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** UCB presents latest data from generalized myasthenia gravis portfolio at=
2023 AANEM Annual Meeting and MGFA Scientific Session
------------------------------------------------------------
=C2=B7 14 presentations =E2=80=93 including 3 oral sessions =E2=80=93 have =
been selected by AANEM and MGFA for inclusion within scientific programs
=C2=B7 Results presented across UCB=E2=80=99s generalized myasthenia gravis=
(gMG) portfolio, including Open Label Extension data from the MycarinG and=
RAISE studies=C2=A0
=C2=B7 Presentations showcase additional data on RYSTIGGO^=C2=AE (rozanolix=
izumab-noli) and ZILBRYSQ^=C2=AE (zilucoplan), following recent regulatory =
approvals for the treatment of gMG in adult patients, alongside real-world =
MG data and its use in better understanding patient experiences
=C2=B7 UCB will also host a symposium, =E2=80=9CNew Horizons: Navigating a =
New Treatment Landscape for gMG=E2=80=9D on November 1, 12:00 PM MT.
Brussels (Belgium), 1st November 2023: 07:00 (CET) UCB (Euronext Brussels: =
UCB), a global biopharmaceutical company, today announced that it will be p=
resenting results from across its portfolio in generalized myasthenia gravi=
s (gMG) at the American Association of Neuromuscular & Electrodiagnostic Me=
dicine (AANEM) annual meeting and the Myasthenia Gravis Association of Amer=
ica Scientific Session, taking place November 1-4, 2023.
Additional results from the MycarinG and RAISE studies,^1,2 and their open-=
label extension studies, will be presented, investigating UCB=E2=80=99s roz=
anolixizumab-noli, a subcutaneously (SC)-injected monoclonal antibody targe=
ting the neonatal Fc receptor (FcRn)^3,4 and zilucoplan, a self-administere=
d, subcutaneously injected =C2=A0peptide inhibitor of complement component =
5 (C5 inhibitor) in adults with gMG.^5 These two Phase 3 trials supported U=
.S., EU, and Japanese regulatory filings of both rozanolixizumab-noli and z=
ilucoplan.=C2=A0
Zilucoplan was recently approved by the U.S. Food and Drug Administration (=
FDA) for the treatment of generalized myasthenia gravis (gMG) in adult pati=
ents who are anti-acetylcholine receptor (AChR),^6 following FDA approval o=
f rozanolixizumab-noli for treatment of gMG in adult patients who are anti-=
AChR antibody-positive or anti-muscle-specific tyrosine kinase (MuSK) antib=
ody-positive earlier this year.^7 Zilucoplan and rozanolixizumab were also =
recently approved in Japan by the Japanese Ministry of Health, Labour and W=
elfare (MHLW)^8. Both medicines are also under review by the European Medic=
ines Agency (EMA) for the treatment of adults with gMG, with zilucoplan hav=
ing recently received a positive CHMP opinion.=C2=A0
These data further inform UCB=E2=80=99s innovative approach to evolving sci=
ence into meaningful solutions that help improve outcomes and help address =
unmet needs of people living with gMG.
=E2=80=9CAdditional results being presented at AANEM 2023 and the MGFA Scie=
ntific Sessions from the MycarinG and RAISE studies and their open-label ex=
tensions demonstrate UCB=E2=80=99s commitment to finding treatment options =
that provide sustained efficacy for patients with gMG, and reinforce the de=
pth and strength of our expanding rare disease pipeline and portfolio,=E2=
=80=9D said Donatello Crocetta, Head of Global Rare Disease & Rare Medical,=
UCB. =E2=80=9CFollowing on from our recent approvals for rozanolixizumab a=
nd zilucoplan in the U.S. and Japan for the treatment of adult patients wit=
h gMG, we=E2=80=99re very excited to be contributing new treatment options =
to people living with this rare neuromuscular disease.=E2=80=9D
As part of ongoing work to reveal better understanding of the patient and s=
ocietal burden of gMG, UCB will also present posters on real-world data pro=
viding insights into the impact of social determinants of health on treatme=
nt of people with MG and the increase in risk of gMG exacerbation and healt=
hcare resource utilization (HCRU) associated with higher MG-ADL scores.=C2=
=A0
Further demonstrating their commitment to finding solutions for unmet needs=
within the gMG community, UCB will also present study designs for Phase 2/=
3 studies to assess zilucoplan and rozanolixizumab-noli in pediatric patien=
ts with gMG. In total, fourteen abstracts will be presented, including thre=
e as oral presentations.
=E2=80=9CFor people living with gMG, the burden of disease is great and it=
=E2=80=99s important for us as a company to build the body of evidence arou=
nd the complexities of this disease,=E2=80=9D said Kim Moran, Head of U.S. =
Rare Disease, UCB. =E2=80=9CWe=E2=80=99re committed to creating patient val=
ue by pursuing a portfolio of differentiated solutions that are aligned to =
the needs and objectives of the generalized myasthenia gravis community.=E2=
=80=9D
UCB data included within MGFA Scientific Session:
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=C2=A0=C2=A0 =C2=A0=C2=A0=C2=A0 =C2=A0
UCB Data included in AANEM Scientific Program:
=C2=A0
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In addition to contributing to the AANEM and MGFA scientific programme, UCB=
will be hosting a sponsored therapeutic update session entitled =E2=80=9CN=
ew Horizons: Navigating a New Treatment Landscape for gMG=E2=80=9D onsite a=
t the congress venue on November 1 at 12:00 PM MT.
About generalized Myasthenia Gravis (gMG)
gMG is a rare autoimmune disease with a global prevalence of 100=E2=80=9335=
0 cases per every 1 million people.^9 People living with gMG can experience=
a variety of symptoms, including severe muscular weakness that can result =
in double vision, drooping eyelids, difficulty with swallowing, chewing and=
talking, as well as life-threatening weakness of the muscles of respiratio=
n.^10,11
In MG, pathogenic autoantibodies can impair synaptic transmission at the ne=
uromuscular junction (NMJ) by targeting specific proteins on the post-synap=
tic membrane.^12 This disrupts the ability of the nerves to stimulate the m=
uscle and results in a weaker contraction. gMG can occur in any race, gende=
r or age.^10,11
About zilucoplan
Zilucoplan is a once-daily SC, self-administered peptide inhibitor of compl=
ement component 5 (C5 inhibitor). As the only once-daily generalized myasth=
enia gravis (gMG) target therapy for self-administration by adult patients =
with anti acetylcholine receptor (AChR) antibody-positive gMG, zilucoplan i=
nhibits complement-mediated damage to the neuromuscular junction through it=
s targeted mechanism of action.^13=C2=A0
In October 2023, zilucoplan was approved by the U.S. (Food and Drug Adminis=
tration) FDA for the treatment of gMG in adult patients who are anti-acetyl=
choline receptor (AchR) antibody-positive.^6
In September 2023, the Committee for Medicinal Products for Human Use (CHMP=
) of the European Medicines Agency (EMA) issued a positive opinion recommen=
ding granting marketing authorization for zilucoplan in the European Union =
(EU) as an add-on to standard therapy for the treatment of gMG in adult pat=
ients who are anti-AChR antibody-positive.^14 A final decision on approval =
in the EU is expected before the end of the year, in line with the EMA=E2=
=80=99s standard review timeline.=C2=A0
Also in September 2023, the Japanese Ministry of Health, Labour and Welfare=
(MHLW) approved zilucoplan for the treatment of gMG in adult patients (onl=
y for patients who =C2=A0inadequately respond to steroids or other immunosu=
ppressants).^8
Zilucoplan is currently under review by the Australian Therapeutic Goods Ad=
ministration (TGA) and Health Canada for the treatment of adults with gMG. =
Responses from regulatory agencies to these submissions are expected during=
H2 2023 and H1 2024.
Orphan designation was granted by the FDA in 2019 to zilucoplan for the tre=
atment of myasthenia gravis.^15
About rozanolixizumab-noli
In addition to zilucoplan, UCB=E2=80=99s gMG portfolio includes the FDA-app=
roved medicine RYSTIGGO^=C2=AE (rozanolixizumab-noli), a subcutaneously inf=
used monoclonal antibody targeting the neonatal Fc receptor (FcRn).^1,3=C2=
=A0
In June 2023, rozanolixizumab-noli was approved by the FDA, for the treatme=
nt of gMG in adult patients who are anti-acetylcholine receptor (AChR) or a=
nti-muscle-specific tyrosine kinase (MuSK) antibody-positive, having been g=
ranted Priority Review for its Biologic License Application (BLA).^7=C2=A0
In September 2023, rozanolixizumab was granted approval by the Japanese Min=
istry of Health, Labour and Welfare (MHLW) for the treatment of generalized=
myasthenia gravis (gMG) in adult patients (only for patients who inadequat=
ely respond to steroids or other immunosuppressants).^8=C2=A0
Rozanolixizumab is currently under review by the European Medicines Agency =
(EMA), the Center of Drug Evaluation of the China National Medical Products=
Administration, the Australian Therapeutic Goods Administration (TGA), Hea=
lth Canada and Switzerland (Swissmedic) for the treatment of adults with gM=
G. Responses from regulatory agencies to these submissions are expected dur=
ing H2 2023 and H1 2024.=C2=A0
Important Safety Information for ZILBRYSQ^=C2=AE=C2=A0
IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING
What is the most important information I should know about ZILBRYSQ?
ZILBRYSQ is a medicine that affects part of your immune system. ZILBRYSQ ma=
y lower the ability of your immune system to fight certain infections.
=C2=B7 ZILBRYSQ increases your chance of getting serious and life-threateni=
ng meningococcal infections. Meningococcal infections may become life-threa=
tening or fatal if not recognized and treated early.
=C2=B7 You must complete or update two types of meningococcal vaccines (f=
or both serogroup B infections and serogroup A, C, W, and Y infections) at =
least 2 weeks before your first dose of ZILBRYSQ if you have not already ha=
d these vaccines.
=C2=B7 If your healthcare provider decided that urgent treatment with ZIL=
BRYSQ is needed, you should receive meningococcal vaccination(s) as soon as=
possible.
=C2=B7 If you have not completed or updated vaccinations for meningococca=
l infections at least 2 weeks before your first ZILBRYSQ dose and ZILBRYSQ =
therapy must be started right away, you must also receive antibiotics.
o=C2=A0=C2=A0 =C2=A0If you had a meningococcal vaccine in the past, you mig=
ht need additional vaccination before starting ZILBRYSQ. Your healthcare pr=
ovider will decide if you need additional meningococcal vaccination.
o=C2=A0=C2=A0 =C2=A0Meningococcal vaccines do not prevent all meningococcal=
infections. Call your healthcare provider or get emergency medical care ri=
ght away if you get any of these signs and symptoms of a meningococcal infe=
ction:
=C2=B7 headache with nausea or vomiting
=C2=B7 headache and fever
=C2=B7 headache with a stiff neck or stiff back
=C2=B7 fever
=C2=B7 fever and a rash
=C2=B7 confusion
=C2=B7 muscle aches with flu-like symptoms
=C2=B7 eyes sensitive to light
Your healthcare provider will give you a Patient Safety Card about the risk=
of meningococcal infection. Carry it with you at all times during treatmen=
t and for 2 months after your last ZILBRYSQ dose. Your risk of meningococca=
l infection may continue for several weeks after your last dose of ZILBRYSQ=
. It is important to show this card to any healthcare provider who treats y=
ou. This will help them diagnose and treat you quickly.
ZILBRYSQ is only available through a program called the ZILBRYSQ REMS. Befo=
re you can receive ZILBRYSQ, your healthcare provider must:
=C2=B7 enroll in the ZILBRYSQ REMS.
=C2=B7 counsel you about the risk of meningococcal infection.
=C2=B7 give you the Patient Guide, including information about the signs an=
d symptoms of meningococcal infection.
=C2=B7 give you a Patient Safety Card about your risk of meningococcal infe=
ction, as discussed above.
=C2=B7 make sure that you are vaccinated with two types of meningococcal va=
ccines and, if needed, get revaccinated with the meningococcal vaccines. As=
k your healthcare provider if you are not sure if you need to be revaccinat=
ed.
ZILBRYSQ may also increase the risk of other types of serious infections.
=C2=B7 ZILBRYSQ may increase your chance of getting Streptococcus pneumonia=
e and Haemophilus influenzae type b. Your healthcare provider will tell you=
if you should receive the Streptococcus pneumoniae and Haemophilus influen=
zae type b vaccinations.
=C2=B7 Certain people may have an increased risk of gonorrhea infection. Ta=
lk to your healthcare provider about whether you are at risk for gonorrhea =
infection, about gonorrhea prevention, and about regular testing.
Call your healthcare provider right away if you have new signs or symptoms =
of infection.
Who should not use ZILBRYSQ?
Do not use ZILBRYSQ if you have a Neisseria meningitidis infection.
Before you use ZILBRYSQ, tell your healthcare provider about all of your me=
dical conditions, including if you:
=C2=B7 have an infection or fever.
=C2=B7 are pregnant or plan to become pregnant. It is not known if ZILBRYSQ=
will harm your unborn baby.
=C2=B7 are breastfeeding or plan to breastfeed. It is not known if ZILBRYSQ=
passes into your breast milk. Talk to your healthcare provider about the b=
est way to feed your baby if you use ZILBRYSQ.
Tell your healthcare provider about all the medicines you take, including p=
rescription and over-the-counter medicines, vitamins, and herbal supplement=
s.
What are the possible side effects of ZILBRYSQ?
ZILBRYSQ may cause serious side effects, including:
=C2=B7 See =E2=80=9CWhat is the most important information I should know ab=
out ZILBRYSQ?=E2=80=9D
=C2=B7 Inflammation of the pancreas (pancreatitis) and other pancreatic pro=
blems. Pancreatitis and pancreatic cysts have happened in people who use ZI=
LBRYSQ. Your healthcare provider will do blood tests to check your pancreas=
before you start treatment with ZILBRYSQ.
=C2=B7 Call your healthcare provider right away if you have pain in your =
stomach area (abdomen) that will not go away. Your healthcare provider will=
tell you if you should stop using ZILBRYSQ. The pain may be severe or felt=
going from your abdomen to your back. The pain may happen with or without =
vomiting. These may be symptoms of pancreatitis.
The most common side effects of ZILBRYSQ include:
=C2=B7 injection site reactions.
=C2=B7 upper respiratory tract infections.
=C2=B7 diarrhea.
Tell your healthcare provider about any side effect that bothers you or tha=
t does not go away. These are not all the possible side effects of ZILBRYSQ=
. For more information, ask your healthcare provider or pharmacist. Call yo=
ur doctor for medical advice about side effects. You may report side effect=
s to FDA at www.fda.gov/medwatch (https://www.fda.gov/medwatch) or 1-800-FD=
A-1088. You may also report side effects to UCB, Inc. by calling 1-844-599-=
CARE [2273].
See the detailed Instructions for Use that comes with ZILBRYSQ for informat=
ion on how to prepare and inject a dose of ZILBRYSQ, and how to properly th=
row away (dispose of) used ZILBRYSQ prefilled syringes.
INDICATION
What is ZILBRYSQ?
=C2=B7 ZILBRYSQ is a prescription medicine used to treat adults with a dise=
ase called generalized myasthenia gravis (gMG) who are anti-acetylcholine r=
eceptor (AChR) antibody positive.
=C2=B7 It is not known if ZILBRYSQ is safe and effective in children.
Please see the full Prescribing Information (https://www.ucb-usa.com/zilbry=
sq-prescribing-information.pdf) and Medication Guide (https://www.ucb-usa.c=
om/zilbrysq-patient-medication-guide.pdf) for ZILBRYSQ, including the Boxed=
Warning regarding Serious Meningococcal Infections. Please see the Instruc=
tions for Use for the ZILBRYSQ Single-Dose Prefilled Syringe. Talk to your =
healthcare provider about your condition or your treatment. For more inform=
ation, go to www.ZILBRYSQ.com (https://www.zilbrysq.com/) or call 1-844-599=
-2273.
Important Safety Information for RYSTIGGO^=C2=AE=C2=A0
IMPORTANT SAFETY INFORMATION AND INDICATION
WHAT IS RYSTIGGO?
RYSTIGGO is a prescription medicine used to treat adults with a disease cal=
led generalized myasthenia gravis (gMG) who are acetylcholine receptor (ant=
i-AChR) antibody positive or muscle-specific tyrosine kinase (anti-MuSK) an=
tibody positive.
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT RYSTIGGO (rozano=
lixizumab-noli)?
RYSTIGGO may cause serious side effects, including:
=C2=B7 Infection: RYSTIGGO may increase the risk of infection. In clinical =
studies, the most common infections were upper respiratory tract infections=
, COVID-19, urinary tract infections, and herpes simplex infections. Your h=
ealthcare provider should check you for infections before starting and duri=
ng treatment with RYSTIGGO. Tell your healthcare provider if you have any h=
istory of infections. Tell your healthcare provider right away if you have =
signs or symptoms of an infection during treatment with RYSTIGGO. Some of t=
he signs and symptoms may include fever, chills, frequent and/or painful ur=
ination, cough, runny nose, wheezing, shortness of breath, fatigue, sore th=
roat, excess phlegm, nasal discharge, back pain, and/or chest pain.
=C2=B7 Aseptic Meningitis: RYSTIGGO could cause aseptic meningitis. Tell yo=
ur healthcare provider right away if you develop any signs or symptoms of m=
eningitis during treatment with RYSTIGGO such as severe headache, neck stif=
fness, drowsiness, fever, sensitivity to light, painful eye movements, naus=
ea, and vomiting.
=C2=B7 Hypersensitivity Reactions: RYSTIGGO can cause swelling and rash. Yo=
ur healthcare provider should monitor you during and after treatment and di=
scontinue RYSTIGGO if needed. Tell your healthcare provider immediately abo=
ut any undesirable reactions you experience after administration.
Before taking RYSTIGGO, tell your healthcare provider about all of your med=
ical conditions, including if you:
=C2=B7 Have a history of infection or think you have an active infection
=C2=B7 Have received or are scheduled to receive a vaccine (immunization). =
The use of vaccines during RYSTIGGO treatment has not been studied, and the=
safety with live or live-attenuated vaccines is unknown. Administration of=
live or live-attenuated vaccines is not recommended during treatment with =
RYSTIGGO. Completion of age-appropriate vaccines according to vaccination g=
uidelines before starting a new treatment cycle with RYSTIGGO is recommende=
d.
=C2=B7 Are pregnant or plan to become pregnant or are breastfeeding or plan=
to breastfeed.
Tell your healthcare provider about all the medicines you take, including p=
rescription and over-the-counter medicines, vitamins, and herbal supplement=
s.
WHAT ARE THE POSSIBLE SIDE EFFECTS OF RYSTIGGO?
RYSTIGGO may cause serious side effects, including:
=C2=B7 See "What is the most important information I should know about RYST=
IGGO?"
The most common side effects of RYSTIGGO include:
=C2=B7 headache
=C2=B7 infections
=C2=B7 diarrhea
=C2=B7 fever
=C2=B7 hypersensitivity reactions
=C2=B7 nausea
These are not all the possible side effects of RYSTIGGO. For more informati=
on, ask your healthcare provider or pharmacist. Tell your healthcare provid=
er about any side effect that bothers you or that does not go away. Call yo=
ur healthcare provider for medical advice about side effects. You are encou=
raged to report negative side effects of prescription drugs to the FDA. Vis=
it www.fda.gov/medwatch (https://www.fda.gov/medwatch) or call 1-800-FDA-10=
88. You may also report side effects to UCB, Inc. by calling 1-844-599-CARE=
[2273].
Please see the full Prescribing Information (https://www.ucb-usa.com/RYSTIG=
GO-prescribing-information.pdf) and talk to your healthcare provider about =
your condition or your treatment.
For further information, contact UCB:=C2=A0
Global Rare Disease Communications
Jim Baxter
T +32.2.473.78.85.01=C2=A0
jim.baxter@ucb.com =C2=A0
UCB Rare Disease Communications (Japan)
T +81.03.6864.7650
Corporate Communications, Media Relations
Laurent Schots=C2=A0
T +32.2.559.92.64 =C2=A0
Laurent.schots@ucb.com =C2=A0
Investor Relations
Antje Witte =C2=A0 =C2=A0 =C2=A0 =C2=A0=C2=A0
T +32.2.559.94.14=C2=A0
antje.witte@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=
5.5 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=
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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=
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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=
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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. Bril V, et al. Safety and efficacy of rozanolixizumab in patients with g=
eneralised myasthenia gravis (MycarinG): a randomised, double-blind, placeb=
o-controlled, adaptive phase 3 study. Lancet Neurol. 2023;22(5):383-94.
2. Howard JF Jr, et al. Safety and efficacy of zilucoplan in patients with =
generalised myasthenia gravis (RAISE): a randomised, double-blind, placebo-=
controlled, phase 3 study. Lancet Neurol. 2023;22(5):395-406.=C2=A0
3. Smith B, et al. Generation and characterization of a high affinity anti-=
human FcRn antibody, rozanolixizumab, and the effects of different molecula=
r formats on the reduction of plasma IgG concentration. MAbs. 2018;10:1111-=
30.
4. Kiessling P, et al. The FcRn inhibitor rozanolixizumab reduces human ser=
um IgG concentration: A randomized phase 1 study. Sci Transl Med. 2017;9(41=
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ebo-Controlled, Multicenter Clinical Trial. JAMA Neurol. 2020 May 1;77(5):5=
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6. ZILBRYSQ^=C2=AE U.S. Prescribing Information: https://www.ucb-usa.com/zi=
lbrysq-prescribing-information.pdf. Accessed October 2023.
7. RYSTIGGO^=C2=AE U.S. Prescribing Information: https://www.ucb-usa.com/RY=
STIGGO-prescribing-information.pdf. Accessed October 2023.
8. Data on file: Japan MHLW, 25 September 2023.
9. Punga AR, et al. Epidemiology, diagnostics, and biomarkers of autoimmune=
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11. Myasthenia Gravis Foundation of America. MG Quick Facts. https://myasth=
enia.org/MG-Education/MG-Quick-Facts. Accessed October 2023.=C2=A0
12. Juel VC, Massey JM. Myasthenia gravis. Orphanet J Rare Dis. 2007;2:44.
13. Howard JF Jr, et al. Safety and efficacy of zilucoplan in patients with=
generalised myasthenia gravis (RAISE): a randomised, double-blind, placebo=
-controlled, phase 3 study. Lancet Neurol. 2023;22(5):395-406.=C2=A0
14. CHMP Positive Opinion: Zilbrysq https://www.ema.europa.eu/en/medicines/=
human/summaries-opinion/zilbrysq. Accessed October 2023.
15. US Food and Drug Administration. https://www.accessdata.fda.gov/scripts=
/opdlisting/oopd/detailedIndex.cfm?cfgridkey=3D699319. Accessed October 202=
3.
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