GlobeNewswire by notified

Bavarian Nordic Expands Capacity with U.S. Contract Manufacturer for Filling of Smallpox/Monkeypox Vaccines

Share
  • U.S. FDA approved facility operated by Grand River Aseptic Manufacturing will assist in filling of already manufactured bulk vaccine to expedite deliveries of monkeypox vaccines to the U.S.
  • Agreement will significantly expand Bavarian Nordic’s manufacturing capacity for the benefit of the U.S. and globally
  • Expedited tech transfer has already started, allowing for manufacturing of first doses in 2022

COPENHAGEN, Denmark, August 18, 2022 – Bavarian Nordic A/S (OMX: BAVA) announced today that the Company has entered into an agreement with Grand River Aseptic Manufacturing (GRAM), a U.S. based contract manufacturer, for fill and finish of JYNNEOS smallpox/monkeypox vaccine. As announced on July 15, 2022, Bavarian Nordic received an additional order for 2.5 million doses the vaccine from the U.S. Biomedical Advanced Research and Development Authority (BARDA), a part of the Administration for Strategic Preparedness and Response (ASPR), which will be filled at GRAM using bulk vaccine already manufactured and invoiced under previous contracts with BARDA. Combined with previous orders, BARDA has requested a total of 5.5 million doses for delivery in 2022 and 2023.

The tech transfer of the production process to GRAM has already been initiated. The aim is to complete the tech transfer within three months – a process which could normally take up to nine months, thus enabling GRAM to start manufacturing later this year.

By adding the capacity of GRAM to fulfil a significant part of the orders from BARDA, Bavarian Nordic will be able to expedite delivery of vials to the U.S. while also freeing up capacity for other countries. The Company has already taken several steps to increase the filling capacity at its own manufacturing site in Denmark, now operating at double the capacity as before the monkeypox outbreak in May 2022 with an expectation to further increase over the coming months. Additionally, the Company’s bulk manufacturing is now operational after a planned shutdown, allowing for production of new bulk vaccine. In parallel, the Company is exploring additional partnerships to further increase the manufacturing capacity in order to improve global access to the vaccine.

Bob Fenton, Coordinator of the White House National Monkeypox Response said: “Rapidly increasing the supply and safe delivery of monkeypox vaccine to Americans at the highest risk of contracting the virus is a top priority for President Biden. This partnership between Bavarian Nordic and GRAM will significantly increase the capacity to fill and finish government-owned doses – for the first time in the U.S. – and allow us to deliver our current and future supply more quickly to locations nationwide.” 

Paul Chaplin, President and CEO of Bavarian Nordic said: “We have been working diligently since the beginning of the monkeypox outbreak to expand our manufacturing capacity and the agreement with GRAM is an important step. With this agreement we will significantly expand our manufacturing capabilities into the United States allowing Bavarian Nordic to meet the growing worldwide demand.”

About our 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. The Company has supplied nearly 30 million doses of the vaccine to the U.S., with the vast majority being delivered for emergency use - and now expired - before approval of the vaccine by the FDA in 2019, which included an approval for the monkeypox indication as the only vaccine having obtained this to-date.

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 for supply of freeze-dried vaccines. Under this contract Bavarian Nordic has produced bulk vaccine, corresponding to approximately 13 million doses. In May 2022, BARDA exercised the first contract options for conversion of the bulk vaccine to freeze-dried doses, anticipated for delivery in 2023-2025. In light of the current global monkeypox outbreak, BARDA has requested 5.5 million doses to be manufactured and delivered in 2022 and 2023 using the existing bulk vaccine, which will be filled in the current liquid-frozen formulation.

About Grand River Aseptic Manufacturing, Inc.
Grand River Aseptic Manufacturing, Inc., a prominent parenteral drug contract development and manufacturing organization with advanced technology, delivers customized solutions to meet clients’ fill and finish needs from development through commercialization. With capabilities for biologics, small molecules and vaccines, Grand River Aseptic Manufacturing’s elite equipment and staff supports pharmaceutical development and cGMP manufacturing, analytical testing, and regulatory filing.

About the Administration for Strategic Preparedness and Response
ASPR, an agency within the U.S. Department of Health and Human Services, leads the nation's medical and public health preparedness for, response to, and recovery from disasters and public health emergencies. Within ASPR, BARDA invests in the innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products – needed to combat health security threats.

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 also approved 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.

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

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

Remuneration of Director by distribution of Millicom (Tigo) shares23.9.2022 23:00:00 CEST | Press release

Remuneration of Director by distribution of Millicom (Tigo) shares Luxembourg, September 23, 2022 – Millicom International Cellular S.A. ("Millicom") announces that, in accordance with the resolution of its shareholders at the annual general meeting held on May 4, 2022, it has distributed a total of 1,150 shares to one of the members of its Board of Directors as part of their non-executive director remuneration for the period from the date of the 2022 AGM to the 2023 AGM, to be held in May 2023. Details of the distributions are disclosed on Millicom’s website. -END- For further information, please contact Press: Yocasta Valdez, Sr. Manager Digital Media & Corporate Communications press@millicom.comInvestors: Michel Morin, VP Investor Relations Sarah Inmon, Director Investor Relations investors@millicom.com About Millicom Millicom (NASDAQ U.S.: TIGO, Nasdaq Stockholm: TIGO_SDB) is a leading provider of fixed and mobile telecommunications services in Latin America. Through our TIGO® and

Enento Group signed EUR 180 million syndicated loan agreement23.9.2022 16:00:00 CEST | Press release

ENENTO GROUP PLC, INVESTOR NEWS ON 23 SEPTEMBER 2022 AT 5.00 P.M. EET Enento Group signed EUR 180 million syndicated loan agreement Enento Group has today signed a new long-term financing agreement to be used for refinancing of its current financing arrangement. The financing agreement consists of a EUR 150 million long-term loan as well as a EUR 30 million revolving credit facility. The agreement is for three years and includes two one-year options for extension of the loan period. The loan replaces the financing agreement that was signed in October 2018 of a EUR 160 million long-term loan and a EUR 20 million revolving credit facility. The revolving credit facility has been unutilised. The margins of the financing agreement are linked to Enento Group´s financial covenants and include an option to link the margin also to sustainability criteria in the future. OP Corporate Bank, Danske Bank and Nordea Bank were acting as Mandated Lead Arrangers and Bookrunners. OP Corporate Bank acted

Nordic American Tankers Ltd (NYSE: NAT) – Solid rates and earnings23.9.2022 14:55:12 CEST | Press release

Friday, September 23, 2022 Dear Shareholders and Investors, This is to reconfirm that the business of NAT(rates, earnings) is solid and prospects are good. For contacts, please see at the end of this communication. Sincerely, Herbjorn Hansson Founder, Chairman & CEO Nordic American Tankers Limited CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS Matters discussed in this press release may constitute forward-looking statements. The Private Securities Litigation Reform Act of 1995 provides safe harbor protections for forward-looking statements in order to encourage companies to provide prospective information about their business. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions and other statements, which are other than statements of historical facts. The Company desires to take advantage of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and

Rolf Jansson appointed acting Managing Director of Leipurin23.9.2022 12:00:00 CEST | Press release

Aspo Plc Stock exchange release September 23, 2022 at 1 p.m. Rolf Jansson appointed acting Managing Director of Leipurin The last workday of Heli Arantola, CEO of Aspo Group subsidiary Leipurin, has been specified as September 30, 2022. As announced on Aspo’s stock exchange release on June 27, 2022, Arantola has resigned to join another company. Aspo Group’s CEO Rolf Jansson will take on the role of acting Managing Director of Leipurin from October 1, 2022. In addition, Aspo’s Vice President of Corporate Development Mikko Heikkilä takes responsibility for Leipurin’s selected strategic projects. The selection process for Leipurin’s new Managing Director is underway. Aspo Plc Rolf Jansson CEO Further information, please contact: Rolf Jansson, CEO, Aspo Plc, tel. +358 400 600 264, rolf.jansson@aspo.com Distribution: Nasdaq Helsinki Key media www.aspo.com Aspo creates value by owning and developing business operations sustainably and in the long term. Our companies aim to be market leaders

Norsk Hydro: Primærinnsider Helena Nonka selger aksjer23.9.2022 11:20:00 CEST | Pressemelding

Helena Nonka, konserndirektør for Corporate Development, har den 23. september 2022 solgt 1528 aksjer til 59,58 kroner per aksje. I mai 2022, ble Helena Nonka tildelt disse 1528 aksjene under langtidsinsentivprogrammet (LTI) som medlem av konsernledelsen. Helena Nonka har besluttet å forlate Hydro, og hennes siste dag vil være 30. september 2022. Provenyet fra salget skal tilfalle Norsk Hydro ASA. Denne opplysningen er informasjonspliktig etter verdipapirhandelloven §5-12. Investorkontakt: Line Haugetraa +47 41406376 line.haugetraa@hydro.com Mediakontakt: Halvor Molland +47 92979797 Halvor.Molland@hydro.com Vedlegg KRT 1500 Helena Nonka 2022 23 09