LEO-PHARMA

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LEO Pharma today announced new data demonstrating long-term improvements in psoriasis on the nail with Kyntheum^® (brodalumab) when compared to placebo or ustekinumab.¹ Psoriasis on the nail, which is challenging to treat,² affects approximately half of the estimated 125 million people living with psoriasis worldwide.^2,3 The data were presented at the 76^th annual American Academy of Dermatology (AAD) meeting in San Diego, California, US.

Psoriasis is a common, chronic, immune-mediated, inflammatory disease that primarily involves the skin, but also impacts emotional, psychological and physical health.⁴ The heavy and far-reaching burden of the disease can be disabling and stigmatising with a substantial negative impact on those affected and their families.⁴ Due to the visible nature of the condition, psoriasis on the nail can be particularly upsetting for patients.⁴ In moderate to severe cases, psoriasis on the nail can be painful and restrict movement in the fingers and toes.⁵

The efficacy of Kyntheum^® in psoriasis on the nail (as measured by NAPSI,* the nail psoriasis severity index) was assessed based on the outcomes of two randomised Phase III clinical studies, AMAGINE-2 and -3. Results showed that in patients with psoriasis on the nail, Kyntheum^® decreased the NAPSI score in the most affected nail at week 52 and was associated with a lower NAPSI score than ustekinumab and placebo.¹ Patients continuously receiving Kyntheum^® 210 mg changed from a mean NAPSI score of 9.6 at baseline to 1.6 at week 52; patients receiving ustekinumab changed from a mean NAPSI score of 9.9 at baseline to 2.4 at week 52. Across all patients, the profile of treatment-emergent adverse events was similar in those taking Kyntheum^® 210 mg and ustekinumab.¹

“Although psoriasis on the nail can be challenging to treat, these data add to the growing body of evidence showing biologic medications to be highly efficacious treatments,” said Kim Domela Kjoeller, Executive Vice President, Global Research & Development, LEO Pharma. “These, and other data presented at AAD, reinforce the safety and efficacy of Kyntheum ^® and solidify its positioning as a leading biologic treatment option for people living with psoriasis.”

Additional pooled data evaluating the long-term safety of Kyntheum^® in the Phase III AMAGINE-1,-2,-3 clinical trials were also presented at AAD.⁶ After two years, the safety profile of Kyntheum^® was similar to that observed during the first year of exposure with no new safety signals.⁶ Of the 3,587 patients evaluated at year two, the most common treatment-emergent adverse events were arthralgia (joint pain) (n=196), headache (n=155) and candida infections (n=111).⁶

Kyntheum^® is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy.⁷ It is the first and only biologic treatment for psoriasis that targets the receptors through which the interleukin (IL)-17 cytokines – a family of proteins involved in immune responses – need to signal to cause the inflammation associated with psoriasis. This mechanism of action is different to all other anti-IL-17 psoriasis biologics currently available.^8,9 Other anti-IL-17 biologics target the IL-17A cytokine alone.^7,9,10,11

* The Nail Psoriasis Severity Index (NAPSI) is a tool used to assess nail involvement in patients with psoriasis.

- ENDS-

NOTES TO EDITORS

About Kyntheum ^®
The efficacy and safety of brodalumab was evaluated in three clinical trials: AMAGINE-1, AMAGINE-2 and AMAGINE-3.⁷ In total, the trials included 4,373 patients with moderate-to-severe psoriasis,⁷ the largest study population in the development program of any new biologic treatment in psoriasis to date.^{10,11,12,13,14,15} Results indicated brodalumab provided rapid,^16,17 and sustained response¹⁸ as well as high levels of skin clearance⁷ and improved health-related quality of life.¹⁹

About LEO Pharma
LEO Pharma helps people achieve healthy skin. By offering care solutions to patients in more than 100 countries globally, LEO Pharma supports people in managing their skin conditions. LEO Pharma offers a comprehensive range of integrated care solutions for control and relief of psoriasis. By expanding its portfolio into biologics, through the approval of Kyntheum^® , the company is set to become the world’s leading dermatology company.

Founded in 1908 and owned by the LEO Foundation, the healthcare company has devoted decades of research and development to delivering products and solutions to people with skin conditions. LEO Pharma is headquartered in Denmark and employs around 5,000 people worldwide.

For more information, visit www.leo-pharma.com

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References

¹ Elewski B, et al. Improvement in Nail Psoriasis With Brodalumab Treatment Over 52 Weeks: An Analysis of Two Phase 3 Studies. Poster 6448 presented at: 76th American Academy of Dermatology; February 16-20, 2018; San Diego, CA

² The National Psoriasis Foundation. Available from: https://www.psoriasis.org/about-psoriasis/specific-locations/hands-feet-nails (Accessed February 2018)

³ The International Federation of Psoriasis Associations. Available from: https://ifpa-pso.com/ (Accessed February 2018)

⁴ World Health Organization (WHO). Global Report on Psoriasis. Available from: http://apps.who.int/iris/bitstream/10665/204417/1/9789241565189_eng.pdf (Accessed February 2018)

⁵ Psoriasis Association. Available from: https://www.psoriasis-association.org.uk/psoriasis-and-treatments/types-of-psoriasis (Accessed February 2018)

⁶ Papp K, et al. Long-term Safety of Brodalumab for the Treatment of Moderate-to-Severe Psoriasis: 2-Year Data From 3 Pivotal Phase 3 Clinical Trials. Poster 6402 presented at: 76th American Academy of Dermatology; February 16-20, 2018; San Diego, CA

⁷ Kyntheum^® . Summary of Product Characteristics 2017. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003959/WC500232913.pdf (Accessed February 2018)

⁸ Coimbra S, et al. Core Evidence . 2014;9:89-97

⁹ Campa M, et al. Dermatol Ther 2016;6:1–12

¹⁰ Cosentyx^®. Summary of Product Characteristics. August 2017. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/003729/WC500183132.pdf (Accessed February 2018).

¹¹ Taltz^® . Summary of Product Characteristics. January 2018. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003943/WC500205804.pdf (Accessed February 2018).

¹² Stelara^® . Summary of Product Characteristics. December 2017. Available from: https://www.medicines.org.uk/emc/medicine/32569 (Accessed February 2018).

¹³ Enbrel^® . Summary of Product Characteristics. October 2017. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000262/WC500027361.pdf (Accessed February 2018).

¹⁴ Humira^® . Summary of Product Charateristics. October 2017. Available from: https://www.medicines.org.uk/emc/medicine/31860 (Accessed February 2018).

¹⁵ Remicade^® . Summary of Product Characteristics. August 2017. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR^_ -_Product_Information/human/000240/WC500050888.pdf (Accessed February 2018).

¹⁶ Russell CB, et al. J Immunol . 2014; 192: 3828-36

¹⁷ Blauvelt A, et al. J Am Acad Dermatol. 2017; in press

¹⁸ Supplement to: Lebwohl M, et al. N Engl J Med. 2015;373:1318–28

¹⁹ Gordon KB, et al. Br J Dermato . 2014;170:705–15

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