-Dordaviprone addresses a significant unmet
patient need for patients with rare, high-grade brain
tumors-
-Transaction to add near-term
commercial opportunity to Jazz's pipeline-
-Transaction represents total cash
consideration of approximately $935
million, or $8.55 per
share-
DUBLIN and DURHAM,
N.C., March 5, 2025 /PRNewswire/ -- Jazz
Pharmaceuticals plc (Nasdaq: JAZZ) ("Jazz" or the "Company") and
Chimerix (Nasdaq: CMRX) ("Chimerix"), today announced the companies
have entered into a definitive agreement for Jazz to acquire
Chimerix for $8.55 per share in cash,
representing a total consideration of approximately $935 million. The transaction has been approved
by both companies and is expected to close in the second quarter of
2025.
Chimerix's lead clinical asset is dordaviprone, a novel
first-in-class small molecule treatment in development for H3
K27M-mutant diffuse glioma, a rare, high-grade brain tumor that
most commonly affects children and young adults. There are no U.S.
Food and Drug Administration (FDA)-approved therapies specifically
for H3 K27M-mutant diffuse glioma patients; radiation is the most
common treatment approach. A New Drug Application (NDA) for
accelerated approval of dordaviprone in recurrent H3 K27M-mutant
diffuse glioma was recently accepted and granted Priority Review by
FDA. FDA has set a target Prescription Drug User Fee Act (PDUFA)
action date of August 18, 2025. If
approved in the U.S., dordaviprone may be eligible for a Rare
Pediatric Disease Priority Review Voucher (PRV). Separately,
dordaviprone is being studied in the ongoing Phase 3 ACTION trial,
evaluating its use in newly diagnosed, non-recurrent H3 K27M-mutant
diffuse glioma patients following radiation treatment, potentially
extending this treatment option into the front-line setting.
"Adding dordaviprone to our oncology R&D pipeline will
further diversify our portfolio with a medicine that addresses a
significant unmet need with no other FDA-approved therapies and
limited treatment options for this patient population. If approved,
dordaviprone has the potential to rapidly become a standard of care
for a rare oncology disease and also contribute durable revenue
beginning in the near-term," said Bruce
Cozadd, chairman and chief executive officer, Jazz
Pharmaceuticals. "We are encouraged by the dordaviprone clinical
trial results to date and look forward to closing the proposed
acquisition and working with our new colleagues from Chimerix to
fully leverage our combined R&D and commercial expertise to
deliver this novel therapy to patients, beginning as early as the
second half of this year."
"We are excited to reach this agreement with Jazz
Pharmaceuticals as they bring global scale to broaden our
dordaviprone commercial strategy," said Mike Andriole, President and CEO of Chimerix.
"The transaction, if approved, provides the opportunity to advance
access to dordaviprone to reach more patients globally. This
announcement is the culmination of years of scientific work by our
incredibly talented team, and will deliver significant and certain
value to our shareholders."
Key Highlights
- Strategic fit that will strengthen Jazz's presence in the rare
oncology space and reinforces commitment to patients with rare
diseases with significant unmet need
- Dordaviprone has been shown to benefit patients with recurrent
H3 K27M-mutant diffuse glioma across several clinical studies, with
a consistently favorable safety profile both as monotherapy and in
combination with other treatment approaches including
radiation
- With no currently approved therapies for H3 K27M-mutant diffuse
glioma patients, dordaviprone has the potential to rapidly become a
standard of care and a meaningful therapy for patients with limited
treatment options
- Potential near-term commercial launch in the U.S., if approved
- FDA has accepted an NDA for dordaviprone seeking accelerated
approval for treatment of H3 K27M-mutant diffuse glioma in adult
and pediatric patients with progressive disease following prior
therapy
- NDA has been granted Priority Review and assigned a PDUFA
target action date of August 18, 2025
- Following the closing of the proposed acquisition and in
collaboration with its new colleagues from Chimerix, Jazz plans to
leverage its combined development and commercial capabilities to
continue advancing the dordaviprone clinical trial program and
execute a strong commercial launch, if approved in the U.S.
- Will create an additional durable revenue opportunity for Jazz
with patent protection into 2037, with potential to receive patent
term extension
- Ongoing Phase 3 ACTION trial has potential to confirm clinical
benefit of dordaviprone in recurrent H3 K27M-mutant diffuse glioma
and extend its use to front-line patients
Transaction Terms
Under the terms of the merger
agreement, Jazz will commence an all-cash tender offer to acquire
all outstanding shares of Chimerix's common stock, whereby Chimerix
shareholders will be offered $8.55
per share in cash, representing a total consideration of
approximately $935 million. This
reflects an approximately 72% premium based on the closing trading
price on March 4, 2025. Upon the
successful completion of the tender offer, Jazz will acquire all
shares not acquired in the tender through a second-step merger for
the same consideration per share paid in the tender offer.
Jazz expects to fund the transaction through existing cash and
investments.
Closing Conditions
The transaction is subject to
customary closing conditions, including the tender of a majority of
the outstanding shares of Chimerix's voting common stock and other
conditions. Chimerix's Board of Directors unanimously recommends
that Chimerix shareholders tender their shares in the tender
offer.
Advisors
Guggenheim Securities is serving as financial
advisor to Jazz Pharmaceuticals, and Wachtell, Lipton, Rosen &
Katz is serving as legal advisor.
Centerview Partners LLC is serving as financial advisor to
Chimerix, and Skadden, Arps, Slate, Meagher & Flom LLP and
Cooley LLP are serving as legal advisors.
About Dordaviprone
Dordaviprone (ONC201) is a novel
first-in-class small molecule imipridone that selectively targets
the mitochondrial protease ClpP and dopamine receptor D2
(DRD2). Dordaviprone's unique mechanism of action includes
alterations of key epigenetic modifications such as reversal of H3
K27me3-loss, which is the hallmark of H3 K27M-mutant gliomas.
About Jazz Pharmaceuticals
Jazz Pharmaceuticals plc
(NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose
is to innovate to transform the lives of patients and their
families. We are dedicated to developing life-changing medicines
for people with serious diseases — often with limited or no
therapeutic options. We have a diverse portfolio of marketed
medicines, including leading therapies for sleep disorders and
epilepsy, and a growing portfolio of cancer treatments. Our
patient-focused and science-driven approach powers pioneering
research and development advancements across our robust pipeline of
innovative therapeutics in oncology and neuroscience. Jazz is
headquartered in Dublin, Ireland
with research and development laboratories, manufacturing
facilities and employees in multiple countries committed to serving
patients worldwide. Please visit www.jazzpharmaceuticals.com for
more information.
About Chimerix
Chimerix is a biopharmaceutical company
with a mission to develop medicines that meaningfully improve and
extend the lives of patients facing deadly diseases. The Company's
most advanced clinical-stage development program, dordaviprone, is
in development for H3 K27M-mutant glioma. The Company is conducting
Phase 1 dose escalation studies of ONC206 to evaluate safety and PK
data.
Caution Concerning Forward-Looking Statements
This
communication contains forward-looking statements that involve
risks and uncertainties relating to future events and the future
performance of Jazz Pharmaceuticals plc. ("Jazz") and Chimerix,
Inc. ("Chimerix"), including statements regarding Jazz's proposed
acquisition of Chimerix, the anticipated occurrence, manner and
timing of the proposed tender offer, the closing of the proposed
acquisition and the prospective benefits of the proposed
acquisition, including benefits from dordaviprone's potential to
improve the standard of care for a rare oncology disease and also
contribute durable revenue beginning in the near-term;
dordaviprone's potential to rapidly become a standard of care and a
meaningful therapy for patients with limited treatment options; the
potential for a near-term commercial launch of dordaviprone in the
U.S. if approved; the potential of the ongoing Phase 3 ACTION trial
to confirm clinical benefit of dordaviprone in recurrent H3
K27M-mutant diffuse glioma and extend its use in first-line
patients; dordaviprone potentially being eligible for a Rare
Pediatric Disease PRV; Jazz's anticipated source of funds for
the proposed acquisition; and other statements that are not
historical facts. Actual results could differ materially from those
anticipated in these forward-looking statements. Except as required
by law, each of Jazz and Chimerix assume no obligation to update
these forward-looking statements, whether as a result of new
information, future events or otherwise. These statements, which
represent each of Jazz's and Chimerix's current expectations or
beliefs concerning various future events that are subject to
significant risks and uncertainties, may contain words such as
"may," "will," "would," "could," "expect," "anticipate," "intend,"
"plan," "believe," "estimate," "project," "seek," "should,"
"strategy," "future," "opportunity," "potential" or other similar
words and expressions indicating future results. Risks that may
cause these forward-looking statements to be inaccurate include,
without limitation: uncertainties as to the timing of the
tender offer; uncertainties as to how many of Chimerix's
stockholders will tender their stock in the offer; the possibility
that competing offers will be made; the possibility that various
closing conditions for the transaction may not be satisfied or
waived, including that a governmental entity may prohibit, delay,
or refuse to grant approval for the consummation of the transaction
(or only grant approval subject to adverse conditions or
limitations); the difficulty of predicting the timing or outcome of
regulatory approvals or actions, if any; the possibility that the
transaction does not close; risks related to the parties' ability
to realize the anticipated benefits of the proposed acquisition,
including the possibility that the expected benefits from the
proposed acquisition will not be realized or will not be realized
within the expected time period and that Jazz and Chimerix will not
be integrated successfully or that such integration may be more
difficult, time-consuming or costly than expected; the risk that
competing offers or acquisition proposals will be made; the effects
of the transaction on relationships with employees, customers,
suppliers, other business partners or governmental entities;
negative effects of this announcement or the consummation of the
proposed acquisition on the market price of Jazz's ordinary shares
or Chimerix's common stock and/or Jazz's or Chimerix's operating
results; significant transaction costs; unknown or inestimable
liabilities; the risk of litigation and/or regulatory actions
related to the proposed acquisition; Jazz's ability to fund the
acquisition with existing cash and investments; effectively
launching and commercializing products and product candidates such
as dordaviprone, if approved; the successful completion of
development and regulatory activities with respect to dordaviprone;
obtaining and maintaining adequate coverage and reimbursement for
Jazz's or Chimerix's products; the time-consuming and uncertain
regulatory approval process, including the risk that Chimerix's NDA
for dordaviprone seeking accelerated approval for treatment of H3
K27M-mutant diffuse glioma in adult and pediatric patients with
progressive disease following prior therapy may not be approved by
FDA in a timely manner or at all, and that Chimerix and/or Jazz may
not receive a Rare Pediatric Disease PRV upon potential approval of
dordaviprone; the costly and time-consuming pharmaceutical product
development and the uncertainty of clinical success, including
risks related to failure or delays in successfully initiating or
completing clinical trials and assessing patients, including with
respect to current and planned future clinical trials of
dordaviprone; global economic, financial, and healthcare system
disruptions and the current and potential future negative impacts
to Jazz's or Chimerix's business operations and financial results;
the sufficiency of Jazz's or Chimerix's cash flows and capital
resources; Jazz's or Chimerix's ability to achieve targeted or
expected future financial performance and results and the
uncertainty of future tax, accounting and other provisions and
estimates; and other risks and uncertainties affecting Jazz and
Chimerix, including those described from time to time under the
caption "Risk Factors" and elsewhere in their respective filings
and reports with the U.S. Securities and Exchange Commission (the
"SEC"), including Jazz's Annual Report on Form 10-K for the fiscal
year ended December 31, 2024 and
Chimerix's Quarterly Report on Form 10-Q for the quarterly period
ended September 30, 2024 and Annual
Report on Form 10-K for the fiscal year ended December 31, 2023 as well as the Tender Offer
Statement on Schedule TO and related tender offer documents to be
filed by Jazz and its acquisition subsidiary, Pinetree Acquisition
Sub, Inc., and the Solicitation/Recommendation Statement on
Schedule 14D-9 to be filed by Chimerix. Any forward-looking
statements are made based on the current beliefs and judgments of
Jazz's and Chimerix's management, and the reader is cautioned not
to rely on any forward-looking statements made by Jazz or Chimerix.
Except as required by law, Jazz and Chimerix do not undertake any
obligation to update (publicly or otherwise) any forward-looking
statement, including without limitation any financial projection or
guidance, whether as a result of new information, future events, or
otherwise.
Additional Information and Where to Find It
The tender
offer referenced in this communication has not yet commenced. This
communication is for informational purposes only and is neither an
offer to purchase nor a solicitation of an offer to sell any
securities, nor is it a substitute for the tender offer materials
that Chimerix, Jazz or its acquisition subsidiary, Pinetree
Acquisition Sub, Inc., is expected to file with the SEC upon the
commencement of the tender offer. The solicitation and offer to
tender and the offer to buy Chimerix stock will only be made
pursuant to a tender offer statement on Schedule TO, including an
Offer to Purchase and related tender offer materials that Jazz and
its acquisition subsidiary, Pinetree Acquisition Sub, Inc. is
expected to file with the SEC. At the time the tender offer is
commenced, Jazz and its acquisition subsidiary will file a Tender
Offer Statement on Schedule TO and thereafter Chimerix is expected
to file a Solicitation/Recommendation Statement on Schedule 14D-9
with the SEC with respect to the tender offer. CHIMERIX'S
STOCKHOLDERS AND OTHER INVESTORS ARE URGED TO READ CAREFULLY THE
TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED
LETTER OF TRANSMITTAL AND CERTAIN OTHER TENDER OFFER DOCUMENTS), AS
WELL AS THE SOLICITATION/RECOMMENDATION STATEMENT ON SCHEDULE 14D-9
BECAUSE THEY WILL EACH CONTAIN IMPORTANT INFORMATION THAT HOLDERS
OF CHIMERIX SECURITIES AND OTHER INVESTORS SHOULD CONSIDER BEFORE
MAKING ANY DECISION WITH RESPECT TO THE TENDER OFFER. The Offer to
Purchase, the related Letter of Transmittal, certain other tender
offer documents, as well as the Solicitation/Recommendation
Statement on Schedule 14D-9, will be made available to all
stockholders of Chimerix at no expense to them and will also be
made available for free at the SEC's website at www.sec.gov.
Additional copies may be obtained for free by contacting either
Jazz or Chimerix. Copies of the documents filed with the SEC by
Chimerix will be available free of charge on Chimerix's website at
https://www.chimerix.com or by contacting Chimerix at
IR@chimerix.com. Copies of the documents filed with the SEC by Jazz
will be available free of charge on Jazz's website at
https://investor.jazzpharma.com or by contacting Jazz's
Investor Relations Department at investorinfo@jazzpharma.com.
In addition to the Offer to Purchase, the related Letter of
Transmittal and certain other tender offer documents, as well as
the Solicitation/Recommendation Statement on Schedule 14D-9, Jazz
and Chimerix each file annual, quarterly and current reports, proxy
statements and other information with the SEC, which are available
to the public over the internet at the SEC's website at
http://www.sec.gov.
Contacts
Investors:
Jeff
Macdonald
Executive Director, Investor Relations
Jazz Pharmaceuticals plc
InvestorInfo@jazzpharma.com
Ireland +353 1 634 3211
U.S. +1 650 496 2717
Media:
Kristin
Bhavnani
Head of Global Corporate Communications
Jazz Pharmaceuticals plc
CorporateAffairsMediaInfo@jazzpharma.com
Ireland +353 1 637 2141
U.S. +1 215 867 4948
Chimerix Investors:
Will
O'Connor
Stern Investor Relations
212-362-1200
Chimerix Media:
Dan
Moore / Paige Macpherson /
Dylan O'Keefe
Collected Strategies
cmrx-cs@collectedstrategies.com
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