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** UCB showcases commitment to treatment and management of epilepsy at the =
34th International Epilepsy Congress
------------------------------------------------------------
=C2=B7 Scientific presentations illustrate impact, breadth and real-world v=
alue of UCB=E2=80=99s epilepsy treatment portfolio
=C2=B7 Sponsored symposia debate clinical approaches in the management of e=
pilepsy, as well as discuss latest scientific advances and health-tech supp=
ort solutions for people living with epilepsy
Brussels (Belgium), 27 August =E2=80=93 07:00 (CET): UCB today reinforced i=
ts commitment to the treatment and management of epilepsy at the 34th Inter=
national Epilepsy Congress (IEC, 28 Aug- 1 Sep), showcasing a broad range o=
f clinical data and real-world experience with its approved anti-seizure me=
dicines, as well as highlighting the role that health-technology solutions =
can play in helping people living with epilepsy and their healthcare provid=
ers manage their condition.=C2=A0
=E2=80=9CIt=E2=80=99s our goal to redefine the future of epilepsy medicine,=
aspiring to bring even greater value to people living with seizures,=E2=80=
=9D said Charl van Zyl, Executive Vice President Neurology & Head of Europe=
/International Markets at UCB. =E2=80=9CFor more than 30 years, we have pro=
vided solutions that have helped transform the treatment landscape and impr=
oved the lives of millions of people living with epilepsy. Our commitment h=
as never been stronger; we are utilizing our experience and expertise to de=
velop new differentiated medicines and are dedicated to advancing technolog=
y support solutions that address specific unmet patient needs. It is our ai=
m that one day, our transformative science will even lead to solutions that=
are disease-modifying, impacting the underlying causes of the disease.=E2=
=80=9D
At the congress, UCB will be reporting data from several studies on BRIVIAC=
T^=C2=AE (brivaracetam). These data cover several recent real-world evidenc=
e studies for epilepsy patients living with partial onset seizures, reinfor=
cing the efficacy and tolerability of the medicine, as well and clinical st=
udies on the safety and tolerability of its intravenous formulation for use=
in pediatric populations. Additional data will also report the efficacy an=
d tolerability of adjunctive Vimpat^=C2=AE (lacosamide) as a treatment for =
primary generalized tonic-clonic seizures. =E2=80=9CThese studies further d=
emonstrate UCB=E2=80=99s commitment to scientific and medical knowledge exc=
hange and creating value for a broad cross-section of people living with ep=
ilepsy,=E2=80=9D added Prof. Konrad Werhahn, Global Head Epilepsy Medical A=
ffairs at UCB.
Alongside the presentation of these data, UCB will be facilitating two sate=
llite symposia to debate current issues in epilepsy care and to showcase in=
novative digital and scientific approaches to the current and future treatm=
ent and management of epilepsy. The first symposium entitled =E2=80=98Bridg=
ing the gap: what do patients want from the management of their epilepsy?=
=E2=80=99 is hosted by Christian Brandt MD, Head of Department, Bethel Epil=
epsy Center in Germany. A key topic of debate will be the importance of man=
aging patient preference in the context of efficacy and tolerability, in ch=
oosing anti-seizure medications.=C2=A0
The second symposium, entitled =E2=80=98The future of the epilepsies: innov=
ation, transformation and evolution=E2=80=99 is introduced by Marte Syverts=
en MD, PhD, Department of Neurology at Vestre Viken Hospital Trust in Norwa=
y featuring guest speakers from leading epilepsy technology support provide=
rs =C2=A0Helpilepsy, Healios, and Neuro event labs. Alexandre Moreau, Head =
of Epilepsy at UCB comments: =E2=80=9CIn epilepsy, digital technology offer=
s a significant opportunity to enhance treatment decisions and enable coord=
ination of care. UCB has a number of investments and partnerships with lead=
ing health technology providers, and alongside our own scientific innovatio=
n, see this as a key component of future epilepsy treatment and care.=E2=80=
=9D=C2=A0
For registered attendees at IEC, the timings for the symposia are:
=C2=B7 Bridging the gap: what do patients want from the management of their=
epilepsy? Monday 30th August, 19:00=E2=80=9320:00 UTC+1=C2=A0
=C2=B7 The future of the epilepsies: innovation, transformation and evoluti=
on. Monday 30th August, 08:00=E2=80=9309:00 UTC+1=C2=A0
The following is a guide to the UCB-sponsored poster presentations at the 3=
4th International Epilepsy Congress (IEC 2021), Virtual Meeting (28th Augus=
t to 1st September 2021):
Brivaracetam e-Posters
=C2=B7 Effectiveness and tolerability of adjunctive brivaracetam in patient=
s with secondary generalized (focal to bilateral tonic-clonic) seizures in =
Germany. Lerche H, Knake S, Rosenow F, Schulze-Bonhage A, Elmoufti S, Leuni=
kava I, Schulz AL, Dimova S, Hopp P=C2=A0
=C2=B7 Cognitive performance and retention after 12-month adjunctive brivar=
acetam in difficult-to-treat patients with epilepsy in a real-life setting.=
Steinhoff BJ, Christensen J, Doherty CP, Majoie M, Schultz AL, Brock F, Le=
unikava I, Leach JP
=C2=B7 Pharmacokinetics, safety, and tolerability of intravenous brivaracet=
am in pediatric patients with epilepsy: an open-label trial. Farkas K, Kang=
H, Fogarasi, Bozorg A, James G, Krauwinkel W, Morita D, Will E, Elshoff JP=
=C2=A0
=C2=B7 Tolerability and efficacy of brivaracetam in adults with focal seizu=
res by concomitant antiepileptic drug use: post-hoc analysis. Ryvlin P, Dim=
ova S, Elmoufti S, Floricel F, Laloyaux C, Nondonfaz X, Biton V=C2=A0
=C2=B7 Pharmacokinetics, safety, and tolerability of intravenous brivaracet=
am in neonates with seizures: interim analysis of a phase 2/3, open label t=
rial. Krauwinkel W, Will E, Morita D, Floricel F, Elshoff JP, Pressler R
Lacosamide e-Posters
=C2=B7 Adjunctive lacosamide as treatment for primary generalized tonic-clo=
nic seizures (PGTCS): efficacy and tolerability by baseline PGTCS frequency=
. Vossler DG, Knake S, O=E2=80=99Brien TJ, Watanabe M, Dimova S, Steiniger-=
Brach B, Williams P, Roebling R
About Epilepsy^1-3
Epilepsy is a common neurological condition worldwide and affects approxima=
tely 50 million people.^1 Epilepsy and seizures can develop in any person a=
t any age,^2 and is usually diagnosed after a person has had at least two s=
eizures (or after one seizure with a high risk for more) that were not caus=
ed by some known medical condition.^3=C2=A0
About UCB in Epilepsy
UCB has a rich heritage in epilepsy with over 20 years of experience in the=
research and development of antiepileptic drugs. As a company with a long-=
term commitment to epilepsy research, our goal is to address unmet medical =
needs. Our scientists are proud to contribute to advances in the understand=
ing of epilepsy and its treatment. We partner and create super-networks wit=
h world-leading scientists and clinicians in academic institutions, pharmac=
eutical companies, and other organizations who share our goals. At UCB, we =
are inspired by patients, and driven by science in our commitment to suppor=
t patients with epilepsy.
About UCB
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 more than 8 000 people op=
erating in more than 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
About BRIVIACT^=C2=AE (brivaracetam)
Important Safety Information about BRIVIACT^=C2=AE in the EU and EEA^4
BRIVIACT=C2=AE (brivaracetam) is indicated as adjunctive therapy in the tre=
atment of partial onset seizures with or without secondary generalisation i=
n adults, adolescents and children from 4 years of age with epilepsy. Contr=
aindications Hypersensitivity to the active substance, other pyrrolidone de=
rivatives or any of the excipients. Special warnings and precautions for us=
e Suicidal ideation and behaviour have been reported in patients treated wi=
th anti-epileptic drugs (AEDs) in several indications, including BRIVIACT=
=C2=AE. Patients should be monitored for signs of suicidal ideation and beh=
aviour and appropriate treatment should be considered. Patients (and caregi=
vers) should be advised to seek medical advice should any signs of suicidal=
ideation or behaviour emerge. BRIVIACT=C2=AE film-coated tablets contain l=
actose. Patients with rare hereditary problems of galactose intolerance, to=
tal lactase deficiency or glucose-galactose malabsorption should not take B=
RIVIACT=C2=AE. Brivaracetam film-coated tablets, solution for injection/inf=
usion and oral solution contain less than 1 mmol sodium (23mg) per tablet/v=
ial/ml respectively, that is to say essentially =E2=80=98sodium free=E2=80=
=99. The oral solution contains 239.8 mg sorbitol (E420) in each ml. Patien=
ts with hereditary fructose intolerance (HFI) should not take this medicina=
l product. The oral solution contains methyl parahydroxybenzoate (E218), wh=
ich may cause allergic reactions (possibly delayed). Brivaracetam oral solu=
tion contains propylene glycol (E1520). Posology No dose adjustment is need=
ed in adults with impaired renal function. Based on data in adults, no dose=
adjustment is necessary neither in paediatric patients with impaired renal=
function. In adults with hepatic impairment, a 50 mg/day starting dose sho=
uld be considered. In children and adolescents weighing 50 kg or greater, a=
50 mg/day starting dose is recommended. A maximum daily dose of 150 mg adm=
inistered in 2 divided doses is recommended for all stages of hepatic impai=
rment. In children and adolescents weighing less than 50 kg, a 1 mg/kg/day =
starting dose is recommended. The maximum dose should not exceed 3 mg/kg/da=
y. No clinical data are available in paediatric patients with hepatic impai=
rment. Interaction with other medicinal products and other forms of interac=
tion. With co-administration of BRIVIACT=C2=AE 200 mg single dose and ethan=
ol 0.6 g/L continuous infusion in healthy subjects there was no pharmacokin=
etic interaction, but the effect of alcohol on psychomotor function, attent=
ion and memory was doubled. Intake of BRIVIACT=C2=AE with alcohol is not re=
commended. Limited clinical data are available implying that coadministrati=
on of cannabidiol may increase the plasma exposure of brivaracetam, possibl=
y through CYP2C19 inhibition, but the clinical relevance is uncertain. In h=
ealthy
subjects, co-administration with rifampicin, a strong enzyme-inducer (600 m=
g/day for 5 days), decreased BRIVIACT=C2=AE area under the plasma concentra=
tion curve (AUC) by 45%. Prescribers should consider adjusting the dose of =
BRIVIACT=C2=AE for patients starting or ending treatment with rifampicin. O=
ther strong enzyme-inducers (such as St John=C2=B4s wort [Hypericum perfora=
tum]) may also decrease the systemic exposure of BRIVIACT=C2=AE. Therefore,=
starting or ending treatment with St John=E2=80=99s wort should be done wi=
th caution. In vitro studies have shown that brivaracetam exhibits little o=
r no inhibition of CYP450 isoforms except for CYP2C19. Brivaracetam may inc=
rease plasma concentrations of medicinal products metabolised by CYP2C19 (e=
.g., lanzoprazole, omeprazole, diazepam). CYP2B6 induction has not been inv=
estigated in vivo and BRIVIACT=C2=AE may decrease plasma concentrations of =
medicinal products metabolised by CYP2B6 (e.g. efavirenz). In vitro studies=
have also shown that BRIVIACT=C2=AE has inhibitory effects on OAT3. BRIVIA=
CT=C2=AE 200 mg/day may increase plasma concentrations of medicinal product=
s transported by OAT3. BRIVIACT=C2=AE plasma concentrations are decreased w=
hen co-administered with strong enzyme inducing antiepileptic drugs (carbam=
azepine, phenobarbital, phenytoin) but no dose adjustment is required. Effe=
cts on ability to drive and use machines BRIVIACT=C2=AE, has minor or moder=
ate influence on the ability to drive and use machines. Patients should be =
advised not to drive a car or to operate other potentially hazardous machin=
es until they are familiar with the effects of BRIVIACT=C2=AE, on their abi=
lity to perform such activities. Undesirable effects. The most frequently r=
eported adverse reactions with BRIVIACT=C2=AE (reported by >10% of patients=
) were somnolence (14.3%) and dizziness (11.0%). They were usually mild to =
moderate in intensity. Somnolence and fatigue (8.2 %) were reported at high=
er incidences with increasing dose. Very common adverse reactions (=E2=89=
=A51% to <10%) were influenza, decreased appetite, depression, anxiety, ins=
omnia, irritability, convulsion, vertigo, upper respiratory tract infection=
s, cough, nausea, vomiting, constipation and fatigue. Neutropenia has been =
reported in 0.5% (6/1,099) BRIVIACT=C2=AE patients and 0% (0/459) placebo-t=
reated patients. Four of these patients had decreased neutrophil counts at =
baseline, and experienced additional decrease in neutrophil counts after in=
itiation of BRIVIACT=C2=AE. None of the six cases were severe, required any=
specific treatment, led to BRIVIACT=C2=AE discontinuation or had associate=
d infections. Suicidal ideation was reported in 0.3 % (3/1099) of BRIVIACT=
=C2=AE treated patients and 0.7 % (3/459) of placebo-treated patients. In s=
hort-term clinical studies of BRIVIACT=C2=AE in patients with epilepsy, the=
re were no cases of completed suicide and suicide attempt, however both wer=
e reported in the long-term open-label extension studies. Reactions suggest=
ive of immediate (Type I) hypersensitivity have been reported in a small nu=
mber of BRIVIACT=C2=AE patients (9/3022) during clinical development. The s=
afety profile of brivaracetam observed in children was consistent with the =
safety profile observed in adults. In the open label, uncontrolled, long-te=
rm studies suicidal ideation was reported in 4.7 % of paediatric patients (=
more common in adolescents) compared with 2.4 % of adults and behavioural d=
isorders were reported in 24.8 % of paediatric patients compared with 15.1 =
% of adults. The majority of events were mild or moderate in intensity, wer=
e non-serious, and did not lead to discontinuation of study drug. An additi=
onal adverse reaction reported in children was psychomotor hyperactivity (4=
.7 %). There are limited safety data from open-label studies in children fr=
om 1 month to <4 years of age. Limited data are available on neurodevelopme=
nt in children <4 years of age. No clinical data are available in neonates.=
Overdose There is limited clinical experience with BRIVIACT=C2=AE overdose=
in humans. Somnolence and dizziness were reported in a healthy subject tak=
ing a single dose of 1,400 mg of BRIVIACT=C2=AE. There is no specific antid=
ote. Treatment of an overdose should include general supportive measures. S=
ince less than 10% of BRIVIACT=C2=AE is excreted in urine, haemodialysis is=
not expected to significantly enhance BRIVIACT=C2=AE clearance.
Refer to the European Summary of Product Characteristics for other adverse =
reactions and full prescribing information. Date of revision: 25 November 2=
020.=C2=A0
http://www.ema.europa.eu/ =C2=A0=C2=A0
About VIMPAT^=C2=AE (lacosamide)
Important Safety Information about VIMPAT^=C2=AE in the EU and EEA^5 =C2=A0
VIMPAT^=C2=AE is indicated as monotherapy in the treatment of partial-onset=
seizures with or without secondary generalisation in adults, adolescents a=
nd children from 4 years of age with epilepsy. VIMPAT^=C2=AE is indicated a=
s adjunctive therapy in the treatment of partial-onset seizures with or wit=
hout secondary generalisation in adults, adolescents and children from 4 ye=
ars of age with epilepsy and in the treatment of primary generalised tonic-=
clonic seizures in adults, adolescents and children from 4 years of age wit=
h idiopathic generalised epilepsy. VIMPAT^=C2=AE therapy can be initiated w=
ith either oral or IV administration. For the paediatric population, the ph=
ysician should prescribe the most appropriate formulation and strength acco=
rding to weight and dose. A single loading dose may be initiated in patient=
s in situations when the physician determines that rapid attainment of laco=
samide steady state plasma concentration and therapeutic effect is warrante=
d. It should be administered under medical supervision with consideration o=
f the potential for increased incidence of serious cardiac arrhythmia and C=
NS adverse reactions. Administration of a loading dose has not been studied=
in acute conditions such as status epilepticus. Use of a loading dose is n=
ot recommended in adolescents and children weighing less than 50 kg. Admini=
stration of a loading dose has not been studied in children. A maximum dose=
of 300 mg/day is recommended for paediatric patients weighing 50 kg or mor=
e and for adult patients with mild to moderate hepatic impairment. =C2=A0Ba=
sed on data in adults, in paediatric patients weighing less than 50 kg with=
mild to moderate hepatic impairment, a reduction of 25 % of the maximum do=
se should be applied. Lacosamide should be administered to adult and paedia=
tric patients with severe hepatic impairment only when the expected therape=
utic benefits are anticipated to outweigh the possible risks. The dose may =
need to be adjusted while carefully observing disease activity and potentia=
l side effects in the patient. In adolescents and adults weighing 50 kg or =
more with mild to moderate hepatic impairment a loading dose of 200mg may b=
e considered, but further dose titration (>200 mg daily) should be performe=
d with caution. In paediatric patients weighing 50 kg or more and in adult =
patients with mild or moderate renal impairment a loading dose of 200 mg ma=
y be considered, but further dose titration (> 200 mg daily) should be perf=
ormed with caution. In paediatric patients weighing 50 kg or more and in ad=
ult patients with severe renal impairment (CLCR =E2=89=A4 30 ml/min) or wit=
h end-stage renal disease, a maximum dose of 250 mg/day is recommended and =
the dose titration should be performed with caution. In paediatric patients=
weighing less than 50 kg with severe renal impairment (CLCR =E2=89=A4 30 m=
l/min) and in those with end-stage renal disease, a reduction of 25 % of th=
e maximum dose is recommended. Contraindications: Hypersensitivity to the a=
ctive substance or any of the excipients; known second- or third-degree atr=
ioventricular (AV) block. Special warnings and precautions for use: Treatme=
nt with VIMPAT=C2=AE has been associated with dizziness which could increas=
e the occurrence of accidental injury or falls. Therefore, patients should =
be advised to exercise caution until they are familiar with the potential e=
ffects of the medicine. New onset or worsening of myoclonic seizures has be=
en reported in both adult and paediatric patients with PGTCS, in particular=
during titration. In patients with more than one seizure type, the observe=
d benefit of control for one seizure type should be weighed against any obs=
erved worsening in another seizure type. Dose-related prolongations in PR i=
nterval with VIMPAT=C2=AE have been observed in clinical studies. =C2=A0VIM=
PAT^=C2=AE should be used with caution in patients with underlying proarrhy=
thmic conditions such as patients with known cardiac conduction problems or=
severe cardiac disease (e.g. myocardial ischaemia/infarction, heart failur=
e, structural heart disease or cardiac sodium channelopathies) or patients =
treated with medicinal products affecting cardiac conduction, including ant=
iarrhythmics and sodium channel blocking antiepileptic medicinal products, =
as well as in elderly patients. In these patients it should be considered t=
o perform an ECG before a Vimpat dose increase above 400mg/day and after Vi=
mpat is titrated to steady-state. In the placebo-controlled studies of VIMP=
AT^=C2=AE in epilepsy patients, atrial fibrillation or flutter were not rep=
orted; however both have been reported in open-label epilepsy studies and i=
n post-marketing experience. In post-marketing experience, AV block (includ=
ing second degree or higher AV block) has been reported. In patients with p=
roarrhythmic conditions, ventricular tachyarrhythmia has been reported. In =
rare cases, these events have led to asystole, cardiac arrest and death in =
patients with underlying proarrhythmic conditions. Patients should be made =
aware of the symptoms of cardiac arrhythmia (e.g. slow, rapid or irregular =
pulse, palpitations, shortness of breath, feeling lightheaded, fainting). P=
atients should be counselled to seek immediate medical advice if these symp=
toms occur. Suicidal ideation and behaviour have been reported in patients =
treated with antiepileptic medicinal products in several indications. There=
fore patients should be monitored for signs of suicidal ideation and behavi=
ours and appropriate treatment should be considered. Patients (and caregive=
rs of patients) should be advised to seek medical advice should signs of su=
icidal ideation or behaviour emerge. The safety and efficacy of lacosamide =
in paediatric patients with epilepsy syndromes in which focal and generalis=
ed seizures may coexist have not been determined. VIMPAT^=C2=AE syrup conta=
ins sodium methyl parahydroxybenzoate (E219) which may cause allergic react=
ions (possibly delayed). Vimpat Syrup contains sorbitol (E420). Patients wi=
th rare hereditary problems of fructose intolerance should not take this me=
dicine. Sorbitol may cause gastrointestinal discomfort and mild laxative ef=
fect. The syrup contains aspartame (E951), a source of phenylalanine, which=
may be harmful for people with phenylketonuria. Vimpat syrup contains prop=
ylene glycol (E1520). VIMPAT=C2=AE syrup contains 1.42 mg sodium per ml, eq=
uivalent to 0.07 % of the WHO recommended maximum daily intake of 2 g sodiu=
m for an adult. VIMPAT^=C2=AE solution for infusion contains 59.8 mg sodium=
per vial, equivalent to 3% of the WHO recommended maximum daily intake of =
2 g sodium for an adult. Effects on ability to drive and use machines: VIMP=
AT^=C2=AE may have minor to moderate influence on the ability to drive and =
use machines. VIMPAT^=C2=AE treatment has been associated with dizziness or=
blurred vision. Accordingly patients should be advised not to drive a car =
or to operate other potentially hazardous machinery until they are familiar=
with the effects of VIMPAT^=C2=AE on their ability to perform such activit=
ies. Undesirable effects: The most common adverse reactions (=E2=89=A510%) =
are dizziness, headache, diplopia, and nausea. They were usually mild to mo=
derate in intensity. Some were dose-related and could be alleviated by redu=
cing the dose. Incidence and severity of CNS and gastrointestinal (GI) adve=
rse reactions usually decreased over time. Incidence of CNS adverse reactio=
ns such as dizziness may be higher after a loading dose. Other common adver=
se reactions (=E2=89=A51% - <10%) are depression, confusional state, insomn=
ia, balance disorder, myoclonic seizures, ataxia, memory impairment, cognit=
ive disorder, somnolence, tremor, nystagmus, hypoesthesia, dysarthria, dist=
urbance in attention, paraesthesia, vision blurred, vertigo, tinnitus, vomi=
ting, constipation, flatulence, dyspepsia, dry mouth, diarrhoea, pruritus, =
rash, muscle spasms, gait disturbance, asthenia, fatigue, irritability, fee=
ling drunk, injection site pain or discomfort (local adverse events associa=
ted with intravenous administration), irritation (local adverse events asso=
ciated with intravenous administration), fall, and skin laceration, contusi=
on. The use of VIMPAT^=C2=AE is associated with dose-related increase in th=
e PR interval. Adverse reactions associated with PR interval prolongation (=
e.g. atrioventricular block, syncope, bradycardia) may occur. Additional ad=
verse reactions reported in PGTCS patients were myoclonic epilepsy and atax=
ia. The most frequently reported adverse reactions were dizziness and somno=
lence. The most common adverse reactions resulting in discontinuation of la=
cosamide therapy were dizziness and suicidal ideation. The safety profile o=
f lacosamide in placebo-controlled and in open-label studies (n=3D408) in a=
djunctive therapy in children from 4 years of age with partial- onset seizu=
res was consistent with the safety profile observed in adults although the =
frequency of some adverse reactions (somnolence, vomiting and convulsion) w=
as increased and additional adverse reactions (nasopharyngitis, pyrexia, ph=
aryngitis, decreased appetite, lethargy and abnormal behaviour) have been r=
eported in paediatric patients: nasopharyngitis (15.7 %), vomiting (14.7 %)=
, somnolence (14.0 %), dizziness (13.5 %), pyrexia (13.0 %), convulsion (7.=
8 %), decreased appetite (5.9 %), pharyngitis (4.7 %), lethargy (2.7 %) and=
abnormal behaviour (1.7 %).=C2=A0
Laboratory abnormalities: Abnormalities in liver function tests have been o=
bserved in placebo-controlled studies with VIMPAT^=C2=AE in adult patients =
with partial-onset seizures who were taking 1-3 concomitant antiepileptic m=
edicinal products. Elevations of ALT to =E2=89=A53xULN occurred in 0.7% (7/=
935) of VIMPAT^=C2=AE patients and 0% (0/356) of placebo patients. Multiorg=
an Hypersensitivity Reactions: Multiorgan hypersensitivity reactions (also =
known as Drug Reaction with Eosinophilia and Systemic Symptoms, DRESS) have=
been reported in patients treated with some antiepileptic medicinal produc=
ts. These reactions are variable in expression but typically present with f=
ever and rash and can be associated with involvement of different organ sys=
tems. If multiorgan hypersensitivity reaction is suspected, VIMPAT^=C2=AE s=
hould be discontinued.=C2=A0
Refer to the European Summary of Product Characteristics for other adverse =
reactions and full prescribing information. Date of revision: 10 June 2021.=
http://www.ema.europa.eu/
For further information:=C2=A0
Media=C2=A0
Nick Francis
Neurology Communications, UCB=C2=A0
T: +44 7769 307745=C2=A0
nick.francis@ucb.com=C2=A0
Antje Witte=C2=A0
Investor Relations, UCB=C2=A0
T+32 2 559 9414,=C2=A0
antje.witte@ucb.com
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: changes i=
n general economic, business and competitive conditions, the inability to o=
btain necessary regulatory approvals or to obtain them on acceptable terms =
or within expected timing, costs associated with research and development, =
changes in the prospects for products in the pipeline or under development =
by UCB, effects of future judicial decisions or governmental investigations=
, safety, quality, data integrity or manufacturing issues; potential or act=
ual data security and data privacy breaches, or disruptions of our informat=
ion technology systems, product liability claims, challenges to patent prot=
ection for products or product candidates, competition from other products =
including biosimilars, changes in laws or regulations, exchange rate fluctu=
ations, 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 discovered or identified in the pipeline, o=
r that new indications for existing products will be developed and approved=
. Movement from concept to commercial product is uncertain; preclinical res=
ults do not guarantee safety and efficacy of product candidates in humans. =
So far, the complexity of the human body cannot be reproduced in computer m=
odels, cell culture systems or animal models. The length of the timing to c=
omplete clinical trials and to get regulatory approval for product marketin=
g has varied in the past and UCB expects similar unpredictability going for=
ward. Products or potential products which are the subject of partnerships,=
joint ventures or licensing collaborations may be subject to disputes betw=
een the partners or may prove to be not as safe, effective or commercially =
successful as UCB may have believed at the start of such partnership. UCB=
=E2=80=99 efforts to acquire other products or companies and to integrate t=
he operations of such acquired companies may not be as successful as UCB ma=
y have believed at the moment of acquisition. Also, UCB or others could dis=
cover safety, side effects or manufacturing problems with its products and/=
or devices after they are marketed. The discovery of significant problems w=
ith a product similar to one of UCB=E2=80=99s products that implicate an en=
tire class of products may have a material adverse effect on sales of the e=
ntire class of affected products. Moreover, sales may be impacted by intern=
ational and domestic trends toward managed care and health care cost contai=
nment, including pricing pressure, political and public scrutiny, customer =
and prescriber patterns or practices, and the reimbursement policies impose=
d by third-party payers as well as legislation affecting biopharmaceutical =
pricing and reimbursement activities and outcomes. Finally, a breakdown, cy=
berattack or information security breach could compromise the confidentiali=
ty, integrity and availability 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.=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
References
1. Meyer AC, Dua T and Ma J et al. Global disparities in the epilepsy treat=
ment gap: a systemic review. Bull World Health Organ. 2010; 88: 260-266
2. Epilepsy Foundation. Who gets epilepsy? Available at: https://www.epilep=
sy.com/learn/about-epilepsy-basics/who-gets-epilepsy. (Last accessed: July =
2021).
3. Epilepsy Foundation : About Epilepsy : the basics. Available at: https:/=
/www.epilepsy.com/learn/about-epilepsy-basics (Last accessed: July 2021).
4. European Medicines Agency. BRIVIACT=C2=AE (brivaracetam) Summary of Prod=
uct Characteristics (SmPC). Available at: https://www.ema.europa.eu/en/docu=
ments/product-information/briviact-epar-product-information_en.pdf (Last ac=
cessed: July 2021).
5. European Medicines Agency. VIMPAT=C2=AE (lacosamide) Summary of Product =
Characteristics (SmPC). Available at: https://www.ema.europa.eu/en/document=
s/product-information/vimpat-epar-product-information_en.pdf (Last accessed=
: July 2021).
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