Emergent BioSolutions Receives $50 Million Contract Option from BARDA to Procure Doses of CYFENDUS® (Anthrax Vaccine Adsorbed, Adjuvanted)
Emergent BioSolutions (NYSE: EBS) has received a $50 million contract option from BARDA for its CYFENDUS® anthrax vaccine. The deliveries are scheduled between now and April 2025. This follows a previous $30 million contract modification for the same vaccine. CYFENDUS®, FDA-approved in July 2023, is a two-dose anthrax vaccine for post-exposure prophylaxis in individuals aged 18-65.
The contract strengthens national anthrax preparedness against potential bioterrorist incidents, as anthrax is classified as a Tier 1 biological select agent. Emergent's anthrax portfolio also includes BioThrax® vaccine and two treatments: Anthrasil® and raxibacumab.
Emergent BioSolutions (NYSE: EBS) ha ricevuto dalle BARDA un'opzione contrattuale di $50 milioni per il suo vaccino contro l'antrace CYFENDUS®. Le consegne sono programmate tra ora e aprile 2025. Questo segue una precedente modifica contrattuale di $30 milioni per lo stesso vaccino. CYFENDUS®, approvato dalla FDA a luglio 2023, è un vaccino contro l'antrace in due dosi per la profilassi post-esposizione in individui di età compresa tra 18 e 65 anni.
Il contratto rafforza la preparazione nazionale contro l'antrace in caso di potenziali incidenti di bioterrorismo, poiché l'antrace è classificato come agente biologico di selezione di Tier 1. Il portafoglio di vaccini contro l'antrace di Emergent include anche il vaccino BioThrax® e due trattamenti: Anthrasil® e raxibacumab.
Emergent BioSolutions (NYSE: EBS) ha recibido una opción de contrato de $50 millones de BARDA para su vacuna contra el ántrax CYFENDUS®. Las entregas están programadas entre ahora y abril de 2025. Esto sigue a una modificación contractual anterior de $30 millones para la misma vacuna. CYFENDUS®, aprobada por la FDA en julio de 2023, es una vacuna de dos dosis para la profilaxis post-exposición en individuos de entre 18 y 65 años.
El contrato refuerza la preparación nacional para el ántrax frente a posibles incidentes de bioterrorismo, ya que el ántrax está clasificado como un agente biológico de selección de Nivel 1. El portafolio de ántrax de Emergent también incluye la vacuna BioThrax® y dos tratamientos: Anthrasil® y raxibacumab.
Emergent BioSolutions (NYSE: EBS)는 CYFENDUS® 탄저균 백신에 대해 BARDA로부터 5천만 달러 계약 옵션을 받았습니다. 납품은 지금부터 2025년 4월까지 예정되어 있습니다. 이는 동일한 백신에 대한 3천만 달러 계약 수정 이전의 결과입니다. CYFENDUS®는 2023년 7월 FDA 승인을 받은 두 번 접종하는 탄저균 백신으로, 18세에서 65세 사이의 개인을 위한 노출 후 예방 접종에 사용됩니다.
이 계약은 탄저균이 1등급 생물 선택 대행체로 분류되기 때문에 잠재적인 생물 테러 사건에 대한 국가적 탄저균 준비 태세를 강화합니다. Emergent의 탄저균 포트폴리오에는 BioThrax® 백신과 두 가지 치료제인 Anthrasil® 및 raxibacumab도 포함되어 있습니다.
Emergent BioSolutions (NYSE: EBS) a reçu une option de contrat de 50 millions de dollars de la BARDA pour son vaccin contre l'anthrax CYFENDUS®. Les livraisons sont prévues entre maintenant et avril 2025. Cela fait suite à une modification de contrat précédente de 30 millions de dollars pour le même vaccin. CYFENDUS®, approuvé par la FDA en juillet 2023, est un vaccin contre l'anthrax administré en deux doses pour la prophylaxie post-exposition chez les individus âgés de 18 à 65 ans.
Ce contrat renforce la préparation nationale contre l'anthrax en cas d'incidents potentiels de bioterrorisme, car l'anthrax est classé comme un agent biologique de sélection de Niveau 1. Le portefeuille d'anthrax d'Emergent comprend également le vaccin BioThrax® et deux traitements : Anthrasil® et raxibacumab.
Emergent BioSolutions (NYSE: EBS) hat von BARDA eine Vertragsoption in Höhe von 50 Millionen US-Dollar für seinen CYFENDUS® Impfstoff gegen Milzbrand erhalten. Die Lieferungen sind zwischen jetzt und April 2025 geplant. Dies folgt einer früheren Vertragsänderung über 30 Millionen US-Dollar für denselben Impfstoff. CYFENDUS®, der im Juli 2023 von der FDA zugelassen wurde, ist ein Milzbrandimpfstoff in zwei Dosen zur postexpositionellen Prophylaxe bei Personen im Alter von 18 bis 65 Jahren.
Der Vertrag stärkt die nationale Milzbrandvorbereitung gegen potenzielle bioterroristische Vorfälle, da Milzbrand als Tier-1-Biowaffen -auswahlagente klassifiziert ist. Das Milzbrandportfolio von Emergent umfasst auch den BioThrax® Impfstoff sowie zwei Behandlungen: Anthrasil® und raxibacumab.
- Secured new $50 million BARDA contract for CYFENDUS® vaccine
- Additional to recent $30 million contract modification
- Deliveries scheduled for completion by April 2025
- Maintains strong government partnership in biodefense sector
- None.
Insights
The
The company's diversified anthrax franchise, including multiple FDA-approved products (CYFENDUS®, BioThrax®, Anthrasil® and raxibacumab), demonstrates a strong competitive moat in the biodefense sector. The continued government procurement indicates stable demand and reinforces Emergent's position as a key supplier for national security preparedness.
CYFENDUS® represents a significant advancement in anthrax prevention, requiring only two doses compared to traditional vaccines. Its recent FDA approval for post-exposure prophylaxis and subsequent government contracts validate its clinical importance. The vaccine's strategic value is enhanced by anthrax's classification as a Tier 1 biological select agent, indicating its critical role in biodefense preparedness.
The comprehensive portfolio approach, combining both preventive vaccines and therapeutic treatments, positions Emergent as a full-spectrum solution provider for anthrax threats. This integrated strategy aligns with modern biodefense protocols requiring multiple layers of protection.
GAITHERSBURG, Md., Dec. 16, 2024 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today announced that the Biomedical Advanced Research and Development Authority (BARDA) within the Administration for Strategic Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services has awarded a
Deliveries are expected to begin this calendar year and be complete by April 2025. This award follows a previously announced contract modification of
CYFENDUS® vaccine was approved by the U.S. Food & Drug Administration (FDA) in July 2023 as a two-dose anthrax vaccine for post-exposure prophylaxis use in individuals 18 through 65 years of age. Anthrax is a Tier 1 biological select agent due to its potential to be used for a bioterrorist incident and threat to public health and national security.
“An anthrax emergency continues to be a significant public health threat due to its ability to be easily disseminated, lethality, and potential for widespread impact,” said Paul Williams, senior vice president, products head at Emergent. “This procurement award further bolsters anthrax preparedness and demonstrates Emergent’s commitment to public health preparedness.”
In addition to the CYFENDUS® vaccine, Emergent’s anthrax franchise includes the BioThrax® vaccine, which continues to serve a critical purpose, as well as two treatments, Anthrasil® [Anthrax Immune Globulin Intravenous (Human)], a polyclonal antibody therapeutic, and raxibacumab, a monoclonal antibody therapeutic.
This project has been supported 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 under contract HHSO100201600030C.
About CYFENDUS® (Anthrax Vaccine Adsorbed, Adjuvanted)
Indication
CYFENDUS® (Anthrax Vaccine Absorbed, Adjuvanted) is a vaccine indicated for post-exposure prophylaxis of anthrax disease following suspected or confirmed exposure to Bacillus anthracis in persons 18 through 65 years of age when given with recommended antibacterial drugs.
The efficacy of CYFENDUS® vaccine for post-exposure prophylaxis (PEP) is based solely on studies in animal models of inhalational anthrax.
Important Safety Information
Contraindication: Do not take CYFENDUS® vaccine if you are allergic to CYFENDUS® vaccine, BioThrax® (Anthrax Vaccine Adsorbed) or any ingredient of the vaccine.
Allergic reactions: Appropriate medical treatment and supervision must be available after receiving CYFENDUS® vaccine to manage possible serious allergic reactions. Get medical help right away if you have any symptoms of a serious allergic reaction.
Altered Immunocompetence: Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished immune response to CYFENDUS® vaccine.
Pregnancy: CYFENDUS® vaccine can cause fetal harm when administered to a pregnant individual. Before getting CYFENDUS® vaccine, tell your healthcare provider if you may be pregnant, plan to get pregnant soon, or are nursing a baby.
Adverse reactions: The most common adverse reactions reported were tenderness, pain, warmth, itching, swelling, redness, bruising, arm motion limitations, muscle aches, tiredness, headache, and fever.
U.S. Prescribing Information
The full Prescribing Information for CYFENDUS® vaccine can be found here.
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 plan to protect or enhance 1 billion lives by 2030, 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 development, availability, and government procurement of CYFENDUS® vaccine and the continued development of Emergent’s anthrax franchise, 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
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