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** Update on U.S. FDA Review of Biologics License Application (BLA) for bim=
ekizumab
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Brussels (Belgium), 13th May 2022 =E2=80=93 08:00 CEST =E2=80=93 Regulated =
Information =E2=80=93 Inside Information =E2=80=93 UCB, a global biopharmac=
eutical company, announced today that the U.S. Food and Drug Administration=
(FDA) has issued a Complete Response Letter (CRL) regarding the Biologics =
License Application (BLA) for bimekizumab for the treatment of adults with =
moderate to severe plaque psoriasis.=C2=A0
The letter indicates that the FDA cannot approve the application in its cur=
rent form. The CRL states that certain pre-approval inspection observations=
must be resolved before approval of the application. We are cooperating wi=
th the FDA and are working to address these observations as expeditiously a=
s possible.=C2=A0
UCB is committed to bringing bimekizumab to patients worldwide. In August 2=
021, bimekizumab received marketing authorization in countries of the Europ=
ean Union (EU)/European Economic Area (EEA) and Great Britain, for the trea=
tment of moderate to severe plaque psoriasis in adults who are candidates f=
or systemic therapy.^1,2=C2=A0In January 2022, bimekizumab received marketi=
ng authorization in Japan for the treatment of plaque psoriasis, generalize=
d pustular psoriasis and psoriatic erythroderma in patients who are not suf=
ficiently responding to existing treatments.^3 In February and March 2022, =
bimekizumab received marketing authorization in Canada and Australia, respe=
ctively, for the treatment of moderate to severe plaque psoriasis in adults=
who are candidates for systemic therapy or phototherapy.^4,5
In context of the CRL, UCB is reviewing its financial guidance for 2022.
About Psoriasis
Psoriasis is a common, chronic inflammatory disease with primary involvemen=
t of the skin.^6 This skin condition affects men and women of all ages and =
ethnicities.^6 Psoriasis signs and symptoms can vary but may include red pa=
tches of skin covered with silvery scales; dry, cracked skin that may bleed=
; and thickened, pitted or ridged nails.^7 Psoriasis also has a considerabl=
e psychological and quality-of-life impact, potentially affecting work, rec=
reation, relationships, sexual functioning, family and social life.^8=C2=A0=
=C2=A0 =C2=A0 =C2=A0=C2=A0
About bimekizumab=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.^9=C2=A0
For further information, contact UCB:=C2=A0
Corporate Communications
Laurent Schots
T +32.2.559.92.64=C2=A0
email laurent.schots@ucb.com
Investor Relations
Antje Witte
T +32.2.559.94.14=C2=A0
email antje.witte@ucb.com=C2=A0
Brand Communications
Eimear O=E2=80=99Brien
T +32.2.559.92.71
Email eimear.obrien@ucb.com
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=
5.8 billion in 2021. 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. BIMZELX (bimekizumab) EU Summary of Product Characteristics https://www.=
ema.europa.eu/en/documents/product-information/bimzelx-epar-product-informa=
tion_en.pdf. Last accessed May 2022.
2. BIMZELX (bimekizumab) GB Summary of Product Characteristics https://www.=
medicines.org.uk/emc/product/12834; https://www.medicines.org.uk/emc/produc=
t/12833. Last accessed May 2022.
3. Pharmaceuticals and Medical Devices Agency https://www.pmda.go.jp/englis=
h/review-services/reviews/approved-information/drugs/0001.html. Last access=
ed May 2022.
4. BIMZELX (bimekizumab) Canada Product Monograph. Available at: https://pd=
f.hres.ca/dpd_pm/00064702.PDF. Last accessed: May 2022.=C2=A0
5. https://www.tga.gov.au/apm-summary/bimzelx (https://www.tga.gov.au/apm-s=
ummary/bimzelx. Last accessed May 2022) . Last accessed May 2022.=C2=A0
6. National Psoriasis Foundation. About Psoriasis. Available at: https://ww=
w.psoriasis.org/about-psoriasis/. Last accessed: May 2022.
7. Mayo Clinic. Psoriasis: Symptoms & Causes. Available at: =C2=A0 https://=
www.mayoclinic.org/diseases-conditions/psoriasis/symptoms-causes/syc-203558=
40. Last accessed: May 2022.
8. Moon HS, Mizara A, McBride SR. Psoriasis and psycho-dermatology. Dermato=
l Ther (Heidelb). 2013;3(2):117-130.
9. 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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