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** UCB to Present Eight Bimekizumab Abstracts at AAD 2023 with Results from=
Studies in Psoriasis, Psoriatic Arthritis and Hidradenitis Suppurativa
------------------------------------------------------------
=C2=B7 Phase 3 data on investigational bimekizumab in the treatment of adul=
ts with moderate to severe hidradenitis suppurativa to be presented as a la=
te-breaking platform presentation=C2=A0
=C2=A0
Brussels (Belgium), 16th March 2023 =E2=80=93 07:00 (CET) =E2=80=93 UCB, a =
global biopharmaceutical company, today announced that it will present eigh=
t bimekizumab abstracts across a range of IL-17 mediated diseases^1,2=C2=A0=
=E2=80=93 moderate to severe plaque psoriasis, active psoriatic arthritis =
(PsA) and moderate to severe hidradenitis suppurativa (HS) =E2=80=93 at the=
2023 American Academy of Dermatology (AAD) Annual Meeting in New Orleans, =
U.S., 17=E2=80=9321 March. The abstracts have been accepted as one late-bre=
aking oral platform presentation and seven posters including three with ora=
l presentations. The platform presentation will share the first detailed da=
ta from the two Phase 3 studies, BE HEARD I and BE HEARD II, evaluating the=
efficacy and safety of bimekizumab compared with placebo in the treatment =
of adults with moderate to severe HS.^3,4=C2=A0=C2=A0
=E2=80=9CThe Phase 3 results for hidradenitis suppurativa further demonstra=
te UCB=E2=80=99s dedication to improving treatment options for patients wit=
h chronic diseases and reinforce our commitment to advancing dermatological=
care through cutting-edge science,=E2=80=9D said Emmanuel Caeymaex, Execut=
ive Vice President, Immunology Solutions and Head of U.S., UCB.
In the U.S., the efficacy and safety of bimekizumab have not been establish=
ed for any indication and it is not approved by the U.S. Food and Drug Admi=
nistration. In the European Union and Great Britain, bimekizumab is approve=
d for the treatment of moderate to severe plaque psoriasis in adults who ar=
e candidates for systemic therapy.^5,6=C2=A0 UCB is investigating bimekizum=
ab in PsA and HS. The efficacy and safety of bimekizumab in PsA and HS have=
not been established, and it is not approved for use in these indications =
by any regulatory authority worldwide.
Five of the eight abstracts at AAD 2023 will share data on bimekizumab in t=
he treatment of moderate to severe plaque psoriasis including data evaluati=
ng bimekizumab in the treatment of nail psoriasis from the BE RADIANT phase=
3b trial. Two abstracts evaluating bimekizumab for the treatment of active=
PsA will also be presented.
=C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 The following is a guide to the U=
CB-sponsored abstracts at AAD 2023:
Hidradenitis Suppurativa
=C2=B7 Bimekizumab in patients with moderate-to-severe hidradenitis suppura=
tiva: 48-week efficacy and safety from BE HEARD I & II, two phase 3, random=
ized, double-blind, placebo controlled, multicenter studies.=C2=A0Kimball A=
B, Zouboulis CC, Sayed C et al.=C2=A0
Saturday March 18: 13:00=E2=80=9313:10
Psoriasis
=C2=B7 Bimekizumab maintenance of response and safety in patients with mode=
rate to severe plaque psoriasis: Results from the open-label extension peri=
od (Weeks 48=E2=80=93144) of the BE RADIANT phase 3b trial.=C2=A0Strober B,=
Puig L, Blauvelt A et al.
# 43778
Sunday March 19: 13:00=E2=80=9313:05
=C2=B7 Bimekizumab versus secukinumab for the treatment of nail psoriasis i=
n patients with moderate to severe plaque psoriasis: Results from the BE RA=
DIANT phase 3b trial.=C2=A0Eyerich K, Gottlieb AB, Piaserico S et al.
# 43878
Sunday March 19: 13:30=E2=80=9313-35
=C2=B7 Bimekizumab safety and tolerability in patients with moderate to sev=
ere plaque psoriasis: Analysis of pooled data from up to three years of tre=
atment in five phase 3/3b clinical trials.=C2=A0Gordon KB, Gooderham M, Fol=
ey P et al.
# 43758
Sunday March 19: 15:10=E2=80=9315:15
=C2=B7 Itching in patients with moderate to severe plaque psoriasis: The re=
lationship between improvements in Psoriasis Area and Severity Index and pa=
tient-reported symptoms in the BE RADIANT phase 3b trial.=C2=A0Augustin M, =
Langley RG, Warren RB et al.
# 42664
=C2=B7 Bimekizumab in patients with moderate to severe plaque psoriasis: In=
jection site reactions through two years of the BE RADIANT phase 3b trial a=
nd open-label extension with one-year comparison to secukinumab.=C2=A0Soung=
J, Rosmarin D, L=C3=B3pez Ferrer A et al.
# 43802
Psoriatic Arthritis
=C2=B7 Bimekizumab improved efficacy measures in patients with active psori=
atic arthritis and moderate or severe psoriasis: Pooled 16-week results fro=
m phase 3 randomized, placebo-controlled studies BE OPTIMAL and BE COMPLETE=
.=C2=A0Gottlieb AB, Asahina A, Merola JF et al.
# 43024
=C2=B7 Bimekizumab in bDMARD-na=C3=AFve patients with psoriatic arthritis a=
nd skin involvement: Analysis of radiographic progression at Week 16 of BE =
OPTIMAL, a phase 3, multicenter, randomized, placebo-controlled, active ref=
erence study.=C2=A0Merola JF, Asahina A, Gisondi P et al.
# 43744
Notes to editors:
About bimekizumab
Bimekizumab is a humanized monoclonal IgG1 antibody that is designed to sel=
ectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F)=
, two key cytokines driving inflammatory processes.^5,7=C2=A0 In the U.S., =
the efficacy and safety of bimekizumab have not been established for any in=
dication and it is not approved by the U.S. Food and Drug Administration.
In August 2021, bimekizumab was first approved in the European Union (EU)/E=
uropean Economic Area (EEA) and in Great Britain, for the treatment of mode=
rate to severe plaque psoriasis in adults who are candidates for systemic t=
herapy.^5,6 The label information may differ in other countries where appro=
ved. Please check local prescribing information.=C2=A0
About BIMZELX^=C2=AE =E2=96=BC(bimekizumab) in the EU/EEA =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 =C2=A0 =C2=A0 =
=C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 In th=
e EU/EEA, BIMZELX^=C2=AE is indicated for the treatment of moderate to seve=
re plaque psoriasis in adults who are candidates for systemic therapy.^5
BIMZELX^=C2=AE =E2=96=BC=C2=A0(bimekizumab) EU/EEA Important Safety Informa=
tion in Psoriasis
The most frequently reported adverse reactions with bimekizumab were upper =
respiratory tract infections (14.5%) (most frequently nasopharyngitis) and =
oral candidiasis (7.3%). Common adverse reactions (=E2=89=A51/100 to <1/10)=
were oral candidiasis, tinea infections, ear infections, herpes simplex in=
fections, oropharyngeal candidiasis, gastroenteritis, folliculitis, headach=
e, dermatitis and eczema, acne, injection site reactions, fatigue. Elderly =
may be more likely to experience certain adverse reactions such as oral can=
didiasis, dermatitis and eczema when using bimekizumab.
Bimekizumab is contraindicated in patients with hypersensitivity to the act=
ive substance or any of the excipients and in patients with clinically impo=
rtant active infections (e.g. active tuberculosis).=C2=A0
Bimekizumab may increase the risk of infections. Treatment with bimekizumab=
must not be administered in patients with any clinically important active =
infection. Patients treated with bimekizumab should be instructed to seek m=
edical advice if signs or symptoms suggestive of an infection occur. Prior =
to initiating treatment with bimekizumab, patients should be evaluated for =
tuberculosis (TB) infection. Bimekizumab should not be given in patients wi=
th active TB and patients receiving bimekizumab should be monitored for sig=
ns and symptoms of active TB.=C2=A0
Cases of new or exacerbations of inflammatory bowel disease have been repor=
ted with bimekizumab. Bimekizumab is not recommended in patients with infla=
mmatory bowel disease. If a patient develops signs and symptoms of inflamma=
tory bowel disease or experiences an exacerbation of pre-existing inflammat=
ory bowel disease, bimekizumab should be discontinued and appropriate medic=
al management should be initiated. Serious hypersensitivity reactions inclu=
ding anaphylactic reactions have been observed with IL-17 inhibitors. If a =
serious hypersensitivity reaction occurs, administration of bimekizumab sho=
uld be discontinued immediately and appropriate therapy initiated.=C2=A0
Live vaccines should not be given in patients treated with bimekizumab.
Please consult the summary of product characteristics in relation to other =
side effects, full safety and prescribing information. https://www.ema.euro=
pa.eu/en/documents/product-information/bimzelx-epar-product-information_en.=
pdf
EU summary of product characteristics date of revision December 2022.
Last accessed: March 2023.
=C2=A0=E2=96=BC=C2=A0This medicinal product is subject to additional monito=
ring. This will allow quick identification of new safety information. Healt=
hcare professionals are asked to report any suspected adverse reactions=C2=
=A0
For further information, contact UCB:=C2=A0
Investor Relations
Antje Witte
T +32.2.559.94.14=C2=A0
email antje.witte@ucb.com=C2=A0=C2=A0
Corporate Communications
Laurent Schots=C2=A0
T +32.2.559.92.64=C2=A0
email laurent.schots@ucb.com
Brand Communications
Eimear O=E2=80=99Brien
T +32.2.559.92.71
email eimear.obrien@ucb.com=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 8,600 peopl=
e in approximately 40 countries, the company generated revenue of =E2=82=AC=
5.5 billion in 2022. UCB is listed on Euronext Brussels (symbol: UCB). Foll=
ow us on Twitter: @UCB_news.
Forward looking statements=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 partners=
hips, joint ventures or licensing collaborations may be subject to differen=
ces 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 p=
artnership. UCB=E2=80=99s efforts to acquire other products or companies an=
d to integrate the operations of such acquired companies may not be as succ=
essful as UCB may have believed at the moment of acquisition. Also, UCB or =
others could discover safety, side effects or manufacturing problems with i=
ts products and/or devices after they are marketed. The discovery of signif=
icant problems with a product similar to one of UCB=E2=80=99s products that=
implicate an entire class of products may have a material adverse effect o=
n sales of the entire class of affected products. Moreover, sales may be im=
pacted by international and domestic trends toward managed care and health =
care cost containment, including pricing pressure, political and public scr=
utiny, customer and prescriber patterns or practices, and the reimbursement=
policies imposed by third-party payers as well as legislation affecting bi=
opharmaceutical pricing and reimbursement activities and outcomes. Finally,=
a breakdown, cyberattack or information security breach could compromise t=
he confidentiality, integrity and availability of UCB=E2=80=99s data and sy=
stems.=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
References
1. Fletcher JK, Moran B, Petrasca A, et al. IL=E2=80=9017 in inflammatory s=
kin diseases psoriasis and hidradenitis suppurativa Clin Exp Immunol 2020; =
201(2): 121=E2=80=93134.
2. Mills KHG, IL-17 and IL-17-producing cells in protection versus patholog=
y Nature Reviews Immunology 2023; 23: 38=E2=80=9354=C2=A0
3. 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://clinicaltrials.gov/ct2/show/NCT04242=
446?term=3Dbe+heard&draw=3D2&rank=3D1. Last accessed: March 2023=C2=A0
4. 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 II). Available at: https://clinicaltrials.gov/ct2/show/NCT0424=
2498 Last accessed: March 2023
5. BIMZELX^=C2=AE (bimekizumab) EU Summary of Product Characteristics, Dece=
mber 2022. Available at:=C2=A0https://www.ema.europa.eu/en/documents/produc=
t-information/bimzelx-epar-product-information_en.pdf. Last accessed: March=
=C2=A02023.
6. BIMZELX^=C2=AE (bimekizumab) GB Summary of Product Characteristics. Avai=
lable at: https://www.medicines.org.uk/emc/product/12834/smpc#gref. Last ac=
cessed: March 2023.
7. Glatt S, Helmer E, Haier B, et al. First-in-human randomized study of bi=
mekizumab, a humanized monoclonal antibody and selective dual inhibitor of =
IL-17A and IL-17F, in mild psoriasis. Br J Clin Pharmacol. 2017;83(5):991-1=
001.
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