Emergent BioSolutions Announces the Execution of Contract Options Valued at $67.4 Million to Procure Additional TEMBEXA® (brincidofovir) to Support National Preparedness Efforts
Emergent BioSolutions Inc. (NYSE: EBS) has announced the execution of two contract options valued at $67.4 million for the procurement of additional TEMBEXA® (brincidofovir) treatment courses. This order supports the U.S. government's national preparedness efforts against human smallpox. The contract options, CLIN0004A and CLIN0005A, are part of Emergent's existing 10-year contract with a maximum potential value of $568 million.
TEMBEXA® is indicated for treating human smallpox disease in adult and pediatric patients, including neonates. The funding, secured through 2027, will ensure a continued supply of TEMBEXA® to address the threat of smallpox. This project is funded by the Department of Health and Human Services, Administration for Strategic Preparedness and Response, and Biomedical Advanced Research and Development Authority (BARDA) under contract number 75A50122C00047.
Emergent BioSolutions Inc. (NYSE: EBS) ha annunciato l'esecuzione di due opzioni contrattuali del valore di 67,4 milioni di dollari per l'approvvigionamento di ulteriori cicli di trattamento TEMBEXA® (brincidofovir). Questo ordine supporta gli sforzi di preparazione nazionale del governo degli Stati Uniti contro il vaiolo umano. Le opzioni contrattuali, CLIN0004A e CLIN0005A, fanno parte del contratto esistente di Emergent della durata di 10 anni con un valore potenziale massimo di 568 milioni di dollari.
TEMBEXA® è indicato per il trattamento della malattia da vaiolo umano in pazienti adulti e pediatrici, compresi i neonati. Il finanziamento, garantito fino al 2027, assicurerà una fornitura continua di TEMBEXA® per affrontare la minaccia del vaiolo. Questo progetto è finanziato dal Dipartimento della Salute e dei Servizi Umani, Amministrazione per la Preparazione Strategica e la Risposta, e dall'Autorità per la Ricerca e lo Sviluppo Biomedico Avanzato (BARDA) sotto il numero di contratto 75A50122C00047.
Emergent BioSolutions Inc. (NYSE: EBS) ha anunciado la ejecución de dos opciones de contrato valoradas en 67,4 millones de dólares para la adquisición de cursos de tratamiento adicionales de TEMBEXA® (brincidofovir). Este pedido respalda los esfuerzos de preparación nacional del gobierno de EE. UU. contra la varicela humana. Las opciones de contrato, CLIN0004A y CLIN0005A, son parte del contrato existente de 10 años de Emergent con un valor potencial máximo de 568 millones de dólares.
TEMBEXA® está indicado para el tratamiento de la enfermedad de la varicela humana en pacientes adultos y pediátricos, incluidos los recién nacidos. La financiación, asegurada hasta 2027, garantizará un suministro continuo de TEMBEXA® para abordar la amenaza de la varicela. Este proyecto está financiado por el Departamento de Salud y Servicios Humanos, la Administración para la Preparación Estratégica y la Respuesta, y la Autoridad de Investigación y Desarrollo Biomédico Avanzado (BARDA) bajo el número de contrato 75A50122C00047.
Emergent BioSolutions Inc. (NYSE: EBS)는 TEMBEXA® (brincidofovir) 치료 과정을 추가로 조달하기 위해 6,740만 달러 상당의 두 개 계약 옵션을 실행했다고 발표했습니다. 이 주문은 미국 정부의 인류 두창 대비 국가 차원의 준비 노력을 지원합니다. 계약 옵션 CLIN0004A와 CLIN0005A는 Emergent의 최대 5억 6,800만 달러의 잠재적 가치를 가진 10년 기존 계약의 일부입니다.
TEMBEXA®는 성인 및 소아 환자, 신생아를 포함한 인류 두창 질병 치료를 위해 적응증이 있습니다. 2027년까지 확보된 자금은 두창의 위협에 대응하기 위해 TEMBEXA®의 지속적인 공급을 보장합니다. 이 프로젝트는 보건복지부, 전략적 준비 및 대응 관리국, 생물의학 고급 연구 개발 권한(BARDA)의 자금 지원으로 진행되며, 계약 번호는 75A50122C00047입니다.
Emergent BioSolutions Inc. (NYSE: EBS) a annoncé l'exécution de deux options de contrat d'une valeur de 67,4 millions de dollars pour l'acquisition de cours de traitement supplémentaires de TEMBEXA® (brincidofovir). Cette commande soutient les efforts de préparation nationale du gouvernement américain contre la variole humaine. Les options de contrat, CLIN0004A et CLIN0005A, font partie du contrat existant de 10 ans d'Emergent, d'une valeur maximale potentielle de 568 millions de dollars.
TEMBEXA® est indiqué pour le traitement de la maladie à variole humaine chez les patients adultes et pédiatriques, y compris les nouveau-nés. Le financement, assuré jusqu'en 2027, garantira un approvisionnement continu de TEMBEXA® pour faire face à la menace de la variole. Ce projet est financé par le ministère de la Santé et des Services sociaux, l'Administration pour la préparation stratégique et la réponse, ainsi que par l'Autorité de recherche et de développement biomédical avancé (BARDA) sous le numéro de contrat 75A50122C00047.
Emergent BioSolutions Inc. (NYSE: EBS) hat die Ausführung von zwei Vertragsoptionen im Wert von 67,4 Millionen USD für die Beschaffung zusätzlicher Behandlungszyklen mit TEMBEXA® (brincidofovir) bekannt gegeben. Dieser Auftrag unterstützt die nationalen Vorbereitungsmaßnahmen der US-Regierung gegen das menschliche Pockenvirus. Die Vertragsoptionen, CLIN0004A und CLIN0005A, sind Teil des bestehenden 10-Jahres-Vertrags von Emergent mit einem maximalen potenziellen Wert von 568 Millionen USD.
TEMBEXA® ist zur Behandlung von menschlichen Pocken bei Erwachsenen und pädiatrischen Patienten, einschließlich Neugeborenen, angezeigt. Die bis 2027 gesicherte Finanzierung wird eine kontinuierliche Versorgung mit TEMBEXA® gewährleisten, um der Bedrohung durch Pocken entgegenzuwirken. Dieses Projekt wird vom Ministerium für Gesundheit und Soziale Dienste, der Verwaltung für strategische Vorbereitung und Reaktion sowie der Biomedical Advanced Research and Development Authority (BARDA) unter der Vertragsnummer 75A50122C00047 finanziert.
- Secured $67.4 million contract options for TEMBEXA® procurement
- Part of a larger 10-year contract with maximum potential value of $568 million
- Funding secured through 2027 for continued TEMBEXA® supply
- None.
Insights
The execution of contract options valued at
Importantly, this deal strengthens Emergent's position in the biodefense sector, particularly in smallpox preparedness. The extended funding through 2027 offers revenue visibility and operational stability. However, investors should note that government contracts can be subject to political and budgetary changes.
While this news is positive, Emergent's recent financial challenges and manufacturing issues should be considered. This contract may help in rebuilding investor confidence, but it's important to monitor the company's ability to execute and maintain quality standards in light of past setbacks.
The U.S. government's continued investment in TEMBEXA® underscores the ongoing importance of smallpox preparedness in national security strategy. This contract extension demonstrates confidence in Emergent's product and the perceived threat level of smallpox as a potential bioweapon.
TEMBEXA®'s unique position as a treatment for smallpox in all age groups, including neonates, gives it a competitive edge in the biodefense market. The extended procurement through 2027 suggests a long-term commitment to maintaining a stockpile, which could deter potential adversaries from developing smallpox as a bioweapon.
However, the biodefense market is specialized and dependent on government priorities. Changes in threat assessments or budget allocations could impact future contracts. Investors should monitor global biosecurity trends and U.S. preparedness policies to gauge the long-term prospects for TEMBEXA® and Emergent's role in national security.
GAITHERSBURG, Md., Sept. 26, 2024 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) (“Emergent”) today announced that two contract options have been secured to procure additional treatment courses of TEMBEXA® (brincidofovir) to sustain the U.S. government’s national preparedness posture against human smallpox. TEMBEXA® is indicated for the treatment of human smallpox disease in adult and pediatric patients, including neonates. The order is valued at
“This announcement highlights the strength of the longstanding partnership between Emergent and the U.S. government to meet the country’s preparedness needs,” said Paul Williams, senior vice president, products business, Emergent. We look forward to continuing to deliver TEMBEXA® to support smallpox preparedness.”
The existing contract includes optional procurement CLINs that can be exercised throughout the 10-year contract period of performance with a maximum potential value of
This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA) 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.
Important Information about TEMBEXA® (brincidofovir)
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: 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.
TEMBEXA® has a BOXED WARNING for 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.
The Warnings and Precautions for TEMBEXA® include:
- 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 coadministered 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.
Common adverse reactions (occurring in at least
Please read full Prescribing Information for TEMBEXA® for additional safety information here.
About Smallpox
Smallpox is a highly contagious disease caused by the variola virus. Historically, smallpox was one of the deadliest diseases in history with a case fatality rate of approximately 30 percent. Despite successful eradication of smallpox in the 1970s, there is considerable concern that variola virus could reappear, either through accidental release or as a weapon of bioterrorism. According to the U.S. Centers for Disease Control and Prevention, variola virus is ranked in the highest risk category for bioterrorism agents (Category A) due to its ease of transmission, high mortality rate, and potential to cause public panic and social disruption. Based on a recent report – The Department of Health and Human Services Fiscal Year 2023 Public Health and Social Services Emergency Fund Justification of Estimates for Appropriations Committee – smallpox remains a threat of high concern to both the domestic and international community.
About Emergent BioSolutions
At Emergent, our mission is to protect and enhance life. For 25 years, we’ve been at work defending people from things we hope will never happen—so we are prepared just in case they ever do. We provide solutions for complex and urgent public health threats through a portfolio of vaccines and therapeutics that we develop and manufacture for governments and consumers. We also offer a range of integrated contract development and manufacturing services for pharmaceutical and biotechnology customers. To learn more about how we help protect public health, 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 the exercise by BARDA of any optional future procurements under the contract (75A50122C00047) to supply TEMBEXA® to the U.S. government, 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 Emergent’s current intentions, beliefs, and expectations regarding future events. Emergent cannot guarantee that any forward-looking statement will be accurate. Readers should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from Emergent’s 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, Emergent does not undertake to update any forward-looking statement to reflect new information, events or circumstances. There are a number of important factors that could cause Emergent’s actual results to differ materially from those indicated by any forward-looking statements.
Readers should consider this cautionary statement, as well as the risk factors identified in Emergent’s periodic reports filed with the U.S. Securities and Exchange Commission when evaluating Emergent’s 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
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