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UCB Media Room: BIMZELX®▼ (bimekizumab) Receives First Positive Health Technology Assessment Worldwide

INFORMATION REGLEMENTEE


[06/09/2021 | 07:08]
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** BIMZELX^=C2=AE=E2=96=BC (bimekizumab) Receives First Positive Health Tec=
hnology Assessment Worldwide
------------------------------------------------------------

=C2=B7 The UK=E2=80=99s National Institute for Health and Care Excellence p=
ublished its final Technology Appraisal Guidance recommending bimekizumab a=
s a treatment option for adults with severe plaque psoriasis=C2=A0
=C2=B7 This first positive health technology assessment worldwide recognize=
s the value that bimekizumab can bring to patients, healthcare systems and =
societies=C2=A0

Brussels, Belgium =E2=80=93 6th September 2021 =E2=80=93 0700 CEST =E2=80=
=93 UCB, a global biopharmaceutical company, today announced that the Natio=
nal Institute for Health and Care Excellence (NICE), the UK health technolo=
gy assessment body that appraises new medicines for use in England and Wale=
s, has published its final Technology Appraisal Guidance (TAG) recommending=
BIMZELX^=C2=AE (bimekizumab) as a treatment option for adults with severe =
plaque psoriasis who have not responded to other systemic treatments, or if=
these treatments are contraindicated, or not tolerated.^1=C2=A0This positi=
ve guidance is the outcome of the first health technology assessment for bi=
mekizumab worldwide.

=E2=80=9CThe positive health technology assessment by NICE recognizes the v=
alue that bimekizumab can bring to patients, to healthcare systems and to s=
ocieties, and is underpinned by UCB=E2=80=99s commitment to ensuring access=
to our innovative medicines in a timely manner,=E2=80=9D said Emmanuel Cae=
ymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB=
. =E2=80=9CWe are delighted with the speed in which bimekizumab could be av=
ailable to psoriasis patients in England and Wales, and support NICE=E2=80=
=99s appraisal of our new psoriasis treatment option.=E2=80=9D
=C2=A0
Bimekizumab is the first medicine to be evaluated and recommended through N=
ICE=E2=80=99s new Expedited Low-Risk Fast Track Appraisal, and National Hea=
lth Service (NHS) funding for bimekizumab could be available in England and=
Wales within approximately one month.^1=C2=A0

NICE made its recommendations based on a submission that included efficacy =
and safety data from the bimekizumab Phase 3 clinical program in psoriasis.=
^1 It considered that evidence from these trials showed that bimekizumab wa=
s more effective than adalimumab, secukinumab and ustekinumab.^1 NICE also =
concluded that indirect comparisons suggested that bimekizumab was similarl=
y or more effective than other biological treatments, including risankizuma=
b, brodalumab and ixekizumab.^1=C2=A0

Further health technology assessments of bimekizumab are underway in countr=
ies in the European Union (EU), with decisions anticipated later in the yea=
r.=C2=A0

In August 2021, bimekizumab received marketing authorization in Great Brita=
in,^2=C2=A0and in countries of the EU,^3 for the treatment of moderate to s=
evere plaque psoriasis in adults who are candidates for systemic therapy.=
=C2=A0

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

About BIMZELX (bimekizumab)=C2=A0
Bimekizumab is a humanized IgG1 monoclonal antibody that selectively binds =
with high affinity to IL-17A, IL-17F and IL-17AF cytokines, blocking their =
interaction with the IL-17RA/IL-17RC receptor complex.^3=C2=A0Elevated conc=
entrations of IL-17A and IL-17F have been implicated in the pathogenesis of=
several immune-mediated inflammatory diseases including plaque psoriasis.^=
3 Bimekizumab inhibits these proinflammatory cytokines, resulting in the no=
rmalization of skin inflammation and, as a consequence, improvement in clin=
ical symptoms associated with psoriasis.^3

Bimzelx^=C2=AE=E2=96=BC (bimekizumab) EU/EEA* Important Safety Information
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.*EU/EEA means Europe=
an Union/European Economic Area

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=C2=A0

Last accessed: September 2021.

=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.=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=
inue=E2=80=9D and similar expressions. These forward-looking statements are=
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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=
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es in tax laws or the administration of such laws, and hiring and retention=
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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=
ips, joint ventures or licensing collaborations may be subject to differenc=
es 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 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=
ssful as UCB may have believed at the moment of acquisition. Also, UCB or o=
thers could discover safety, side effects or manufacturing problems with it=
s products and/or devices after they are marketed. The discovery of signifi=
cant 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 on=
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a breakdown, cyberattack or information security breach could compromise th=
e confidentiality, integrity and availability of UCB=E2=80=99s data and sys=
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=
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

For further information, contact UCB:=C2=A0

Corporate Communications
Laurent Schots=C2=A0
Media Relations, UCB =C2=A0
T+32.2.559.92.64 =C2=A0Laurent.schots@ucb.com=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

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=C2=A0 =C2=A0
References

1. NICE Technology Appraisal Guidance. Bimekizumab for treating moderate to=
severe plaque psoriasis. https://www.nice.org.uk/guidance/ta723 Last acces=
sed September 2021=C2=A0
2. BIMZELX (bimekizumab) GB Summary of Product Characteristics https://bit.=
ly/Bimzelx-SmPC-Pre-filled-Syringe =C2=A0https://bit.ly/Bimzelx-SmPC-Pre-fi=
lled-Pen. Last accessed September 2021
3. 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 September 2021

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