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Las autoridades sanitarias de Estados Unidos acaban de firmar un acuerdo por 119 millones de dólares que se destinarán a la compra de vacunas contra el «nuevo virus» de la viruela del simio, después de que ayer se anunciara un posible caso de un hombre en Massachusetts y hoy se hayan anunciado seis posibles casos más.

 

La Autoridad de Investigación y Desarrollo Biomédico Avanzado, agencia gubernamental dedicada a combatir las pandemias y el bioterrorismo, firmó el contrato millonario con la farmacéutica danesa Bavarian Nordic según ha dado a conocer la propia compañía mediante este comunicado.

 

BAVARIAN NORDIC TO MANUFACTURE FIRST FREEZE-DRIED DOSES OF SMALLPOX VACCINE UPON EXERCISE OF CONTRACT OPTION BY THE U.S. GOVERNMENT

• USD 119 million option exercised for the manufacturing of freeze-dried JYNNEOS^® in 2023 and 2024
• This represents the first set of options with a total value of USD 299 million to convert the existing bulk vaccine, previously purchased by BARDA, to approximately 13 million freeze-dried JYNNEOS doses

COPENHAGEN, Denmark, May 18, 2022 – Bavarian Nordic A/S (OMX: BAVA) announced today that the U.S. Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, has exercised the first options under the contract to supply a freeze-dried version of JYNNEOS^® smallpox vaccine, thus allowing for the first doses of this version to be manufactured and invoiced in 2023 and 2024.

The options have a value of USD 119 million and represent the first options exercised to convert bulk vaccine, which has already been manufactured and invoiced under previous contracts with BARDA, into freeze dried doses of JYNNEOS smallpox vaccine. Additional options on the contract valued at USD 180 million, if exercised support conversion of up to a total of approximately 13 million freeze dried doses of JYNNEOS smallpox vaccine that are expected to be manufactured in 2024 and 2025. The majority of the bulk vaccine for these doses has already been manufactured and invoiced.

The transfer of the freeze-drying process to our new fill and finish plant in Kvistgaard was initiated last year and following an FDA inspection in 2022 will lead to commercial manufacturing in 2023. A supplement to the existing liquid frozen JYNNEOS BLA will be made comprising the Phase 3 data, which has already been completed and reported, together with the manufacturing data to support the approval of the freeze-dried version of JYNNEOS in 2024. In parallel to these activities, we will, with the award of this first option, begin to manufacture and invoice freeze-dried JYNNEOS doses in 2023 and 2024.

Paul Chaplin, President and CEO of Bavarian Nordic said: “We are pleased to announce the exercise of the first options under our contract with the U.S. government to deliver a freeze-dried version of the smallpox vaccine with an improved shelf-life, which will be manufactured at our new fill and finish facility. This marks a significant milestone in our long-standing partnership with the U.S. government to ensure availability of life-saving vaccines for the entire population.”

The contents of this announcement do not affect the Company’s expectations for the financial results for 2022.

This project has been supported in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201700019C.

About our smallpox vaccine contracts with the U.S. government
Since 2003, Bavarian Nordic has worked with the U.S. government on the development, manufacturing and supply of a non-replicating smallpox vaccine to ensure all populations can be protected from smallpox, including people with weakened immune systems who are at high risk of adverse reactions to traditional smallpox vaccines, which are based on replicating vaccinia virus strains. To date, the Company has supplied nearly 30 million doses of the liquid-frozen version to HHS, with the vast majority being delivered for emergency use before approval of the vaccine by the FDA in 2019.

Since 2009, BARDA has supported the development of a freeze-dried version of the vaccine with longer shelf-life to replace the stockpile and in 2017 awarded the Company a ten-year contract valued at USD 539 million for supply of freeze-dried vaccines. Part of this contract (USD 37 million) has funded the Phase 3 study. Also, under this contract Bavarian Nordic has produced bulk vaccine worth of USD 253 million which will add to the existing stock of bulk manufactured under previous orders, collectively resulting in approximately 13 million doses for future delivery. The majority of the contract (USD 299 million), however, will be realized upon supply of the freeze-dried doses, which will be manufactured at the Company’s the new fill-finish facility.

About Bavarian Nordic
Bavarian Nordic is a fully integrated vaccines company focused on the development, manufacturing and commercialization of life-saving vaccines. We are a global leader in smallpox vaccines and have been a long-term supplier to the U.S. Government of a non-replicating smallpox vaccine, which has been approved by the FDA, also for the protection against monkeypox. The vaccine is approved as a smallpox vaccine in Europe and Canada. Our commercial product portfolio furthermore contains market-leading vaccines against rabies and tick-borne encephalitis. Using our live virus vaccine platform technology, MVA-BN^®, we have created a diverse portfolio of proprietary and partnered product candidates designed to save and improve lives by unlocking the power of the immune system, including an Ebola vaccine, which is licensed to the Janssen Pharmaceutical Companies of Johnson & Johnson. We are also committed to the development of a next generation COVID-19 vaccine. For more information visit www.bavarian-nordic.com.

Forward-looking statements
This announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of our control, that could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning our plans, objectives, goals, future events, performance and/or other information that is not historical information. All such forward-looking statements are expressly qualified by these cautionary statements and any other cautionary statements which may accompany the forward-looking statements. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law.

Contacts
Europe: Rolf Sass Sørensen, Vice President Investor Relations, Tel: +45 61 77 47 43
US: Graham Morrell, Paddock Circle Advisors, graham@paddockcircle.com, Tel: +1 781 686 9600

Company Announcement no. 17 / 2022

Published on May 18, 2022, 7:25 CET

 

 

Comunicado de Bavarian Nordic

En el comunicado de la compañía farmacéutica se informa de que fabricarán las primeras dosis liofilizadas de la vacuna contra la viruela tras el ejercicio de la opción de contrato por parte del Gobierno de Estados Unidos.

En el texto puede leerse que «Bavarian Nordic A/S (OMX: BAVA) anunció hoy (por el 18 de mayo) que la Autoridad de Investigación y Desarrollo Biomédico Avanzado de EE. UU. (BARDA), parte de la Oficina del Subsecretario de Preparación y Respuesta del Departamento de EE. de Salud y Servicios Humanos, ha ejercido las primeras opciones del contrato de suministro de una versión liofilizada de la vacuna contra la viruela JYNNEOS® ^, lo que permitirá fabricar y facturar las primeras dosis de esta versión en 2023 y 2024.»

«Las opciones tienen un valor de USD 119 millones y representan las primeras opciones ejercidas para convertir la vacuna a granel, que ya ha sido fabricada y facturada bajo contratos anteriores con BARDA, en dosis liofilizadas de vacuna contra la viruela JYNNEOS. Las opciones adicionales sobre el contrato valoradas en USD 180 millones, si se ejercen, respaldan la conversión de hasta un total de aproximadamente 13 millones de dosis liofilizadas de la vacuna contra la viruela JYNNEOS que se espera fabricar en 2024 y 2025. La mayoría de la vacuna a granel para estos dosis ya ha sido fabricada y facturada.«

La transferencia del proceso de liofilización a la nueva planta, según informa la compañía, para el llenado y acabado en Kvistgaard se inició el año pasado, y tras una inspección de la FDA en 2022, se llevará a cabo la producción comercial en 2023.

La compañía explica que «desde 2003, Bavarian Nordic ha trabajado con el gobierno de los EE. UU. en el desarrollo, la fabricación y el suministro de una vacuna contra la viruela que no se replica para garantizar que todas las poblaciones puedan estar protegidas contra la viruela, incluidas las personas con sistemas inmunitarios debilitados que corren un alto riesgo de reacciones adversas a las vacunas tradicionales contra la viruela, que se basan en la replicación de cepas del virus vaccinia. Hasta la fecha, la empresa ha suministrado casi 30 millones de dosis de la versión líquida congelada al HHS, y la gran mayoría se entregó para uso de emergencia antes de que la FDA aprobara la vacuna en 2019.»

«Desde 2009, BARDA ha apoyado el desarrollo de una versión liofilizada de la vacuna con una vida útil más larga para reemplazar la reserva y en 2017 otorgó a la Compañía un contrato de diez años valorado en USD 539 millones para el suministro de vacunas liofilizadas. Parte de este contrato (USD 37 millones) ha financiado el estudio de Fase 3. Además, en virtud de este contrato, Bavarian Nordic ha producido vacunas a granel por valor de 253 millones de dólares estadounidenses, que se sumarán a las existencias existentes de vacunas a granel fabricadas bajo pedidos anteriores, lo que en conjunto dará como resultado aproximadamente 13 millones de dosis para entregas futuras. Sin embargo, la mayor parte del contrato (USD 299 millones) se realizará con el suministro de las dosis liofilizadas, que se fabricarán en la nueva planta de llenado y acabado de la Compañía.»

 

 

 

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