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** UCB Completes Acquisition of Zogenix, Inc.
------------------------------------------------------------
=C2=B7 Broadens and builds upon UCB=E2=80=99s role as a leader in, and our =
continued commitment to, addressing unmet needs of people living with epile=
psy
=C2=B7 Total transaction value of up to approximately US$ 1.9 billion / =E2=
=82=AC 1.7 billion. This consists of US$ 26.00 in cash per Zogenix share pl=
us a milestone-based contingent value right for a potential cash payment of=
US$ 2.00 per share=C2=A0
=C2=B7 Acquisition is expected to contribute to UCB=E2=80=99s revenue growt=
h, be dilutive to 2022 earnings and be accretive to UCB=E2=80=99s earnings =
from 2023 onwards. UCB=E2=80=99s financial guidance to be updated during Q2=
2022 as planned
Brussels (Belgium), 7 March 2022=E2=80=93 18:00 (CET) - UCB (Euronext: UCB)=
today announced the successful completion of the previously announced tran=
saction to acquire Zogenix (NASDAQ: ZGNX) for US$ 26.00 per share plus a mi=
lestone-based contingent value right for a potential cash payment of US$ 2.=
00 per share. The total transaction is valued at up to approximately US $1.=
9 billion / =E2=82=AC1.7 billion*.
Charl van Zyl, Executive Vice President, Neurology & Head of Europe/Interna=
tional Markets, UCB, said: =E2=80=9CWe are very pleased to reach today=E2=
=80=99s milestone at the earliest opportunity and to welcome the Zogenix te=
am to the UCB family. We have a lot of important work ahead of us to delive=
r on our ambition of creating even greater value for people living with sev=
ere forms of epilepsy. Together we will bring FINTEPLA^=C2=AE (fenfluramine=
) oral solution to many more people around the world living with Dravet syn=
drome, and soon we hope, additional indications as well.=E2=80=9D
As of the tender offer expiration, the shares validly tendered and not with=
drawn represented approximately 67% of Zogenix=E2=80=99s outstanding shares=
. At the effective time of the merger, and subject to any perfected apprais=
al rights, all of the remaining shares of Zogenix common stock not purchase=
d in the offer were cancelled and converted into the right to receive the s=
ame consideration per share offered in the tender offer. Pursuant to the te=
rms of the merger agreement, Purchaser merged with and into Zogenix on 7 Ma=
rch 2022.=C2=A0
As a result of the merger, Zogenix has become a wholly-owned subsidiary of =
UCB and the common stock of Zogenix will be delisted from the NASDAQ Global=
Market.
Financial guidance
UCB will update its financial guidance during Q2 2022 as planned. As announ=
ced earlier, UCB expects this acquisition to contribute to 2022 revenue imm=
ediately and to have a dilutive impact to the 2022 earnings. It is expected=
that the acquisition will be earnings accretive from 2023 onwards.=C2=A0
About FINTEPLA^=C2=AE (fenfluramine) C-IV
FINTEPLA^=C2=AE (fenfluramine) oral solution is a prescription medication a=
pproved in the U.S. and Europe, and under regulatory review in Japan, for t=
he treatment of seizures associated with Dravet syndrome in patients two ye=
ars of age and older.^1,2 A Type II Variation Application has also been sub=
mitted to the European Medicines Agency (EMA), and a supplemental NDA is un=
der priority review by the U.S. Food and Drug Administration (FDA).^3,4
In the United States, FINTEPLA is available only through a restricted distr=
ibution program called the FINTEPLA REMS program. FINTEPLA is available in =
Europe under a controlled access program requested by the EMA to prevent of=
f-label use for weight management and to confirm that prescribing physician=
s have been informed of the need for periodic cardiac monitoring in patient=
s taking FINTEPLA. Further information is available at www.FinteplaREMS.com=
or by telephone at +1 877 964 3649.=C2=A0
IMPORTANT SAFETY INFORMATION for FINTEPLA
BOXED WARNING: VALVULAR HEART DISEASE and PULMONARY ARTERIAL HYPERTENSION
=C2=B7 There is an association between serotonergic drugs with 5-HT2B recep=
tor agonist activity, including fenfluramine (the active ingredient in FINT=
EPLA), and valvular heart disease and pulmonary arterial hypertension.
=C2=B7 Echocardiogram assessments are required before, during, and after tr=
eatment with FINTEPLA.
=C2=B7 FINTEPLA is available only through a restricted program called the F=
INTEPLA REMS.
CONTRAINDICATIONS
FINTEPLA is contraindicated in patients with hypersensitivity to fenflurami=
ne or any of the excipients in FINTEPLA and with concomitant use of, or wit=
hin 14 days of, the administration of monoamine oxidase inhibitors because =
of an increased risk of serotonin syndrome.
WARNINGS AND PRECAUTIONS
Valvular Heart Disease and Pulmonary Arterial Hypertension (see Boxed Warni=
ng): Because of the association between serotonergic drugs with 5-HT2B rece=
ptor agonist activity, including fenfluramine (the active ingredient in FIN=
TEPLA), and valvular heart disease and pulmonary arterial hypertension, car=
diac monitoring via echocardiogram is required prior to starting treatment,=
during treatment, and after treatment with FINTEPLA concludes. Cardiac mon=
itoring via echocardiogram can aid in early detection of this condition. In=
clinical trials of up to 3 years in duration, no patient receiving FINTEPL=
A developed valvular heart disease or pulmonary arterial hypertension.
Monitoring: Prior to starting treatment, patients must undergo an echocardi=
ogram to evaluate for valvular heart disease and pulmonary arterial hyperte=
nsion. Echocardiograms should be repeated every 6 months, and once at 3-6 m=
onths post treatment with FINTEPLA.
If valvular heart disease or pulmonary arterial hypertension is observed on=
an echocardiogram, the prescriber must consider the benefits versus the ri=
sks of initiating or continuing treatment with FINTEPLA.
FINTEPLA REMS Program (see Boxed Warning): FINTEPLA is available only throu=
gh a restricted distribution program called the FINTEPLA Risk Evaluation an=
d Mitigation Strategy (REMS) Program. Prescribers must be certified by enro=
lling in the FINTEPLA REMS. Prescribers must counsel patients receiving FIN=
TEPLA about the risk of valvular heart disease and pulmonary arterial hyper=
tension, how to recognize signs and symptoms of valvular heart disease and =
pulmonary arterial hypertension, the need for baseline (pretreatment) and p=
eriodic cardiac monitoring via echocardiogram during FINTEPLA treatment, an=
d cardiac monitoring after FINTEPLA treatment. Patients must enroll in the =
FINTEPLA REMS and comply with ongoing monitoring requirements. The pharmacy=
must be certified by enrolling in the FINTEPLA REMS and must only dispense=
to patients who are authorized to receive FINTEPLA. Wholesalers and distri=
butors must only distribute to certified pharmacies. Further information is=
available at www.FinteplaREMS.com or by telephone at 1-877-964-3649.
Decreased Appetite and Decreased Weight: FINTEPLA can cause decreases in ap=
petite and weight. Decreases in weight appear to be dose related. Most pati=
ents resumed the expected measured increases in weight by the end of the op=
en-label extension study. Weight should be monitored regularly during treat=
ment with FINTEPLA and dose modifications should be considered if a decreas=
e in weight is observed.
Somnolence, Sedation, and Lethargy: FINTEPLA can cause somnolence, sedation=
, and lethargy. Other central nervous system (CNS) depressants, including a=
lcohol, could potentiate these effects of FINTEPLA. Prescribers should moni=
tor patients for somnolence and sedation and should advise patients not to =
drive or operate machinery until they have gained sufficient experience on =
FINTEPLA to gauge whether it adversely affects their ability to drive or op=
erate machinery.
Suicidal Behavior and Ideation: Antiepileptic drugs (AEDs) increase the ris=
k of suicidal thoughts or behaviors in patients taking these drugs for any =
indication. Patients treated with an AED for any indication should be monit=
ored for the emergence or worsening of depression, suicidal thoughts or beh=
aviors, or any unusual changes in mood or behavior.
Anyone considering prescribing FINTEPLA or any other AED must balance the r=
isk of suicidal thoughts or behaviors with the risks of untreated illness. =
Epilepsy and many other illnesses for which AEDs are prescribed are themsel=
ves associated with morbidity and mortality and an increased risk of suicid=
al thoughts and behaviors. Should suicidal thoughts and behaviors emerge du=
ring treatment, consider whether the emergence of these symptoms in any giv=
en patient may be related to the illness being treated.
Withdrawal of Antiepileptic Drugs: As with most AEDs, FINTEPLA should gener=
ally be withdrawn gradually because of the risk of increased seizure freque=
ncy and status epilepticus. If withdrawal is needed because of a serious ad=
verse reaction, rapid discontinuation can be considered.
Serotonin Syndrome: Serotonin syndrome, a potentially life-threatening cond=
ition, may occur with FINTEPLA, particularly during concomitant administrat=
ion of FINTEPLA with other serotonergic drugs, including, but not limited t=
o, selective serotonin-norepinephrine reuptake inhibitors (SNRIs), selectiv=
e serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants (TCAs), =
bupropion, triptans, dietary supplements (eg, St. John=E2=80=99s Wort, tryp=
tophan), drugs that impair metabolism of serotonin (including monoamine oxi=
dase inhibitors [MAOIs], which are contraindicated with FINTEPLA), dextrome=
thorphan, lithium, tramadol, and antipsychotics with serotonergic agonist a=
ctivity. Patients should be monitored for the emergence of signs and sympto=
ms of serotonin syndrome, which include mental status changes (eg, agitatio=
n, hallucinations, coma), autonomic instability (eg, tachycardia, labile bl=
ood pressure, hyperthermia), neuromuscular signs (eg, hyperreflexia, incoor=
dination), and/or gastrointestinal symptoms (eg, nausea, vomiting, diarrhea=
). If serotonin syndrome is suspected, treatment with FINTEPLA should be st=
opped immediately and symptomatic treatment should be started.
Increase in Blood Pressure: FINTEPLA can cause an increase in blood pressur=
e. Significant elevation in blood pressure, including hypertensive crisis, =
has been reported rarely in adult patients treated with fenfluramine, inclu=
ding patients without a history of hypertension. Monitor blood pressure in =
patients treated with FINTEPLA. In clinical trials of up to 3 years in dura=
tion, no patient receiving FINTEPLA developed hypertensive crisis.
Glaucoma: Fenfluramine can cause mydriasis and can precipitate angle closur=
e glaucoma. Consider discontinuing treatment with FINTEPLA in patients with=
acute decreases in visual acuity or ocular pain.
ADVERSE REACTIONS
The most common adverse reactions (incidence at least 10% and greater than =
placebo) were decreased appetite; somnolence, sedation, lethargy; diarrhea;=
constipation; abnormal echocardiogram; fatigue, malaise, asthenia; ataxia,=
balance disorder, gait disturbance; blood pressure increased; drooling, sa=
livary hypersecretion; pyrexia; upper respiratory tract infection; vomiting=
; decreased weight; fall; status epilepticus.
To report SUSPECTED ADVERSE REACTIONS, contact Zogenix Inc. at 1-866-964-36=
49 (1-866-Zogenix) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch (https:=
//www.fda.gov/medwatch) .
DRUG INTERACTIONS
Strong CYP1A2 and CYP2B6 Inducers: Coadministration with rifampin or a stro=
ng CYP1A2 and CYP2B6 inducer will decrease fenfluramine plasma concentratio=
ns. Consider an increase in FINTEPLA dosage when co-administered with rifam=
pin or a strong CYP1A2 and CYP2B6 inducer.
USE IN SPECIFIC POPULATIONS
Administration to patients with moderate or severe renal impairment or to p=
atients with hepatic impairment is not recommended.
Please see full Prescribing Information (https://zogenix.com/pi/Fintepla-pr=
escribing-information.pdf) , including Boxed Warning, for additional import=
ant information on FINTEPLA.
Footnote:
[*Total transaction value fully diluted].
For further information, contact UCB:=C2=A0
Investor Relations
Antje Witte
T +32.2.559.9414
antje.witte@ucb.com
Corporate Communications
Laurent Schots, Media Relations
T+32.2.559.9264
Laurent.schots@ucb.com=C2=A0=C2=A0 =C2=A0
Nick Francis=C2=A0
T +44 7769 307745
Nick.francis@ucb.com
Erica Puntel (U.S. Media)
T +404 938 5359
Erica.puntel@ucb.com
=C2=A0=C2=A0 =C2=A0
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 approximately 8 600 peopl=
e in approximately 40 countries, the company generated revenue of =E2=82=AC=
5.8 billion in 2021. UCB is listed on Euronext Brussels (symbol: UCB). Fol=
low us on Twitter: @UCB_news.
Forward looking statements=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 but not limited to, the ability o=
f UCB to successfully integrate the operations of Zogenix as planned or at =
all, estimates of revenues, operating margins, capital expenditures, cash, =
other financial information, expected legal, arbitration, political, regula=
tory or clinical results or practices and other such estimates and results.=
By their nature, such forward-looking statements are not guarantees of fut=
ure performance and are subject to known and unknown risks, uncertainties a=
nd assumptions which might cause the actual results, financial condition, p=
erformance or achievements of UCB, or industry results, to differ materiall=
y from those that may be expressed or implied by such forward-looking state=
ments contained in this press release. Important factors that could result =
in such differences include: the global spread and impact of COVID-19, chan=
ges in general economic, business and competitive conditions, the inability=
to obtain necessary regulatory approvals or to obtain them on acceptable t=
erms or within expected timing, costs associated with research and developm=
ent, changes in the prospects for products in the pipeline or under develop=
ment by UCB, effects of future judicial decisions or governmental investiga=
tions, safety, quality, data integrity or manufacturing issues; potential o=
r actual data security and data privacy breaches, or disruptions of our inf=
ormation technology systems, product liability claims, challenges to patent=
protection for products or product candidates, competition from other prod=
ucts including biosimilars, changes in laws or regulations, exchange rate f=
luctuations, 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 pipeli=
ne, or that new indications for existing products will be developed and app=
roved. Movement from concept to commercial product is uncertain; preclinica=
l results do not guarantee safety and efficacy of product candidates in hum=
ans. So far, the complexity of the human body cannot be reproduced in compu=
ter models, cell culture systems or animal models. 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 =
future.
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.
References
1. FINTEPLA Summary of Product Characteristics. January 2022.
2. FINTEPLA^=C2=AE (fenfluramine) oral solution CIV.U.S. Prescribing Inform=
ation.=C2=A0
3. Zogenix Press Release. Zogenix Submits Type II Variation Application to =
the European Medicines Agency (EMA) to Expand the Use of FINTEPLA^=C2=AE (F=
enfluramine) for the Treatment of Seizures Associated with Lennox-Gastaut S=
yndrome. Accessed 5 March 2022.
4. Zogenix Press Release. Zogenix Announces U.S. FDA Acceptance for Priorit=
y Review of Supplemental New Drug Application for FINTEPLA^=C2=AE (Fenflura=
mine) for the Treatment of Seizures Associated with Lennox-Gastaut Syndrome=
(LGS). Access 5 March 2022.
GenericFile
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