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UCB Media Room: Bimekizumab FDA and EMA regulatory milestone

INFORMATION REGLEMENTEE


[22/09/2020 | 07:03]
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4otXXEGxF3RM7bSv-2FrInG-2BRke3qXvmhhY44pttU-2BzGqhBVkcMDgs4-3D

** 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=
=C2=A0

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.

About BE VIVID
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=
4tNED-2FM8iDZJQyQ53jATUZDECZjoLWyCfZIxnO42xcxLTM-2B6vXux8o66LawS03W85AZ9tTo=
HEm6-2FSi8CoCnLrYX1O3bhO0R-2BlNxt2lbhJRwBDQoY5SOViohxsEnC-2B4slgoxR_xDPID0v=
OuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52=
Zlf-2FOeoCOG9ekocVj-2F2X9c9g1wZGRW4T-2FACedIyBro03QEJ8XTRZbndX7NJ-2FhXb91-2=
BWSUA0OoyVaDIHEXr8qVtTiXPWKlF4N-2FLKbpPk4StutAlGRQAbWZKBYUMJYILRbegNLapifPb=
c9OLX9j8toOpRk8QCoKeaymDRiphJXKTP3w-2BHk4zoxrCRn91G1dJTSYg-2FkwRvegxqSryf-2=
BUwTV0iXTpdDZzQASiwPFKuqWO3n2f6pbVn0nYfyM2Jj8T8k1iVVY6ZwJJamMloGr-2FhFthemy=
toY-3D .^20=C2=A0

About BE READY
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-=
2FM8iDZJQyQ53jATUZDECZjoLWyCfZIxnO42xcxLTM-2B6vXux8o66LawS03W8cjK6vTWvpRkGq=
Q08VIlpQg-3D-3DLDlQ_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI3b8sYN46DL86b=
Sl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c9g1wZGRW4T-2FACedIyBro=
03QEJ8XTRZbndX7NJ-2FhXb91-2BWSUA0OoyVaDIHEXr8qVtTiXPWKlF4N-2FLKbpPk4StutAlG=
RQAbWZKBYUMJYILRbegNLapTd21r-2BZP-2BzaYVU2uImxo4JwLaGoeFL9zl4uEZJRmG9XM0wD-=
2BnPu43NUS6d0SVdiJnAqD-2FaKbIjPnsVzej-2FU-2BxVsLP5rXc1tVrTfVUZu2rVsErhMKsix=
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=
pn=3D4tNED-2FM8iDZJQyQ53jATUQt7TX3s4n5oOHYNVgrDojHrF3PZ8lMxIL4k8NfidHSUSVq-=
2B5l4iYerq0AzPDb3uTw-3D-3DcgHI_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI3b=
8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c9g1wZGRW4T-=
2FACedIyBro03QEJ8XTRZbndX7NJ-2FhXb91-2BWSUA0OoyVaDIHEXr8qVtTiXPWKlF4N-2FLKb=
pPk4StutAlGRQAbWZKBYUMJYILRbegNLak5Zrpeag2CTnkf-2F8Ux55qrq1hNz-2FqcIRXD4wNo=
qhwwGZIz3RF-2F7CqLjJYCAKd3B-2FaMqoquRB6Q9w8UCA4IbZnDt4sbp7NoouvDc4Ii5umsJS9=
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=
ZJQyQ53jATUXZJD59ZUodhGC-2FyJVE-2BjXw-2Fd0j1C70r-2FZ058zOLCiGbZ5kwDne5pqWmt=
C3RaE79UoXIIW06Rn4SiUSjb9usSxCtL2XOTxpBKqPpRjHakitxn0TjNSzL3D0bySEdnkxaSbNE=
9LuCMXtNi7jF2wKW2TUzoJBhNhFh7DRwrk-2BIYZQQSlBq_xDPID0vOuylFAU8fv4e60wei4Jxq=
EGBdVWu7KiDwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2=
F2X9c9g1wZGRW4T-2FACedIyBro03QEJ8XTRZbndX7NJ-2FhXb91-2BWSUA0OoyVaDIHEXr8qVt=
TiXPWKlF4N-2FLKbpPk4StutAlGRQAbWZKBYUMJYILRbegNLaujTEEUYJ80DPbbYuwSxSdQidh7=
6zh41CvrUYlAaqac1eJ6y3U0zFj-2FGEc19SMKuLUYhPSKtbEjl6oE3gSBZphs5-2Fz8kDqU7Ck=
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=
inue=E2=80=9D and similar expressions. These forward-looking statements are=
based on current plans, estimates and beliefs of management. All statement=
s, other than statements of historical facts, are statements that could be =
deemed forward-looking statements, including estimates of revenues, operati=
ng margins, capital expenditures, cash, other financial information, expect=
ed legal, arbitration, political, regulatory or clinical results or practic=
es and other such estimates and results. By their nature, such forward-look=
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, =
or industry results, to differ materially from those that may be expressed =
or implied by such forward-looking statements contained in this press relea=
se. Important factors that could result in such differences include: the gl=
obal spread and impact of COVID-19, changes in general economic, business a=
nd competitive conditions, the inability to obtain necessary regulatory app=
rovals or to obtain them on acceptable terms or within expected timing, cos=
ts associated with research and development, changes in the prospects for p=
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=
candidates, competition from other products including biosimilars, changes=
in laws or regulations, exchange rate fluctuations, changes or uncertainti=
es in tax laws or the administration of such laws, and hiring and retention=
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=
results do not guarantee safety and efficacy of product candidates in huma=
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=
eting has varied in the past and UCB expects similar unpredictability going=
forward. Products or potential products which are the subject of partnersh=
ips, joint ventures or licensing collaborations may be subject to differenc=
es disputes between the partners or may prove to be not as safe, effective =
or commercially successful as UCB may have believed at the start of such pa=
rtnership. UCB=E2=80=99 efforts to acquire other products or companies and =
to integrate the operations of such acquired companies may not be as succes=
sful as UCB may have believed at the moment of acquisition. Also, UCB or ot=
hers could discover safety, side effects or manufacturing problems with its=
products and/or devices after they are marketed. The discovery of signific=
ant problems with a product similar to one of UCB=E2=80=99s products that i=
mplicate an entire class of products may have a material adverse effect on =
sales of the entire class of affected products. Moreover, sales may be impa=
cted by international and domestic trends toward managed care and health ca=
re cost containment, including pricing pressure, political and public scrut=
iny, customer and prescriber patterns or practices, and the reimbursement p=
olicies imposed by third-party payers as well as legislation affecting biop=
harmaceutical pricing and reimbursement activities and outcomes. Finally, a=
breakdown, cyberattack or information security breach could compromise the=
confidentiality, integrity and availability of UCB=E2=80=99s data and syst=
ems.=C2=A0

Given these uncertainties, you should not place undue reliance on any of su=
ch forward-looking statements. There can be no guarantee that the investiga=
tional or approved products described in this press release will be submitt=
ed or approved for sale or for any additional indications or labelling in a=
ny market, or at any particular time, nor can there be any guarantee that s=
uch products will be or will continue to be commercially successful in the =
future.

UCB is providing this information, including forward-looking statements, on=
ly as of the date of this press release and it does not reflect any potenti=
al impact from the evolving COVID-19 pandemic, unless indicated otherwise. =
UCB is following the worldwide developments diligently to assess the financ=
ial significance of this pandemic to UCB. UCB expressly disclaims any duty =
to update any information contained in this press release, either to confir=
m the actual results or to report or reflect any change in its forward-look=
ing statements with regard thereto or any change in events, conditions or c=
ircumstances on which any such statement is based, unless such statement is=
required pursuant to applicable laws and regulations.=C2=A0

Additionally, information contained in this document shall not constitute a=
n offer to sell or the solicitation of an offer to buy any securities, nor =
shall there be any offer, solicitation or sale of securities in any jurisdi=
ction in which such offer, solicitation or sale would be unlawful prior to =
the registration or qualification under the securities laws of such jurisdi=
ction.=C2=A0
=C2=A0
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
=C2=A0
References:=C2=A0 =C2=A0=C2=A0 =C2=A0

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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 =
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UNZmB2X2ZqTMCMssVajJKm2UC6RNjXC9kJ4a4cn3rO-2FeYatqUwPFYiS2bSsB0Fefe-2F7pokp=
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KBYUMJYILRbegNLapGulu0tGPRk5Ahu9DYV4dJqwGvU91Y7MFGpol4Xv-2FWUtDRP0ELdF-2B1E=
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