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

Gemalto and GlobalmatiX Go Full Speed with High Performance IoT Automotive Telematics13.12.2018 06:00Pressemelding

To meet growing demand for secure, high performance IoT telematics solutions, Gemalto and GlobalmatiX, a fully owned subsidiary of Softing AG, have teamed up to deliver an innovative solution that excelled in the grueling Porsche GT4 Cup championship race. The Gemalto Cinterion LTE Cat. 1 IoT Module and a Gemalto eSIM delivered secure, reliable wireless connectivity for the GlobalmatiX Telematics Control Unit (xTCU) enabling continuous monitoring, communications and remote predictive maintenance. The solution is available immediately to global OEMs. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181212005599/en/ Automotive Telematics. Credit: GlobalmatiX Gemalto-enabled telematics device is racecar tested and approved Installed in a Porsche Cayman GT4 racecar, the Gemalto-enabled GlobalmatiX xTCU device was put to the test at Nürburgring racecourse, excelling under extreme conditions of heat, vibration and speeds of up to 28

Tilray® Announces International Advisory Board13.12.2018 05:01Pressemelding

Tilray, Inc. (NASDAQ:TLRY), a global pioneer in cannabis production and distribution, today announced the formation of its International Advisory Board, an esteemed group of business and government leaders who will provide guidance to Tilray’s executive team and Board of Directors as the company pursues its aggressive global growth strategy. “We are honored to welcome this impressive group of distinguished leaders to the Tilray team,” says Brendan Kennedy, Tilray CEO. “As we pioneer the future of our industry around the world, the experts on our International Advisory Board will advise us on our rapidly expanding global business.” Inaugural members of Tilray’s International Advisory Board include: Governor Howard Dean is a former Democratic National Committee (DNC) Chairman, presidential candidate, six-term Governor of Vermont, and physician. Gov. Dean is also the founder of Democracy for America, a lecturer at Yale University and a strategic consultant for the global law firm Dentons.

AIDUS Coin Successfully Raises Investment from CoinBene, the World's Leading Exchange13.12.2018 00:00Pressemelding

AISYS GLOBAL PTE. LTD. announced that it has received investment from CoinBene, one of the world’s leading crypto assets exchanges. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181212005153/en/ Investment contract ceremony between CoinBene and AISYS GLOBAL. Left: CoinBene CMO Daniel Lee. Right AISYS GLOBAL Founder Ted Min (Photo: Business Wire) AISYS GLOBAL is building the AIDUS Decentralized Fund Platform (ADFP), where users can subscribe to funds only via AIDUS coin. ADFP is the platform to connect investors and asset management companies with AIDUS coin without barriers of borders, language, currency. The most important part of the ADFP is the Smart QTS (Quant Trading System), which boasts an annual average return of 100% (as of December 1, 2018). Smart QTS is an automated trading program that has been validated through more than 15 years of development and over four years of operational performance. The weekly returns

The Epic Showdown Against the Black Mage Begins Now in MapleStory12.12.2018 22:12Pressemelding

MapleStory, the iconic free-to-play global MMORPG from Nexon, has launched the final chapter of the war with the game’s long-awaited villain, the Black Mage. The most anticipated clash event in Maple history brings two brand new Tenebris areas, an epic duel against Black Mage’s leading Commander Verus Hilla, and the monumental battle against the Black Mage himself. Players level 200 or higher who have completed the 5th job advancement can access the Labyrinth of Suffering, Tenebris’ second area. At the end of the quest, players will find Verus Hilla, one of the Black Mage’s leading Commanders, ready to fight. Limina, Tenebris’ final area, is also available as players must help the Tenebris expedition escape dangerous situations inside to complete the Journey of Destiny. In addition, every class will receive a new 5th job skill to fight the Black Mage and once the Maple Alliance gathers enough Determination to power up the Spark of Determination, all out war breaks loose as the highly a

Pacific Drilling Announces Relisting on NYSE12.12.2018 22:11Pressemelding

Pacific Drilling S.A. (OTC: PACDD) (the “Company”) today announced that it has received approval to relist its common shares on the New York Stock Exchange (“NYSE”) under the ticker symbol “PACD.” The Company expects that its common shares will commence trading on the NYSE at the market open on December 18, 2018. About Pacific Drilling With its best-in-class drillships and highly experienced team, Pacific Drilling is committed to becoming the industry’s preferred high-specification, deepwater drilling contractor. Pacific Drilling’s fleet of seven drillships represents one of the youngest and most technologically advanced fleets in the world. Pacific Drilling has its principal offices in Luxembourg and Houston. For more information about Pacific Drilling, including our current Fleet Status, please visit our website at www.pacificdrilling.com. View source version on businesswire.com: https://www.businesswire.com/news/home/20181212005880/en/ Contact information Investor Contact: Johannes

IFF Declares Dividend for Fourth Quarter 201812.12.2018 21:20Pressemelding

Regulatory News: International Flavors & Fragrances Inc. (NYSE:IFF) (Euronext Paris:IFF) (TASE:IFF), a leading innovator of scent, taste, and nutrition, announced that its Board of Directors has declared a regular quarterly cash dividend of $0.73 per share of its common stock, payable on January 7, 2019 to shareholders of record as of December 28, 2018. Meet IFF International Flavors & Fragrances Inc. (NYSE:IFF) (Euronext Paris: IFF) (TASE: IFF) is a leading innovator of scent, taste, and nutrition, with over 110 manufacturing facilities, 100 R&D centers, and 33,000 customers globally. At the heart of our company, we are fueled by a sense of discovery, constantly asking “what if?”. That passion for exploration drives us to co-create unique products that consumers experience in more than 150,000 unique products sold annually. Our 13,000 team members globally take advantage of leading consumer insights, naturals exploration, research and development, creative expertise, and customer inti