https://mb.cision.com/Public/18595/logo/86a99b25f755738d_org.jpg
** UCB Announces PDUFA Date for Bimekizumab
------------------------------------------------------------
Brussels, Belgium =E2=80=93 28 April 2021, 7:00 CEST =E2=80=93 UCB announce=
d today that the U.S. Food and Drug Administration (FDA) has set the Prescr=
iption Drug User Fee Act (PDUFA) date for UCB=E2=80=99s Biologics=C2=A0Lice=
nse Application (BLA) for bimekizumab for the treatment of adults with mode=
rate to severe plaque psoriasis at October 15, 2021.=C2=A0
Bimekizumab for the treatment of adults with moderate to severe plaque psor=
iasis is currently under review by the U.S. FDA for the BLA and the Europea=
n Medicines Agency (EMA) for the Marketing Authorization Application (MAA),=
respectively. Regulatory reviews are also underway in Japan, Australia and=
Canada.
Subject to respective approvals, UCB will bring bimekizumab to patients sta=
rting in the second half of 2021.=C2=A0
About Bimekizumab - Bimekizumab is an investigational humanized monoclonal =
IgG^1 antibody that selectively inhibits both IL-17A and IL-17F, two key cy=
tokines driving inflammatory processes.^1=C2=A0IL-17F has overlapping biolo=
gy with IL-17A and drives inflammation independently to IL-17A.^2,3,4,5,6=
=C2=A0Selective inhibition of IL-17F in addition to IL-17A suppresses infla=
mmation to a greater extent than IL-17A inhibition alone.5,6 The safety and=
efficacy of bimekizumab are being evaluated across multiple disease states=
as part of a robust clinical program. The safety and efficacy of bimekizum=
ab have not been established and it is not approved by any regulatory autho=
rity worldwide. Bimekizumab is currently also being evaluated in Phase 3 tr=
ials for potential indications in psoriatic arthritis,^7,8=C2=A0ankylosing =
spondylitis,^9=C2=A0non-radiographic axial spondyloarthritis^10=C2=A0and hi=
dradenitis suppurativa.^11,12
About Psoriasis - Psoriasis is a common, chronic inflammatory disease with =
primary involvement of the skin. This skin condition affects men and women =
of all ages and ethnicities.^13=C2=A0Psoriasis signs and symptoms can vary =
but may include red patches of skin covered with silvery scales; dry, crack=
ed skin that may bleed; and thickened, pitted or ridged nails.^14=C2=A0=C2=
=A0Psoriasis affects nearly three percent of the population, or about 125 m=
illion people worldwide.^15,16=C2=A0Unmet needs remain in the treatment of =
psoriasis. A population-based survey identified that approximately 30 perce=
nt of psoriasis patients reported that their primary goals of therapy, incl=
uding keeping symptoms under control, reducing itching and decreasing flaki=
ng, were not met with their current treatment.^17=C2=A0Psoriasis has a cons=
iderable psychological and quality of life impact, potentially affecting wo=
rk, recreation, relationships, sexual functioning, family and social life.^=
18
About UCB - UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceuti=
cal company focused on the discovery and development of innovative medicine=
s and solutions to transform the lives of people living with severe disease=
s of the immune system or of the central nervous system. With more than 7 6=
00 people in approximately 40 countries, the company generated revenue of =
=E2=82=AC 5.3 billion in 2020. UCB is listed on Euronext Brussels (symbol: =
UCB). Follow us on Twitter: @UCB_news.
Forward looking statements UCB=C2=A0
This press release contains forward-looking statements including, without l=
imitation, 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=9Cestimate=
s=E2=80=9D, =E2=80=9Cmay=E2=80=9D, =E2=80=9Cwill=E2=80=9D, =E2=80=9Ccontinu=
e=E2=80=9D and similar expressions. These forward-looking statements are ba=
sed on current plans, estimates and beliefs of management. All statements, =
other than statements of historical facts, are statements that could be dee=
med forward-looking statements, including estimates of revenues, operating =
margins, capital expenditures, cash, other financial information, expected =
legal, arbitration, political, regulatory or clinical results or practices =
and other such estimates and results. By their nature, such forward-looking=
statements are not guarantees of future performance and are subject to kno=
wn and unknown risks, uncertainties and assumptions which might cause the a=
ctual 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 release.=
Important factors that could result in such differences include: the globa=
l spread and impact of COVID-19, changes in general economic, business and =
competitive conditions, the inability to obtain necessary regulatory approv=
als or to obtain them on acceptable terms or within expected timing, costs =
associated with research and development, changes in the prospects for prod=
ucts in the pipeline or under development by UCB, effects of future judicia=
l decisions or governmental investigations, safety, quality, data integrity=
or manufacturing issues; potential or actual data security and data privac=
y breaches, or disruptions of our information technology systems, product l=
iability claims, challenges to patent protection for products or product ca=
ndidates, competition from other products including biosimilars, changes in=
laws or regulations, exchange rate fluctuations, changes or uncertainties =
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 be d=
iscovered or identified in the pipeline, or that new indications for existi=
ng products will be developed and approved. Movement from concept to commer=
cial product is uncertain; preclinical results do not guarantee safety and =
efficacy of product candidates in humans. So far, the complexity of the hum=
an body cannot be reproduced in computer models, cell culture systems or an=
imal models. The length of the timing to complete clinical trials and to ge=
t regulatory approval for product marketing has varied in the past and UCB =
expects similar unpredictability going forward. Products or potential produ=
cts which are the subject of partnerships, joint ventures or licensing coll=
aborations may be subject to disputes between the partners or may prove to =
be not as safe, effective or commercially successful as UCB may have believ=
ed at the start of such partnership. UCB=E2=80=99 efforts to acquire other =
products or companies and to integrate the operations of such acquired comp=
anies may not be as successful as UCB may have believed at the moment of ac=
quisition. Also, UCB or others could discover safety, side effects or manuf=
acturing problems with its products and/or devices after they are marketed.=
The discovery of significant problems with a product similar to one of UCB=
=E2=80=99s products that implicate an entire class of products may have a m=
aterial adverse effect on sales of the entire class of affected products. M=
oreover, sales may be impacted by international and domestic trends toward =
managed care and health care cost containment, including pricing pressure, =
political and public scrutiny, customer and prescriber patterns or practice=
s, and the reimbursement policies imposed by third-party payers as well as =
legislation affecting biopharmaceutical pricing and reimbursement activitie=
s and outcomes. Finally, a breakdown, cyberattack or information security b=
reach could compromise the confidentiality, integrity and availability of U=
CB=E2=80=99s data and systems. =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.=C2=A0
UCB is providing this information, including forward-looking statements, on=
ly as of the date of this press release and expressly disclaims any duty to=
update any information contained in this press release, either to confirm =
the actual results or to report or reflect any change in its forward-lookin=
g statements with regard thereto or any change in events, conditions or cir=
cumstances on which any such statement is based, unless such statement is r=
equired 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
For further information, UCB:=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
Corporate Communications
Laurent Schots=C2=A0
Media Relations, UCB =C2=A0
T+32.2.559.92.64 =C2=A0Laurent.schots@ucb.com=C2=A0
References:
1. 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.
2. Yang XO, Chang SH, Park H, et al. Regulation of inflammatory responses b=
y IL-17F. J Exp Med. 2008;205(5):1063=E2=80=931075.
3. Hymowitz SG, Filvaroff EH, Yin JP, et al. IL-17s adopt a cystine knot fo=
ld: structure and activity of a novel cytokine, IL-17F, and implications fo=
r receptor binding. EMBO J. 2001;20(19):5332=E2=80=935341.
4. van Baarsen LG, Lebre MC, van der Coelen D, et al. Heterogeneous express=
ion pattern of interleukin 17A (IL-17A), IL-17F and their receptors in syno=
vium of rheumatoid arthritis, psoriatic arthritis and osteoarthritis: possi=
ble explanation for nonresponse to anti-IL-17 therapy? Arthritis Res Ther. =
2014;16(4):426.
5. Maroof A, Okoye R, Smallie T, et al. Bimekizumab dual inhibition of IL-1=
7A and IL-17F provides evidence of IL-17F contribution to chronic inflammat=
ion in disease-relevant cells. Ann Rheum Dis. 2017;76(2):213.
6. Glatt S, Baeten D, Baker T, et al. Dual IL-17A and IL-17F neutralisation=
by bimekizumab in psoriatic arthritis: evidence from preclinical experimen=
ts and a randomised placebo-controlled clinical trial that IL-17F contribut=
es to human chronic tissue inflammation. Ann Rheum Dis. 2018;77(4):523-532.
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://www.clinicaltrials.gov/ct2/show/NCT3896581. L=
ast accessed: April 2021.
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://www.clinicaltrials.gov/ct2/show/NCT03895203. Last =
accessed: April 2021.
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://www.clinicaltrials.gov/ct2/show/NCT03928743. Last accessed:=
April 2021.
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://www.clinicaltrials.gov/ct2/show/NCT039287=
04. Last accessed: April 2021.
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://www.clinicaltrials.gov/ct2/show/NCT=
04242446. Last accessed: April 2021.
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://www.clinicaltrials.gov/ct2/show/NCT042=
42498. Last accessed: April 2021.
13. National Psoriasis Foundation. About Psoriasis. Available at: https://w=
ww.psoriasis.org/about-psoriasis/. Last accessed: March 2021.
14. International Federation of Psoriasis Associations. Available at: www.i=
fpa-pso.com/our-cause//. Last accessed: March 2021.
15. Griffiths C, van der Walt J, et al. The global state of psoriasis disea=
se epidemiology: a workshop report. Br J Dermatol. 2017;177(1):e4=E2=80=93 =
e7.
16. World Health Organization. Global report on psoriasis, 2016. Available =
at: http://apps.who.int/iris/handle/10665/204417. Last accessed: March 2021.
17. 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.
18. Moon HS, Mizara A, McBride SR. Psoriasis and psycho-dermatology. Dermat=
ol Ther (Heidelb). 2013;3(2):117-130.
=C2=A0
GenericFile
20210428 UCB BKZ PDUFA ENG (https://mb.cision.com/Public/18595/3334966/a25f=
952bf6b6af93.pdf)=0D
=0D
______________________=0D
If you would rather not receive future communications from UCB SA, please g=
o to https://eu.vocuspr.com/OptOut.aspx?2973226x20421x67869x1x6868579x24000=
x6&Email=3Dregnews%40symexglobal.com.=0D
UCB SA, All=C3=A9e de la Recherche, 60 ., Brussels, . B - 1070 Belgium=
26/04/2024 20:00
25/04/2024 18:00
25/04/2024 07:01
23/04/2024 20:00
22/04/2024 07:01
19/04/2024 20:00
17/04/2024 07:01
12/04/2024 20:00
12/04/2024 18:01
12/04/2024 07:01