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** UCB showcases commitment to transforming outcomes for people living with=
epilepsy and rare epileptic syndromes at European Pediatric Neurology Soci=
ety (EPNS) Annual Congress
------------------------------------------------------------
=C2=B7 Data presented from UCB=E2=80=99s wide ranging portfolio include the=
safety profile, efficacy, and tolerability of BRIVIACT^=C2=AE (brivaraceta=
m) for the treatment of epileptic seizures in pediatric populations, and a =
review of published studies of the effectiveness of Fintepla^=C2=AE=E2=96=
=BC(fenfluramine) in reducing the frequency of generalized tonic-clonic (GT=
C) seizures in patients with rare epilepsy syndromes
=C2=B7 Survey data presented from a collaboration with European Collaborati=
on for Epilepsy Trials (ECET) Consortium highlight unmet therapeutic needs =
of individuals living with Lennox-Gastaut syndrome in the European Union
=C2=B7 UCB will host a symposium entitled =E2=80=98Dravet syndrome and Lenn=
ox-Gastaut syndrome: what=E2=80=99s next in practice?=E2=80=99, on Thursday=
22nd June 13.00-14.00 (CEST)
Brussels, Belgium, 20 June 2023 =E2=80=93 07.00 AM CET =E2=80=93 UCB will s=
hare the latest data from its epilepsy and rare epilepsy syndrome portfolio=
at the European Pediatric Neurology Society Annual Congress, June 20-24, 2=
023. The company will present seven abstracts, including one podium present=
ation, at the congress, across Dravet syndrome, Lennox-Gastaut syndrome (LG=
S), and focal (partial) epileptic seizures.
Mike Davis, Head of Global Epilepsy & Rare Syndromes, UCB, said: =E2=80=9CA=
t UCB, we aim to positively impact individuals, carers, and families living=
with epilepsies, through differentiated solutions, and we look forward to =
discussing our latest patient-centred data at EPNS. We continue to pioneer =
new research to better understand the fundamental mechanisms of the underly=
ing different forms of epilepsy to foster discovery and development of pote=
ntial disease modifying or even curative therapies, and the theme of the co=
ngress this year =E2=80=93 =E2=80=98From genome and connectome to cure=E2=
=80=99 =E2=80=93 aligns perfectly with our ambitions.=E2=80=9D
In LGS, the presentation of questionnaire survey data from a collaboration =
between Zogenix (now part of UCB) and the European Collaboration for Epilep=
sy Trials (ECET) Consortium, assessing the unmet medical needs of patients^=
1 will be complemented by interim results from a European real-world study =
of patients with LGS.^2 Between these two presentations, unmet needs and as=
sociated disease burden in LGS will be examined from both patient and clini=
cal perspectives. The ECET survey illustrates the difficulty in managing LG=
S patients, finding that 69% (n=3D61 centres) of centres trialled five to t=
en anti-seizure medications and 18% of centres trialled more than ten such =
medications in their search for an effective regimen for each patient.^1=C2=
=A0
In Dravet syndrome, post-hoc pooled responder data from two identical phase=
3 trials of fenfluramine, have been analysed in order to estimate the numb=
er-needed-to-treat (NNT) to reach clinically meaningful response thresholds=
^3. With no head-to-head comparative trials in therapies approved for Drave=
t syndrome, these results may be used to guide clinical treatment decisions=
.^3 Data presented on fenfluramine also include a review of published studi=
es of its effectiveness in reducing the frequency of generalized tonic-clon=
ic (GTC) seizures in patients with rare epilepsy syndromes.^4 GTC seizures =
are a primary risk factor of sudden unexpected death in epilepsy (SUDEP).^5=
=C2=A0
In focal epileptic seizures, data from EXPERIENCE - a pooled analysis of re=
trospective cohorts - will be presented, evaluating the safety profile, tol=
erability, and efficacy of brivaracetam in pediatric patients in routine cl=
inical practice^6. In addition, data on long-term (mean exposure 3.2 patien=
t years) safety profile, tolerability, and efficacy, as well as the cogniti=
ve and behavioural impact of the treatment, will be shared.^7,8
Ana Infante, Head of Epilepsy and European Operations said: =E2=80=9COur co=
mmitment to epilepsy research has never been stronger, and the presentation=
s at EPNS speak to the depth of our data, and the variety of perspectives, =
clinical and patient, which we seek. Deeper insights on unmet needs within =
our therapy areas, such as those of people living with Dravet syndrome and =
Lennox-Gastaut syndrome, help us to target future research, and set our sig=
hts on addressing the issues in developmental and epileptic encephalopathie=
s which impact the lives of patients every day.=E2=80=9D
Industry-sponsored symposium discussing developmental epileptic encephalopa=
thies (DEEs)
=E2=80=98Dravet syndrome and Lennox-Gastaut syndrome: what=E2=80=99s next i=
n practice?=E2=80=99, on Thursday 22nd June 13.00-14.00 (CEST) will elevate=
knowledge and awareness of the impact of DEEs, and the application of the =
latest clinical data to clinical practice through real-world case study dis=
cussion.
UCB presentations during EPNS 2023
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About BRIVIACT^=C2=AE (brivaracetam) in the EU^9
Important Safety Information about BRIVIACT in the EU=C2=A0
BRIVIACT (brivaracetam) is indicated as adjunctive therapy in the treatment=
of partial-onset seizures with or without secondary generalisation in adul=
ts, adolescents and children from 2 years of age with epilepsy. Contraindic=
ations Hypersensitivity to the active substance, other pyrrolidone derivati=
ves or any of the excipients. Special warnings and precautions for use Suic=
idal ideation and behaviour have been reported in patients treated with ant=
i-epileptic drugs (AEDs) in several indications, including BRIVIACT. =C2=A0=
Patients should be monitored for signs of suicidal ideation and behaviour a=
nd appropriate treatment should be considered. Patients (and caregivers) sh=
ould be advised to seek medical advice should any signs of suicidal ideatio=
n or behaviour emerge. BRIVIACT film-coated tablets contain lactose. Patien=
ts with rare hereditary problems of galactose intolerance, total lactase de=
ficiency or glucose-galactose malabsorption should not take BRIVIACT. Briva=
racetam film-coated tablets, solution for injection/infusion and oral solut=
ion contain less than 1 mmol sodium (23mg) per tablet/vial/ml respectively,=
that is to say essentially =E2=80=98sodium free=E2=80=99. The oral solutio=
n contains 168 mg sorbitol (E420) in each ml. Patients with hereditary fruc=
tose intolerance (HFI) should not take this medicinal product. The oral sol=
ution contains methyl parahydroxybenzoate (E218), which may cause allergic =
reactions (possibly delayed). Brivaracetam oral solution contains propylene=
glycol (E1520). Posology No dose adjustment is needed in adults with impai=
red renal function. Based on data in adults, no dose adjustment is necessar=
y neither in paediatric patients with impaired renal function. No clinical =
data are available in paediatric patients with renal impairment. In patient=
s with hepatic impairment, the following adjusted doses, administered in 2 =
divided doses, approximately 12 hours apart, are recommended for all stages=
of hepatic impairment: In adults, adolescents and children weighing =E2=89=
=A550 kg, a 50 mg/day starting dose is recommended, with a maximum daily do=
se of 150 mg/day. For adolescents and children weighing from 20 kg to <50 k=
g, a 1 mg/kg/day starting dose is recommended, with a maximum daily dose of=
3 mg/kg/day. For children weighing from 10 kg to <20 kg, a 1 mg/kg/day sta=
rting dose is recommended, with a maximum daily dose of 4 mg/kg/day. No cli=
nical data are available in paediatric patients with hepatic impairment. In=
teraction with other medicinal products and other forms of interaction. Wit=
h co-administration of BRIVIACT 200 mg single dose and ethanol 0.6 g/L cont=
inuous infusion in healthy subjects there was no pharmacokinetic interactio=
n, but the effect of alcohol on psychomotor function, attention and memory =
was doubled. Intake of BRIVIACT with alcohol is not recommended. Limited cl=
inical data are available implying that coadministration of cannabidiol may=
increase the plasma exposure of brivaracetam, possibly through CYP2C19 inh=
ibition, but the clinical relevance is uncertain. In healthy subjects, co-a=
dministration with rifampicin, a strong enzyme-inducer (600 mg/day for 5 da=
ys), decreased BRIVIACT area under the plasma concentration curve (AUC) by =
45%. Prescribers should consider adjusting the dose of BRIVIACT for patient=
s starting or ending treatment with rifampicin. Other strong enzyme-inducer=
s (such as St John=C2=B4s wort [Hypericum perforatum]) may also decrease th=
e systemic exposure of BRIVIACT. Therefore, starting or ending treatment wi=
th St John=E2=80=99s wort should be done with caution. In vitro studies hav=
e shown that brivaracetam exhibits little or no inhibition of CYP450 isofor=
ms except for CYP2C19. Brivaracetam may increase plasma concentrations of m=
edicinal products metabolised by CYP2C19 (e.g., lansoprazole, omeprazole, d=
iazepam). CYP2B6 induction has not been investigated in vivo and BRIVIACT m=
ay decrease plasma concentrations of medicinal products metabolised by CYP2=
B6 (e.g. efavirenz). In vitro studies have also shown that BRIVIACT has inh=
ibitory effects on OAT3. BRIVIACT 200 mg/day may increase plasma concentrat=
ions of medicinal products transported by OAT3. BRIVIACT plasma concentrati=
ons are decreased when co-administered with strong enzyme inducing antiepil=
eptic drugs (carbamazepine, phenobarbital, phenytoin) but no dose adjustmen=
t is required. Effects on ability to drive and use machines BRIVIACT, has m=
inor or moderate influence on the ability to drive and use machines. Patien=
ts should be advised not to drive a car or to operate other potentially haz=
ardous machines until they are familiar with the effects of BRIVIACT, on th=
eir ability to perform such activities. Undesirable effects. The most frequ=
ently reported adverse reactions with BRIVIACT (reported by >10% of patient=
s) were somnolence (14.3%) and dizziness (11.0%). They were usually mild to=
moderate in intensity. Somnolence and fatigue were reported at higher inci=
dences with increasing dose. Very common adverse reactions (=E2=89=A51% to =
<10%) were influenza, decreased appetite, depression, anxiety, insomnia, ir=
ritability, convulsion, vertigo, upper respiratory tract infections, cough,=
nausea, vomiting, constipation and fatigue. Neutropenia has been reported =
in 0.5% (6/1,099) BRIVIACT patients and 0% (0/459) placebo-treated patients=
. Four of these patients had decreased neutrophil counts at baseline, and e=
xperienced additional decrease in neutrophil counts after initiation of BRI=
VIACT. None of the six cases were severe, required any specific treatment, =
led to BRIVIACT discontinuation, or had associated infections. Suicidal ide=
ation was reported in 0.3 % (3/1099) of BRIVIACT treated patients and 0.7 %=
(3/459) of placebo-treated patients. In short-term clinical studies of BRI=
VIACT in patients with epilepsy, there were no cases of completed suicide a=
nd suicide attempt, however both were reported in the long-term open-label =
extension studies. Reactions suggestive of immediate (Type I) hypersensitiv=
ity have been reported in a small number of BRIVIACT patients (9/3022) duri=
ng clinical development. The safety profile of brivaracetam observed in chi=
ldren from 1 month of age was consistent with the safety profile observed i=
n adults. In the open label, uncontrolled, long-term studies suicidal ideat=
ion was reported in 4.7 % of paediatric patients assessed from 6 years onwa=
rds (more common in adolescents) compared with 2.4 % of adults and behaviou=
ral disorders were reported in 24.8 % of paediatric patients compared with =
15.1 % of adults. The majority of events were mild or moderate in intensity=
, were non-serious, and did not lead to discontinuation of study drug. An a=
dditional adverse reaction reported in children was psychomotor hyperactivi=
ty (4.7 %). No specific pattern of adverse event (AE) was identified in chi=
ldren from 1 month to < 4 years of age when compared to older paediatric ag=
e groups. No significant safety information was identified indicating the i=
ncreasing incidence of a particular AE in this age group. As data available=
in children younger than 2 years of age are limited, brivaracetam is not i=
ndicated in this age range. No clinical data are available in neonates. Ove=
rdose There is limited clinical experience with BRIVIACT overdose in humans=
. Somnolence and dizziness were reported in a healthy subject taking a sing=
le dose of 1,400 mg of BRIVIACT. The following adverse reactions were repor=
ted with brivaracetam overdose: nausea, vertigo, balance disorder, anxiety,=
fatigue, irritability, aggression, insomnia, depression, and suicidal idea=
tion in the post-marketing experience. In general, the adverse reactions as=
sociated with brivaracetam overdose were consistent with the known adverse =
reactions. There is no specific antidote. Treatment of an overdose should i=
nclude general supportive measures. Since less than 10% of BRIVIACT is excr=
eted in urine, haemodialysis is not expected to significantly enhance BRIVI=
ACT clearance.
Refer to the European Summary of Product Characteristics for other adverse =
reactions and full prescribing information.=C2=A0
https://www.ema.europa.eu/en/documents/product-information/briviact-epar-pr=
oduct-information_en.pdf
About FINTEPLA^=C2=AE=E2=96=BC(fenfluramine) oral solution in EU^10
FINTEPLA is indicated for the treatment of seizures associated with Dravet =
syndrome and Lennox-Gastaut syndrome as an add-on therapy to other anti-epi=
leptic medicines for patients 2 years of age and older. Fenfluramine is a s=
erotonin releasing agent, and thereby stimulates multiple 5-HT receptor sub=
-types through the release of serotonin. Fenfluramine may reduce seizures b=
y acting as an agonist at specific serotonin receptors in the brain, includ=
ing the 5-HT1D, 5-HT2A, and 5-HT2C receptors, and also by acting on the sig=
ma-1 receptor. The precise mode of action of fenfluramine in Dravet syndrom=
e and Lennox-Gastaut syndrome is not known.
Fenfluramine oral solution is available under a controlled access program t=
o ensure regular cardiac monitoring and to mitigate potential off-label use=
.
Please refer to Fintepla, INN-Fenfluramine (europa.eu) (https://www.ema.eur=
opa.eu/en/documents/product-information/fintepla-epar-product-information_e=
n.pdf) (SmPC) before prescribing.
=E2=96=BCThis medicinal product is subject to additional monitoring. This w=
ill allow quick identification of new safety information. Healthcare profes=
sionals are asked to report any suspected adverse reactions.
Important Safety Information about FINTEPLA^=C2=AE=E2=96=BC in EU
Aortic or mitral valvular heart disease and pulmonary arterial hypertension
Because of reported cases of valvular heart disease that may have been caus=
ed by fenfluramine at higher doses used to treat adult obesity, cardiac mon=
itoring must be performed using echocardiography. In the controlled clinica=
l studies of fenfluramine for the treatment of Dravet syndrome and Lennox-G=
astaut syndrome, no valvular heart disease was observed. Prior to starting =
treatment, patients must undergo an echocardiogram to establish a baseline =
prior to initiating treatment and exclude any pre-existing valvular heart d=
isease or pulmonary hypertension. Echocardiogram monitoring should be condu=
cted every 6 months for the first 2 years and annually thereafter. If an ec=
hocardiogram indicates pathological valvular changes, a follow-up echocardi=
ogram should be considered at an earlier timeframe to evaluate whether the =
abnormality is persistent. If pathological abnormalities on the echocardiog=
ram are observed, it is recommended to evaluate the benefit versus risk of =
continuing fenfluramine treatment with the prescriber, caregiver, and cardi=
ologist. If treatment is stopped because of aortic or mitral valvular heart=
disease, appropriate monitoring and follow-up should be provided in accord=
ance with local guidelines for the treatment of aortic or mitral valvular h=
eart disease. With past use in higher doses to treat adult obesity, fenflur=
amine was reported to be associated with pulmonary arterial hypertension. P=
ulmonary arterial hypertension was not observed in the clinical programme, =
but because of the low incidence of this disease, the clinical trial experi=
ence with fenfluramine is inadequate to determine if fenfluramine increases=
the risk for pulmonary arterial hypertension in patients with Dravet syndr=
ome and Lennox-Gastaut syndrome. If echocardiogram findings are suggestive =
of pulmonary arterial hypertension, a repeat echocardiogram should be perfo=
rmed as soon as possible and within 3 months to confirm these findings. If =
the echocardiogram finding is confirmed suggestive of an increased probabil=
ity of pulmonary arterial hypertension defined as =E2=80=9Cintermediate pro=
bability=E2=80=9D by the 2015 European Society of Cardiology (ESC) and the =
European Respiratory Society (ERS) Guidelines, it should lead to a benefit-=
risk evaluation of continuation of Fintepla by the prescriber, carer, and c=
ardiologist. If the echocardiogram finding, after confirmation, suggests of=
a high probability of pulmonary arterial hypertension, as defined by the 2=
015 ESC and ERS Guidelines, it is recommended fenfluramine treatment should=
be stopped.
Decreased appetite and weight loss=C2=A0
Fenfluramine can cause decreased appetite and weight loss. An additive effe=
ct on decreased appetite can occur when fenfluramine is combined with other=
anti-epileptic medicines, for example stiripentol. The decrease in weight =
appears to be dose related. Most subjects resumed weight gain over time whi=
le continuing treatment. The patient's weight should be monitored. A benefi=
t risk evaluation should be undertaken prior to commencing treatment with f=
enfluramine in patients with a history of anorexia nervosa or bulimia nervo=
sa.
Fintepla controlled access programme
A controlled access programme has been created to 1) prevent off-label use =
in weight management in obese patients and 2) confirm that prescribing phys=
icians have been informed of the need for periodic cardiac monitoring in pa=
tients taking Fintepla.=C2=A0
Somnolence
Fenfluramine can cause somnolence. Other central nervous system depressants=
, including alcohol, could potentiate the somnolence effect of fenfluramine=
.
Suicidal behaviour and ideation=C2=A0
Suicidal behaviour and ideation have been reported in patients treated with=
anti-epileptic medicines in several indications. A meta-analysis of random=
ised placebo-controlled trials with anti-epileptic medicines that did not i=
nclude fenfluramine has shown a small increased risk of suicidal behaviour =
and ideation. The mechanism of this risk is not known, and the available da=
ta do not exclude the possibility of an increased risk for fenfluramine. Pa=
tients and caregivers of patients should be advised to seek medical advice =
should any signs of suicidal behaviour and ideation emerge.
Serotonin syndrome
As with other serotonergic agents, serotonin syndrome, a potentially life-t=
hreatening condition, may occur with fenfluramine treatment, particularly w=
ith concomitant use of other serotonergic agents (including SSRIs, SNRIs, t=
ricyclic antidepressants, or triptans); with agents that impair metabolism =
of serotonin such as MAOIs; or with antipsychotics that may affect the sero=
tonergic neurotransmitter systems. Serotonin syndrome symptoms may include =
mental status changes (eg, agitation, hallucinations, coma), autonomic inst=
ability (eg, tachycardia, labile blood pressure, hyperthermia), neuromuscul=
ar aberrations (eg, hyperreflexia, incoordination), and/or gastrointestinal=
symptoms (eg, nausea, vomiting, diarrhoea). If concomitant treatment with =
fenfluramine and other serotonergic agents that may affect the serotonergic=
systems is clinically warranted, careful observation of the patient is adv=
ised, particularly during treatment initiation and dose increases.
Increased seizure frequency
As with other anti-epileptic medicines, a clinically relevant increase in s=
eizure frequency may occur during treatment with fenfluramine, which may re=
quire adjustment in the dose of fenfluramine and/or concomitant anti-epilep=
tic medicines, or discontinuation of fenfluramine, should the benefit-risk =
be negative.=C2=A0
Cyproheptadine=C2=A0
Cyproheptadine is a potent serotonin receptor antagonist and may therefore =
decrease the efficacy of fenfluramine. If cyproheptadine is added to treatm=
ent with fenfluramine, patients should be monitored for worsening of seizur=
es. If fenfluramine treatment is initiated in a patient taking cyproheptadi=
ne, fenfluramine=E2=80=99s efficacy may be reduced.
Glaucoma
Fenfluramine can cause mydriasis and can precipitate angle closure glaucoma=
. Discontinue therapy in patients with acute decreases in visual acuity. Co=
nsider discontinuation if there is ocular pain and another cause cannot be =
determined.
Effect of CYP1A2 and CYP2B6 inducers
Co-administration with strong CYP1A2 inducers or CYP2B6 inducers will decre=
ase fenfluramine plasma concentrations, which may lower the efficacy of fen=
fluramine. If co-administration of a strong CYP1A2 or CYP2B6 inducer with f=
enfluramine is considered necessary, the patient should be monitored for re=
duced efficacy and a dose increase of fenfluramine could be considered prov=
ided that it does not exceed twice the maximum daily dose (52 mg/day). If a=
strong CYP1A2 or CYP2B6 inducer is discontinued during maintenance treatme=
nt with fenfluramine, consider gradual reduction of the fenfluramine dosage=
to the dose administered prior to initiating the inducer.
Effect of CYP1A2 or CYP2D6 inhibitors
Initiation of concomitant treatment with a strong CYP1A2 or CYP2D6 inhibito=
r may result in higher exposure and, therefore, adverse events should be mo=
nitored, and a dose reduction may be needed in some patients.
Coadministration of a single 0.35 mg/kg dose of fenfluramine with fluvoxami=
ne (a strong CYP1A2 inhibitor) at steady state (50 mg once daily) in health=
y volunteers increased the AUC0-t of fenfluramine by a ratio of 2.1-fold an=
d the Cmax by a ratio of 1.2-fold, and decreased the AUC0-t of norfenfluram=
ine by a ratio of 1.3-fold and the Cmax by a ratio of 1.4-fold, as compared=
to fenfluramine administered alone.=C2=A0
Coadministration of a single 0.35 mg/kg dose of fenfluramine with paroxetin=
e (a strong CYP2D6 inhibitor) at steady state (30 mg once daily) in healthy=
volunteers increased the AUC0-t of fenfluramine by a ratio of 1.8-fold and=
the Cmax by a ratio of 1.1-fold, and decreased the AUC0-t of norfenflurami=
ne by a ratio of 1.2-fold and the Cmax by a ratio of 1.3-fold, as compared =
to fenfluramine administered alone.
Excipients
This medicinal product contains sodium ethyl para-hydroxybenzoate (E 215) a=
nd sodium methyl para hydroxybenzoate (E 219) which may cause allergic reac=
tions (possibly delayed). It also contains sulfur dioxide (E 220) which may=
rarely cause severe hypersensitivity reactions and bronchospasm. Patients =
with rare glucose-galactose malabsorption should not take this medicinal pr=
oduct. This medicinal product contains less than 1 mmol sodium (23 mg) per =
the maximum daily dose of 12 mL, that is to say essentially =E2=80=98sodium=
-free=E2=80=99. This medicinal product contains glucose which may be harmfu=
l to the teeth.
BRIVIACT^=C2=AE and FINTEPLA^=C2=AE are registered trademarks of the UCB Gr=
oup of Companies.
For further information, contact UCB:=C2=A0
Global Communications
Nick Francis
T +44 7769 307745
email nick.francis@ucb.com =C2=A0
Corporate Communications
Laurent Schots
T +32.2.559.92.64
email laurent.schots@ucb.com
Investor Relations
Antje Witte
T +32.2.559.94.14
email 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=
in laws or regulations, exchange rate fluctuations, changes or uncertainti=
es in tax laws or the administration of such laws, and hiring and retention=
of its employees. There is no guarantee that new product candidates will b=
e discovered or identified in the pipeline, will progress to product approv=
al or that new indications for existing products will be developed and appr=
oved. Movement from concept to commercial product is uncertain; preclinical=
results do not guarantee safety and efficacy of product candidates in huma=
ns. So far, the complexity of the human body cannot be reproduced in comput=
er models, cell culture systems or animal models. The length of the timing =
to complete clinical trials and to get regulatory approval for product mark=
eting has varied in the past and UCB expects similar unpredictability going=
forward. Products or potential products, which are the subject of partners=
hips, joint ventures or licensing collaborations may be subject to differen=
ces disputes between the partners or may prove to be not as safe, effective=
or commercially successful as UCB may have believed at the start of such p=
artnership. UCB=E2=80=99s efforts to acquire other products or companies an=
d to integrate the operations of such acquired companies may not be as succ=
essful as UCB may have believed at the moment of acquisition. Also, UCB or =
others could discover safety, side effects or manufacturing problems with i=
ts products and/or devices after they are marketed. The discovery of signif=
icant problems with a product similar to one of UCB=E2=80=99s products that=
implicate an entire class of products may have a material adverse effect o=
n sales of the entire class of affected products. Moreover, sales may be im=
pacted by international and domestic trends toward managed care and health =
care cost containment, including pricing pressure, political and public scr=
utiny, customer and prescriber patterns or practices, and the reimbursement=
policies imposed by third-party payers as well as legislation affecting bi=
opharmaceutical pricing and reimbursement activities and outcomes. Finally,=
a breakdown, cyberattack or information security breach could compromise t=
he confidentiality, integrity and availability of UCB=E2=80=99s data and sy=
stems. Given these uncertainties, you should not place undue reliance on an=
y of such forward-looking statements. There can be no guarantee that the in=
vestigational or approved products described in this press release will be =
submitted or approved for sale or for any additional indications or labelli=
ng in any market, or at any particular time, nor can there be any guarantee=
that such products will be or will continue to be commercially successful =
in the future. UCB is providing this information, including forward-looking=
statements, only as of the date of this press release and it does not refl=
ect any potential impact from the evolving COVID-19 pandemic, unless indica=
ted otherwise. UCB is following the worldwide developments diligently to as=
sess the financial significance of this pandemic to UCB. UCB expressly disc=
laims any duty to update any information contained in this press release, e=
ither to confirm the actual results or to report or reflect any change in i=
ts forward-looking statements with regard thereto or any change in events, =
conditions or circumstances on which any such statement is based, unless su=
ch statement is required pursuant to applicable laws and regulations. Addit=
ionally, information contained in this document shall not constitute an off=
er 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 jurisdiction=
in which such offer, solicitation or sale would be unlawful prior to the r=
egistration or qualification under the securities laws of such jurisdiction=
.
References:
1. Tchaicha S, Arzimanoglou A, Holmes E, et al. Assessment of the Unmet Med=
ical Needs of Patients With Lennox-Gastaut Syndrome: A Survey in Collaborat=
ion With the European Collaboration for Epilepsy Trials Consortium. Abstrac=
t 2636 presented at European Paediatric Neurology Society (EPNS), Prague, C=
zech Republic, 20-24 June 2023.
2. Strzelczyk A, Gil-Nagel A, Striano P, et al. Lennox-Gastaut Syndrome cha=
racteristics: Interim results from a European real-world point-in-time stud=
y. Abstract 2109 presented at European Paediatric Neurology Society (EPNS),=
Prague, Czech Republic, 20-24 June 2023.
3. Wheless JW, Dai D, Gammaitoni AR, et al. Fenfluramine Responder Analysis=
and Numbers Needed to Treat: Post-Hoc Pooled Analysis of Two Phase 3 Studi=
es in Dravet Syndrome. Abstract MP06-2635 presented at European Paediatric =
Neurology Society (EPNS), Prague, Czech Republic, 20-24 June 2023.
4. Cross H, Devinsky O, Gil-Nagel A. Effect of Fenfluramine on Generalized =
Tonic-Clonic Seizures in Rare Epilepsy Syndromes: A Review of Published Stu=
dies. Abstract PA03-2633 presented at European Paediatric Neurology Society=
(EPNS), Prague, Czech Republic, 20-24 June 2023.
5. Harden C, Tomson T, Gloss D, et al. Practice Guideline Summary: Sudden U=
nexpected Death in Epilepsy Incidence Rates and Risk Factors: Report of the=
Guideline Development, Dissemination, and Implementation Subcommittee of t=
he American Academy of Neurology and the American Epilepsy Society. Epileps=
y Curr. 2017;17(3):180-187.=C2=A0
6. Soto Insuga V, D'Souza W, Faught E, et al. 12-Month Effectiveness and To=
lerability of Brivaracetam in Pediatric Patients in the Real-World: Subgrou=
p Data From the EXPERIENCE Analysis. Abstract PO04-2117 presented at Europe=
an Paediatric Neurology Society (EPNS), Prague, Czech Republic, 20-24 June =
2023.
7. Klotz A, Lagae L, Fogarasi A, et al. Long-term Safety and Efficacy of Ad=
junctive Brivaracetam in Pediatric Patients with Epilepsy: An Open-label, F=
ollow-up Trial. Abstract P: PO04-2119 presented at European Paediatric Neur=
ology Society (EPNS), Prague, Czech Republic, 20-24 June 2023.
8. Elshoff JP, Fleyshman S, De La Loge C, et al. Cognitive and Behavioral E=
ffects of Adjunctive Brivaracetam in Children and Adolescents with Focal Se=
izures: Final Data From an Open-label Follow-up Trial. P: PO04-2118 present=
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20-24 June 2023.=C2=A0
9. Briviact=C2=AE EU SmPC. https://www.ema.europa.eu/en/documents/product-i=
nformation/briviact-epar-product-information_en.pdf Accessed on May 2023.
10. Fintepla=C2=AE EU SmPC. https://www.ema.europa.eu/en/documents/product-=
information/fintepla-epar-product-information_en.pdf. Accessed on May 2023.
GenericFile
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798971.pdf) Image
Chart 1 June 20 2023 (https://mb.cision.com/Public/18595/3789790/a5fdd52ae9=
159adb_org.png)
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