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** UCB Receives Positive CHMP Opinion Recommending Approval of BIMZELX^=C2=
=AE* (bimekizumab) in the EU for the Treatment of Adults with Moderate to S=
evere Plaque Psoriasis
------------------------------------------------------------
=C2=B7 The positive CHMP opinion is supported by data from three Phase 3 st=
udies where bimekizumab demonstrated superior levels of skin clearance comp=
ared to placebo, ustekinumab and adalimumab=C2=A0
=C2=B7 If approved by the European Commission, bimekizumab will be the firs=
t approved treatment for moderate to severe plaque psoriasis that is design=
ed to selectively and directly inhibit both IL-17A and IL-17F=C2=A0
=C2=B7 The European Commission is expected to deliver its decision on the m=
arketing authorization of bimekizumab, under the trade name BIMZELX^=C2=AE*=
, in approximately two months=C2=A0
Brussels, Belgium =E2=80=93 25th June, 2021 =E2=80=93 11:00 AM CEST =E2=80=
=93 Regulated Information =E2=80=93 Inside Information =E2=80=93 UCB, a glo=
bal biopharmaceutical company, announced today that the European Medicines =
Agency=E2=80=99s (EMA) Committee for Medicinal Products for Human Use (CHMP=
) has adopted a positive opinion recommending granting a marketing authoriz=
ation for BIMZELX^=C2=AE* (bimekizumab), an investigational IL-17A and IL-1=
7F inhibitor, for the treatment of moderate to severe plaque psoriasis in a=
dults who are candidates for systemic therapy.=C2=A0
=E2=80=9CThis positive CHMP opinion is a significant regulatory milestone t=
owards approval of bimekizumab in Europe. We=E2=80=99re delighted by today=
=E2=80=99s decision which recognizes the strength of the psoriasis clinical=
development program. Bimekizumab is testament to our commitment to advanci=
ng science in immuno-dermatology, addressing unmet needs and improving pati=
ent outcomes,=E2=80=9D said Emmanuel Caeymaex, Executive Vice President, Im=
munology Solutions and Head of U.S., UCB.=C2=A0
The positive CHMP opinion is supported by results from three Phase 3 studie=
s =E2=80=93 BE VIVID, BE READY and BE SURE =E2=80=93 which evaluated the ef=
ficacy and safety of bimekizumab in adults with moderate to severe plaque p=
soriasis.^1,2,3=C2=A0 All studies met their co-primary and all ranked secon=
dary endpoints.^1,2,3 Patients treated with bimekizumab achieved superior l=
evels of skin clearance (PASI 90 and IGA 0/1**) at week 16 compared to thos=
e who received adalimumab, placebo and ustekinumab.^1,2,3 Clinical response=
s achieved with bimekizumab at week 16 were maintained up to one year in al=
l studies.^1,2,3 The most frequently reported treatment emergent adverse ev=
ents in bimekizumab-treated patients were nasopharyngitis, oral candidiasis=
, and upper respiratory tract infection.^1,2,3, =C2=A0
If marketing authorization is granted by the European Commission, bimekizum=
ab will become the first approved treatment for patients with moderate to s=
evere plaque psoriasis in the European Union that is designed to selectivel=
y and directly inhibit both IL-17A and IL-17F, two key cytokines driving in=
flammatory processes.^1,2,3 The positive CHMP opinion is a scientific recom=
mendation which is shared with the European Commission for the adoption of =
a decision on an EU-wide marketing authorization. A European Commission mar=
keting authorization through the centralized procedure is valid in all Euro=
pean Union Member States, as well as the European Economic Area countries I=
celand, Liechtenstein and Norway.=C2=A0UCB is committed to bringing bimekiz=
umab to patients worldwide. Bimekizumab is currently under review by the U.=
S. Food and Drug Administration for the treatment of adults with moderate t=
o severe plaque psoriasis. Regulatory reviews are also underway in Japan, A=
ustralia and Canada. The efficacy and safety of bimekizumab are also being =
evaluated in Phase 3 trials in psoriatic arthritis,^5,6=C2=A0 ankylosing sp=
ondylitis,^7=C2=A0non-radiographic axial spondyloarthritis,^8=C2=A0and hidr=
adenitis suppurativa.^9,10
Notes to Editors:=C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =
=C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=
=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =
=C2=A0 =C2=A0=C2=A0
* The proprietary name BIMZELX^=C2=AE has been provisionally accepted by th=
e EMA =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0=
=C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=
=A0 =C2=A0
** PASI 90 - at least a 90 percent improvement in the Psoriasis Area and Se=
verity Index; IGA 0/1 - Investigator=E2=80=99s Global Assessment response o=
f clear or almost clear skin.
About Psoriasis=C2=A0
Psoriasis is a common, chronic inflammatory disease with primary involvemen=
t of the skin.^11=C2=A0This skin condition affects men and women of all age=
s and ethnicities.^11 Psoriasis signs and symptoms can vary but may include=
red patches of skin covered with silvery scales; dry, cracked skin that ma=
y bleed; and thickened, pitted or ridged nails.^12=C2=A0Psoriasis also has =
a considerable psychological and quality-of-life impact, potentially affect=
ing work, recreation, relationships, sexual functioning, family and social =
life.^13
Unmet needs remain in the treatment of psoriasis. A population-based survey=
identified that approximately one in three psoriasis patients reported tha=
t their primary goals of therapy, including keeping symptoms under control,=
reducing itching and decreasing flaking, were not met with their current t=
reatment.^14=C2=A0
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 approximately 8,400 peopl=
e in nearly 40 countries, the company generated revenue of =E2=82=AC5.3 bil=
lion in 2020. UCB is listed on Euronext Brussels (symbol: UCB). Follow us o=
n 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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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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rovals or to obtain them on acceptable terms or within expected timing, cos=
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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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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=
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or commercially successful as UCB may have believed at the start of such pa=
rtnership. UCB=E2=80=99s efforts to acquire other products or companies and=
to integrate the operations of such acquired companies may not be as succe=
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s products and/or devices after they are marketed. The discovery of signifi=
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implicate an entire class of products may have a material adverse effect on=
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pharmaceutical pricing and reimbursement activities and outcomes. Finally, =
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tems.=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=
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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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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=
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For further information, UCB:
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
Corporate Communications
Laurent Schots=C2=A0
Media Relations, UCB =C2=A0
T+32.2.559.92.64 =C2=A0laurent.schots@ucb.com=C2=A0
Brand Communications
Eimear O=E2=80=99Brien,=C2=A0
Brand Communications, UCB
T + 32.2.559.92.71 eimear.obrien@ucb.com
=C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0
References
1. =C2=A0Reich K, Papp KA, Blauvelt A, et al. Bimekizumab versus ustekinuma=
b for the treatment of moderate to severe plaque psoriasis (BE VIVID): effi=
cacy and safety from a 52-week, multicentre, double-blind, active comparato=
r and placebo-controlled phase 3 trial. Lancet. 2021;397(10273):487-498.
2. Gordon KB, Foley P, Krueger JG, et al. Bimekizumab efficacy and safety i=
n moderate to severe plaque psoriasis (BE READY): a multicentre, double-bli=
nd, placebo-controlled, randomised withdrawal phase 3 trial. Lancet. 2021;3=
97(10273):475-486.
3. Warren RB, Blauvelt A, Bagel J, et al. Bimekizumab versus Adalimumab in =
Plaque Psoriasis. =C2=A0N Engl J Med. 2021;10.1056/NEJMoa2102388.
4. UCB Data on File. June 2021.
5. 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://www.clinicaltrials.gov/ct2/show/NCT3896581. L=
ast accessed: June 2021.
6. ClinicalTrials.gov. A study to test the efficacy and safety of bimekizum=
ab in the treatment of subjects with active psoriatic arthritis (BE OPTIMAL=
). =C2=A0Available at: https://www.clinicaltrials.gov/ct2/show/NCT03895203.=
Last accessed: June 2021.
7. 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://www.clinicaltrials.gov/ct2/show/NCT03928743.Last accessed: =
June 2021.
8. ClinicalTrials.gov. A study to evaluate the efficacy and safety of bimek=
izumab in subjects with active nonradiographic axial spondyloarthritis (BE =
MOBILE 1). Available at: https://www.clinicaltrials.gov/ct2/show/NCT0392870=
4. Last accessed: June 2021.
9. ClinicalTrials.gov. A study to evaluate the efficacy and safety of bimek=
izumab in study participants with moderate to severe hidradenitis suppurati=
va (BE HEARD I). Available at: https://www.clinicaltrials.gov/ct2/show/NCT0=
4242446. Last accessed: June 2021.
10. 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://www.clinicaltrials.gov/ct2/show/NCT042=
42498. Last accessed: June 2021.
11. National Psoriasis Foundation. About Psoriasis. Available at: https://w=
ww.psoriasis.org/about-psoriasis/. Last accessed: June 2021.
12. International Federation of Psoriasis Associations. Available at: www.i=
fpa-pso.com/our-cause//. Last accessed: June 2021.
13. Moon HS, Mizara A, McBride SR. Psoriasis and psycho-dermatology. Dermat=
ol Ther (Heidelb). 2013;3(2):117-130.
14. Lebwohl MG, Kavanaugh A, Armstrong AW, et al. US Perspectives in the Ma=
nagement of Psoriasis and Psoriatic Arthritis: Patient and Physician Result=
s from the Population-Based Multinational Assessment of Psoriasis and Psori=
atic Arthritis (MAPP) Survey. Am J Clin Dermatol. 2016; 17(1):87-97.
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