Business Wire

New data presented at the American Academy of Dermatology show LEO Pharma’s Kyntheum® (brodalumab) improves psoriasis on the nail

Jaa

NOT FOR DISTRIBUTION IN THE UNITED STATES OR UNITED KINGDOM:

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 76th 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

Subscribe to our YouTube channel: www.youtube.com/leopharmaglobal

Visit us at LinkedIn: http://www.linkedin.com/company/leo-pharma

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

Contact information

LEO Pharma
Global media contacts
Henrik Steen Heskjær Kyndlev
Head of Global External Communication
Email: HDTDK@leo-pharma.com
Mobile: +45 3140 6180
or
Marie Schleimann Nordlund
Snr Global Patient Communication Manager
Email: CUHDK@leo-pharma.com
Mobile: +45 3126 3734

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

Wells Fargo Seeks Investment Firm License from the French Prudential Supervision and Resolution Authority (ACPR)16.10.2018 14:00Tiedote

`Wells Fargo & Company (NYSE: WFC), today announced it has applied for its investment firm license from the French Prudential Supervision and Resolution Authority (Autorité de Contrôle Prudentiel et de Résolution; ACPR), which is responsible for supervising the French banking and insurance sectors. This announcement is part of the company’s Brexit strategy, which is predicated on supporting the capital markets and investment banking needs of Wells Fargo’s customers in a post Brexit environment. “With Brexit on the horizon, Wells Fargo is committed to providing a transition, which is as seamless as possible, for its markets and investment banking customers within the European Union (EU) and European Economic Area (EEA),” said Alicia Reyes, head of Wells Fargo Securities in Europe, Middle East and Africa. “Wells Fargo has been present in Europe for many decades, and during this time, we have strengthened our relationships with our local authorities and deepened our customer base. Through

KOKUYO to Showcase the Revolutionary "360° Gliding Chair ing" at ORGATEC 201816.10.2018 13:13Tiedote

KOKUYO Co., Ltd. (TOKYO: 7984), a leading provider of office design and furniture in Japan, will take part in ORGATEC 2018 (http://www.orgatec.com/). The exhibition, held in Cologne, Germany, from October 23rd to 27th, is the largest International Trade Fair for Furnishing and Management of Offices and Office Facilities. This year, KOKUYO will present its revolutionary office chair, “360° Gliding Chair ing”, which is never seen before in Europe. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181016005530/en/ The "360° Gliding Chair ing" defines the way you sit. (Photo: Business Wire) “360° Gliding Chair ing” is an office chair with a completely new concept to improve white-collar health and creativity. Nowadays, research confirmed that sitting for long hours not only causes white-collar workers' discomfort but also serious health issues. To address this problem, KOKUYO pioneered the innovative chair, “360° Gliding Chair ing”

Going Digital (Twins): Bentley Inaugurates iTwin™ Services!16.10.2018 12:04Tiedote

The Year in Infrastructure 2018 Conference – Bentley Systems, Incorporated, the leading global provider of comprehensive software solutions for advancing the design, construction, and operations of infrastructure, today announced the forthcoming availability of iTwin™ Services, digital twin cloud services for infrastructure projects (project digital twins) and assets (performance digital twins). iTwin™ Services can be transparently provisioned within Bentley’s Connected Data Environment (CDE) for ProjectWise and AssetWise users. Requirements for Realizing the Potential of Infrastructure Digital Twins Infrastructure asset owners and their teams have recognized the potential for leveraging digital twins in many ambitious use cases including the application of analytics, artificial intelligence (AI) and machine learning (ML) in simulations and decision support throughout the lifecycle of design, construction, and operations. To realize this potential, representations of assets need obviou

Clickadu Chooses Digital Element’s IP Intelligence Solution to Enable Accurate Geotargeting Globally16.10.2018 11:00Tiedote

Digital Element, the global IP geolocation data and services provider, has today announced that expert performance marketing and traffic monetization platform, Clickadu, has chosen its NetAcuity EdgeTM technology, to improve global performance for clients through the provision of enhanced targeting for their campaigns. Clickadu is a powerful ad network for both mobile and web channels, delivering profit optimization for advertisers and publishers across the world. The company allows brand advertisers and media buyers to acquire trusted traffic sources worldwide and generates over 250 million impressions daily – allowing its clients to leverage real-time data performance statistics to target their audiences more effectively. Clickadu selected Digital Element’s IP intelligence and geolocation solution to access global IP datasets with granular accuracy to improve its traffic tracking offering. By using Digital Element’s NetAcuity Edge technology, Clickadu will be able to identify consume

Utimaco Cleared to Complete Acquisition of Atalla16.10.2018 09:55Tiedote

Utimaco, the second largest global provider of Hardware Security Modules (HSMs) today announced it has received United States regulatory approval to complete its acquisition of the Atalla Hardware Security Module (HSM) and Enterprise Secure Key Manager (ESKM) business lines of Micro Focus. The transaction is due to close on November 5, 2018. “This is a significant milestone, and we look forward to bringing the Atalla team under the information security umbrella of Utimaco. After several changes of ownership, we are happy to offer Atalla a long-term home in our HSM and information security business,” said Utimaco CEO, Malte Pollmann. Read more: https://hsm.utimaco.com/news/utimaco-cleared-to-complete-acquisition-of-atalla About Utimaco Utimaco is a worldwide supplier of professional information security solutions and is based in Aachen, Germany with offices worldwide. Since 1983, Utimaco has been developing hardware-based, high-security appliances (Hardware Security Modules) and complia

PM Studios Partners with The Playgroundz Foundation to Develop New Blockchain Project16.10.2018 09:52Tiedote

Software development and video game publisher PM Studios, partnered with the Playgroundz Foundation to help in the development of a new blockchain project. Playgroundz is best described as a “Google” for videogames. It is a platform for videogames and game related services. Playgroundz will be a gateway to a videogame database where developers and gamers can come and virtually do anything game related. We are simply creating a new gaming ecosystem where everything videogame related is decentralized and belongs solely to the players and developers. Playgroundz consists of an AI system, which takes advantage of Big Data and Machine Learning to specifically analyze the traits of users, Marketplace, which utilize Blockchain and Smart Contract in order to make Escrows safe and transparent, and Rewarded Community System, which is based on loyalty users. Based on optimized Machine Learning Algorithm, the analyzed data recommends users with new games, matches users automatically with buyer or

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme