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** UCB Provides Update on U.S. Regulatory Review of Bimekizumab
------------------------------------------------------------
Brussels (Belgium), 19 September 2023 =E2=80=93 Time (23:00 CEST) =E2=80=93=
Regulated Information =E2=80=93 Inside Information =E2=80=93 UCB, a global=
biopharmaceutical company, today provided an update on the Biologics Licen=
se Application (BLA) for bimekizumab for the treatment of adults with moder=
ate to severe plaque psoriasis.=C2=A0
UCB has received the Establishment Inspection Report (EIR) from the U.S. Fo=
od and Drug Administration (FDA) following the pre-license inspection condu=
cted in April 2023 at the Belgium manufacturing facility. The FDA has concl=
uded that this inspection is successfully closed.=C2=A0
The FDA is continuing its review of the BLA for bimekizumab. The Agency has=
not communicated timelines required to take action on the application. =C2=
=A0At this time, UCB no longer anticipates FDA action in Q3, 2023.=C2=A0
UCB continues to collaborate with the FDA to advance and complete the full =
review of the bimekizumab BLA and its label. The next update for the bimeki=
zumab BLA will be shared at the time of the FDA action.=C2=A0
UCB=E2=80=99s previously communicated 2023 financial guidance range remains=
unchanged.=C2=A0
Notes to editors:
About bimekizumab =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
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.^1 In August 2021, bimek=
izumab=E2=96=BC received marketing authorization in countries of the Europe=
an Union (EU)/European Economic Area (EEA) and Great Britain, for the treat=
ment of moderate to severe plaque psoriasis in adults who are candidates fo=
r systemic therapy.^2,3=C2=A0In January 2022, bimekizumab received marketin=
g authorization in Japan for the treatment of plaque psoriasis, generalized=
pustular psoriasis and psoriatic erythroderma in patients who are not suff=
iciently responding to existing treatments.^4 In February 2022, March 2022 =
and April 2023, bimekizumab received marketing authorization in Canada, Aus=
tralia and Mexico, respectively, for the treatment of moderate to severe pl=
aque psoriasis in adults who are candidates for systemic therapy or phototh=
erapy.^5,6=C2=A0In July 2022, October 2022, January 2023 and May 2023 bimek=
izumab was approved in Saudi Arabia^7, Switzerland^8, the United Arab Emira=
tes and Kuwait, respectively, for the treatment of moderate to severe plaqu=
e psoriasis in adults who are candidates for systemic therapy.=C2=A0
In June 2023, bimekizumab was first approved in countries of the EU/EEA, al=
one or in combination with methotrexate for the treatment of active psoriat=
ic arthritis in adults who have had an inadequate response or who have been=
intolerant to one or more disease-modifying antirheumatic drugs.^2 In June=
2023, bimekizumab was first approved in countries of the EU/EEA, for the t=
reatment of adults with active non-radiographic axial spondyloarthritis wit=
h objective signs of inflammation as indicated by elevated C-reactive prote=
in and/or magnetic resonance imaging who have responded inadequately or are=
intolerant to non-steroidal anti-inflammatory drugs, and for the treatment=
of adults with active ankylosing spondylitis who have responded inadequate=
ly or are intolerant to conventional therapy.^2=C2=A0
=E2=96=BC This medicinal product is subject to additional monitoring. This =
will allow quick identification of new safety information. Healthcare profe=
ssionals are asked to report any suspected adverse reactions.
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
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 8,700 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). Follo=
w 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: change=
s in general economic, business and competitive conditions, the inability t=
o obtain necessary regulatory approvals or to obtain them on acceptable ter=
ms or within expected timing, costs associated with research and developmen=
t, changes in the prospects for products in the pipeline or under developme=
nt by UCB, effects of future judicial decisions or governmental investigati=
ons, safety, quality, data integrity or manufacturing issues; potential or =
actual data security and data privacy breaches, or disruptions of our infor=
mation technology systems, product liability claims, challenges to patent p=
rotection for products or product candidates, competition from other produc=
ts including biosimilars, changes in laws or regulations, exchange rate flu=
ctuations, changes or uncertainties in tax laws or the administration of su=
ch laws, and hiring and retention of its employees. There is no guarantee t=
hat new product candidates will be discovered or identified in the pipeline=
, will progress to product approval or that new indications for existing pr=
oducts will be developed and approved. Movement from concept to commercial =
product is uncertain; preclinical results do not guarantee safety and effic=
acy of product candidates in humans. So far, the complexity of the human bo=
dy cannot be reproduced in computer models, cell culture systems or animal =
models. The length of the timing to complete clinical trials and to get reg=
ulatory approval for product marketing has varied in the past and UCB expec=
ts similar unpredictability going forward. Products or potential products, =
which are the subject of partnerships, joint ventures or licensing collabor=
ations may be subject to differences disputes between the partners or may p=
rove to be not as safe, effective or commercially successful as UCB may hav=
e believed at the start of such partnership. UCB=E2=80=99s efforts to acqui=
re other products or companies and to integrate the operations of such acqu=
ired companies may not be as successful as UCB may have believed at the mom=
ent of acquisition. Also, UCB or others could discover safety, side effects=
or manufacturing problems with its products and/or devices after they are =
marketed. The discovery of significant problems with a product similar to o=
ne of UCB=E2=80=99s products that implicate an entire class of products may=
have a material adverse effect on sales of the entire class of affected pr=
oducts. Moreover, sales may be impacted by international and domestic trend=
s toward managed care and health care cost containment, including pricing p=
ressure, political and public scrutiny, customer and prescriber patterns or=
practices, and the reimbursement policies imposed by third-party payers as=
well as legislation affecting biopharmaceutical pricing and reimbursement =
activities and outcomes. Finally, a breakdown, cyberattack or information s=
ecurity breach could compromise the confidentiality, integrity and availabi=
lity of UCB=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.
UCB is providing this information, including forward-looking statements, on=
ly as of the date of this press release. UCB expressly disclaims any duty t=
o update any information contained in this press release, either to confirm=
the actual results or to report or reflect any change in its forward-looki=
ng statements with regard thereto or any change in events, conditions or ci=
rcumstances 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. 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=
=E2=80=931001.
2. BIMZELX (bimekizumab) EU SmPC. https://www.ema.europa.eu/en/documents/pr=
oduct-information/bimzelx-epar-product-information_en.pdf =C2=A0Accessed: S=
eptember 2023.
3. BIMZELX (bimekizumab) GB SmPC. https://www.medicines.org.uk/emc/product/=
12834; https://www.medicines.org.uk/emc/product/12833 Accessed: September 2=
023.
4. Pharmaceuticals and Medical Devices Agency. https://www.pmda.go.jp/engli=
sh/review-services/reviews/approved-information/drugs/0001.html. Accessed: =
September 2023.
5. BIMZELX (bimekizumab) Canada Product Monograph. Available at: https://pd=
f.hres.ca/dpd_pm/00064702.PDF. Accessed: September 2023.
6. BIMZELX. Australian Prescription Medicine Decision Summaries. Available =
at: https://www.tga.gov.au/apm-summary/bimzelx. Accessed: September2023.
7. Saudi Food & Drug Authority. https://www.sfda.gov.sa/sites/default/files=
/2023-04/Bimzelx.pdf. Last accessed: September 2023.
8. Swissmedic. Available at: https:// www.swissmedic.ch/swissmedic/en/home/=
about-us/publications/public-summary-swiss-par/public-summary-swiss-par-bim=
zelx.html (http://www.swissmedic.ch/swissmedic/en/home/about-us/publication=
s/public-summary-swiss-par/public-summary-swiss-par-bimzelx.html) =C2=A0Las=
t accessed: September 2023. =C2=A0
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