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-Dordaviprone addresses a significant unmet patient need for patients with rare, high-grade brain tumors-
-Dordaviprone 满足了罕见高级别脑肿瘤患者的重大未满足需求-
-
-
Transaction to add near-term commercial opportunity to Jazz's pipeline-
交易为Jazz的管道增加了近期的商业机会。
-Transaction represents total cash consideration of approximately
-交易代表了大约总的现金对价
$935 m
9.35亿美元
illion, or
百万,或者
$8.55
8.55美元
per share-
每股-
DUBLIN
都柏林
and
和
DURHAM, N.C.
杜伦,北卡罗来纳州
,
,
March 5, 2025
2025年3月5日
/PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq:
/PRNewswire/ -- Jazz Pharmaceuticals plc (纳斯达克:
JAZZ
爵士乐
) ('Jazz' or the 'Company') and Chimerix (Nasdaq:
)(“Jazz”或“公司”)和Chimerix(纳斯达克:
CMRX
CMRX
) ('Chimerix'), today announced the companies have entered into a definitive agreement for Jazz to acquire Chimerix for
)('Chimerix'),今天宣布两家公司已达成最终协议,Jazz 将收购 Chimerix。
$8.55
8.55美元
per share in cash, representing a total consideration of approximately
每股现金,代表总对价约为
$935 million
9.35亿美元
. The transaction has been approved by both companies and is expected to close in the second quarter of 2025.
该交易已获两家公司批准,预计将于2025年第二季度完成。
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Chimerix
奇米里克斯
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.
Chimerix公司的主要临床资产是dordaviprone,这是一种新型的首创小分子治疗药物,正在开发用于H3 K27M突变型弥漫性胶质瘤,一种罕见的高级别脑肿瘤,最常影响儿童和年轻人。目前尚无美国食品药品监督管理局(FDA)批准的专门针对H3 K27M突变型弥漫性胶质瘤患者的疗法;放射治疗是最常见的治疗手段。
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 .
最近,FDA接受了dordaviprone用于复发性H3 K27M突变型弥漫性胶质瘤的加速批准新药申请(NDA),并授予其优先审查。FDA设定的《处方药使用者费用法案》(PDUFA)目标行动日期为 。
August 18, 2025
2025年8月18日
. 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..
如果在美国获得批准,dordaviprone可能有资格获得罕见儿科疾病优先审查券(PRV)。此外,dordaviprone正在正在进行的3期ACTION试验中进行研究,评估其在放射治疗后用于新诊断、非复发性H3 K27M突变型弥漫性胶质瘤患者中的应用,有望将这种治疗选择扩展到一线治疗环境。
'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 .
“将多拉维普隆加入我们的肿瘤学研发管线,将进一步丰富我们的产品组合,这是一种满足显著未满足需求的药物,目前尚无其他FDA批准的疗法,该患者群体的治疗选择有限。如果获得批准,多拉维普隆有潜力迅速成为一种罕见肿瘤疾病的护理标准,并在近期开始贡献持久的收入。”
Bruce Cozadd
布鲁斯·科扎德
, 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.'.
爵士制药公司董事长兼首席执行官表示:“我们对Dordaviprone的临床试验结果感到鼓舞,并期待完成此次收购提案,与来自Chimerix的新同事合作,充分利用我们合并后的研发和商业专长,将这种新型疗法带给患者,最早可能在今年下半年开始。”
'We are excited to reach this agreement with Jazz Pharmaceuticals as they bring global scale to broaden our dordaviprone commercial strategy,' said
“我们很高兴与Jazz制药公司达成这项协议,因为他们为扩大我们的多拉维普龙商业战略带来了全球规模,”
Mike Andriole
迈克·安德里奥勒
, 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.' .
,Chimerix公司的总裁兼首席执行官。“如果该交易获得批准,将为推动dordaviprone的可及性提供机会,从而惠及全球更多患者。这一宣布是我们极其优秀的团队多年科学工作的结晶,将为我们的股东带来显著且确定的价值。”
Key Highlights
关键亮点
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
战略契合将加强Jazz在罕见肿瘤领域的地位,并重申对存在显著未满足需求的罕见病患者的承诺。
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
Dordaviprone 在多项临床研究中已被证明可使复发性 H3 K27M 突变型弥漫性胶质瘤患者获益,无论是作为单药治疗还是与包括放疗在内的其他治疗方法联合使用,均表现出一贯良好的安全性。
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
目前尚无获批的H3 K27M突变型弥漫性胶质瘤疗法,因此dordaviprone有潜力迅速成为标准治疗方案,并为治疗选择有限的患者提供有意义的治疗手段。
Potential near-term commercial launch in the U.S., if approved
如果获得批准,可能在美国实现近期商业发布。
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
FDA已接受dordaviprone的NDA,寻求加速批准用于治疗H3 K27M突变型弥漫性胶质瘤,适用于先前治疗后病情进展的成人和儿童患者。
NDA has been granted Priority Review and assigned a PDUFA target action date of August 18, 2025
新药申请(NDA)已获得优先审查,并被分配了2025年8月18日的PDUFA目标行动日期。
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..
在拟议收购完成后,并与来自Chimerix的新同事合作,Jazz计划利用其综合开发和商业能力,继续推进dordaviprone临床试验项目,并在美国获批后执行强有力的商业上市。
Will create an additional durable revenue opportunity for Jazz with patent protection into 2037, with potential to receive patent term extension
将为Jazz创造一个额外的持久收入机会,专利保护至2037年,并有可能获得专利期限延长。
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
正在进行的第三阶段 ACTION 试验有可能确认多拉维普龙在复发性 H3 K27M 突变型弥漫性胶质瘤中的临床益处,并将其使用范围扩展到一线患者。
Transaction Terms
交易条款
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
根据合并协议的条款,Jazz 将发起全现金要约收购 Chimeryx 公司所有已发行的普通股,Chimerix 的股东将被提供
$8.55
8.55美元
per share in cash, representing a total consideration of approximately
每股现金,代表总计约
$935 million
9.35亿美元
. This reflects an approximately 72% premium based on the closing trading price on
这反映出基于收盘交易价格大约72%的溢价。
March 4, 2025
2025年3月4日
. 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.
在要约收购成功完成后,Jazz 将通过第二步合并收购在要约中未收购的所有股份,每股支付与要约收购相同的对价。
Jazz expects to fund the transaction through existing cash and investments.
爵士乐公司预计将通过现有的现金和投资为交易提供资金。
Closing Conditions
关闭条件
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.
该交易受制于惯例的交割条件,包括提交奇米里克斯过半数尚未清偿的有表决权普通股以及其他条件。奇米里克斯董事会一致建议奇米里克斯股东在要约收购中交出他们的股份。
Advisors
顾问
Guggenheim Securities is serving as financial advisor to Jazz Pharmaceuticals, and Wachtell, Lipton, Rosen & Katz is serving as legal advisor.
古根海姆证券公司担任爵士制药公司的财务顾问,而沃奇尔·利普顿·罗森·卡茨律师事务所则担任法律顾问。
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.
Centerview Partners LLC 担任 Chimerix 的财务顾问,而 Skadden、Arps、Slate、Meagher & Flom LLP 和 Cooley LLP 担任法律顾问。
About Dordaviprone
关于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..
Dordaviprone(ONC201)是一种新型的首创小分子咪唑酮,可选择性靶向线粒体蛋白酶ClpP和多巴胺受体D2(DRD2)。Dordaviprone的独特作用机制包括改变关键的表观遗传修饰,例如逆转H3 K27me3丢失,这是H3 K27M突变型胶质瘤的标志。
About Jazz Pharmaceuticals
关于Jazz制药公司
Jazz Pharmaceuticals plc (NASDAQ:
Jazz Pharmaceuticals plc (纳斯达克:
JAZZ
爵士乐
) 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.
)是一家全球生物制药公司,其宗旨是通过创新来改变患者及其家人的生活。我们致力于为患有严重疾病的人群——通常面临有限或无治疗选择——开发改变生命的药物。我们拥有多样化的上市药物组合,包括针对睡眠障碍和癫痫的领先疗法,并且我们的癌症治疗产品线也在不断扩展。
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 .
我们以患者为中心、以科学为驱动的方法,推动了我们在肿瘤学和神经科学领域创新治疗的强大研发管线的开创性研究和开发进展。Jazz 总部位于 。
Dublin, Ireland
爱尔兰都柏林
with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit
在多个国家设有研发实验室、制造设施和员工,致力于为全球患者服务。请访问
www.jazzpharmaceuticals.com
www.jazzpharmaceuticals.com
for more information.
更多信息,请参阅。
About Chimerix
关于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..
Chimerix是一家生物制药公司,其使命是开发能够有效改善和延长致命疾病患者生命的药物。该公司最先进的临床阶段开发项目dordaviprone正在用于治疗H3 K27M突变型胶质瘤的开发中。公司正在进行ONC206的1期剂量递增研究,以评估安全性和药代动力学数据。
Caution Concerning Forward-Looking Statements
关于前瞻性陈述的警告声明
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.
本通讯包含涉及未来事件和Jazz Pharmaceuticals plc(“Jazz”)及Chimerix, Inc.(“Chimerix”)未来表现的前瞻性声明,这些声明存在风险和不确定性,包括关于Jazz拟议收购Chimerix的声明、拟议要约收购预期的发生、方式和时间、拟议收购的完成以及拟议收购的预期收益,包括dordaviprone在改善一种罕见肿瘤疾病护理标准方面的潜力,并从近期开始贡献持久收入;dordaviprone有望迅速成为护理标准,并为治疗选择有限的患者提供有意义的疗法;dordaviprone在美国近期内实现商业化上市的潜力。
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.
如果获得批准;正在进行的第三阶段ACTION试验有望证实dordaviprone在复发性H3 K27M突变型弥漫性胶质瘤中的临床益处,并将其用途扩展至一线患者;dordaviprone可能有资格获得罕见儿科疾病优先审评券(PRV);Jazz计划用于拟议收购的资金来源;以及其他非历史事实的陈述。
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,' .
实际结果可能与这些前瞻性陈述中预期的结果有重大差异。除非法律要求,Jazz和Chimerix均不承担更新这些前瞻性陈述的义务,不论是否由于新信息、未来事件或其他原因。这些陈述代表了Jazz和Chimerix当前对未来事件的期望或信念,涉及重大风险和不确定性,可能包含诸如“可能”、“将”、“会”、“能够”、“预计”、“预期”、“打算”、“计划”等词语。
December 31, 2024
2024年12月31日
and Chimerix's Quarterly Report on Form 10-Q for the quarterly period ended
Chimerix公司截至季度末的10-Q表季度报告
September 30, 2024
2024年9月30日
and Annual Report on Form 10-K for the fiscal year ended
并附上截至财政年度末的10-K表格年度报告
December 31, 2023
2023年12月31日
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.
以及Jazz及其收购子公司Pinetree Acquisition Sub, Inc.将提交的附表TO要约收购声明和相关要约收购文件,还有Chimerix将提交的附表14D-9征集/建议声明。任何前瞻性陈述均基于Jazz和Chimerix管理层的当前信念和判断,读者应注意不要依赖Jazz或Chimerix作出的任何前瞻性陈述。
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..
除非法律要求,Jazz和Chimerix不承担更新任何前瞻性声明的义务,包括但不限于任何财务预测或指导,无论是否由于新信息、未来事件或其他原因。
Additional Information and Where to Find It
更多信息及其查找位置
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.
本通讯中提到的要约收购尚未开始。此通讯仅用于提供信息,既不是购买证券的要约,也不是出售任何证券的要约邀请,也不能替代Chimerix、Jazz或其收购子公司Pinetree Acquisition Sub, Inc.预计在要约收购开始时将向美国证券交易委员会提交的要约收购材料。
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.
征求和要约收购以及购买Chimerix股票的要约,将仅根据Jazz及其收购子公司Pinetree Acquisition Sub, Inc.预计向美国证券交易委员会(SEC)提交的TO表格上的要约收购声明(包括购买要约和相关的要约收购材料)进行。
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.
在要约收购开始时,Jazz及其收购子公司将提交一份附表TO的要约收购声明,此后Chimerix预计将向美国证券交易委员会提交一份附表14D-9的征集/建议声明以回应该要约收购。强烈建议CHIMERIX的股东及其他投资者仔细阅读要约收购材料(包括购买要约、相关的转送函及某些其他要约收购文件),以及附表14D-9上的征集/建议声明,因为这些文件将包含CHIMERIX证券持有人及其他投资者在做出任何与要约收购相关决定之前应考虑的重要信息。
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 .
购买要约、相关的转递函、某些其他要约收购文件,以及 Schedule 14D-9 上的征集/建议声明,将免费提供给 Chimerix 的所有股东,并且还将在 SEC 的网站上免费提供。
www.sec.gov
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
通过联系Jazz或Chimerix,可以免费获取更多副本。Chimerix向美国证券交易委员会提交的文件副本在其官网网站上可免费获取,网址为
https://www.chimerix.com
https://www.chimerix.com
or by contacting Chimerix at
或通过联系Chimerix at
IR@chimerix.com
IR@chimerix.com
. Copies of the documents filed with the SEC by Jazz will be available free of charge on Jazz's website at
向美国证券交易委员会提交的文件副本将在 Jazz 的网站上免费提供,网址为
https://investor.jazzpharma.com
https://investor.jazzpharma.com
or by contacting Jazz's Investor Relations Department at
或通过联系 Jazz 的投资者关系部门
investorinfo@jazzpharma.com
投资者信息@爵士制药.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 .
除购买要约、相关的转递函及某些其他要约文件,以及在Schedule 14D-9上的征集/建议声明外,Jazz和Chimerix各自还向美国证券交易委员会(SEC)提交年报、季报、当前报告、委托书和其它信息,公众可通过SEC网站查阅这些信息。
http://www.sec.gov
http://www.sec.gov
.
。
Contacts
联系人
Investors:
投资者:
Jeff Macdonald
杰夫·麦克唐纳
Executive Director, Investor Relations
投资者关系执行董事
Jazz Pharmaceuticals plc
爵士制药公司
InvestorInfo@jazzpharma.com
投资者信息@jazzpharma.com
Ireland +353 1 634 3211
爱尔兰 +353 1 634 3211
U.S. +1 650 496 2717
美国 +1 650 496 2717
Media:
媒体:
Kristin Bhavnani
克莉丝汀·巴夫纳尼
Head of Global Corporate Communications
全球企业传播主管
Jazz Pharmaceuticals plc
爵士制药公司
CorporateAffairsMediaInfo@jazzpharma.com
企业事务媒体信息@jazzpharma.com
Ireland
爱尔兰
+353 1 637 2141
+353 1 637 2141
U.S. +1 215 867 4948
美国 +1 215 867 4948
Chimerix Investors:
Chimerix 投资者:
Will O'Connor
威尔·奥康纳
Stern Investor Relations
星巴克投资者关系
212-362-1200
212-362-1200
Chimerix Media:
奇米里克斯媒体:
Dan Moore
丹·摩尔
/
/
Paige Macpherson
佩奇·麦克弗森
/
/
Dylan O'Keefe
迪伦·奥基夫
Collected Strategies
收集的策略
cmrx-cs@collectedstrategies.com
cmrx-cs@collectedstrategies.com
SOURCE Jazz Pharmaceuticals plc
来源:Jazz Pharmaceuticals plc
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