Emergent BioSolutions Secures $17 Million Contract Modification for Oral Suspension TEMBEXA® (brincidofovir), a Smallpox Antiviral, and Strengthens Overall U.S. Supply Chain
Emergent BioSolutions (NYSE:EBS) has secured a $17 million contract modification from BARDA to supply TEMBEXA® (brincidofovir) oral suspension, a smallpox antiviral treatment. The modification follows FDA's recent approval of manufacturing scale-up for the oral suspension formulation.
The contract builds upon previously announced options from September 2024 under Emergent's existing 10-year contract with BARDA. The oral suspension formulation is specifically designed for patients who have difficulty swallowing due to age or medical conditions, strengthening the U.S. government's preparedness against potential smallpox outbreaks.
Emergent BioSolutions (NYSE:EBS) ha ottenuto una modifica contrattuale di 17 milioni di dollari da BARDA per fornire TEMBEXA® (brincidofovir) in sospensione orale, un trattamento antivirale contro la vaiola. La modifica arriva dopo l'approvazione da parte della FDA dell'aumento della produzione per la formulazione in sospensione orale.
Il contratto si basa sulle opzioni già annunciate a settembre 2024 all'interno dell'attuale contratto decennale di Emergent con BARDA. La formulazione in sospensione orale è specificamente pensata per i pazienti che hanno difficoltà a deglutire a causa dell'età o di condizioni mediche, rafforzando la preparazione del governo degli Stati Uniti contro potenziali focolai di vaiolo.
Emergent BioSolutions (NYSE:EBS) ha asegurado una modificación de contrato de 17 millones de dólares de BARDA para suministrar TEMBEXA® (brincidofovir) en suspensión oral, un tratamiento antiviral contra la viruela. La modificación se produce tras la reciente aprobación por la FDA de ampliar la fabricación de la formulación en suspensión oral.
El contrato se apoya en las opciones anunciadas previamente en septiembre de 2024 dentro del actual contrato de 10 años de Emergent con BARDA. La formulación en suspensión oral está diseñada específicamente para pacientes que tienen dificultad para deglutir debido a la edad o condiciones médicas, fortaleciendo la preparación del gobierno de los EE. UU. ante posibles brotes de viruela.
에머전트 바이오솔루션스(Emergent BioSolutions, NYSE:EBS)가 BARDA로부터 TEMBEXA®(brincidofovir) 구강 분말 현탁액 공급을 위한 자 1,700만 달러 계약 수정를 확보했습니다. 이는 천연두 항바이러스 치료제입니다. 이 수정은 구강 현탁액 제형의 제조 규모 확장에 대한 FDA의 최근 승인을 따른 것입니다.
이 계약은 BARDA와의 10년 계약 아래 2024년 9월에 발표된 기존 옵션을 기반으로 합니다. 구강 현탁액 제형은 연령이나 의학적 상태로 인해 삼키기 어려운 환자들을 대상으로 설계되었으며, 미국 정부의 잠재적 천연두 발발에 대한 대비를 강화합니다.
Emergent BioSolutions (NYSE:EBS) a obtenu une modification de contrat de 17 millions de dollars de BARDA pour fournir TEMBEXA® (brincidofovir) en suspension orale, un traitement antiviral contre la variole. La modification fait suite à l'approbation récente par la FDA de l'augmentation de la production pour la formulation en suspension orale.
Le contrat s'appuie sur les options annoncées précédemment en septembre 2024 dans le cadre du contrat de 10 ans d'Emergent avec BARDA. La formulation en suspension orale est spécialement conçue pour les patients qui ont des difficultés à avaler en raison de l'âge ou de conditions médicales, renforçant la préparation du gouvernement américain face à d'éventuelles éclosions de variole.
Emergent BioSolutions (NYSE:EBS) hat von BARDA eine Vertragsänderung im Wert von 17 Mio. USD erhalten, um TEMBEXA® (Brincidofovir) als orale Suspension zu liefern, eine antivirale Behandlung gegen Pocken. Die Änderung folgt auf die jünge FDA-Genehmigung zur Skalierung der Herstellung der oralen Suspension.
Der Vertrag baut auf zuvor im September 2024 angekündigten Optionen im Rahmen des bestehenden 10-Jahres-Vertrags von Emergent mit BARDA auf. Die orale Suspension ist speziell für Patienten konzipiert, die aufgrund von Alter oder medizinischen Bedingungen Schwierigkeiten beim Schlucken haben, und stärkt die Bereitschaft der US-Regierung gegen potenzielle Pockenausbrüche.
Emergent BioSolutions (NYSE:EBS) حصلت على تعديل عقد بقيمة 17 مليون دولار من BARDA لتزويد TEMBEXA® (brincidofovir) بوجود تعويم فموي، وهو علاج مضاد للجدري. يأتي التعديل بعد اعتماد FDA مؤخرًا توسيع التصنيع لصيغة التعويم الفموية.
يعتمد العقد على الخيارات المعلنة سابقًا في سبتمبر 2024 ضمن العقد الحالي لمدة 10 سنوات مع BARDA. تم تصميم صيغة التعويم الفموية خصيصًا للمرضى الذين يعانون من صعوبات في البلع بسبب العمر أو الظروف الطبية، مما يعزز جاهزية الحكومة الأمريكية تجاه تفشٍ محتمل للجدري.
Emergent BioSolutions (NYSE:EBS) 已从 BARDA 获得一项价值 1700 万美元的合同修改，以供应 TEMBEXA®（brincidofovir）口服悬液，这是一种天花抗病毒治疗药物。此次修改是在 FDA 最近批准口服悬液制剂放大生产之后。
该合同基于 2024 年 9 月在 Emergent 与 BARDA 的现有 10 年合同下先前宣布的选项。口服悬液制剂专为那些因年龄或医疗状况而吞咽困难的患者设计，增强美国政府对潜在天花疫情的应对准备。
- Secured new $17 million contract modification from BARDA
- FDA approval received for manufacturing scale-up of TEMBEXA oral suspension
- Strengthens existing 10-year contract relationship with U.S. government
- Expands product offering with oral suspension formulation for vulnerable populations
- None.
Insights
EBS secures $17M contract modification for TEMBEXA oral suspension, strengthening revenue visibility within its 10-year BARDA agreement.
Emergent BioSolutions has successfully expanded its TEMBEXA® revenue stream with a
The oral suspension format represents a strategic product expansion that addresses an important vulnerability in biodefense preparedness - ensuring treatment options for patients who struggle with pill swallowing, particularly children and medically compromised individuals. This formulation variation strengthens the product's market position within the government's medical countermeasure stockpile.
What's particularly valuable about this contract modification is that it occurs within Emergent's existing 10-year agreement with BARDA, suggesting continued government confidence in the company as a critical supplier. The domestic manufacturing emphasis also aligns with current U.S. policy priorities on supply chain security for essential medicines and countermeasures.
This
GAITHERSBURG, Md., Sept. 15, 2025 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today announced it has received a
“Our newly secured contract modification and ongoing collaboration with BARDA and its procurement of TEMBEXA® (brincidofovir) oral suspension formulation reinforces the critical need for a continuous supply of countermeasures to help address smallpox disease among vulnerable patient populations during a potential outbreak,” said Paul Williams, senior vice president, head of products business, global government & public affairs at Emergent. “We are proud of our efforts to increase manufacturing scale to respond to customers’ immediate needs by strengthening our U.S. manufacturing and supply chain process and serving as a trusted partner supporting the U.S. government to address this serious national health security threat.”
This newly exercised contract modification (CLIN0004B) to supply TEMBEXA® builds upon the previously announced options (CLIN0004A and CLIN0005A) from September 2024, and are all under Emergent’s existing 10-year contract. This project has been funded in whole or in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; the Biomedical Advanced Research and Development Authority under contract number 75A50122C00047.
About TEMBEXA®
TEMBEXA® is an oral antiviral approved by the FDA in June 2021 for the treatment of human smallpox disease caused by variola virus in adult and pediatric patients, including neonates. TEMBEXA® is formulated as 100 mg tablets and 10 mg/mL oral suspension dosed once weekly for two weeks. The oral suspension formulation is particularly important for patients who have difficulty swallowing due to age or medical status.
Indication
TEMBEXA is an orthopoxvirus nucleotide analog DNA polymerase inhibitor and is indicated for the treatment of human smallpox disease in adult and pediatric patients, including neonates.
Limitations of Use: (1) TEMBEXA is not indicated for the treatment of diseases other than human smallpox disease. (2) The effectiveness of TEMBEXA for 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. (3) TEMBEXA efficacy may be reduced in immunocompromised patients based on studies in immune deficient animals.
Select Important Safety Information
Boxed Warning: Increased Risk for Mortality When Used for Longer Duration
An increased incidence of mortality was seen in TEMBEXA-treated subjects compared to placebo-treated subjects in a 24-week clinical trial when TEMBEXA was evaluated in another disease.
Warnings and Precautions: Elevations in Hepatic Transaminases and Bilirubin: May cause increases in serum transaminases (ALT or AST) and serum bilirubin. Monitor liver laboratory parameters before and during treatment. Diarrhea and Other Gastrointestinal Adverse Events: Diarrhea and additional gastrointestinal adverse events including nausea, vomiting, and abdominal pain may occur. Monitor patients, provide supportive care, and if necessary, do not give the second and final dose of TEMBEXA. Coadministration with Related Products: TEMBEXA should not be co-administered with intravenous cidofovir. Embryo-fetal Toxicity: May cause fetal harm. Advise individuals of childbearing potential of the potential risk to the fetus and to use effective contraception. Carcinogenicity: TEMBEXA should be considered a potential human carcinogen. Do not crush or divide TEMBEXA tablets. Male Infertility: Based on testicular toxicity in animal studies, TEMBEXA may irreversibly impair fertility in individuals of reproductive potential.
Adverse Reactions: The most common adverse reactions (occurring in at least
To report Suspected Adverse Reactions, contact Emergent BioSolutions at 1-877-246-8472 or medicalinformation@ebsi.com
Please see the Prescribing Information for TEMBEXA for full safety information.
About Emergent BioSolutions
At Emergent, our mission is to protect and save lives. For over 25 years, we’ve been at work preparing those entrusted with protecting public health. We deliver protective and life-saving solutions for health threats like smallpox, mpox, botulism, Ebola, anthrax and opioid overdose emergencies. To learn more about how we help prepare communities around the world for today’s health challenges and tomorrow’s threats, visit our website and follow us on LinkedIn, X, Instagram, Apple Podcasts and Spotify.
Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including statements regarding Emergent’s ability to increase manufacturing scale of TEMBEXA® to respond to customer needs, are forward-looking statements. We generally identify forward-looking statements by using words like “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “should,” “will,” “would,” and similar expressions or variations thereof, or the negative thereof, but these terms are not the exclusive means of identifying such statements. Forward-looking statements are based on our current intentions, beliefs, and expectations regarding future events based on information that is currently available. We cannot guarantee that any forward-looking statement will be accurate. Readers should realize that if underlying assumptions prove inaccurate or if known or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Readers are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events, or circumstances.
Readers should consider this cautionary statement, as well as the risk factors identified in our periodic reports filed with the U.S. Securities and Exchange Commission, when evaluating our forward-looking statements.
Investor Contact:
Richard S. Lindahl
Executive Vice President, CFO
lindahlr@ebsi.com
Media Contact:
Assal Hellmer
Vice President, Communications
mediarelations@ebsi.com
FAQ
What is the value of Emergent BioSolutions' (EBS) new BARDA contract modification?
What is TEMBEXA used for and who will benefit from the oral suspension?
When did the FDA approve the manufacturing scale-up for TEMBEXA oral suspension?
How does this contract modification relate to Emergent BioSolutions' existing BARDA contract?
