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UCB Media Room: bimekizumab BE SURE detailed results

INFORMATION REGLEMENTEE


[31/10/2020 | 07:04]
https://u7061146.ct.sendgrid.net/ls/click?upn=3D4tNED-2FM8iDZJQyQ53jATUb513=
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** Bimekizumab Phase 3 Data Shows Superior Skin Clearance Over Humira^=C2=
=AE in Moderate-to-Severe Psoriasis Patients
------------------------------------------------------------

=C2=B7 Data from the Phase 3 BE SURE study demonstrated that patients treat=
ed with investigational IL-17A and IL-17F inhibitor bimekizumab achieved si=
gnificantly higher PASI 90 and PASI 100 skin clearance rates, compared to H=
umira^=C2=AE (adalimumab), at week 16, which were maintained up to one year=
with both four and eight week dosing
=C2=B7 Skin clearance rates rapidly increased in patients who switched from=
adalimumab to bimekizumab at week 24, with response rates at week 56 compa=
rable to patients treated with bimekizumab throughout the study

Brussels, Belgium =E2=80=93 October 31, 2020 =E2=80=93 UCB, a global biopha=
rmaceutical company, today announced the detailed results of the head-to-he=
ad Phase 3 BE SURE study, which demonstrated that patients treated with inv=
estigational IL-17A and IL-17F inhibitor bimekizumab achieved superior skin=
clearance, as compared to adalimumab, in adults with moderate-to-severe pl=
aque psoriasis.^1=C2=A0These findings were presented for the first time as =
an oral presentation at the European Academy of Dermatology and Venereology=
Congress, taking place virtually between October 29-31, 2020.

BE SURE met all primary and secondary ranked endpoints.^1 The co-primary en=
dpoints were at least a 90 percent improvement in the Psoriasis Area and Se=
verity Index (PASI 90) and Investigator Global Assessment (IGA) of clear or=
almost clear (IGA 0/1) versus adalimumab at week 16. Secondary endpoints i=
ncluded PASI 90 and IGA 0/1 at weeks 24 and 56, and PASI 100 at weeks 16 an=
d 24.=C2=A0

In BE SURE, patients treated with bimekizumab achieved significantly higher=
PASI 90, IGA 0/1 and PASI 100 skin clearance rates compared to patients tr=
eated with adalimumab at week 16.^1 In patients that started bimekizumab at=
baseline, response rates were maintained up to a year. Rapid increases in =
skin clearance rates were seen in patients who switched from adalimumab to =
bimekizumab at week 24.^1 The safety and efficacy of bimekizumab have not b=
een established, and it is not approved by any regulatory authority worldwi=
de.

=E2=80=9CIn BE SURE, we saw significantly higher skin clearance rates with =
bimekizumab compared with one of the most commonly used biologic treatments=
in psoriasis. The study results also demonstrated the potential benefits o=
f switching patients who are being treated with adalimumab to bimekizumab,=
=E2=80=9D said study investigator, Professor Richard Warren, Salford Royal =
NHS Foundation Trust and The University of Manchester, United Kingdom.

=E2=80=9CThese findings from BE SURE, the third positive study in the psori=
asis clinical development program, are further evidence of bimekizumab=E2=
=80=99s superior depth of response. The results also add to the mounting ev=
idence supporting the potential value of selective inhibition of IL-17F, in=
addition to IL-17A, for rapid, complete and durable skin clearance, if app=
roved by health authorities. UCB is proud to be developing innovative solut=
ions for psoriasis patients,=E2=80=9D said Emmanuel Caeymaex, Executive Vic=
e President Immunology Solutions and Head of US, UCB.

In BE SURE, 86.2 percent of patients treated with bimekizumab achieved almo=
st clear skin (PASI 90), compared with 47.2 percent of patients treated wit=
h adalimumab at week 16 (p<0.001).^1 Additionally, 85.3 percent of patients=
treated with bimekizumab achieved IGA 0/1, versus 57.2 percent of patients=
treated with adalimumab at week 16 (p<0.001).1 Significantly more patients=
treated with bimekizumab achieved complete skin clearance (PASI 100) than =
those treated with adalimumab: 60.8 percent versus 23.9 percent at week 16,=
and 66.8 percent versus 29.6 percent at week 24 (p<0.001 for each comparis=
on).^1=C2=A0

In the two bimekizumab study arms, PASI 90, PASI 100 and IGA 0/1 response r=
ates were maintained through to week 56.^1 These results were observed acro=
ss both dosing regimens: bimekizumab every four weeks (Q4W dosing) until we=
ek 56, or Q4W dosing for 16 weeks, followed by bimekizumab every eight week=
s (Q8W dosing) from week 16 to week 56.^1 In patients treated with adalimum=
ab, response rates for PASI 90, PASI 100 and IGA 0/1 rapidly increased afte=
r patients were switched to bimekizumab Q4W dosing at week 24, through to w=
eek 56.^1 At week 56, response rates in switched patients were comparable t=
o those who had been treated with bimekizumab throughout the study.^1=C2=A0

Through weeks 0=E2=80=9324, the active comparator period, treatment emergen=
t adverse events (TEAEs) and serious TEAEs were comparable for patients rec=
eiving bimekizumab (71.5 percent and 1.6 percent, respectively) and adalimu=
mab (69.8 percent and 3.1 percent).^1 Through weeks 0=E2=80=9356, 81.4 perc=
ent and 5.1 percent of patients receiving bimekizumab (including those who =
switched from adalimumab) experienced TEAEs and serious TEAEs, respectively=
.^1 The most common TEAEs that were observed for bimekizumab through weeks =
0=E2=80=9356 were nasopharyngitis (20.9 percent), oral candidiasis (16.2 pe=
rcent) and upper respiratory tract infection (9.0 percent).^1=C2=A0Through =
week 56, there were no suicidal ideation/behavior, inflammatory bowel disea=
se, or major adverse cardiac events reported in patients treated with bimek=
izumab.^1=C2=A0

About BE SURE=C2=A0=C2=A0 =C2=A0
BE SURE is a Phase 3, randomized, double-blind study comparing the efficacy=
and safety of bimekizumab to adalimumab in adult patients with moderate-to=
-severe chronic plaque psoriasis. The active-controlled initial treatment p=
eriod of 24 weeks is followed by a dose-blind maintenance treatment period =
until week 56. BE SURE enrolled 478 participants with chronic plaque psoria=
sis for at least six months prior to screening and with an affected body su=
rface area of at least 10 percent, PASI of at least 12 and IGA score equal =
to or greater than three on a five-point scale.^2=C2=A0=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. For additional details on the study, visit BE=
SURE on clinicaltrials.gov (https://u7061146.ct.sendgrid.net/ls/click?upn=
=3D4tNED-2FM8iDZJQyQ53jATUQt7TX3s4n5oOHYNVgrDojHrF3PZ8lMxIL4k8NfidHSUSVq-2B=
5l4iYerq0AzPDb3uTw-3D-3D1j7X_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI3b8s=
YN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c9g1waAImiQ8HE=
TxYFreXnNuhi0oKEChSR274S0ID8TidYxnIkQe-2FsWWEk75AXvkbY81HVPF1I4fHmmJ9YkaqY9=
apn0o9UY-2BnmJv7CfrTXyja5TKFPQLBaku3sFFp7tfQzPPXyWPxRvK3-2FBDYvRN4AdCnrR9qc=
p68qh-2FmM-2BadM-2BVSy3bWbac-2FL-2F-2FYK4xtf2wbdxHBXbIWN-2BWKLNhR-2BoS41vSC=
34ooUexJO8g6Z3rCFShsVdT70QWTTDWHIkQJTZwAppmik-3D .^2 UCB announced topline =
findings from BE SURE in December 2019. For additional details, visit: BE S=
URE on UCB.com (https://u7061146.ct.sendgrid.net/ls/click?upn=3D4tNED-2FM8i=
DZJQyQ53jATUXZJD59ZUodhGC-2FyJVE-2BjXw-2Fd0j1C70r-2FZ058zOLCiGbZ5kwDne5pqWm=
tC3RaE79UoXIIW06Rn4SiUSjb9usSxCtL2XOTxpBKqPpRjHakitxn0TjNSzL3D0bySEdnkxaSbN=
E9LuCMXtNi7jF2wKW2TUzoJBhNhFh7DRwrk-2BIYZQQsU2J_xDPID0vOuylFAU8fv4e60wei4Jx=
qEGBdVWu7KiDwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-=
2F2X9c9g1waAImiQ8HETxYFreXnNuhi0oKEChSR274S0ID8TidYxnIkQe-2FsWWEk75AXvkbY81=
HVPF1I4fHmmJ9YkaqY9apn0o9UY-2BnmJv7CfrTXyja5TKGjibQKKIwKXxdZpAD3xnVAGY3tAxf=
6BIdsFVDfloQY0l8RBHIIJuvG-2FEA2EAvVF-2FFVAMZQb7JQtxxKeciuOv5meL828yddlKFmkK=
ZJH4LWACbXbuKbLcrlhH5Lj-2FeQCgo2JEEigDjfAuQhw-2B5r0lg8-3D .=C2=A0

Humira^=C2=AE is a registered trademark of AbbVie, Inc.

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.^3=C2=A0IL-17F has overlapping biology with IL-17A and dr=
ives inflammation independently to IL-17A.^4,5,6,7,8=C2=A0Selective inhibit=
ion of IL-17F in addition to IL-17A suppresses inflammation to a greater ex=
tent than IL-17A inhibition alone.^7,8 The safety and efficacy of bimekizum=
ab are being evaluated across multiple disease states as part of a robust c=
linical program.=C2=A0

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.^9=C2=A0Psoriasis signs and symptoms can vary but may include red=
patches of skin covered with silvery scales; dry, cracked skin that may bl=
eed; and thickened, pitted or ridged nails.^10

Psoriasis affects nearly three percent of the population, or about 125 mill=
ion people worldwide.^6 Unmet needs remain in the treatment of psoriasis. A=
population-based survey identified that approximately 30 percent of psoria=
sis patients reported that their primary goals of therapy, including keepin=
g symptoms under control, reducing itching and decreasing flaking, were not=
met with their current treatment.^11=C2=A0Psoriasis has a considerable psy=
chological and quality of life impact, potentially affecting work, recreati=
on, relationships, sexual functioning, family and social life.^12=C2=A0

About UCB
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
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=
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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, =
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=
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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.

For further information, UCB:=C2=A0
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=C2=A0
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
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GenericFile
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