- Transaction broadens and builds upon UCB's role as a leader
in, and our continued commitment to, addressing unmet needs of
people living with epilepsy, complementing existing medicines and
expanding clinical development pipeline of epilepsy and rare
disease therapies
- Adds treatment option for specific, vulnerable patient
populations with FINTEPLA® (fenfluramine) C-IV oral
solution - approved for seizures associated with Dravet syndrome,
with potential in other significant seizure disorders including
Lennox-Gastaut syndrome
- Total transaction* value of up to
approximately US$ 1.9 billion / € 1.7
billion. This consists of US$ 26.00 in cash per Zogenix share
plus a milestone-based contingent value right for a potential cash
payment of US$ 2.00 per share
BRUSSELS and EMERYVILLE, Calif., Jan. 19, 2022 /PRNewswire/ -- Regulated
information – Inside information – UCB (Euronext: UCB) and
Zogenix (NASDAQ: ZGNX) announced today that the companies have
entered into a definitive agreement under which UCB would acquire
Zogenix, Inc., a global biopharmaceutical company commercializing
and developing therapies for rare diseases. Under the terms of the
agreement, UCB will commence a tender offer to purchase all
outstanding shares of Zogenix for a purchase price per share of
US$ 26.00 in cash at closing, plus a
contingent value right (CVR) for a potential cash payment of
US$ 2.00 upon EU approval by
December 31, 2023, of
FINTEPLA® as an orphan medicine for treatment of
Lennox-Gastaut syndrome (LGS). The upfront consideration represents
a 72% premium to Zogenix shares based on the 30-day volume weighted
average closing stock price of Zogenix prior to signing. The total
transaction is valued at up to approximately US$ 1.9 billion / € 1.7 billion.
The board of directors of both companies have unanimously
approved the transaction, the closing of which remains subject to
the tender of shares representing at least a majority of the total
number of Zogenix's outstanding shares, receipt of required
antitrust clearances, and other customary conditions.
The transaction will broaden and build upon UCB's role as a
leader in, and our continued commitment to, addressing unmet needs
of people living with specific or rare forms of epilepsy, in
particular, adding FINTEPLA® to UCB's existing
product line. FINTEPLA® has been approved by the U.S. Food and
Drug Administration (FDA)1 and the European Medicines
Agency (EMA)2 and is under regulatory review in
Japan3, for the
treatment of seizures associated with Dravet syndrome in patients
two years of age and older. Zogenix is also pursuing indications
for the use of FINTEPLA® in the treatment of
seizures associated with additional rare epilepsies, Lennox-Gastaut
syndrome (LGS) and CDKL5 Deficiency Disorder (CDD)4.
Zogenix has submitted a Type II Variation Application to the
EMA5, and the U.S. FDA recently accepted for filing
Zogenix's supplemental New Drug Application (sNDA)6,
granting Priority Review, for LGS. Beginning in childhood, Dravet
syndrome and Lennox-Gastaut syndrome are two of the most
devastating and life-long forms of epilepsy
7,8,9,10.
"The proposed acquisition of Zogenix reinforces UCB's
sustainable patient value strategy and continued commitment to
addressing unmet needs of people living with epilepsy with an
increasing focus on those living with specific or rare forms of
epilepsy, where few options exist. Complementing UCB's existing
therapeutic offerings, the Zogenix acquisition provides UCB with an
approved medicine for a life-threatening, rare infant- and
childhood-onset epilepsy marked by frequent and severe
treatment-resistant seizures, that are particularly challenging to
treat," said Charl van Zyl,
Executive Vice President, Neurology & Head of Europe/International Markets, UCB. "Utilizing
our deep expertise, experience and global capabilities, we plan to
accelerate access for patients to the treatment. We look forward to
welcoming the Zogenix team to UCB, benefiting from their insights
and working together to maximize the reach and impact of their
medicines for the benefit of as many people as possible."
"We are delighted to announce UCB's proposed acquisition of
Zogenix, recognizing the value of our lead medicine, both for the
important role it has already begun to play for Dravet patients and
their caregivers, and for its potential to help many others in the
future," said Stephen J. Farr, PhD,
President and Chief Executive Officer of Zogenix. "We are excited
for the potential opportunities ahead of us, working together to
accelerate our mission and progress to improve the care of patients
in need of new therapies. We believe this transaction is in the
best interests of both patients and our shareholders."
Strategic Benefits
- Builds on UCB's continued epilepsy ambitions:
Acquisition provides medicine that complements UCB's existing
symptomatic treatments, bringing significant and differentiated
value to patients suffering from Dravet syndrome and, if approved,
from seizures associated with Lennox-Gastaut syndrome and
potentially other rare epilepsies.
- Expands benefits for patients globally: UCB brings an
established global footprint, together with deep research and
development, commercial, medical, and regulatory expertise in
epilepsy, which will be utilized to rapidly advance and optimize
the availability of these new treatments and reach additional
patients.
- Enhances future epilepsy pipeline and strategic priorities
in rare/orphan diseases: Zogenix's pipeline will add to UCB's
short-term and long-term epilepsy pipeline, as well as provide
critical learnings in rare/orphan disease health ecosystems.
- Enhances UCB's top-line growth: FINTEPLA® was
launched in the U.S. and Europe in
2020 and has significant potential for usage in other seizure
types. It is expected that the proposed acquisition, if completed,
will contribute to UCB's revenue growth upon closing and will be
accretive to UCB's earnings in 2023.
Transaction Terms, Approvals and Time to Closing
Under the terms of the acquisition agreement, UCB, through a
wholly-owned subsidiary, Zinc Merger Sub, Inc., will initiate a
tender offer to acquire all outstanding shares of Zogenix for a
purchase price of US$ 26.00 per share
in cash, plus one non-tradeable CVR. The CVR will entitle holders
to an additional cash payment of US$
2.00 per share if a regulatory milestone related to approval
of FINTEPLA® for treatment of seizures associated
with Lennox-Gastaut syndrome (LGS) is achieved by or before
December 31, 2023. The closing of the
tender offer will be subject to certain conditions, including the
tender of shares representing at least a majority of the total
number of Zogenix's outstanding shares, receipt of required
antitrust clearances, and other customary conditions. Upon the
successful completion of the tender offer, UCB's acquisition
subsidiary will be merged into Zogenix, and any remaining shares of
common stock of Zogenix will be cancelled and converted into the
right to receive the same consideration per share offered in the
tender offer. The transaction is expected to close by the end of
the second quarter of 2022. There can be no assurance any payments
will be made with respect to the CVR.
Financing and Guidance
The acquisition of Zogenix will be financed by a combination of
available cash resources and a new term loan. The transaction is
not subject to any financing condition. In addition to contributing
to UCB's revenue growth after closing, the acquisition of Zogenix
is expected to be accretive to UCB's earnings from 2023
onwards.
Advisors
Lazard and Barclays are acting as financial advisors to UCB in
relation to the transaction. Covington & Burling LLP is acting
as legal advisor to UCB on this transaction.
BofA Securities and SVB Leerink are acting as financial advisors
to Zogenix on this transaction. Latham & Watkins LLP is acting
as legal advisor to Zogenix on this transaction.
UCB Conference call
UCB hosts a Capital Markets Call 19th January 2022, at 08:30am
EST / 13:30 GMT / 14:30 CET. Please register via the UCB Investor
Relations website: www.ucb.com/investors
About Dravet Syndrome
Dravet syndrome is a rare, devastating and life-long form of
epilepsy that generally begins in infancy and is marked by
frequent, treatment-resistant seizures, significant developmental,
motor, and behavioral impairments, and an increased risk of sudden
unexpected death in epilepsy (SUDEP). Affecting one in 15,700 live
births in the U.S. and approximately one in 20,000 to 40,000 live
births in Europe, most patients
follow a course of developmental delay with cognitive, motor and
behavioral deficits that persist into adulthood. Dravet syndrome
severely impacts quality of life for patients, families, and
caregivers due to the high physical, emotional, caregiving, and
financial burden associated with the disease7,8,9.
About FINTEPLA® (fenfluramine) C-IV
FINTEPLA® (fenfluramine) oral solution is a
prescription medication used to treat seizures associated with
Dravet syndrome in patients two years of age and older 11,
12. FINTEPLA possesses dual activities to inhibit seizures:
as a serotonergic agent, acting as a potent 5-HT releaser with
agonist activity at 5-HT1D, 2A, and 2C receptors, and as a
positive modulator of Sigma1R. FINTEPLA is approved
in the U.S. and Europe, and
under regulatory review in Japan,
for the treatment of seizures associated with Dravet syndrome. The
U.S. Food and Drug Administration (FDA) has accepted for filing the
company's supplemental New Drug Application (sNDA) and granted
Priority Review for the use of FINTEPLA for the treatment of
seizures associated with Lennox-Gastaut syndrome (LGS).
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 European Medicines Agency 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.
About Lennox-Gastaut Syndrome
Lennox-Gastaut syndrome (LGS) is a rare and devastating lifelong
childhood-onset epilepsy that can arise from multiple different
causes. LGS is characterized by many different seizure types,
including many that result in frequent falls and injuries. The
intellectual and behavioral problems associated with LGS, as well
as around-the-clock care requirements, add to the complexity of
life with this disease10.
About Zogenix
Zogenix is a global biopharmaceutical company committed to
developing and commercializing therapies with the potential to
transform the lives of patients and their families living with rare
diseases. The company's first rare disease therapy,
FINTEPLA® (fenfluramine) oral solution, has been
approved by the U.S. Food and Drug Administration (FDA) and
the European Medicines Agency and is under regulatory review in
Japan for the treatment of
seizures associated with Dravet syndrome, a rare, severe lifelong
epilepsy. The U.S. FDA recently accepted for filing Zogenix's
supplemental New Drug Application (sNDA) and granted Priority
Review for the use of FINTEPLA for the treatment of seizures
associated with an additional rare epilepsy, Lennox-Gastaut
syndrome (LGS). Zogenix is also initiating a study of FINTEPLA in a
genetic epilepsy called CDKL5 Deficiency Disorder (CDD) and is
collaborating with Tevard Biosciences to identify and develop
potential next-generation gene therapies for Dravet syndrome and
other genetic epilepsies. The company has an additional late-stage
development program, MT-1621, in a mitochondrial disease called TK2
deficiency13.
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 more than
8,000 people in approximately 40 countries, the company generated
revenue of €5.3 billion in 2020. UCB is listed on Euronext Brussels
(symbol: UCB). Follow us on Twitter: @UCB_news.
Important Information About the Tender Offer
The tender offer described in this press release has not yet
commenced. This press release is for informational purposes only
and is neither an offer to purchase nor a solicitation of an offer
to sell any shares of the common stock of Zogenix, Inc. ("Zogenix")
or any other securities, nor is it a substitute for the tender
offer materials described herein. At the time the planned tender
offer is commenced, a tender offer statement on Schedule (TO),
including an offer to purchase, a letter of transmittal and related
documents, will be filed by UCB S.A. ("UCB") and Zinc Merger Sub,
Inc., a wholly-owned subsidiary of UCB, with the Securities and
Exchange Commission (the "SEC"), and a solicitation/recommendation
statement on Schedule 14D-9 will be filed by Zogenix with the
SEC.
INVESTORS AND SECURITY HOLDERS ARE URGED TO READ BOTH THE TENDER
OFFER MATERIALS CAREFULLY (INCLUDING AN OFFER TO PURCHASE, A
RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER TENDER OFFER
DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT ON
SCHEDULE 14D-9 REGARDING THE OFFER, AS THEY MAY BE AMENDED FROM
TIME TO TIME, WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN
IMPORTANT INFORMATION THAT INVESTORS AND SECURITY HOLDERS SHOULD
CONSIDER BEFORE MAKING ANY DECISION REGARDING TENDERING THEIR
SECURITIES.
Investors and security holders may obtain a free copy of the
Offer to Purchase, the related Letter of Transmittal, certain other
tender offer documents and the Solicitation/Recommendation
Statement (when available) and other documents filed with the SEC
at the website maintained by the SEC at www.sec.gov or by directing
such requests to the Information Agent for the Offer, which will be
named in the tender offer statement. In addition, Zogenix files
annual, quarterly and current reports and other information with
the SEC, which is available to the public from commercial
document-retrieval services and at the SEC's website at
www.sec.gov. Copies of the documents filed with the SEC by UCB in
connection with the Offer may be obtained at no charge on UCB's
internet website at www.ucb.com or by contacting UCB at Allée de la
Recherche, 60 1070 Brussels,
Belgium, or Tel: +32 2 559 99 99. Copies of the documents
filed with the SEC by Zogenix may be obtained at no charge on
Zogenix's internet website at www.zogenix.com or by contacting
Zogenix at 5959 Horton St Fl 5, Emeryville, California, 94608, USA, or Tel: +1 (510) 550 8300.
Forward-Looking Statement of UCB, S.A.
This news release of UCB, S.A., Brussels, Belgium (the "company") includes
statements that are not statements of historical fact, or
"forward-looking statements," including with respect to the
company's proposed acquisition of Zogenix. Such forward-looking
statements include, but are not limited to, the ability of the
company and Zogenix to complete the transactions contemplated by
the merger agreement, including the parties' ability to satisfy the
conditions to the consummation of the offer contemplated thereby
and the other conditions set forth in the merger agreement,
statements about the expected timetable for completing the
transaction, the company's and Zogenix's beliefs and expectations
and statements about the benefits sought to be achieved in the
company's proposed acquisition of Zogenix, the potential effects of
the acquisition on both the company and Zogenix, the possibility of
any termination of the merger agreement, as well as the expected
benefits and success of Zogenix's product candidates. These
statements are based upon the current beliefs and expectations of
the company's management and are subject to significant risks and
uncertainties. There can be no guarantees that the conditions to
the closing of the proposed transaction will be satisfied on the
expected timetable or at all or that pipeline products will receive
the necessary regulatory approvals or that they will prove to be
commercially successful. If underlying assumptions prove inaccurate
or risks or uncertainties materialize, actual results may differ
materially from those set forth in the forward-looking
statements.
Risks and uncertainties include but are not limited to,
uncertainties as to the timing of the offer and the subsequent
merger; uncertainties as to how many of Zogenix's shares will be
tendered in the offer by Zogenix's stockholders; the risk that
competing offers or acquisition proposals will be made; the
possibility that various conditions to the consummation of the
offer and the merger may not be satisfied or waived; the effects of
disruption from the transactions contemplated by the merger
agreement and the impact of the announcement and pendency of the
transactions on Zogenix's business; the risk that stockholder
litigation in connection with the offer or the merger may result in
significant costs of defense, indemnification and liability; the
risks related to non-achievement of the CVR milestones and that
holders of the CVRs will not receive payments in respect of the
CVRs; the global spread and impact of COVID-19, changes in general
economic, business and competitive conditions, the inability to
obtain 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 actual data
security and data privacy breaches, or disruptions of our
information technology systems, product 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
uncertainties in tax laws or the administration of such laws, and
hiring and retention of its employees.
UCB expressly disclaims any obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise, except to the extent required by
law.
Forward-Looking Statement of Zogenix, Inc.
Zogenix cautions you that statements included in this press
release that are not a description of historical facts are
forward-looking statements. Words such as "believes,"
"anticipates," "plans," "expects," "indicates," "will," "intends,"
"potential," "suggests," "assuming," "designed," and similar
expressions are intended to identify forward-looking statements.
These statements include: the ability of Zogenix and UCB to
complete the transactions contemplated by the merger agreement,
including the parties' ability to satisfy the conditions to the
consummation of the offer contemplated thereby and the other
conditions set forth in the merger agreement, statements about the
expected timetable for completing the transaction, Zogenix's and
UCB's beliefs and expectations and statements about the benefits
sought to be achieved in the transaction, the potential effects of
the acquisition on both Zogenix and UCB, the possibility of any
termination of the merger agreement, as well as the expected
benefits and success of Zogenix's product candidates. These
statements are based on Zogenix's current beliefs and expectations.
The inclusion of forward-looking statements should not be regarded
as a representation by Zogenix that any of its plans will be
achieved. Actual results may differ from those set forth in this
release due to uncertainties as to the timing of the offer and the
subsequent merger; uncertainties as to how many of Zogenix's shares
will be tendered in the offer by Zogenix's stockholders; the
possibility that various conditions to the consummation of the
offer and the merger may not be satisfied or waived; the effects of
disruption from the transactions contemplated by the merger
agreement and the impact of the announcement and pendency of the
transactions on Zogenix's business; the risk that stockholder
litigation in connection with the offer or the merger may result in
significant costs of defense, indemnification and liability; the
risks related to non-achievement of the CVR milestones and that
holders of the CVRs will not receive payments in respect of the
CVRs; the global spread and impact of COVID-19; changes in general
economic, business and competitive conditions; and the potential
inability to obtain necessary regulatory approvals or to obtain
them on acceptable terms or within expected timing. You are
cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date hereof,
and Zogenix undertakes no obligation to revise or update this press
release to reflect events or circumstances after the date hereof.
All forward-looking statements are qualified in their entirety by
this cautionary statement. This caution is made under the safe
harbor provisions of Section 21E of the Private Securities
Litigation Reform Act of 1995.
Footnote:
[*Total transaction value
fully diluted].
References:
1. FDA News Release.
FDA Approves New Therapy for Dravet Syndrome. June 25, 2020.
2. Meeting
highlights from the Committee for Medicinal Products for Human Use
(CHMP) 12-15 October
2020.
3. Zogenix Press Release. Zogenix
Submits New Drug Application for FINTEPLA® (Fenfluramine) in
Japan for the Treatment of
Epileptic Seizures Associated with Dravet Syndrome. 21st December 2021.
4.
Zogenix Pipeline Presentation. November
2021.
5. 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.
20th December
2021.
6. 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).
1st December
2021.
7. Dravet C. The Core Dravet
Syndrome Phenotype. Epilepsia. 2011 Apr;52 Suppl 2:3-9.
2.
8. Dravet C. Dravet syndrome history. Dev
Med Child Neurol. 2011 Apr;53 Suppl 2:1-6.
9.
Wu YW, Sullivan J, McDaniel SS, et al. Incidence of Dravet Syndrome
in the US Population. Pediatrics. 2015
Nov;136(5):e1310-1315.
10. National Institute
of Neurological Disorders and Stroke. Lennox-Gastaut Syndrome
Information Page. Last Accessed Jan
2022.
11. Fintepla Summary of Product
Characteristics. January
2022.
12. Fintepla U.S. Prescribing
Information. January
2022.
13. Zogenix Presentation. MT-1621
Virtual Investor Event. November
2021.