immune inflammatory response in psoriasis.^5,6,7,8 Guselkumab is a self-injectable treatment for psoriasis (following training). Treatment requires two starter doses, one initially and the other four weeks later, followed by a maintenance dose once every eight weeks (q8w) thereafter.^5,6

The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to guselkumab, which is currently approved in the US, Canada and Europe.

For complete European Union (EU) prescribing and safety information, please visit: https://www.medicines.org.uk/emc/medicine/34321

▼ Adverse events should be reported. This medicinal product is subject to additional monitoring and it is therefore important to report any suspected adverse events related to this medicinal product. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Janssen-Cilag Ltd on 01494 567447.

About Psoriasis

What it is

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.¹³ The inconsistent nature of psoriasis means that even when plaques appear to subside, patients can have ongoing concerns over their return.

Impact

Psoriasis can cause great physical and psychological burden. Mental health issues are common among people with psoriasis, and the impact it can have on quality of life is comparable with diabetes and cancer.¹⁴ Psoriasis is also associated with several comorbidities including psoriatic arthritis, cardiovascular diseases, metabolic syndrome, chronic obstructive pulmonary disorder (COPD) and osteoporosis.¹⁵ In addition, many individuals are faced with social exclusion, discrimination and stigma because of their disease.¹⁶

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 https://www.janssen.com/emea/ . Follow us on Twitter: @JanssenEMEA. Janssen-Cilag Ltd 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 and potential availability in Europe of guselkumab. 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 Ltd or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including 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; 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 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.

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References

¹ National Institute of Health and Care Excellence (NICE). Guselkumab for treating moderate to severe plaque psoriasis [TA521]. Available at: www.nice.org.uk/guidance/TA521 . Last accessed June 2018.

² National Institute of Health and Care Excellence (NICE). Psoriasis (moderate, severe) - guselkumab [ID1075]. Available at: www.nice.org.uk/guidance/indevelopment/gid-ta10232/documents . Last accessed June 2018.

³ Gemeinsamer Bundesausschuss. Reasons for the decision of the Common Federal Committee on an amendment to the Medicinal Products Directive (AM-RL): Annex XII -Decisions on the benefit assessment of Medicines containing new active substances according to § 35a SGB V - Guselkumab. Available at: https://www.g-ba.de/downloads/40-268-4987/2018-05-17_AM-RL-XII_Guselkumab_D-330_TrG.pdf . Last accessed June 2018.

⁴ European Medicines Agency. 2017. Available at: https://www.medicines.org.uk/emc/medicine/34321 . Accessed June 2018.

⁵ Blauvelt, A et al. (2017) Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: Results from the phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial. J Am Acad Dermatol . 76(3):405-17.

⁶ Reich, K et al . (2017) Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the treatment of patients with moderate to severe psoriasis with randomized withdrawal and retreatment: Results from the phase III, double-blind, placebo- and active comparator-controlled VOYAGE 2 trial. J Am Acad Dermatol . 76(3):418-31.

⁷ Langley, RG et al . (2018) Efficacy and safety of guselkumab in patients with psoriasis who have an inadequate response to ustekinumab: results of the randomized, double-blind, phase III NAVIGATE trial. Br J Dermatol . 178(1):114-123.

⁸ Bachelez, H. (2017) Interleukin 23 inhibitors for psoriasis: not just another number. The Lancet . 390(10091):208-10.

⁹ Ortonne JP and Prinz JC. (2004) Alefacept: a novel and selective biologic agent for the treatment of chronic psoriasis. Europ J Dematol . 14:41-5.

¹⁰ Griffiths, C et al . (2017) Two-year Efficacy and Safety of Guselkumab for Treatment of Moderate to Severe Psoriasis: Phase 3 VOYAGE 1 Trial. 26th European Academy of Dermatology and Venereology Congress (EADV), 13–17 Sept, 2017; Geneva, Switzerland. D3T01.1I.

¹¹ ClinicalTrials.gov. A Study to Evaluate the Comparative Efficacy of CNTO 1959 (Guselkumab) and Secukinumab for the Treatment of Moderate to Severe Plaque-type Psoriasis (ECLIPSE). Identifier NCT03090100. Available at: https://clinicaltrials.gov/ct2/show/NCT03090100 . Last accessed June 2018.

¹² ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis. Identifier NCT03158285. Available at: clinicaltrials.gov/ct2/show/NCT03158285 . Last accessed June 2018.

¹³ British Skin Foundation. Psoriasis. Available at: www.britishskinfoundation.org.uk/SkinInformation/AtoZofSkindisease/Psoriasis.aspx . Last accessed June 2018.

¹⁴ Bajorek Z et al . The impact of long term conditions on employment and the wider UK economy. The Work Foundation . Available at: www.theworkfoundation.com/wp-content/uploads/2016/11/397_The-impact-of-long-term-conditions-on-the-economy.pdf . Last accessed June 2018.

¹⁵ Nijsten T et al . (2009) Complexity of the association between psoriasis and comorbidities. Journal of Investigative Dermatology . 129(7):1601–1603.

¹⁶ World Health Organization (2016) Global Report on Psoriasis. Available at: apps.who.int/iris/bitstream/10665/204417/1/9789241565189_eng.pdf . Last accessed June 2018.

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