BRUSSELS, Belgium and
ATLANTA, March 7, 2022 /PRNewswire/ -- UCB (Euronext: UCB)
today announced the successful completion of the previously
announced transaction to acquire Zogenix (NASDAQ: ZGNX) for
US$ 26.00 per share plus a
milestone-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 / €1.7 billion*.
Charl van Zyl, Executive Vice
President, Neurology & Head of Europe/International Markets, UCB, said: "We
are very pleased to reach today's milestone at the earliest
opportunity and to welcome the Zogenix team to the UCB family. We
have a lot of important work ahead of us to deliver on our ambition
of creating even greater value for people living with severe forms
of epilepsy. Together we will bring
FINTEPLA® (fenfluramine) oral solution to many more
people around the world living with Dravet syndrome and, soon we
hope, additional indications as well."
As of the tender offer expiration, the shares validly tendered
and not withdrawn represented approximately 67% of Zogenix's
outstanding shares. At the effective time of the merger, and
subject to any perfected appraisal rights, all of the remaining
shares of Zogenix common stock not purchased in the offer were
cancelled and converted into the right to receive the same
consideration per share offered in the tender offer. Pursuant to
the terms of the merger agreement, Purchaser merged with and into
Zogenix on 7 March 2022.
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 announced earlier, UCB
expects this acquisition to contribute to 2022 revenue immediately
and to have a dilutive impact to the 2022 earnings. It is expected
that the acquisition will be earnings accretive from 2023
onwards.
About FINTEPLA® (fenfluramine)
C-IV
FINTEPLA® (fenfluramine) oral solution
is a prescription medication approved in the U.S. and
Europe, and under regulatory
review in Japan, for the treatment
of seizures associated with Dravet syndrome in patients two
years of age and older.1,2 A Type II Variation
Application has also been submitted to the European Medicines
Agency (EMA), and a supplemental NDA is under priority review by
the U.S. Food and Drug Administration (FDA).3,4
In the United States, FINTEPLA
is available only through a restricted distribution program called
the FINTEPLA REMS program. FINTEPLA is available in Europe under a controlled access program
requested by the EMA to prevent off-label use for weight management
and to confirm that prescribing physicians have been informed of
the need for periodic cardiac monitoring in patients taking
FINTEPLA. Further information is available at www.FinteplaREMS.com
or by telephone at +1 877 964 3649.
Please see full Prescribing Information, including Boxed
Warning, for additional important information on FINTEPLA.
IMPORTANT SAFETY INFORMATION for FINTEPLA
BOXED WARNING: VALVULAR HEART DISEASE and PULMONARY ARTERIAL
HYPERTENSION
- There is an association between serotonergic drugs with
5-HT2B receptor agonist activity, including fenfluramine (the
active ingredient in FINTEPLA), and valvular heart disease and
pulmonary arterial hypertension.
- Echocardiogram assessments are required before, during, and
after treatment with FINTEPLA.
- FINTEPLA is available only through a restricted program
called the FINTEPLA REMS.
CONTRAINDICATIONS
FINTEPLA is contraindicated in patients with hypersensitivity to
fenfluramine or any of the excipients in FINTEPLA and with
concomitant use of, or within 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 Warning): Because of the association between
serotonergic drugs with 5-HT2B receptor agonist activity, including
fenfluramine (the active ingredient in FINTEPLA), and valvular
heart disease and pulmonary arterial hypertension, cardiac
monitoring via echocardiogram is required prior to starting
treatment, during treatment, and after treatment with FINTEPLA
concludes. Cardiac monitoring via echocardiogram can aid in early
detection of this condition. In clinical trials of up to 3 years in
duration, no patient receiving FINTEPLA developed valvular heart
disease or pulmonary arterial hypertension.
Monitoring: Prior to starting treatment, patients must
undergo an echocardiogram to evaluate for valvular heart disease
and pulmonary arterial hypertension. Echocardiograms should be
repeated every 6 months, and once at 3-6 months 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 risks of initiating or continuing treatment
with FINTEPLA.
FINTEPLA REMS Program (see Boxed Warning): FINTEPLA
is available only through a restricted distribution program called
the FINTEPLA Risk Evaluation and Mitigation Strategy (REMS)
Program. Prescribers must be certified by enrolling in the FINTEPLA
REMS. Prescribers must counsel patients receiving FINTEPLA about
the risk of valvular heart disease and pulmonary arterial
hypertension, how to recognize signs and symptoms of valvular heart
disease and pulmonary arterial hypertension, the need for baseline
(pretreatment) and periodic cardiac monitoring via echocardiogram
during FINTEPLA treatment, and 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
distributors 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 appetite and weight. Decreases in weight
appear to be dose related. Most patients resumed the expected
measured increases in weight by the end of the open-label extension
study. Weight should be monitored regularly during treatment with
FINTEPLA and dose modifications should be considered if a decrease
in weight is observed.
Somnolence, Sedation, and Lethargy: FINTEPLA can
cause somnolence, sedation, and lethargy. Other central nervous
system (CNS) depressants, including alcohol, could potentiate these
effects of FINTEPLA. Prescribers should monitor 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 operate machinery.
Suicidal Behavior and Ideation: Antiepileptic drugs
(AEDs) increase the risk of suicidal thoughts or behaviors in
patients taking these drugs for any indication. Patients treated
with an AED for any indication should be monitored for the
emergence or worsening of depression, suicidal thoughts or
behaviors, or any unusual changes in mood or behavior.
Anyone considering prescribing FINTEPLA or any other AED must
balance the risk of suicidal thoughts or behaviors with the risks
of untreated illness. Epilepsy and many other illnesses for which
AEDs are prescribed are themselves associated with morbidity and
mortality and an increased risk of suicidal thoughts and behaviors.
Should suicidal thoughts and behaviors emerge during treatment,
consider whether the emergence of these symptoms in any given
patient may be related to the illness being treated.
Withdrawal of Antiepileptic Drugs: As with most
AEDs, FINTEPLA should generally be withdrawn gradually because of
the risk of increased seizure frequency and status epilepticus. If
withdrawal is needed because of a serious adverse reaction, rapid
discontinuation can be considered.
Serotonin Syndrome: Serotonin syndrome, a
potentially life-threatening condition, may occur with FINTEPLA,
particularly during concomitant administration of FINTEPLA with
other serotonergic drugs, including, but not limited to, selective
serotonin-norepinephrine reuptake inhibitors (SNRIs), selective
serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants
(TCAs), bupropion, triptans, dietary supplements (eg, St. John's
Wort, tryptophan), drugs that impair metabolism of serotonin
(including monoamine oxidase inhibitors [MAOIs], which are
contraindicated with FINTEPLA), dextromethorphan, lithium,
tramadol, and antipsychotics with serotonergic agonist activity.
Patients should be monitored for the emergence of signs and
symptoms of serotonin syndrome, which include mental status changes
(eg, agitation, hallucinations, coma), autonomic instability (eg,
tachycardia, labile blood pressure, hyperthermia), neuromuscular
signs (eg, hyperreflexia, incoordination), and/or gastrointestinal
symptoms (eg, nausea, vomiting, diarrhea). If serotonin syndrome is
suspected, treatment with FINTEPLA should be stopped immediately
and symptomatic treatment should be started.
Increase in Blood Pressure: FINTEPLA can cause an
increase in blood pressure. Significant elevation in blood
pressure, including hypertensive crisis, has been reported rarely
in adult patients treated with fenfluramine, including patients
without a history of hypertension. Monitor blood pressure in
patients treated with FINTEPLA. In clinical trials of up to 3 years
in duration, no patient receiving FINTEPLA developed hypertensive
crisis.
Glaucoma: Fenfluramine can cause mydriasis and can
precipitate angle closure 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,
salivary hypersecretion; pyrexia; upper respiratory tract
infection; vomiting; decreased weight; fall; status
epilepticus.
To report SUSPECTED ADVERSE REACTIONS, contact Zogenix Inc.
at +1 866 964 3649 (1-866-Zogenix) or FDA at 1-800-FDA-1088
or www.fda.gov/medwatch.
DRUG INTERACTIONS
Strong CYP1A2 and CYP2B6 Inducers: Coadministration with
rifampin or a strong CYP1A2 and CYP2B6 inducer will decrease
fenfluramine plasma concentrations. Consider an increase in
FINTEPLA dosage when coadministered with rifampin or a strong
CYP1A2 and CYP2B6 inducer.
USE IN SPECIFIC POPULATIONS
Administration to patients with moderate or severe renal
impairment or to patients with hepatic impairment is not
recommended.
Please see full Prescribing Information,
including Boxed Warning, for additional important information on
FINTEPLA.
Footnote:
[*Total transaction value fully
diluted].
For further information, contact UCB:
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
Nick Francis
T +44 7769 307745
Nick.francis@ucb.com
Erica Puntel (U.S. Media)
T +404 938 5359
Erica.puntel@ucb.com
About UCB
UCB, Brussels, Belgium
(www.ucb.com) is a global biopharmaceutical company focused on the
discovery and development of innovative medicines and solutions to
transform the lives of people living with severe diseases of the
immune system or of the central nervous system. With approximately
8 600 people in approximately 40 countries, the company
generated revenue of € 5.8 billion in 2021. UCB is listed on
Euronext Brussels (symbol: UCB). Follow us on Twitter:
@UCB_news.
Forward looking statements
This press release contains forward-looking statements
including, without limitation, statements containing the words
"believes", "anticipates", "expects", "intends", "plans", "seeks",
"estimates", "may", "will", "continue" and similar expressions.
These forward-looking statements are based on current plans,
estimates and beliefs of management. All statements, other than
statements of historical facts, are statements that could be deemed
forward-looking statements, including but not limited to, the
ability of 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, 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 known and unknown risks,
uncertainties and assumptions which might cause the 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 release. Important factors that could result in such
differences include: the global spread and impact of COVID-19,
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them on acceptable terms or within expected timing, costs
associated with research and development, changes in the prospects
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or actual data security and data privacy breaches, or disruptions
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is uncertain; preclinical results do not guarantee safety and
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©2022 UCB, Inc., Smyrna, GA
30080. All rights reserved. US-P-OT--2200007
References
- FINTEPLA Summary of Product Characteristics. January 2022.
- FINTEPLA® (fenfluramine) oral solution CIV.U.S.
Prescribing Information.
- Zogenix Press Release. Zogenix Submits Type II Variation
Application to the European Medicines Agency (EMA) to Expand the
Use of FINTEPLA® (Fenfluramine) for the Treatment of
Seizures Associated with Lennox-Gastaut Syndrome. Accessed
5 March 2022.
- Zogenix Press Release. Zogenix Announces U.S. FDA Acceptance
for Priority Review of Supplemental New Drug Application for
FINTEPLA® (Fenfluramine) for the Treatment of Seizures
Associated with Lennox-Gastaut Syndrome (LGS). Accessed
5 March 2022.
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SOURCE UCB, Inc.