On March 5, 2025 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) ("Jazz" or the "Company") and Chimerix (Nasdaq: CMRX) ("Chimerix"), reported 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 (Press release, Jazz Pharmaceuticals, MAR 5, 2025, View Source [SID1234650902]). The transaction has been approved by both companies and is expected to close in the second quarter of 2025.
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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
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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
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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
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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
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Potential near-term commercial launch in the U.S., if approved
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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
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NDA has been granted Priority Review and assigned a PDUFA target action date of August 18, 2025
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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.
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Will create an additional durable revenue opportunity for Jazz with patent protection into 2037, with potential to receive patent term extension
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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.