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Chimerix Announces Closing of TEMBEXA Sale to Emergent BioSolutions

Chimerix Announces Closing of TEMBEXA Sale to Emergent BioSolutions

Chimerix宣布完成向Emerging BioSolutions出售TEMBEXA
GlobeNewswire ·  2022/09/26 16:11

- $238 Million in Upfront Payment Received at Closing with Additional $136.5 Million in Potential Milestone Payments Plus Royalties -

-成交时收到2.38亿美元的预付款,另外还有1.365亿美元的潜在里程碑付款和特许权使用费-

DURHAM, N.C., Sept. 26, 2022 (GLOBE NEWSWIRE) -- Chimerix, Inc. (NASDAQ:CMRX), a biopharmaceutical company whose mission is to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases, today announced the closing of its sale of TEMBEXA® to Emergent BioSolutions Inc. (EBS or Emergent).

北卡罗来纳州达勒姆,9月2022年26日(环球社)--中国化工股份有限公司(纳斯达克:CMRX)是一家生物制药公司,其使命是开发有意义地改善和延长面临致命疾病的患者的生命的药物,该公司今天宣布完成对TEMBEXA的出售®艾默生生物解决方案公司(EBS或艾默生)。

"The closing of our sale of TEMBEXA to Emergent allows Chimerix to accelerate the value of this product while still participating in its longer-term potential. As we look ahead, our balance sheet is enhanced significantly to support the ongoing development of our oncology franchise. This includes ONC201 which has demonstrated durable responses and an attractive safety profile in a genetically defined population of patients with H3 K27M mutant high-grade glioma. This would represent the first approved therapy specifically targeting patients with this invariably lethal disease," said Mike Sherman, Chief Executive Officer of Chimerix.

Chimerix首席执行官Mike·谢尔曼表示:“我们将TEMBEXA出售给Emergent的交易完成后,Chimerix可以加快这一产品的价值,同时仍能参与其长期潜力。展望未来,我们的资产负债表将显著增强,以支持我们肿瘤专营权的持续发展。其中包括ONC201,它已经在H3 K27M突变的高级别胶质瘤患者中展示了持久的反应和诱人的安全性。这将是第一种专门针对这种始终致命的疾病患者的已获批准的治疗方法,”Chimerix首席执行官Mike表示。

EBS paid Chimerix $238 million at closing. The closing amount was subject to the terms of the agreement executed between Biomedical Advanced Research and Development Authority (BARDA) and Chimerix for the procurement of TEMBEXA. Additional future economics from the transaction include:

EBS在交易结束时向Chimerix支付了2.38亿美元。最后成交金额取决于生物医学高级研究和发展局(BARDA)与Chimerix签署的TEMBEXA采购协议的条款。这笔交易带来的其他未来经济效益包括:

  • Potential milestone payments of up to $124 million (up to $31 million for each of the remaining BARDA procurement options, due within 30 days of exercise);
  • 15% royalty on gross profit from sales of TEMBEXA outside the U.S.;
  • 20% royalty on gross profit from sales of TEMBEXA in the U.S. that are in excess of 1.7 million treatment courses; and
  • Up to an additional $12.5 million upon achievement of certain developmental milestones.  
  • 可能的里程碑付款,最高可达1.24亿美元(剩余的BARDA采购选项,每项付款最高可达3100万美元,应在行使后30天内支付);
  • 对TEMBEXA在美国以外地区的销售毛利润征收15%的特许权使用费;
  • 对TEMBEXA在美国销售超过170万疗程的毛利润征收20%的特许权使用费;以及
  • 在实现某些发展里程碑的情况下,最高可额外获得1250万美元。

Development and procurement of TEMBEXA have been supported in part with federal funds from BARDA, in the Administration for Strategic Preparedness and Response in the Department of Health and Human Services under Contracts HHSO100201100013C and 75A50122C00047.

根据合同HHSO100201100013C和75A50122C00047,TEMBEXA的开发和采购部分得到了BARDA、卫生与公众服务部战略准备和反应管理局的联邦资金的支持。

About TEMBEXA

关于TEMBEXA

TEMBEXA (brincidofovir) is a nucleotide analog lipid-conjugate designed to mimic a natural monoacyl phospholipid to achieve effective intracellular concentrations of the active antiviral metabolite, cidofovir diphosphate. Cidofovir diphosphate exerts its orthopoxvirus antiviral effects by acting as an alternate substrate inhibitor for viral DNA synthesis mediated by viral DNA polymerase.

TEMBEXA(布林多福韦)是一种核苷酸类脂结合物,旨在模仿天然单酰基磷脂,实现有效的抗病毒代谢物西多福韦二磷酸的细胞内浓度。西多福韦二磷酸通过作为病毒DNA聚合酶介导的病毒DNA合成的替代底物抑制物发挥其正痘病毒的抗病毒作用。

In June 2021, the U.S. Food and Drug Administration granted approval of TEMBEXA for the treatment of smallpox as a medical countermeasure. TEMBEXA is an oral antiviral formulated as 100 mg tablets and 10 mg/mL oral suspension dosed once weekly for two weeks. TEMBEXA is indicated for the treatment of human smallpox disease caused by variola virus in adult and pediatric patients, including neonates. TEMBEXA is not indicated for the treatment of diseases other than human smallpox disease. The effectiveness of TEMBEXA for the treatment of smallpox disease has not been determined in humans because adequate and well-controlled field trials have not been feasible and inducing smallpox disease in humans to study the drug's efficacy is not ethical. TEMBEXA efficacy may be reduced in immunocompromised patients based on studies in immune deficient animals.

2021年6月,美国食品和药物管理局批准TEMBEXA用于治疗天花,作为一种医学对策。TEMBEXA是一种口服抗病毒药物,由100毫克片剂和10毫克/毫升口服混悬液组成,每周服用一次,连续两周。TEMBEXA用于治疗由天花病毒引起的成人和儿童患者的天花疾病,包括新生儿。TEMBEXA不适用于治疗人类天花疾病以外的其他疾病。TEMBEXA在人类身上治疗天花疾病的有效性尚未确定,因为充分和良好控制的现场试验并不可行,而且在人类身上诱导天花疾病来研究该药物的疗效是不道德的。根据对免疫缺陷动物的研究,TEMBEXA在免疫低下患者中的疗效可能会降低。

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, ONC201, is in development for H3 K27M-mutant glioma.

Chimerix是一家生物制药公司,其使命是开发有意义地改善和延长面临致命疾病的患者的生命的药物。该公司最先进的临床阶段开发计划ONC201正在为H3 K27M突变胶质瘤开发。

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include those relating to, among other things, procurements under the BARDA contract and potential future payments in connection with the transaction. Among the factors and risks that could cause actual results to differ materially from those indicated in the forward-looking statements are risks that the initial delivery or any subsequent deliveries of TEMBEXA will not occur as planned, or at all; risks that future payments in connection with the transaction will not be made; risks related to the timing and completion of the Phase 3 Study of ONC201, and additional risks set forth in the Company's filings with the Securities and Exchange Commission. These forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements.

前瞻性陈述
本新闻稿包含1995年《私人证券诉讼改革法》所指的前瞻性陈述,这些陈述会受到风险和不确定性的影响,这些风险和不确定性可能会导致实际结果与预期的大不相同。前瞻性表述包括与BARDA合同下的采购以及与该交易有关的未来可能付款有关的表述。可能导致实际结果与前瞻性陈述中指出的结果大不相同的因素和风险包括:TEMBEXA的初始交付或任何后续交付不按计划进行或根本不交付的风险;与交易相关的未来付款无法进行的风险;与ONC201第三阶段研究的时间和完成相关的风险;以及该公司提交给证券交易委员会的文件中陈述的其他风险。这些前瞻性陈述代表公司截至本新闻稿发布之日的判断。然而,该公司没有任何更新这些前瞻性陈述的意图或义务。

CONTACT:
Investor Relations:
Michelle LaSpaluto
919 972-7115
ir@chimerix.com 

联系方式:
投资者关系:
米歇尔·拉斯帕卢托
919 972-7115
邮箱:ir@chierix.com

Will O'Connor
Stern Investor Relations
212-362-1200
will@sternir.com

威尔·奥康纳
斯特恩投资者关系
212-362-1200
邮箱:Will@sternir.com


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