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 jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

Zephyr Endobronchial Valves Improve Breathing, Quality of Life and Activity for Severe Emphysema Patients in US Pivotal Trial22.5.2018 20:19Tiedote

Pulmonx® Corp. today announced positive one-year results from the U.S. LIBERATE pivotal trial of the Zephyr® Endobronchial Valve, a minimally-invasive treatment for severe emphysema, an advanced form of chronic obstructive pulmonary disease (COPD). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180522006139/en/ Zephyr Endobronchial Valves (Photo: Business Wire) “The LIBERATE Study definitively proves that Zephyr Valves offer clinically meaningful improvements in three important areas for patients – the ability to breathe better, be more active, and enjoy an improved quality of life,” said the study’s lead investigator, Gerard Criner, MD, FACP, FACCP, Chair and Professor of Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University. He continued, “All primary and secondary endpoints were met, with Zephyr Valve treatment showing significant improvement for patients across multiple measures of breathing a

Seoul Semiconductor Announces the Availability of a Series of AC LED Modules22.5.2018 19:03Tiedote

Seoul Semiconductor, a leading global innovator of LED products and technology, announces a comprehensive series of AC LED modules that use the company’s patented Acrich AC LED technology. The modules are offered in designs from 200 to 10,000 lumens in round, rectangular and linear formats. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180522006054/en/ Seoul Semiconductor Announces the Availability of a Series of AC LED Modules (Photo: Business Wire) These AC modules integrate Seoul Semiconductor’s patented Acrich AC driver technology with the company’s advanced LEDs, enabling the design of compact light fixtures with superior lighting performance, making these modules ideal for a wide range of lighting applications. “Lighting designers who are looking to significantly reduce the size, weight, and volume of their luminaire designs can select one of our standard round, rectangular, or linear AC module designs to develop a co

Medicortex Finland Announces Agreement with Pro-Lab22.5.2018 16:58Tiedote

Medicortex Finland Oy announces that it has entered into an agreement with a Canadian company Pro-Lab Diagnostics Inc. Pro-Lab will be responsible for the regulatory process and registration of the ProbTBI™ brain injury detection kit in Canada and UK. Following a brain injury, the diagnostic test will detect in urine and saliva a unique brain injury biomarker which has been discovered and characterized by Medicortex. The agreement gives Pro-Lab exclusive rights for sales in the UK and Canada from which Medicortex will receive royalties. The agreement between the parties is confidential and no other details about the content of the agreement are disclosed. Pro-Lab will be responsible for the clinical validation of the kit prior to the commercial launch in the territories. In addition to the licensing agreement, the parties intend to initiate a development collaboration, the details of which are being discussed currently. “We are very proud that Pro-Lab Diagnostics has chosen to cooperat

ResMed Studies Show Remote Monitoring and Automated Resupply Improve Adherence to PAP Therapy22.5.2018 15:55Tiedote

Remote patient monitoring and resupply programs have been shown to improve patient adherence to positive airway pressure (PAP) therapy, according to two separate studies presented by ResMed (NYSE: RMD, ASX: RMD) this week at the ATS 2018 International Conference. Remote monitoring boosts compliance In the first study, medXcloud, a ResMed-assembled group of healthcare key opinion leaders, examined de-identified data of more than 2.6 million U.S. PAP users from ResMed’s world-leading remote monitoring network, AirView. Using this big data approach, researchers observed excellent adherence among patients initiating PAP therapy: 75 percent achieved the CMS compliance threshold.* This rate compares very favorably with that of non-cloud-connected PAP therapy and other chronic medical therapies – both around 50 percent. Plus, the large sample suggests that the findings are generalizable and likely to reflect real-world clinical care. Resupply program boosts long-term compliance In a separate

Asuragen to Launch the AmplideX® PCR/CE DMPK Kit and Present Growing Genetic Testing Portfolio at 2018 European Society of Human Genetics (ESHG) Conference22.5.2018 15:00Tiedote

Asuragen, Inc., a molecular diagnostics company delivering high-quality, easy to use products for complex testing in genetics and oncology, today announced the launch of the AmplideX® PCR/CE DMPK Kit* to simplify analysis of repeat expansions within the DMPK gene, which is implicated in myotonic dystrophy type I (DM1), also known as Steinert’s disease. DM1 is an inherited form of muscular dystrophy that affects the muscles as well as multiple other organ systems, and its severity is largely determined by the size of the CTG trinucleotide repeat expansion within the DMPK gene. These expansions commonly extend beyond a thousand CTG repeats and therefore have required the use of cumbersome Southern blot technology to estimate their size. “The AmplideX DMPK Kit represented a significant improvement over our existing process for analyzing large DMPK expansions,” said Doctor Sophie Rondeau, PharmD, PhD, and Professor Jean-Paul Bonnefont, MD, PhD, of the Necker-Enfants Malades Hospital in Par

Phil Brakewell Set to Lead WilsonHCG's Executive Search Efforts Across EMEA; Forbes Ranks WilsonHCG Among Best Executive Recruiting Firms22.5.2018 15:00Tiedote

WilsonHCG, global leader and premium provider of innovative talent solutions, further expands its Executive Search division with the appointment of Director Phil Brakewell. Phil, who brings more than 14 years of talent acquisition leadership experience and most recently served as Head of Executive Search for ResourceBank, will be responsible for leading WilsonHCG’s efforts in the EMEA region. Prior to joining ResourceBank, Phil held consultant and resourcing leadership positions at Hitchenor Wakeford and The Caudwell Group – where he was responsible for developing the business internationally and drove innovative search solutions on behalf of a diverse range of clients. “WilsonHCG’s reputation speaks for itself,” said Phil. “WilsonHCG tailors its key service offerings – including Executive Search – to suit individual client needs, and I am thrilled to be part of such a dedicated, innovative team. The new Director position, covering EMEA, demonstrates our commitment to both Executive Se

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