Business Wire

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

Del

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

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

Softomotive and Accelerate RPA Partner to Help Enterprises Achieve Faster Time to Value from RPA22.6.2018 15:13Pressemelding

Softomotive, a world–class Robotic Process Automation (RPA) technology provider offering best time to value and affordability for all sizes and types of enterprises, is pleased to announce a strategic partnership with AccelerateRPA, a high calibre professional services provider of trained and certified RPA Consultants within Robotic Process Automation. This partnership means that customers and end users of Softomotive’s software, will have additional knowledgeable and professional guidance available to help achieve significant value quickly from their investment in RPA. Companies who are looking to implement Softomotive’s RPA product suite (WinAutomation and ProcessRobot software) will now have direct access to AccelerateRPA’s highly skilled consultants and Developers. Further, AccelerateRPA has also become a licensed reseller of Softomotive’s products, offering customers a single point of contact for delivering both RPA software and services. Ashley Hudson, Director of AccelerateRPA,

Ascend Performance Materials Announces Price Increase for Intermediate Materials22.6.2018 14:00Pressemelding

Ascend Performance Materials announced today a price increase for its intermediate materials. The price increase will take effect globally on July 1, 2018, and includes the following terms: Material Price Increase Terms Hexamethylene diamine (HMD) $0.17/lb. • As contracts allow. • Non-contract business – price determined on an order-by-order basis. Acrylonitrile (AN) $0.20/lb. • As contracts allow. • Non-contract business – price determined on an order-by-order basis. Customers should contact their local sales representative for additional information. About Ascend Performance Materials Ascend Performance Materials is a global premium provider of high-quality plastics, fibers and chemicals and is the world’s largest integrated producer of PA66 resin. Headquartered in Houston, Texas, Ascend has eight global locations, including five fully-integrated manufacturing facilities located in the southeastern United States, all dedicated to the innovation and safe production of nylon 6,6. With

Different Countries, Different Customs: Get Ready for the Motorbike Holidays with Moto-tyres.co.uk22.6.2018 13:41Pressemelding

Pack your bags, close the boot and get away on holiday? When you start your holidays on a motorcycle, you usually have to consider a few things more when getting ready for your trip. The right preparation is therefore a must. So that nothing stands in the way of a smooth journey, Moto-tyres.co.uk has put together some tips for your next trip. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180622005345/en/ Different countries, different customs: get ready for the motorbike holidays with Moto-tyres.co.uk (Photo: Business Wire) Whether a weekend trip or extended adventure, it all depends on the right equipment. Functional clothing, protectors and rain protection are a must on long trips. Wearing a suitable motorcycle helmet is a legal requirement almost everywhere. However, there are also very different rules and regulations for motorbike equipment and accessories depending on the destination, and you should familiarise yoursel

Boehringer Ingelheim bolsters biologics research and development with 230 million euro investment in new development center22.6.2018 12:00Pressemelding

Today Boehringer Ingelheim announced a 230 million euro investment into a new Biologicals Development Center (BDC) at the company’s Research and Development site in Biberach, Germany during the foundation stone laying for the new center. “The BDC is another key building block supporting the company’s long-term strategy for increasing the pipeline’s share of biologicals. This is particularly driven by two of our core areas, immune oncology and immunology,” says Dr. Fridtjof Traulsen, Corporate Senior Vice President Development at Boehringer Ingelheim. “The share of new biological entities in Boehringer Ingelheim’s research pipeline has been consistently increasing over the past few years and has now reached forty percent.” The BDC will help to maximize synergies by integrating biologicals analytical and process development as well as manufacturing for clinical studies into one seamless unit, while at the same time increasing development capacity. Following a staggered launch beginning i

Announcement by Viking Corp on Tecnotree22.6.2018 11:09Pressemelding

In the interests of stakeholder transparency, this announcement provides background and context to Viking's file bankruptcy proceedings upon Tecnotree: As many of you will now know, Viking Corp was recently forced to file bankruptcy proceedings upon Tecnotree, which were withdrawn on the 19 June. In the interests of stakeholder transparency, we make this Announcement to provide background and context to this action. Firstly, we would reflect on the recent history of our attempts to partner with Tecnotree and all its stakeholders. Viking launched a Tender Offer (TO), having conducted detailed discussions with the Tecnotree Board and our advisors. On the basis of those discussions, we were very confident that the TO price of 10 cents per share provided truly superior value for shareholders. So did the Tecnotree Board as evidenced by their unanimous recommendation of our Offer and of course, further evidenced by the current prevailing market price. This TO was supported in the most vigoro

HeartSciences Named “Start-Up to Watch”22.6.2018 11:00Pressemelding

HeartSciences is delighted to have been highlighted as “Start-Up to Watch” in the June 8, 2018 issue of the MedTech Strategist. The article titled “HEARTSCIENCES: ARTIFICIAL INTELLIGENCE IMPROVES FRONTLINE RISK STRATIFICATION FOR HEART DISEASES” discusses HeartSciences’ role in addressing the current challenges and significant unmet need to identify heart disease at an early stage and reduce the high prevalence of expensive diagnostic testing with low yields. The article highlights the enormous opportunity for HeartSciences’ breakthrough MyoVista® Wavelet ECG (wavECG™) technology to benefit patients and to reduce health system costs and references a recently published study titled “Prediction of Abnormal Myocardial Relaxation From Signal Processed Surface ECG” in the Journal of American College of Cardiology (JACC). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180622005088/en/ MyoVista Wavelet ECG Cardiac Testing Device (P