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UCB Media Room: Bimekizumab FDA and EMA regulatory milestone


[22/09/2020 | 07:03]

** UCB Achieves Important Regulatory Milestone for Bimekizumab

=C2=B7 The U.S. Food and Drug Administration (FDA) and European Medicines A=
gency (EMA) have accepted marketing application submissions for bimekizumab=
for the treatment of adults with moderate to severe plaque psoriasis
=C2=B7 This accepted submission is supported by a robust data package inclu=
ding three Phase 3 studies which demonstrate superiority of bimekizumab to =
placebo, Stelara^=C2=AE (ustekinumab) and Humira^=C2=AE (adalimumab) in ach=
ieving skin clearance at week 16

Brussels, Belgium =E2=80=93 22th September 2020, 07:00 CEST =E2=80=93 UCB, =
a global biopharmaceutical company, today announced that the FDA and EMA ha=
ve accepted the Biologics License Application (BLA) and Marketing Authoriza=
tion Application (MAA), respectively, for bimekizumab for the treatment of =
adults with moderate to severe plaque psoriasis.=C2=A0

=E2=80=9CAfter a series of positive Phase 3 data readouts, we are delighted=
to announce that the U.S. FDA and EMA have accepted our applications to fi=
le bimekizumab as a potential new treatment for psoriasis. This milestone b=
rings us one step closer to being able to offer a meaningful new treatment =
option for people living with this debilitating disease. UCB is committed t=
o providing innovative solutions for people living with serious inflammator=
y diseases like psoriasis,=E2=80=9D said Emmanuel Caeymaex, Executive Vice =
President Immunology Solutions and Head of US, UCB.

The marketing application submissions for bimekizumab are based on data fro=
m a global Phase 3 clinical development program in psoriasis.^1,2,3=C2=A0 A=
ll Phase 3 studies met their primary endpoints, demonstrating that bimekizu=
mab-treated patients achieved superior skin clearance, at week 16, compared=
to those who received placebo and Humira^=C2=AE (adalimumab) as measured b=
y the Psoriasis Area and Severity Index (PASI 90) and an Investigator Globa=
l Assessment (IGA) response of clear or almost clear skin (IGA 0/1).^1,2,3=

All the Phase 3 studies met their ranked secondary endpoints.^1,2,3 Two stu=
dies demonstrated superior total skin clearance at week 16, as measured by =
PASI 100, confirming the superiority of bimekizumab over existing biologic =
treatments Stelara^=C2=AE (ustekinumab) and adalimumab.^2,3 Furthermore, bi=
mekizumab was superior to placebo, ustekinumab and adalimumab in achieving =
rapid response, defined as PASI 75 at week 4.^1,2,3 Clinical responses were=
maintained up to one year in all studies.^1,2,3 The safety profile of bime=
kizumab continues to be consistent with earlier clinical studies with no ne=
w safety signals identified.^1,2,3,4,5,6=C2=A0

The safety and efficacy of bimekizumab have not been established and it is =
not approved by any regulatory authority worldwide. Bimekizumab is currentl=
y also being evaluated in Phase 3 trials for potential indications in psori=
atic arthritis,^7,8=C2=A0 ankylosing spondylitis,^9=C2=A0non-radiographic a=
xial spondyloarthritis^10=C2=A0and hidradenitis suppurativa.^11,12=C2=A0

About Bimekizumab
Bimekizumab is an investigational humanized monoclonal IgG1 antibody that s=
electively inhibits both IL-17A and IL-17F, two key cytokines driving infla=
mmatory processes.^13=C2=A0IL-17F has overlapping biology with IL-17A and d=
rives inflammation independently to IL-17A.^14,15,16,17,18=C2=A0 Selective =
inhibition of IL-17F in addition to IL-17A suppresses inflammation to a gre=
ater extent than IL-17A inhibition alone.^11,12 The safety and efficacy of =
bimekizumab are being evaluated across multiple disease states as part of a=
robust clinical program.

BE VIVID is a randomized, 52-week, double-blind, placebo- and active-contro=
lled study designed to assess the=C2=A0efficacy and safety of bimekizumab i=
n adult patients with moderate to severe chronic plaque psoriasis.^19=C2=A0=
BE VIVID enrolled 570 participants with chronic plaque psoriasis for at lea=
st six months prior to screening and with an affected body surface area of =
at least 10 percent and PASI of at least 12 and IGA score >=3D3 on a 5-poin=
t scale.^20=C2=A0

The co-primary endpoints of the study were PASI 90 response (defined as a p=
atient who achieves 90 percent improvement from baseline in the PASI score)=
at week 16, and Investigators=E2=80=99 Global Assessment (IGA) 0 or 1 resp=
onse (defined as clear or almost clear with at least a 2-category improveme=
nt relative to baseline) at week 16.^20 UCB announced topline findings from=
BE VIVID in October 2019. For additional details on the study, visit BE VI=
VID on clinicaltrials.gov (https://u7061146.ct.sendgrid.net/ls/click?upn=3D=
toY-3D .^20=C2=A0

BE READY is a Phase 3, randomized, 56-week, double-blind, placebo-controlle=
d study, with an initial
treatment period followed by a randomized-withdrawal period, designed to as=
sess the efficacy and safety of bimekizumab in adult patients with moderate=
to severe chronic plaque psoriasis.^20=C2=A0BE READY enrolled 435 particip=
ants with chronic plaque psoriasis for at least six months prior to screeni=
ng and with an affected body=C2=A0surface area of at least 10 percent and P=
ASI of at least 12 and IGA score >=3D3 on a 5-point scale.^21=C2=A0

The co-primary endpoints of the study were PASI 90 response (defined as a p=
atient who achieves a 90 percent improvement in PASI) and IGA response (def=
ined as clear or almost clear with at least a two-category improvement rela=
tive to baseline) at week 16.^21 UCB announced topline findings from BE REA=
DY in November 2019. For additional details on the study, visit BE READY on=
clinicaltrials.gov (https://u7061146.ct.sendgrid.net/ls/click?upn=3D4tNED-=
VeySvrryfsGVUNgGdbK6yrYxeDOCzyKfO0-3D .^21=C2=A0

About BE SURE=C2=A0=C2=A0 =C2=A0
BE SURE is a Phase 3, randomized, double-blind study comparing bimekizumab =
to adalimumab in adult patients with moderate to severe chronic plaque psor=
iasis; the active-controlled initial treatment period of 24 weeks is follow=
ed by a dose-blind maintenance treatment period until week 56.^21=C2=A0BE S=
URE enrolled 480 participants with chronic plaque psoriasis for at least si=
x months prior to screening and with an affected body surface area of at le=
ast 10 percent, PASI of at least 12 and IGA score equal to or greater than =
three on a five-point scale.^19=C2=A0

The co-primary endpoints of the study were PASI 90 response (defined as a p=
atient who achieves a 90 percent improvement in PASI) and IGA response (def=
ined as clear or almost clear with at least a two-category improvement rela=
tive to baseline) at week 16.^19 For additional details on the study, visit=
BE SURE on clinicaltrials.gov (https://u7061146.ct.sendgrid.net/ls/click?u=
E17WDjmz3E2L66Q2KYgvO4MV9gNN3m213C-2BT9SiDU-3D .^19 UCB announced topline f=
indings from BE SURE in December 2019. For additional details, visit: BE SU=
RE on UCB.com (https://u7061146.ct.sendgrid.net/ls/click?upn=3D4tNED-2FM8iD=
1bVf3zm3d-2B3aiJ19huO7veluDHRhaX3MEScnqZlzCgZirxCeeZq1Q-3D .

Humira^=C2=AE is a registered trademark of AbbVie, Inc; Stelara=C2=AE is a =
registered trademark of Johnson & Johnson.

About Psoriasis
Psoriasis is a common, chronic inflammatory disease with primary involvemen=
t of the skin. This skin condition affects men and women of all ages and et=
hnicities.^22=C2=A0Psoriasis signs and symptoms can vary but may include re=
d patches of skin covered with silvery scales; dry, cracked skin that may b=
leed; and thickened, pitted or ridged nails.^23

Psoriasis affects nearly three percent of the population, or about 125 mill=
ion people worldwide.^22 Unmet needs remain in the treatment of psoriasis. =
A population-based survey identified that approximately 30 percent of psori=
asis patients reported that their primary goals of therapy, including keepi=
ng symptoms under control, reducing itching and decreasing flaking, were no=
t met with their current treatment.^24=C2=A0Psoriasis has a considerable ps=
ychological and quality of life impact, potentially affecting work, recreat=
ion, relationships, sexual functioning, family and social life.^25

UCB Response to COVID-19
UCB is committed to helping those impacted by the novel coronavirus, COVID-=
19. This includes helping patients maintain access to and answering any que=
stions about UCB medicines. We are also working closely with regulatory aut=
horities to ensure the safety of all clinical trial participants and invest=
igators, maintain compliance with good clinical practice, and minimize risk=
s to trial integrity. The evolving COVID-19 pandemic has placed tremendous =
strain on medical healthcare systems worldwide as they focus on the ongoing=
extraordinary medical emergency. Taking this into consideration, UCB has t=
aken measures to protect patients, healthcare providers, our employees, and=
the communities we serve around the world.

About UCB=C2=A0
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company =
focused on the discovery and development of innovative medicines and soluti=
ons to transform the lives of people living with severe diseases of the imm=
une system or of the central nervous system. With more than 7,600 people in=
approximately 40 countries, the company generated revenue of =E2=82=AC 4.9=
billion in 2019. UCB is listed on Euronext Brussels (symbol: UCB). Follow =
us on Twitter: @UCB_news.

Forward looking statements UCB=C2=A0
This press release may contain forward-looking statements including, withou=
t limitation, statements containing the words =E2=80=9Cbelieves=E2=80=9D, =
=E2=80=9Canticipates=E2=80=9D, =E2=80=9Cexpects=E2=80=9D, =E2=80=9Cintends=
=E2=80=9D, =E2=80=9Cplans=E2=80=9D, =E2=80=9Cseeks=E2=80=9D, =E2=80=9Cestim=
ates=E2=80=9D, =E2=80=9Cmay=E2=80=9D, =E2=80=9Cwill=E2=80=9D, =E2=80=9Ccont=
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based on current plans, estimates and beliefs of management. All statement=
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deemed forward-looking statements, including estimates of revenues, operati=
ng margins, capital expenditures, cash, other financial information, expect=
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ing statements are not guarantees of future performance and are subject to =
known and unknown risks, uncertainties and assumptions which might cause th=
e actual results, financial condition, performance or achievements of UCB, =
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or implied by such forward-looking statements contained in this press relea=
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obal spread and impact of COVID-19, changes in general economic, business a=
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roducts in the pipeline or under development by UCB, effects of future judi=
cial decisions or governmental investigations, safety, quality, data integr=
ity or manufacturing issues; potential or actual data security and data pri=
vacy breaches, or disruptions of our information technology systems, produc=
t liability claims, challenges to patent protection for products or product=
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of its employees. There is no guarantee that new product candidates will b=
e discovered or identified in the pipeline, will progress to product approv=
al or that new indications for existing products will be developed and appr=
oved. Movement from concept to commercial product is uncertain; preclinical=
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ns. So far, the complexity of the human body cannot be reproduced in comput=
er models, cell culture systems or animal models. The length of the timing =
to complete clinical trials and to get regulatory approval for product mark=
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rtnership. UCB=E2=80=99 efforts to acquire other products or companies and =
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Given these uncertainties, you should not place undue reliance on any of su=
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UCB is providing this information, including forward-looking statements, on=
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UCB is following the worldwide developments diligently to assess the financ=
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For further information, UCB:

Corporate Communications
Laurent Schots=C2=A0
Media Relations, UCB =C2=A0
T+32.2.559.92.64 =C2=A0Laurent.schots@ucb.com=C2=A0

Investor Relations
Antje Witte =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0
Investor Relations, UCB
T +32.2.559.94.14 antje.witte@ucb.com

Isabelle Ghellynck,
=C2=A0Investor Relations, UCB
T+32.2.559.9588, isabelle.ghellynck@ucb.com=C2=A0

Brand Communications
Andrea Levin Christopher,
Immunology Communications, UCB
T +1.404.483.7329, andrea.christopher@ucb.com=C2=A0
References:=C2=A0 =C2=A0=C2=A0 =C2=A0

Gordon K, Foley P, Krueger J, et al. Efficacy and safety of bimekizumab in =
patients with moderate-to-severe plaque psoriasis: results from BE READY, a=
56-week Phase 3, randomized, double-blinded, placebo-controlled study with=
randomized withdrawal. Late-breaking research; Abstract at AAD 2020.

2. Reich K, Papp KA, Blauvelt A, et al. Efficacy and safety of bimekizumab =
in patients with moderate-to-severe plaque psoriasis: results from BE VIVID=
, a 52-week Phase 3, randomized, double-blinded, ustekinumab- and placebo-c=
ontrolled study. Late-breaking research; Abstract at AAD 2020.
3. UCB Pharma Data on File January 2019.
4. UCB Pharma Data on File September 2020.
5. Blauvelt A, Merola JF, Papp KA, et al. Durability of responses with bime=
kizumab, a selective dual inhibitor of interleukin (IL)-17A and -17F, in mo=
derate-to-severe chronic plaque psoriasis in a 60-week randomized, double-b=
linded, Phase 2b study (BE ABLE 2). Abstract presented virtually for AAD 20=
6. Papp K, Merola J, Gottlieb A, et al. Dual neutralization of both interle=
ukin 17A and interleukin 17F with bimekizumab in patients with psoriasis: R=
esults from BE ABLE 1, a 12-week randomized, double-blinded, placebo-contro=
lled phase 2b trial. J Am Acad Dermatol. 2018;79(2):277-286.e10.
7. ClinicalTrials.gov. A study to evaluate the efficacy and safety of bimek=
izumab in the treatment of subjects with active psoriatic arthritis (BE COM=
PLETE). Available at: https://u7061146.ct.sendgrid.net/ls/click?upn=3D4tNED=
t5zeSwOkskwe3PpmSBWH3tQHg-3D Last accessed: September 2020.
8. ClinicalTrials.gov. A study to test the efficacy and safety of bimekizum=
ab in the treatment of subjects with active psoriatic arthritis (BE OPTIMAL=
). Available at: https://u7061146.ct.sendgrid.net/ls/click?upn=3D4tNED-2FM8=
e1OXCEiADGRPzEVsxgcMF4-3D Last accessed: September 2020.
9. ClinicalTrials.gov. A study to evaluate the efficacy and safety of bimek=
izumab in subjects with active ankylosing spondylitis (BE MOBILE 2). Availa=
ble at: https://u7061146.ct.sendgrid.net/ls/click?upn=3D4tNED-2FM8iDZJQyQ53=
bxXXRQ-2F9eH130D0-3D Last accessed: September 2020.
10. ClinicalTrials.gov. A study to evaluate the efficacy and safety of bime=
kizumab in subjects with active nonradiographic axial spondyloarthritis (BE=
MOBILE 1). Available at: https://u7061146.ct.sendgrid.net/ls/click?upn=3D4=
JQdfL9e0KspNz4G1pwxgjWs4MvL2qZZtK6Y-3D Last accessed: September 2020.
11. ClinicalTrials.gov. A study to evaluate the efficacy and safety of bime=
kizumab in study participants with moderate to severe hidradenitis suppurat=
iva (BE HEARD I). Available at: https://u7061146.ct.sendgrid.net/ls/click?u=
ebRyguGpNlW1QmS1Hi7fQPztbqkgS7tSvma4g-3D Last accessed: September 2020.
12. ClinicalTrials.gov. A study to test the efficacy and safety of bimekizu=
mab in study participants with moderate to severe hidradenitis suppurativa =
(BE HEARD II). Available at: https://u7061146.ct.sendgrid.net/ls/click?upn=
s8oFyYOUOAIMFARLgheSxbJS31VsJZIBur9ZM-3D Last accessed: September 2020.
13. Glatt S, Helmer E, Haier B, et al. First-in-human randomized study of b=
imekizumab, a humanized monoclonal antibody and selective dual inhibitor of=
IL-17A and IL-17F, in mild psoriasis. Br J Clin Pharmacol. 2017;83(5):991-=
14. Yang XO, Chang SH, Park H, et al. Regulation of inflammatory responses =
by IL-17F. J Exp Med. 2008;205(5):1063=E2=80=931075.
15. Hymowitz SG, Filvaroff EH, Yin JP, et al. IL-17s adopt a cystine knot f=
old: structure and activity of a novel cytokine, IL-17F, and implications f=
or receptor binding. Embo J. 2001;20(19):5332=E2=80=935341.
16. van Baarsen LG, Lebre MC, van der Coelen D, et al. Heterogeneous expres=
sion pattern of interleukin 17A (IL-17A), IL-17F and their receptors in syn=
ovium of rheumatoid arthritis, psoriatic arthritis and osteoarthritis: poss=
ible explanation for nonresponse to anti-IL-17 therapy? Arthritis Res Ther.=
17. Maroof A, Okoye R, Smallie T, et al. Bimekizumab dual inhibition of IL-=
17A and IL-17F provides evidence of IL-17F contribution to chronic inflamma=
tion in disease-relevant cells. Abstract THU0038. Ann Rheum Dis. 2017;76(Su=
ppl 2):213.
18. Glatt S, Baeten D, Baker T, et al. Dual IL-17A and IL-17F neutralisatio=
n by bimekizumab in psoriatic arthritis: evidence from preclinical experime=
nts and a randomised placebo-controlled clinical trial that IL-17F contribu=
tes to human chronic tissue inflammation. Ann Rheum Dis. 2018;77(4):523-532.
19. ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Bime=
kizumab Compared to Placebo and an Active Comparator in Adult Subjects With=
Moderate to Severe Chronic Plaque Psoriasis (BE VIVID). Available at: http=
FBNMlf-2Fimv5Y0-3D Last accessed: September 2020.
20. ClinicalTrials.gov. A Study With a Initial Treatment Period Followed by=
a Randomized-withdrawal Period to Evaluate the Efficacy and Safety of Bime=
kizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis =
(BE READY). Available at: https://u7061146.ct.sendgrid.net/ls/click?upn=3D4=
VWwZyBqhMnWsAbcLZOgFQcdJPiOFEWR-2BHwkZNVw-2Bp9g-3D Last accessed: September=
21. Clinicaltrials.gov. A Study to Evaluate the Efficacy and Safety of Bime=
kizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis =
(BE SURE). Available at: https://u7061146.ct.sendgrid.net/ls/click?upn=3D4t=
TlBAMflfHVxqtTWcFmW2F2SuXKp8jvhk-3D Last accessed: September 2020.
22. National Psoriasis Foundation. Statistics. Available at: https://u70611=
4V7wyp8-3D Last accessed: September 2020.
23. International Federation of Psoriasis Associations. Available at: https=
lTu4Hy1zjdzfZCyI6pa4GHvU0BnLiQ-2FAvAp5LU3Iq5xQXwKLc-3D Last accessed: Septe=
mber 2020.
24. Lebwohl MG, Kavanaugh A, Armstrong AW et al. US Perspectives in the Man=
agement of Psoriasis and Psoriatic Arthritis: Patient and Physician Results=
from the Population-Based Multinational Assessment of Psoriasis and Psoria=
tic Arthritis (MAPP) Survey. Am J Clin Dermatol. 2016;17(1):87-97.
25. Moon HS, Mizara A, McBride SR. Psoriasis and psycho-dermatology. Dermat=
ol Ther (Heidelb). 2013;3(2):117-130.

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