Oral OTEZLA®▼ (Apremilast) Receives Positive Nice Recommendation for Adults with Psoriatic Arthritis

First-in-class oral treatment for psoriatic arthritis made available
via the National Health Service (NHS)

STOCKLEY PARK, England–(BUSINESS WIRE)–Celgene announced today that the National Institute for Health and Care
Excellence (NICE) has issued a final appraisal determination (FAD)
recommending the use of OTEZLA (apremilast) for the treatment of adult
patients with active psoriatic arthritis who have had an inadequate
response to or have been unable to tolerate Disease Modifying
Anti-Rheumatic Drugs (DMARDs).1 OTEZLA does not require
pre-screening for tuberculosis or regular laboratory monitoring.2

Psoriatic arthritis is a chronic disease that causes significant
strain on NHS resources,”
said Dr Helena Marzo-Ortega, Honorary
Senior Lecturer and Consultant at Leeds Teaching Hospitals NHS Trust.
“Addressing the symptoms of both psoriasis and psoriatic arthritis, the
availability of OTEZLA on the NHS marks a major milestone in the
management of psoriatic arthritis.”

Psoriatic arthritis is a complex disease which involves multiple
manifestations that can impact skin and joints and is most common in
people aged 30 years to 50 years.3 It is estimated that over
296,000 people in the UK are affected by this incapacitating disease.4,5
Living with psoriatic arthritis can hinder a person’s ability to carry
out simple everyday activities; from getting in or out of bed, to
walking outdoors on flat ground.6

Following initial negative guidance issued by NICE in September 2015,
OTEZLA was reappraised under the NICE Rapid Review process.1
OTEZLA, alone or in combination with DMARDs, is now recommended with a
Patient Access Scheme for adults with active psoriatic arthritis when:

  • they have peripheral arthritis with 3 or more tender joints and 3 or
    more swollen joints and
  • their disease has not responded to adequate trials of at least 2
    standard DMARDs, given either alone or in combination1

Today’s decision brings access for patients in England and Wales in line
with those in Scotland, where OTEZLA was recommended by the Scottish
Medicines Consortium (SMC) in June 2015.7

Dr Dani Thomas, Medical Director, Celgene UK & Ireland, commented: We
are delighted that patients in England and Wales can now access OTEZLA
via the NHS, bringing availability in line with patients in Scotland.
OTEZLA’s novel mechanism of action and oral administration provides
psoriatic arthritis patients with a much needed treatment option.
Celgene will continue our dedication to develop and deliver innovative
medicines for people affected by diseases where there is a high unmet
need.

OTEZLA is an oral treatment for psoriatic arthritis that works by
reducing the activity of an enzyme called phosphodiesterase 4 (PDE4),
which is involved in the process of inflammation.8 By
reducing the activity of this enzyme, OTEZLA can help to control the
inflammation associated with psoriatic arthritis, and thereby reduce the
signs and symptoms of the condition.9, 10

The Psoriatic Arthritis Long-term Assessment
of Clinical Efficacy (PALACE) programme is one of the
largest global clinical development programmes ever conducted in
psoriatic arthritis and it measured the efficacy and safety of OTEZLA.11
Across PALACE 1, 2 and 3, significantly more patients on OTEZLA achieved
ACR20 at Week 16 than those on placebo.8

OTEZLA has demonstrated proven and durable efficacy in psoriatic
arthritis, with improvement in swollen and tender joints, as well as
pre-existing dactylitis (inflammation of fingers and toes, commonly
known as “sausage fingers and toes”) and enthesitis (inflammation at
sites where tendons or ligaments insert into bone) with a statistically
significant improvement in physical function.8 The most
common adverse reactions in Phase III clinical studies were diarrhoea
and nausea. These adverse reactions generally occurred within the first
two weeks of treatment and usually resolved within four weeks.2

– Ends –

NOTES TO EDITORS

About OTEZLA®

OTEZLA® is an oral inhibitor of phosphodiesterase 4 (PDE4)
specific for cyclic adenosine monophosphate (cAMP).8 PDE4
inhibition results in increased intracellular cAMP levels which is
thought to indirectly modulate the production of inflammatory mediators.9,10

OTEZLA, alone or in combination with Disease Modifying Anti-Rheumatic
Drugs (DMARDs), was approved by the European Medicines Agency in 2015
for the treatment of psoriatic arthritis in adult patients who have had
an inadequate response or who have been intolerant to a prior DMARD
therapy.

OTEZLA was also licensed by the European Commission for the treatment of
moderate to severe chronic plaque psoriasis in adult patients who do not
respond to, have a contraindication to, or are intolerant to other
systemic therapy including cyclosporine, methotrexate or psoralen and
ultraviolet-A light (PUVA).8

OTEZLA has a novel mechanism of action, offering a treatment option that
does not require pre-screening for tuberculosis or regular laboratory
tests.2 In clinical trials of psoriatic arthritis, treatment
with OTEZLA demonstrated a statistically significant improvement in
physical function vs. placebo as well as improving disease-related
quality of life.12

The Summary of Product Characteristics is available here.

About Psoriatic Arthritis

Psoriatic arthritis is a painful, chronic inflammatory disease
characterised by pain, stiffness, swelling and tenderness of the joints,
inflammation of specific ligaments and tendons, and decrease in physical
functioning.13 Psoriatic arthritis can impact the ability to
perform day-to-day activities and has been reported to increase work
disability.14,15 Enthesitis (inflammation at sites where
tendons or ligaments insert into bone) and dactylitis (inflammation of
fingers and toes, commonly known as “sausage digits”) are specific
disease manifestations related to psoriatic arthritis.13 Up
to 30% of people with psoriasis may also experience psoriatic arthritis.16

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: @CelgenePinterestLinkedIn and YouTube.

REFERENCES

1 NICE: Apremilast for the treatment of active psoriatic
arthritis

2 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

3 The Cleveland Clinic Foundation. Disease Management chapter
on Psoriatic Arthritis by M. Elaine Husni. Available at: http://www.clevelandclinicmeded.com/medicalpubs/diseasemanagement/rheumatology/psoriatic-arthritis/
Last accessed December 2016

4 Population estimates for UK, England and Wales, Scotland
and Northern Ireland. Available at: https://www.ons.gov.uk/peoplepopulationandcommunity/populationandmigration/populationestimates/datasets/populationestimatesforukenglandandwalesscotlandandnorthernireland
Last accessed December 2016.

5 NICE: Costing statement: Implementing the NICE guidance on
ustekinumab for treating active psoriatic arthritis (rapid review of
technology appraisal guidance 313) (TA340). Published: May 2015

6 Lebwohl et al.Patient perspectives in the management
of psoriasis: Results from the population-based Multinational Assessment
of Psoriasis and Psoriatic Arthritis Survey. J Am Acad Dermatol.
2014 0190-9622

7 OTEZLA® Detailed Advice Document (DAD) https://www.scottishmedicines.org.uk/files/advice/apremilast__Otezla__plaque_psoriasis_FINAL_May_2015_REVI
SED_010615_for_website.pdf Last accessed December 2016

8 OTEZLA® Summary of Product Characteristics. Current version
available online at www.medicines.org.uk
Last accessed December 2016

9 Schafer P. Apremilast mechanism of action and application
to psoriasis and psoriatic arthritis. Biochem Pharmacol.
2012;83:1583–1590

10 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

11 OTEZLA Clinical development program. Available at: https://www.otezla.net/psoriatic-arthritis/clinical-efficacy/study-design/
Last accessed December 2016

12 Kavanaugh A, Mease PJ, Gomez-Reino JJ, et al.
Treatment of psoriatic arthritis in a phase 3 randomised,
placebo-controlled trial with apremilast, an oral phosphodiesterase 4
inhibitor. Ann Rheum Dis. 2014;73:1020–1026

13 Gottlieb A, et al. Guidelines of care for the
management of psoriasis and psoriatic arthritis: Section 2. Psoriatic
arthritis: overview and guidelines of care for treatment with an
emphasis on the biologics. J Am Acad Dermatol. 2008;58:851
864

14 Lee S, Mendelsohn A, Sarnes E. The burden of psoriatic
arthritis: A literature review from a global health systems perspective. P&T.
2010;35(12):680-689

15 Tillett W, de-Vries C, McHugh NJ. Work disability in
psoriatic arthritis: a systematic review. Rheumatology.
2012;51:275-283

16 National Institute for Health and Care Excellence.
Etanercept, infliximab and adalimumab for the treatment of psoriatic
arthritis: Technology appraisal guidance 199. August 2010

Contacts

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, Investor Relations
T.
+1 908 673 9969
pflanigan@celgene.com