CELGENE
Celgene announced today that adult patients in England and Wales with chronic plaque psoriasis will now have access to oral OTEZLA® (apremilast) following a positive final appraisal determination from the National Institute for Health and Care Excellence (NICE).1 The decision is the conclusion of a NICE Rapid Review and ensures patients in England and Wales will join those in Scotland, who have been benefitting from access to OTEZLA since it was recommended by the Scottish Medicines Consortium (SMC) in June 2015.
Psoriasis has been found to have a detrimental effect on many aspects of patients’ day-to-day lives, impacting everything from ability to dress and participate in sports to their social, work and personal relationships, with 46% of psoriasis patients saying they feel ‘depressed’ about their condition.4 Psoriasis is estimated to affect around 960,000 adults in the UK 5,6 .
Professor Chris Griffiths, Professor of Dermatology, University of Manchester commented: “NICE’s decision to recommend apremilast for the treatment of psoriasis is an important step forward in the management of a disease which for many patients can have a significant detrimental effect on their lives. Apremilast offers patients a much needed new oral treatment option that does not require routine laboratory monitoring. Clinical trials of apremilast demonstrated a reduction in severity of psoriasis and associated itching as well as improvement in hard to treat areas, such as the nails and scalp. The drug has the potential to fill an important gap in the psoriasis treatment pathway and its introduction is welcomed by patients and healthcare practitioners.”
OTEZLA, a tablet, has a novel mechanism of action offering a treatment option that does not require pre-screening for tuberculosis or regular laboratory monitoring.2
NICE recognises the clinical benefit and innovation of OTEZLA by recommending it for use in England and Wales as an option for treating chronic plaque psoriasis in adults whose disease has not responded to other systemic therapies, including ciclosporin, methotrexate and PUVA (psoralen and ultraviolet-A light), or when these treatments are contraindicated or not tolerated, only if:
- the disease is severe, as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 101
Carla Renton, Information and Communications Manager at the Psoriasis Association remarked: “This decision is welcomed by the Psoriasis Association. People with psoriasis have a chronic and complex condition that can have a profound effect on quality of life and mental wellbeing, as well as physical health. An increase in the choice of treatment options for people with psoriasis is invaluable in helping them regain control of their condition and of their day to day lives.”
Dr Dani Thomas, Medical Director, Celgene UK & Ireland commented: “Celgene has been working with NICE over the past year to ensure patients in England and Wales can benefit from OTEZLA. We are delighted that eligible people with psoriasis looking for a much needed oral treatment will now have access to OTEZLA.”
OTEZLA is an oral treatment for psoriasis, and works by reducing the activity of an enzyme called phosphodiesterase 4 (PDE4), which is involved in the process of inflammation. By reducing the activity of this enzyme, OTEZLA can help to control the inflammation associated with psoriasis, and thereby reduce the signs and symptoms of the condition.7,8 Over 100,000 patients worldwide have already been treated with OTEZLA.9
In clinical trials, treatment with OTEZLA for psoriasis showed a reduction in psoriatic skin plaques and other signs and symptoms of the disease including itch, skin pain and discomfort. 10,11 OTEZLA is also effective in the treatment of the difficult to treat aspects of scalp, nail and pruritus.10,11
OTEZLA is currently undergoing NICE Rapid Review for active psoriatic arthritis. A positive Appraisal Consultation Document (ACD) recommending OTEZLA for use in the NHS was issued by NICE on 11th October 2016.12 A decision is expected later this year.
Please click here for the OTEZLA Summary of Product Characteristics.
--ENDS--
Notes to editors
About OTEZLA
OTEZLA is an oral inhibitor of phosphodiesterase 4 (PDE4), an enzyme specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels which is thought to indirectly modulate the production of inflammatory mediators.8,9
OTEZLA was licensed by the European Commission in 2015 for the treatment of moderate to severe chronic plaque psoriasis in adult patients who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA).2
In psoriasis, treatment with OTEZLA showed a reduction in psoriatic skin plaques and other signs and symptoms of the disease including itch, skin pain and discomfort, as well as significantly improving nail and scalp psoriasis.9,10 Most adverse reactions were considered to be mild or moderate in severity.2 Gastrointestinal (GI) symptoms including nausea and diarrhoea were the most commonly reported adverse reactions in the Phase III clinical studies. These GI adverse reactions generally occurred within the first two weeks of treatment and the majority resolved within four weeks. 2,3
Additional important safety information based on the Summary of Product Characteristics is available here .
About Psoriasis
Psoriasis is a chronic inflammatory disease of the skin resulting from an uncontrolled immune response.13, 14, 15, 16 It is characterised by the overproduction of skin cells and the formation of thick, red, scaly skin plaques.13,14,15,16 Plaque psoriasis is the most common type of psoriasis.17 About 80 percent of people who develop psoriasis have plaque psoriasis17 which appears as patches of raised, reddish skin covered by silvery-white scales.17 These patches, or plaques, frequently form on the elbows, knees, lower back, and scalp.17 Psoriasis occurs nearly equally in males and females18 and it affects many aspects of patients’ emotional and social well-being as well as daily activities.19, 20
About Celgene
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialisation of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. Celgene UK & Ireland is a subsidiary of Celgene Corporation. For more information, please visit
http://celgene.co.uk/ . Follow Celgene on Social Media: @Celgene , Pinterest , LinkedIn and YouTube .
References
1 NICE Final Appraisal Determination: Apremilast for moderate to severe plaque psoriasis
2 OTEZLA® Summary of Product Characteristics. Current version available online at www.medicines.org.uk
3 Reich K et al. Long-term Safety and Tolerability of Apremilast, an Oral Phosphodiesterase 4 Inhibitor, in Patients With Moderate to Severe Psoriasis: Results From a Phase III, Randomized, Controlled Trial (ESTEEM 1). P8296. Presented at the 72nd Annual Meeting of the American Academy of Dermatology 2014; March 21-25;Denver, CO, USA
4 Weiss SC et al. ‘Quantifying the harmful effect of psoriasis on health-related quality of life.’ Journal of American Academy of Dermatology. 2002. Oct;47(4): 512-8
5 Parisi R, et al. Global epidemiology of psoriasis: a systematic review of incidence and prevalence. J Invest Dermatol. 2013;133(2):377-85
6 Office for National Statistics. Annual Mid-year Population Estimates, 2013. Available from: http://www.ons.gov.uk/ons/dcp171778_367167.pdf . Last accessed May 2015National Institute for Health and Care Excellence. Psoriasis: The assessment and management of psoriasis. NICE guidelines [CG153] Published date: October 2012
7 Schafer P. Apremilast mechanism of action and application to psoriasis and psoriatic arthritis. Biochem Pharmacol . 2012;83:1583–1590.
8 Schafer PH, et al . Apremilast, a cAMP phosphodiesterase-4 inhibitor, demonstrates anti-inflammatory activity in vitro and in a model of psoriasis. Br J Pharmacol . 2010;159:842–855
9 Celgene data on file. UK-I&I160237 September 2016
10 Sobell J, Foley P, Toth D, et al . Effects of Apremilast on Pruritus and Skin Discomfort/Pain Correlate with Improvements in Quality of Life in Patients with Moderate to Severe Plaque Psoriasis. Acta Derm Venereol. 2016;
11 Rich P, Gooderham M, Bachelez H,, et al . Apremilast, an oral phospodiesterase 4 inhibitor, in patients with difficult-to-treat nail and scalp psoriasis; Results of Phase III randomized, controlled trials (ESTEEM 1 and ESTEEM 2). J Am Acad Dermatol. 2016;74(1):134-42. http://www.ncbi.nlm.nih.gov/pubmed/26549249
12 NICE Appraisal Consultation Document: Apremilast for active psoriatic arthritis
13 Racz E, et al . GATA3 expression is decreased in psoriasis and during epidermal regeneration; induction by narrow-band UVB and IL-4. PLoS One . 2011;6:e19806
14 Nestle FO, Kaplan DH, Barker J. Psoriasis. N Engl J Med . 2009;361(5):496-509
15 Reich K. The concept of psoriasis as a systemic inflammation: implications for disease management. JEADV. 2012;26(2): 3–11
16 Nickoloff BJ and Nestle FO. Recent insights into the immunopathogenesis of psoriasis provide new therapeutic opportunities. J Clin Invest . 2004;113(12):1664-1675
17 Villasenor-Park J, Wheeler D, Grandinetti L. Psoriasis: Evolving treatment for a complex disease. CCJM . 2012;79(6)
18 Psoriasis Association. About Psoriasis. Available from: https://www.psoriasis association.org.uk/pages/view/about-psoriasis. Last accessed June 2016
19 Kurd SK, et al . The risk of depression, anxiety and suicidality in patients with psoriasis: A population-based cohort study. Arch Dermatol . 2010;146(8):891-895
20 Hrehorów E, et al . Patients with psoriasis feel stigmatized. Acta Derm Venereol . 2012;92(1):67-72 2
View source version on businesswire.com: http://www.businesswire.com/news/home/20161020005561/en/
Contact:
Celgene UK & Ireland
Media:
Amanda Simonds
Senior
Corporate Affairs and Patient Advocacy Manager
T. 020 8831 8672
asimonds@celgene.com
or
Celgene
Investors:
Patrick
E. Flanigan III
Corporate Vice President
T. +1 908 673 9969
pflanigan@celgene.com
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
MultiBank Group Confirms $MBG Token TGE Set for July 22, 202512.7.2025 11:14:00 CEST | Press release
MultiBank Group, the world’s largest financial derivatives institution has officially announced that the Token Generation Event (TGE) for its highly anticipated $MBG Token will take place on July 22, 2025. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250712404220/en/ MultiBank Group has officially announced that the Token Generation Event (TGE) for its highly anticipated $MBG Token will take place on July 22, 2025. This milestone will mark the full activation of the $MBG Token on the blockchain, enabling holders to view and manage their balances across supported platforms. Following the token minting, users will be able to trade $MBG via MultiBank.io, the Group’s regulated crypto exchange and Uniswap, the world’s leading decentralized platform. The $MBG Token has garnered global attention for its rare combination of real-world utility, institutional backing, and strong deflationary mechanics. It is underpinned by $29 billi
Elegen and Nutcracker Therapeutics to Pilot First Fully Cell-Free Manufacturing Process for RNA-based Personalized Cancer Therapeutics11.7.2025 14:00:00 CEST | Press release
Fully cell-free process aims to further democratize personalized cancer therapeutic manufacturing with shorter turnaround times and negligible bioburden and endotoxin risks. Elegen, a global leader in next-generation DNA manufacturing, and Nutcracker Therapeutics, a global leader in next-generation RNA design and manufacturing, today announced the launch of a pilot program to demonstrate the industry’s first fully synthetic, cell-free manufacturing platform for RNA-based personalized cancer therapeutics (PCTs). The pilot marks another step toward making PCTs more accessible, timely, and scalable. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250711152688/en/ As late-stage PCT clinical trials progress and therapy developers work to create the next generation of PCTs, the speed, reliability, scaling and cost of traditional production methods pose a major challenge. Specifically, the first step of DNA template production is hi
$MBG Token Pre-Sale Set for July 15 — Only 7 Million Tokens Available at $0.3511.7.2025 10:17:00 CEST | Press release
MultiBank Group, the world’s largest financial derivatives institution headquartered in Dubai, has confirmed that its highly anticipated $MBG Token pre-sale will go live on July 15, with demand expected to be intense. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250711737311/en/ With only 7 million $MBG tokens up for grabs at an exclusive entry price of $0.35, this is a rare opportunity to secure early access to what many are calling the year’s most powerful utility asset. With only 7 million tokens up for grabs at an exclusive entry price of $0.35, this is a rare opportunity to secure early access to what many are calling the year’s most powerful utility asset. Early participants can join simultaneously on MultiBank.io, the Group’s regulated crypto exchange, and Uniswap, the world’s leading decentralized platform. Supported by $29 billion in real assets and powered by over $35 billion in daily turnover, $MBG is engineered
Live Story Raises €2.7 Million to Revolutionize the Digital Experience11.7.2025 10:05:00 CEST | Press release
With a round led by Vertis, the next-generation CMS platform accelerates its focus onAI, performance, and European expansion. Target: surpass €10M in recurring revenueby 2027. Live Story, the tech company founded by Stefano Mocellini, has closed a €2.7 million seed round led by Vertis, one of Italy’s leading early-growth venture capital firms. The funding will support the company’s international expansion and technological development, with a clear goal: to exceed €10 million in annual recurringrevenue by 2027. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250711335560/en/ “We invested in Live Story because it addresses one of the major inefficiencies in digital commerce: the slow and rigid management of visual and narrative content,” says Alessandro Pontari, Partner at Vertis SGR. “The platform helps brands drastically reduce their time-to-market through a visual CMS that integrates seamlessly with any tech stack. In a wor
With a Score of 84 out of 100, Sagemcom Is Awarded the EcoVadis Platinum Medal: a Prestigious Recognition of its CSR Commitment11.7.2025 09:00:00 CEST | Press release
Sagemcom Group is proud to announce that it has been awarded, for the third time, the Platinum Medal by EcoVadis, the highest distinction granted by the leading global platform for assessing Corporate Social Responsibility (CSR) performance. This medal places Sagemcom in the top 1% of companies evaluated worldwide, across all industries. With a score of 84 out of 100, Sagemcom reaffirms its position as a committed leader in ecological transition, business ethics, sustainable supply chain management, and social responsibility. “The EcoVadis Platinum Medal is more than just an award — it is the recognition of our collective efforts to embed sustainable development principles at the heart of our corporate strategy and culture,” says Sylvaine Couleur, Executive Vice President, CSR & Communication. “Achieving this level demonstrates that our commitments are tangible, impactful, and internationally recognized. This distinction strengthens our determination to further advance and expand our C
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom