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UCB Media Room: Vimpat FDA PGTCS Approval


[17/11/2020 | 13:04]

** UCB=E2=80=99s VIMPAT^=C2=AE (lacosamide) CV now approved by FDA in U.S. =
for primary generalized tonic-clonic seizures and expanded pediatric use fo=
r people living with epilepsy

=C2=B7 New approval for VIMPAT^=C2=AE (lacosamide) CV in the U.S. as adjunc=
tive therapy in the treatment of primary generalized tonic-clonic seizures =
(PGTCS) in patients four years of age and older=C2=A0
=C2=B7 All three VIMPAT formulations, including injection for intravenous u=
se, are now indicated for the treatment of partial-onset seizures and as ad=
junctive therapy in the treatment of PGTCS in patients four years of age an=
d older=C2=A0
=C2=B7 These approvals further help patients with epilepsy who may have had=
limited treatment options in the past, while reinforcing UCB=E2=80=99s lea=
dership in transforming epilepsy care
=C2=B7 In October, the Committee for Medicinal Products for Human Use (CHMP=
) of the European Medicines Agency (EMA) issued a positive opinion for VIMP=
AT as adjunctive therapy in the treatment of PGTCS in adults, adolescents a=
nd children from four years of age with idiopathic generalized epilepsy

Brussels, Belgium, Atlanta, Ga., November 17, 2020: UCB, a global pharmaceu=
tical company, today announced that the U.S. Food and Drug Administration (=
FDA) has approved VIMPAT=C2=AE (lacosamide) CV as adjunctive therapy in the=
treatment of primary generalized tonic-clonic seizures (PGTCS) in patients=
four years of age and older and VIMPAT injection for intravenous use in ch=
ildren four years of age and older.^1 PGTCS is a type of seizure that occur=
s all over the brain, affecting both sides of the brain from the start, cau=
sing muscles to stiffen and convulsions to occur for up to a few minutes.^2

=E2=80=9CThese approvals underscore UCB=E2=80=99s commitment to people livi=
ng with epilepsy and our focus on finding solutions for specific unmet need=
s within the epilepsy community.=E2=80=9D said Mike Davis, Head of U.S. Neu=
rology at UCB. =E2=80=9CWe are pleased that VIMPAT is now available as a tr=
eatment option for people living with primary generalized tonic-clonic seiz=
ures on their journey to seizure control.=E2=80=9D

The PGTCS approval is based, in part, on results of a Phase 3 study recentl=
y published in the Journal of Neurology, Neurosurgery & Psychiatry.^3 =C2=
=A0Adjunctive treatment with VIMPAT resulted in a significantly lower risk =
of developing a second PGTCS during the 24-week treatment period, with the =
corresponding risk reduction being 45% (p=3D0.001), and a significantly hig=
her rate of freedom from PGTCS during the treatment period compared with pl=
acebo (31.3% vs 17.2%, p=3D0.011).^1=C2=A0

People living with generalized tonic-clonic seizures have an increased risk=
of injury^4 and those who experienced three or more in one year had a fift=
een-fold increased risk of sudden unexpected death in epilepsy.^5

=E2=80=9CThe treatment of primary generalized tonic-clonic (convulsive) sei=
zures is challenging, with about one-third of patients still being refracto=
ry while on therapy,=E2=80=9D said David Vossler, MD, FAAN FACNS FAES, Depa=
rtment of Neurology, University of Washington, Seattle, USA. =E2=80=9CBolst=
ered by a wealth of data demonstrating VIMPAT=E2=80=99s efficacy and safety=
, this new indication gives people suffering from PGTCS a chance at freedom=
from these seizures, which many have never experienced.=E2=80=9D

Results from the Phase 3 study showed that VIMPAT was generally tolerated i=
n patients with idiopathic generalised epilepsy (IGE) and PGTCS. The most c=
ommon adverse reactions (=E2=89=A510%) reported in patients treated with VI=
MPAT were dizziness (23%), somnolence (17%), headache (14%), and nausea (10=
%) compared to 7%, 14%, 10%, and 6%, respectively, of patients who received=

Regarding the expanded pediatric population, VIMPAT tablets and oral soluti=
on were already approved to treat partial-onset seizures in adults and chil=
dren four years and older as monotherapy and adjunctive therapy. In the US,=
VIMPAT injection was previously approved for the treatment of partial-onse=
t seizures only in adult patients (17 years of age and older).

In Europe VIMPAT is currently not indicated in patients with PGTCS, however=
, in October =C2=A02020, the Committee for Medicinal Products for Human Use=
(CHMP) of the European Medicines Agency (EMA) issued a positive opinion fo=
r VIMPAT as adjunctive therapy in the treatment of PGTCS in adults, adolesc=
ents and children from four years of age with idiopathic generalized epilep=
sy.^6 Regulatory reviews for use of VIMPAT in the treatment of PGTCS are al=
so underway in the Japan and Australia.

About Epilepsy
Epilepsy is the main symptom of a variety of chronic disorders of the brain=
. It is the fourth most common neurological condition worldwide and affects=
approximately 65 million people. Anyone can develop epilepsy; it occurs ac=
ross all ages, races and genders, and is defined as one or more unprovoked =
epileptic seizures with a risk of further seizures.^7

About UCB in Epilepsy
UCB has a rich heritage in epilepsy with over 20 years of experience in the=
research and development of anti-epileptic 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 understan=
ding of epilepsy and its treatment. We partner and create super-networks wi=
th world-leading scientists and clinicians in academic institutions, pharma=
ceutical companies, and other organizations who share our goals. At UCB, we=
are inspired by patients, and driven by science in our commitment to suppo=
rt patients with epilepsy.

About UCB=C2=A0
UCB, Brussels, Belgium (www.ucb-usa.com) is a global biopharmaceutical comp=
any focused on the discovery and development of innovative medicines and so=
lutions to transform the lives of people living with severe diseases of the=
immune system or the central nervous system. With more than 7,600 people i=
n approximately 40 countries, the company generated revenue of =E2=82=AC4.9=
billion in 2019. UCB is listed on Euronext Brussels (symbol: UCB). Follow =
us on Twitter: @UCBUSA.

About VIMPAT^=C2=AE (lacosamide) CV in the U.S.^1
VIMPAT^=C2=AE was approved in the U.S. in 2008 as an add-on therapy for the=
treatment of partial-onset seizures in adult patients with epilepsy. VIMPA=
T was approved as monotherapy for adults in August 2014, and as monotherapy=
or adjunctive therapy in patients four years of age and older with partial=
-onset seizures in 2017. VIMPAT is available in three formulations: oral ta=
blets, oral solution, and intravenous (IV) injection.=C2=A0

VIMPAT^=C2=AE is indicated for the treatment of partial-onset seizures in p=
atients 4 years of age and older.=C2=A0
VIMPAT is indicated as adjunctive therapy in the treatment of primary gener=
alized tonic-clonic seizures in patients 4 years of age and older.=C2=A0



=C2=B7 Suicidal Behavior and Ideation: Antiepileptic drugs (AEDs), includin=
g VIMPAT, increase the risk of suicidal behavior and ideation. Monitor pati=
ents taking VIMPAT for the emergence or worsening of depression, suicidal t=
houghts or behavior, and/or any unusual changes in mood or behavior. Advise=
patients and caregivers to be alert for these behavioral changes and to im=
mediately report them to the healthcare provider.=C2=A0
=C2=B7 Dizziness and Ataxia: VIMPAT may cause dizziness and ataxia in adult=
and pediatric patients. In adult clinical trials for partial-onset seizure=
s, the onset of dizziness and ataxia was most commonly observed during titr=
ation. Advise patients not to drive, operate complex machinery, or engage i=
n other hazardous activities until they are familiar with the effects of VI=
MPAT on their ability to perform such activities.=C2=A0
=C2=B7 Cardiac Rhythm and Conduction Abnormalities

PR Interval Prolongation, Atrioventricular Block, and Ventricular Tachyarrh=

Dose-dependent prolongations in PR interval with VIMPAT have been observed =
in clinical studies in adult patients and in healthy volunteers. When VIMPA=
T is given with other drugs that prolong the PR interval, further PR prolon=
gation is possible.=C2=A0

In the postmarketing setting, there have been reports of cardiac arrhythmia=
s in patients treated with VIMPAT, including bradycardia, AV block, and ven=
tricular tachyarrhythmia, which have rarely resulted in asystole, cardiac a=
rrest, and death. Most, although not all, cases have occurred in patients w=
ith underlying proarrhythmic conditions, or in those taking concomitant med=
ications that affect cardiac conduction or prolong the PR interval. These e=
vents have occurred with both oral and intravenous routes of administration=
and at prescribed doses as well as in the setting of overdose.=C2=A0

VIMPAT should be used with caution in patients with underlying proarrhythmi=
c conditions such as known cardiac conduction problems (e.g., marked first-=
degree AV block, second-degree or higher AV block, and sick sinus syndrome =
without pacemaker), severe cardiac disease (such as myocardial ischemia or =
heart failure, or structural heart disease), and cardiac sodium channelopat=
hies (e.g., Brugada Syndrome).=C2=A0
VIMPAT should also be used with caution in patients on concomitant medicati=
ons that affect cardiac conduction, including sodium channel blockers, beta=
-blockers, calcium channel blockers, potassium channel blockers, and medica=
tions that prolong the PR interval. In such patients, obtaining an ECG befo=
re beginning VIMPAT, and after VIMPAT is titrated to steady-state maintenan=
ce dose, is recommended. In addition, these patients should be closely moni=
tored if they are administered VIMPAT through the intravenous route. Patien=
ts should be made aware of and report cardiac signs or symptoms to their he=
althcare provider right away.=C2=A0

Atrial Fibrillation and Atrial Flutter=C2=A0
VIMPAT administration may predispose to atrial arrhythmias (atrial fibrilla=
tion or flutter), especially in patients with diabetic neuropathy and/or ca=
rdiovascular disease.=C2=A0

=C2=B7 Syncope: VIMPAT may cause syncope in adult and pediatric patients.=
=C2=B7 Withdrawal of Antiepileptic Drugs: Gradually withdraw VIMPAT (over a=
minimum of 1 week) to minimize the potential of increased seizure frequenc=
=C2=B7 Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Also =
known as multi- organ hypersensitivity, has been reported with antiepilepti=
c drugs, including VIMPAT. Some of these events have been fatal or life-thr=
eatening. If signs or symptoms are present, immediately evaluate the patien=
t. Discontinue VIMPAT if an alternative etiology for the signs and symptoms=
cannot be established.=C2=A0
=C2=B7 Risks in Patients with Phenylketonuria: VIMPAT oral solution contain=
s aspartame, a source of phenylalanine, which can be harmful in patients wi=
th phenylketonuria (PKU). A 200 mg dose of VIMPAT oral solution (equivalent=
to 20 mL) contains 0.32 mg of phenylalanine.=C2=A0

Adverse Reactions=C2=A0

=C2=B7 Partial-Onset Seizures: In the adult adjunctive therapy placebo-cont=
rolled clinical trials for partial-onset seizures, the most frequently seen=
adverse reaction with VIMPAT was dizziness (31% vs 8% placebo). Other comm=
on adverse reactions occurring in =E2=89=A510 percent of VIMPAT-treated pat=
ients, and greater than placebo, were headache, nausea, and diplopia. In th=
e adult monotherapy clinical trial, adverse reactions were generally simila=
r to those observed and attributed to drug in adjunctive placebo-controlled=
trials, with the exception of insomnia (observed at a higher rate of =E2=
=C2=B7 Primary Generalized Tonic-Clonic Seizures: In the adjunctive therapy=
placebo-controlled trial for primary generalized tonic-clonic seizures, th=
e adverse reactions were generally similar to those that occurred in the pa=
rtial-onset seizure placebo-controlled trials. The adverse reactions most c=
ommonly reported were dizziness, somnolence, headache, and nausea.
=C2=B7 Pediatric patients: Adverse reactions reported in clinical studies o=
f pediatric patients 4 to less than 17 years of age were similar to those s=
een in adult patients.=C2=A0
=C2=B7 Injection: In adult adjunctive therapy clinical trials for partial-o=
nset seizures, adverse reactions with intravenous administration generally =
were similar to those that occurred with the oral formulation, although int=
ravenous administration was associated with local adverse reactions such as=
injection site=C2=A0pain or discomfort (2.5%), irritation (1%), and erythe=
ma (0.5%). When administering a loading dose, the incidence of CNS adverse =
reactions, such as dizziness, somnolence, and paresthesia, may be higher wi=
th 15-minute administration than over a 30- to 60-minute period. The advers=
e reactions associated with VIMPAT injection in adult patients with primary=
generalized tonic-clonic seizures are expected to be similar to those seen=
in adults with partial-onset seizures. The adverse reactions associated wi=
th VIMPAT injection in pediatric patients are expected to be similar to tho=
se noted in adults. Infusion times less than 30 minutes were not adequately=
studied in pediatric patients.

VIMPAT is a Schedule V controlled substance.=C2=A0
Please refer to full Prescribing Information (https://u7061146.ct.sendgrid.=
-3D .

About VIMPAT^=C2=AE =C2=A0in the EU=C2=A0
VIMPAT^=C2=AE was first launched in the European Union in September 2008, a=
s adjunctive therapy for the treatment of partial-onset seizures with or wi=
thout secondary generalization in adult and adolescent (16-18 years) patien=
ts with epilepsy.=C2=A0

In countries of the EU, VIMPAT^=C2=AE is available as film-coated tablets, =
syrup and solution for infusion. Lacosamide solution for infusion is an alt=
ernative for patients when oral administration is temporarily not feasible.=

Important Safety Information about VIMPAT^=C2=AE in the EU and EEA^8 =C2=A0
VIMPAT^=C2=AE is indicated as monotherapy and 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. VIMPA=
T^=C2=AE therapy can be initiated with either oral or IV administration. Fo=
r the paediatric population, the physician should prescribe the most approp=
riate formulation and strength according to weight and dose. A single loadi=
ng dose may be initiated in patients in situations when the physician deter=
mines that rapid attainment of lacosamide steady state plasma concentration=
and therapeutic effect is warranted. It should be administered under medic=
al supervision with consideration of the potential for increased incidence =
of serious cardiac arrhythmia and CNS adverse reactions. Administration of =
a loading dose has not been studied in acute conditions such as status epil=
epticus. Use of a loading dose is not recommended in adolescents and childr=
en weighing less than 50 kg. Administration of a loading dose has not been =
studied in children. A maximum dose of 300 mg/day is recommended for paedia=
tric patients with mild to moderate hepatic impairment weighing 50 kg or mo=
re and for adult patients with mild to moderate hepatic impairment as well.=
=C2=A0Based on data in adults, in paediatric patients weighing less than 5=
0 kg with mild to moderate hepatic impairment, a reduction of 25 % of the m=
aximum dose should be applied. Lacosamide should be administered to adult a=
nd paediatric patients with severe hepatic impairment only when the expecte=
d therapeutic benefits are anticipated to outweigh the possible risks. The =
dose may need to be adjusted while carefully observing disease activity and=
potential side effects in the patient. In adolescents and adults weighing =
50 kg or more with mild to moderate hepatic impairment a loading dose of 20=
0mg may be considered, but further dose titration (>200 mg daily) should be=
performed 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 may be considered, but further dose titration (> 200 mg daily) shoul=
d be performed with caution. In paediatric patients weighing 50 kg or more =
and in adult patients with severe renal impairment (CLCR =E2=89=A4 30 ml/mi=
n) or with end-stage renal disease, a maximum dose of 250 mg/day is recomme=
nded 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 ml/min) and in those with end-stage renal disease, a reduction of=
25 % of the maximum dose is recommended. Contraindications: Hypersensitivi=
ty to the active substance or any of the excipients; known second- or third=
-degree atrioventricular (AV) block. Special warnings and precautions for u=
se: Treatment with VIMPAT=C2=AE has been associated with dizziness which co=
uld increase the occurrence of accidental injury or falls. Therefore, patie=
nts should be advised to exercise caution until they are familiar with the =
potential effects of the medicine. Dose-related prolongations in PR interva=
l with VIMPAT^=C2=AE have been observed in clinical studies. =C2=A0VIMPAT^=
=C2=AE should be used with caution in patients with underlying proarrhythmi=
c conditions such as patients with known cardiac conduction problems or sev=
ere cardiac disease (e.g. myocardial ischaemia/infarction, heart failure, s=
tructural heart disease or cardiac sodium channelopathies) or patients trea=
ted with medicinal products affecting cardiac conduction, including antiarr=
hythmics and sodium channel blocking antiepileptic medicinal products, as w=
ell as in elderly patients. In these patients it should be considered to pe=
rform an ECG before a Vimpat dose increase above 400mg/day and after Vimpat=
is titrated to steady-state. In the placebo-controlled trials of VIMPAT^=
=C2=AE in epilepsy patients, atrial fibrillation or flutter were not report=
ed; however both have been reported in open-label epilepsy trials and in po=
st-marketing experience. In post-marketing experience, AV block (including =
second degree or higher AV block) has been reported. In patients with proar=
rhythmic conditions, ventricular tachyarrhythmia has been reported. In rare=
cases, these events have led to asystole, cardiac arrest and death in pati=
ents with underlying proarrhythmic conditions. Patients should be made awar=
e of the symptoms of cardiac arrhythmia (e.g. slow, rapid or irregular puls=
e, palpitations, shortness of breath, feeling lightheaded, fainting). Patie=
nts should be counselled to seek immediate medical advice if these symptoms=
occur. Suicidal ideation and behaviour have been reported in patients trea=
ted with antiepileptic medicinal products in several indications. Therefore=
patients should be monitored for signs of suicidal ideation and behaviours=
and appropriate treatment should be considered. Patients (and caregivers o=
f patients) should be advised to seek medical advice should signs of suicid=
al ideation or behaviour emerge. The safety and efficacy of lacosamide in p=
aediatric patients with epilepsy syndromes in which focal and generalised s=
eizures may coexist have not been determined. VIMPAT^=C2=AE syrup contains =
sodium methyl parahydroxybenzoate (E219) which may cause allergic reactions=
(possibly delayed). Vimpat Syrup contains sorbitol (E420). Patients with r=
are hereditary problems of fructose intolerance should not take this medici=
ne. Sorbitol may cause gastrointestinal discomfort and mild laxative effect=
.The syrup contains aspartame (E951), a source of phenylalanine, which may =
be harmful for people with phenylketonuria. Vimpat syrup contains propylene=
glycol (E1520). VIMPAT=C2=AE syrup contains 1.42 mg sodium per ml, equival=
ent to 0.07 % of the WHO recommended maximum daily intake of 2 g sodium for=
an adult. VIMPAT=C2=AE solution for infusion contains 59.8 mg sodium per v=
ial, equivalent to 3% of the WHO recommended maximum daily intake of 2 g so=
dium for an adult. Effects on ability to drive and use machines: VIMPAT=C2=
=AE may have minor to moderate influence on the ability to drive and use ma=
chines. VIMPAT=C2=AE treatment has been associated with dizziness or blurre=
d vision. Accordingly patients should be advised not to drive a car or to o=
perate other potentially hazardous machinery until they are familiar with t=
he effects of VIMPAT=C2=AE on their ability to perform such activities. Und=
esirable effects: The most common adverse reactions (=E2=89=A510%) are dizz=
iness, headache, diplopia, and nausea. They were usually mild to moderate i=
n intensity. Some were dose-related and could be alleviated by reducing the=
dose. Incidence and severity of CNS and gastrointestinal (GI) adverse reac=
tions usually decreased over time. Incidence of CNS adverse reactions such =
as dizziness may be higher after a loading dose. Other common adverse react=
ions (=E2=89=A51% - <10%) are depression, confusional state, insomnia, bala=
nce disorder, memory impairment, cognitive disorder, somnolence, tremor, ny=
stagmus, hypoesthesia, dysarthria, disturbance in attention, paraesthesia, =
vision blurred, vertigo, tinnitus, vomiting, constipation, flatulence, dysp=
epsia, dry mouth, diarrhoea, pruritus, rash, muscle spasms, gait disturbanc=
e, asthenia, fatigue, irritability, feeling drunk, injection site pain or d=
iscomfort (local adverse events associated with intravenous administration)=
, irritation (local adverse events associated with intravenous administrati=
on), fall, and skin laceration, contusion. The use of VIMPAT=C2=AE is assoc=
iated with dose-related increase in the PR interval. Adverse reactions asso=
ciated with PR interval prolongation (e.g. atrioventricular block, syncope,=
bradycardia) may occur. The safety profile of lacosamide in placebo-contro=
lled and in open-label studies (n=3D408) in adjunctive therapy in children =
from 4 years of age was consistent with the safety profile observed in adul=
ts although the frequency of some adverse reactions (somnolence, vomiting a=
nd convulsion) was increased and additional adverse reactions (nasopharyngi=
tis, pyrexia, pharyngitis, decreased appetite, lethargy and abnormal behavi=
our) have been reported in paediatric patients: nasopharyngitis (15.7 %), v=
omiting (14.7 %), somnolence (14.0 %), dizziness (13.5 %), pyrexia (13.0 %)=
, convulsion (7.8 %), decreased appetite (5.9 %), pharyngitis (4.7 %), leth=
argy (2.7 %) and abnormal behaviour (1.7 %).=C2=A0
Laboratory abnormalities: Abnormalities in liver function tests have been o=
bserved in placebo-controlled trials with VIMPAT=C2=AE in adult patients wi=
th partial-onset seizures who were taking 1-3 concomitant antiepileptic med=
icinal products. Elevations of ALT to =E2=89=A53xULN occurred in 0.7% (7/93=
5) of VIMPAT=C2=AE patients and 0% (0/356) of placebo patients. Multiorgan =
Hypersensitivity Reactions: Multiorgan hypersensitivity reactions (also kno=
wn as Drug Reaction with Eosinophilia and Systemic Symptoms, DRESS) have be=
en reported in patients treated with some antiepileptic medicinal products.=
These reactions are variable in expression but typically present with feve=
r and rash and can be associated with involvement of different organ system=
s. If multiorgan hypersensitivity reaction is suspected, VIMPAT=C2=AE shoul=
d be discontinued.=C2=A0

Refer to the European Summary of Product Characteristics for other adverse =
reactions and full prescribing information.

Date of revision: 03 Sept 2019. https://u7061146.ct.sendgrid.net/ls/click?u=

For further information, UCB:

U.S. Neurology Communications
Erica Puntel
U.S. Communications, UCB
T 404.938.5359, erica.puntel@ucb.com =C2=A0=C2=A0

Investor Relations
Antje Witte,
Investor Relations, UCB =C2=A0=C2=A0
T +32.2.559.94.14, antje.witte@ucb.com =C2=A0=C2=A0

Isabelle Ghellynck,
Investor Relations, UCB
T+32.2.559.9588, isabelle.ghellynck@ucb.com=C2=A0


VIMPAT^=C2=AE is a registered trademark used under license from Harris FRC =

Forward looking statements =E2=80=93 UCB
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=
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sed on current plans, estimates and beliefs of management. All statements, =
other than statements of historical facts, are statements that could be dee=
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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=
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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=C2=A0models. The length of the timing=
to complete clinical trials and to get regulatory approval for product mar=
keting has varied in the past and UCB expects similar unpredictability goin=
g forward. Products or potential products which are the subject of partners=
hips, joint ventures or licensing collaborations may be subject to disputes=
between the partners or may prove to be not as safe, effective or commerci=
ally 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 integrat=
e the operations of such acquired companies may not be as successful as UCB=
may have believed at the moment of acquisition. Also, UCB or others could =
discover safety, side effects or manufacturing problems with its products a=
nd/or devices after they are marketed. The discovery of significant problem=
s 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 sales of th=
e entire class of affected products. Moreover, sales may be impacted by int=
ernational and domestic trends toward managed care and health care cost con=
tainment, including pricing pressure, political and public scrutiny, custom=
er and prescriber patterns or practices, and the reimbursement policies imp=
osed by third-party payers as well as legislation affecting biopharmaceutic=
al pricing and reimbursement activities and outcomes. Finally, a breakdown,=
cyberattack or information security breach could compromise the confidenti=
ality, 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 =
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 =
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1. VIMPAT^=C2=AE (lacosamide) CV. U.S. Prescribing Information
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