Oncoceutics, Inc.

Chimerix began attracting deal interest in its experimental brain tumor treatment about 18 months before it signed a $935 million cash exit to Jazz Pharmaceuticals earlier this month, according to a Friday regulatory filing . The filing highlights the broad interest that Chimerix was able to garner for dordaviprone, a potential first-ever medicine for H3 K27M-mutant diffuse glioma. Chimerix nabbed the asset as part of its Oncoceutics acquisition in 2021. The small molecule, also known as ONC201, is up for an FDA approval decision by Aug. 18. An undisclosed global biopharma company approached Chimerix in August 2023 about a potential ex-US licensing deal for the investigational drug. That initial confidentiality agreement with “Party A” kickstarted a year and a half of discussions between the North Carolina biotech and more than half a dozen other unnamed drugmakers interested in dordaviprone, according to the Friday filing. Jazz ultimately won with its $8.55 per-share cash offer. Jazz’s approach began in December 2024 , when its head of corporate development reached out to Chimerix a few days after the biotech said it was seeking accelerated approval of dordaviprone. A week later, on Dec. 19, Party A said it would be willing to acquire dordaviprone and related assets for $350 million upfront plus an additional $100 million if the FDA approved the medicine. The deal terms weren’t good enough, Chimerix replied. A month later, Party A came back and said it would be willing to acquire all of Chimerix for $6.50 per share, plus contingent payments if the biotech reached certain FDA and sales milestones. Meanwhile, Party F asked whether a $5 per-share offer was “attractive.” Chimerix’s financial advisor, Centerview, told the company it had already gotten a higher offer from another bidder. Over the next few weeks, Parties F, E and others dropped out of the discussions. Party F cited “perceived risks around Chimerix’s ongoing Phase 3 ACTION Study,” and Party E cited its “challenges in assessing risk in neuro-oncology,” according to Friday’s regulatory document. For its part, Jazz’s interest began at $5.50 per share on Feb. 6, plus various contingent value rights upon FDA approval, European reimbursement approvals and net sales milestones. Then, on Feb. 18, Chimerix said the FDA accepted its NDA with priority review status. Chimerix CEO Mike Andriole had already telephoned that message to Jazz CEO Bruce Cozadd and a Party A “senior executive” four days before. Weeks later, Jazz revised its proposal to $8.55 per share in cash, removing the riskiness of contingent value rights, which sometimes don’t come to fruition for acquired companies’ shareholders. On that same day, March 3, Party A said it would offer $7.50 per share upfront and a $2 per-share CVR if Chimerix snagged full FDA approval for dordaviprone by Aug. 31, 2032. But the CVR wouldn’t be payable if the Phase 3 trial failed or if Chimerix got a complete response letter from the FDA. In the end, Jazz beat Party A.

Brain cancers are notoriously difficult to treat, with surgery and radiation continuing to be the main options for these malignancies. A rare and aggressive type of brain tumor driven by a particular genetic signature could soon have its first approved drug treatment. Jazz Pharmaceuticals is now committing $935 million to add this prospect to its pipeline. The drug, dordaviprone, was developed by Durham, North Carolina-based Chimerix. The cancer is H3 K27M-mutant diffuse glioma, a high-grade glioma that affects children and young adults. While surgery is a treatment option for brain cancers, it’s usually risky for H3 K27M gliomas because these tumors affect critical parts of the brain and spinal cord. Meanwhile, radiation introduces complication risks and is not curative. “This is a very high unmet need,” Jazz Chief Medical Officer Robert Iannone said, speaking during the company’s presentation Wednesday at TD Cowen’s annual health care conference in Boston. “I’m a pediatric oncologist by training. There really has been no progress in this area. I know from treating these patients, it’s been a very sad situation to have only radiation and surgery as the effective therapy.” Sponsored Post Tackling Messy Provider Data with an NPI-Forward Approach Mike Wirth of ProviderTrust shares insights about the company in this interview at the ViVE 2025 conference in Nashville last month. By ProviderTrust and MedCity News About 2,000 patients are affected by H3 K27M-mutant gliomas annually in the U.S., according to a Chimerix estimate. Dordaviprone is part of a new class of cancer drugs called imipridones. These small molecules target certain G protein-coupled receptors and enzyme targets, altering their activity to lead to cancer cell death. Dordaviprone, known earlier in its development as ONC201, is designed to selectively target mitochondrial protease ClpP and dopamine receptor D2. Phase 2 results showed tumor regression in patients with glioblastoma who exhibited the H3 K27M mutation. In the 50 patients included in the primary efficacy analysis, Chimerix reported a 28% objective response rate and a median duration of response of 10.4 months. A Phase 3 test enrolling patients newly diagnosed with this type of brain cancer could support first-line use of the drug; interim results are expected in the third quarter of 2025. But based on the Phase 2 data, Chimerix is seeking accelerated approval of dordaviprone for recurrent H3 K27M-mutant diffuse glioma. Last month, the FDA accepted the new drug application under priority review, setting an Aug. 18 target date for a regulatory decision. Though cancer is the therapeutic focus of Chimerix, it’s a relatively new area for the company, one of the older biotechs in North Carolina’s Research Triangle. Dordaviprone came from Chimerix’s 2021 cash and stock acquisition of Oncoceutics, a clinical-stage developer of imipridones. Besides the lead drug candidate, the deal also brought ONC206, an imipridone that Chimerix has advanced to Phase 1 testing in central nervous system tumors. Per terms of the Oncoceutics acquisition, that company’s shareholders could receive up to $360 million in milestone payments plus royalties from sales. Chimerix, founded in 2000, began as an antiviral drug developer. For most of the biotech’s history, its focus was brincidofovir, a molecule initially developed for treating cytomegalovirus infection. It failed in that indication, but won FDA approval in 2021 as a treatment for smallpox and is now known by the brand name Tembexa. In 2022, Chimerix sold that drug’s rights to Emergent BioSolutions for $225 million up front and up to $100 million in milestone payments. Chimerix applied the cash toward clinical development of dordaviprone in brain cancer. Sponsored Post Webinar: Tips To Have Your Practice Succeed This Year This on-demand webinar will offer insights and share tips on helping practices run more efficiently. By Elation Health and MedCity News In the past year, Chimerix’s stock price has mostly traded below the $1 mark. Those shares got a significant lift in December after the biotech announced it would seek accelerated approval for dordaviprone. According to acquisition terms disclosed Wednesday, Dublin-based Jazz will pay $8.55 in cash for each Chimerix share, representing a 72% premium to the biotech’s closing stock price on Tuesday. There’s potential for additional financial upside. Because Chimerix’s drug is under priority review, it’s eligible for a rare pediatric disease priority review voucher if the drug is approved. Such vouchers are typically sold to big pharma companies, and they once fetched prices in the range of $100 million. Recent voucher sales have been in the neighborhood of $150 million. The Jazz portfolio currently has five cancer drugs. Chief Financial Officer Philip Johnson described dordaviprone as a “great fit with our oncology business,” adding that the drug can leverage Jazz’s commercial capabilities and offers a patent life extending into 2037 and potentially longer. The Chimerix acquisition fits Jazz’s strategy of acquiring assets for rare opportunities in niche markets, Leerink Partners analyst Marc Goodman wrote in a note to investors. Beyond addressing a high unmet medical need, the deal leverages Jazz’s expertise in rare diseases and oncology. Jazz prefers acquiring late-stage assets that have a potential near-term commercial launch, Goodman said. Leerink is still researching the H3 K27M market opportunity, but he noted that given the size of the patient population for this ultra-rare type of cancer, it makes sense for dordaviprone to fall within the $300,000 to $800,000 price range for orphan drug products. The acquisition has been approved by the boards of both Jazz and Chimerix, but still must meet customary closing conditions including the tender of the majority of the outstanding shares of Chimerix. The companies expect the deal to close in the second quarter of this year.

Jazz Pharmaceuticals will buy North Carolina biotech Chimerix for $935 million in cash, the companies said Wednesday morning. Through the deal, Jazz gets access to a potential first-ever treatment for a rare brain tumor that primarily impacts children and young adults. Chimerix’s small molecule dordaviprone is being speedily reviewed by the FDA for H3 K27M-mutant diffuse glioma. The US regulator is set to decide by Aug. 18. The deal adds to Jazz’s growing presence in oncology. The Dublin-based drugmaker historically has had a role in sleep disorders and epilepsy with marketed medicines such as Epidiolex, but in recent years it has broadened its portfolio to include cancer treatments. Its first pivotal step was the approval of Ziihera a few months ago. “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,” Jazz CEO Bruce Cozadd said in a statement. If the drug is greenlit, Chimerix could get a priority review voucher. The value of PRVs has historically been about $100 million, but has gone up recently. Jazz will be at least the third drug developer to touch dordaviprone. Chimerix got the oral drug from its 2021 acquisition of Oncoceutics , worth more than $400 million if all milestones are paid out. At the time, Chimerix said the drug had a $500 million market opportunity in recurrent glioma. Jazz said the drug candidate has patent protection “into 2037,” and it’s being studied in other indications as well. Chimerix has additional experimental medicines in development for central nervous system tumors. It also has a potential prophylactic and treatment for Covid-19. Chimerix also sold off its FDA-approved smallpox treatment to Emergent BioSolutions in 2022. Jazz plans to buy Chimerix for $8.55 per share $CMRX , about a 72% premium to Tuesday’s closing price. Chimerix’s shares were up 69% before Wednesday’s opening bell, nearly equaling the offer price. Jazz’s share price $JAZZ held nearly flat. The companies anticipate the deal will close next quarter. Last week, Jazz reported fourth-quarter earnings of $1.09 billion, which came above Wall Street’s consensus estimates, Jefferies analyst Akash Tewari wrote in a note. The company’s last major M&A move was the $7.2 billion purchase of GW Pharma in 2021. It got the seizure medication Epidiolex in that deal. Three months ago, Cozadd announced he is retiring and will stay in place until a successor is found. He’ll remain as chair.