GlobeNewswire by notified

Bavarian Nordic to Manufacture First Freeze-dried Doses of Smallpox Vaccine upon Exercise of Contract Option by the U.S. Government

Share
  • 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

Attachment

To view this piece of content from www.globenewswire.com, please give your consent at the top of this page.
To view this piece of content from ml-eu.globenewswire.com, please give your consent at the top of this page.

About GlobeNewswire by notified

GlobeNewswire by notified
GlobeNewswire by notified
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://notified.com

GlobeNewswire by notified is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Subscribe to releases from GlobeNewswire by notified

Subscribe to all the latest releases from GlobeNewswire by notified by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire by notified

Report – ERYTECH’s Combined Shareholders’ Meeting On June 24, 202224.6.2022 22:05:00 CEST | Press release

REPORT –ERYTECH’S COMBINED SHAREHOLDERS’ MEETING ON JUNE 24, 2022 Cambridge, MA (U.S.) and Lyon (France), June24, 2022 – ERYTECH Pharma (Nasdaq& Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, today announcedthat its Annual General Meeting was held on Friday, June 24, 2022. At the meeting, all resolutions for which the Board of Directors recommended a vote in favor were adopted, including: Approval of the annual financial statements and consolidated financial statements for the year ended December 31, 2021;Allocation of the financial year's results;Approval of the statutory auditors’ special report on regulated agreements and commitments with related parties;Approval of the elements of total compensation and benefits paid or allocated for the year ended December 31, 2021, to Gil BEYEN, Chief Executive Officer and Jean-Paul KRESS, Chairman of the Board;Approval of the compens

Cleantech Building Materials: Results of Annual General Meeting24.6.2022 14:54:27 CEST | Press release

24 June 2022 CLEANTECH BUILDING MATERIALS PLC, NASDAQ FIRST NORTH GROWTH MARKET, COPENHAGEN TICKER: CBM ISIN: GBOOBD1LVD21 CLEANTECH BUILDING MATERIALS PLC Results of Annual General Meeting The Annual General Meeting (“AGM”) of Cleantech Building Materials plc (“CBM” or the “Company”) was held in London earlier today, 24 June 2022. Details of the resolutions to be considered at the AGM were published in the Notice of AGM which was posted to Shareholders on 1 June 2022 and is available on the Company’s website: www.cbm-plc.com. All resolutions as set out in the Notice of AGM were duly passed without discussion. In particular, the following resolutions were passed at the AGM. The AGM resolved to authorise the directors of the Company to allot shares and grant rights to subscribe for, or convert any security, into shares. The directors of the Company sought authority for the purposes of section 551 of the Companies Act to exercise all the powers of the Company to allot shares and grant ri

Novartis receives positive CHMP opinion for Scemblix®, a novel treatment for adult patients with chronic myeloid leukemia24.6.2022 13:13:19 CEST | Press release

With unique STAMP mechanism of action, Scemblix could provide a new option for patients in Europe with chronic myeloid leukemia (CML) who have suffered intolerance or inadequate response with at least two prior tyrosine kinase inhibitor treatments1 Positive opinion based on data from pivotal Phase III ASCEMBL trial, showing a near doubling in major molecular response rate for patients treated with Scemblix® (asciminib) vs. Bosulif®* (bosutinib) (25.5% vs. 13.2%) and more than three times lower discontinuation rate due to adverse reactions (5.8% vs 21.1%) at 24 weeks1 CHMP recommendation comes after the approval of Scemblix by the US FDA and other countries’ regulatory authorities, potentially broadening access for more patients to Novartis transformative therapies in CML Basel, June 24, 2022 — Novartis today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting marketing au

Clariant’s shareholders approve all agenda items24.6.2022 11:30:00 CEST | Press release

AD HOC ANNOUNCEMENT PURSUANT TO ART. 53 LR Integrated Report and Group Consolidated Financial Statements for fiscal year 2021 approvedGünter von Au reelected as Chairman of the Board of DirectorsThree new candidates join the Board of Directors: Ahmed Mohamed Alumar, Roberto César Gualdoni, Naveena ShastriConfirmed distribution of CHF 0.40 per shareKPMG confirmed as statutory auditor from 2022 MUTTENZ, JUNE 24, 2022 Clariant, a focused, sustainable, and innovative specialty chemical company, today held its 27th Annual General Meeting (AGM) where the shareholders approved all agenda items and resolutions as proposed by the Board of Directors. The AGM was held virtually, where shareholders were able to exercise their rights exclusively via the independent proxy. Overall, 698'945'298 shares or around 70.19 % of the share capital of Clariant were represented. Günter von Au was reelected as Chairman of the Board of Directors. Additionally, three new members were voted to join by a large majo

Cool Company Ltd. – Mandatory Notification Of Trade24.6.2022 11:01:19 CEST | Press release

EPS Ventures Ltd., close associate of Cyril Ducau, Chair of the Board of Cool Company Ltd. (the “Company”), has on 23 June 2022 acquired 7,865 shares in the Company at a price of NOK 90.274882 per share. Following the transaction, EPS Ventures Ltd. holds a total of 15,591,218 shares in the Company, equivalent to 38.97% of the Company’s shares. Please see the attached notification form in accordance with the Market Abuse Regulation article 19. This information is subject to the disclosure requirements pursuant to Section 5-12 the Norwegian Securities Trading Act Attachment Primary insider notification form