Bavarian Nordic Broadcasts Grant of European Medicines Company PRIME Eligibility for its RSV Vaccine Candidate for the Prevention of Respiratory Syncytial Virus within the Aged

Bavarian Nordic A/S

Bavarian Nordic A/S

COPENHAGEN, Denmark, June 28, 2022 – Bavarian Nordic A/S (OMX: BAVA) at present introduced that the European Medicines Company (EMA) has granted entry to its Precedence Medicines Program (PRIME) for MVA-BN® RSV in lively immunization for the prevention of decrease respiratory tract illness (LRTD) brought on by respiratory syncytial virus (RSV) in adults ≥ 60 years of age. There aren’t any accredited vaccines for RSV, and entry to PRIME was granted after analysis that the accessible scientific information collectively present the potential of MVA-BN-RSV to deal with the unmet medical want within the proposed goal inhabitants.

PRIME is a program launched by the EMA to strengthen help for the event of medication focusing on an unmet medical want. By means of PRIME, the EMA gives early help to drug builders to optimize the technology of strong information on the advantages and dangers of a drug and allow accelerated evaluation of drug functions. This can assist sufferers profit as quickly as attainable from therapies that may considerably enhance their high quality of life. In line with the EMA, just one in 4 PRIME eligibility requests are granted.

For extra data on the PRIME plan, see https://www.ema.europa.eu/en/human-regulatory/research-development/prime-priority-medicines

Paul Chaplin, President and CEO of Bavarian Nordic, mentioned, “Following the granting of Breakthrough Remedy Designation by the U.S. Meals and Drug Administration (FDA) earlier this yr, we’re proud to obtain PRIME entry eligibility for our RSV vaccine candidate, permitting us to pursue accelerated growth and assessment processes with regulatory authorities in the USA and Europe. These grants spotlight the potential of our vaccine to deal with the numerous unmet want for preventive remedy, notably for older adults who could also be in danger for critical RSV issues. As we proceed to recruit into the vaccine’s world Part 3 trial, we stay up for working intently with the EMA and FDA to expedite the trail to approval.

About respiratory syncytial virus (RSV)
RSV is a typical virus that often causes delicate cold-like signs, however in extreme circumstances it could actually result in critical lung infections, together with bronchiolitis and pneumonia, which may in the end result in loss of life. These in danger usually embrace infants and the aged/immunocompromised.

It’s estimated that every yr, RSV-induced infections end in roughly 177,5251 hospitalizations and 14,0001 deaths in adults age 65 and older in the USA, much like influenza. Due to this fact, stopping RSV-induced infections is a high precedence for governments and healthcare professionals worldwide. There’s presently no accredited vaccine towards RSV. As such, RSV constitutes a big and demanding unmet medical want and a possible vaccine market of billions of {dollars} per yr.

About MVA-BN RSV
MVA-BN RSV, Bavarian Nordic’s candidate vaccine for the prevention of RSV, is being developed to be used within the aged. The vaccine incorporates 5 distinct RSV antigens to stimulate a broad immune response towards each RSV subtypes (A and B), mimicking the immune response seen following a pure response to RSV an infection. The incorporation of 5 antigens differentiates MVA-BN RSV from different RSV vaccine candidates presently in growth.

In 2021, Bavarian Nordic reported sturdy outcomes from a double-blind, placebo-controlled Part 2 scientific trial, which enrolled wholesome grownup volunteers, ages 18-50, who had been randomized to obtain both a single vaccination of MVA-BN RSV, i.e. a placebo. . The volunteers had been challenged intranasally with an RSV sort A pressure 28 days after vaccination. A complete of 61 topics had been evaluable.

The research demonstrated a big discount in viral load in vaccinated topics (n=30) in comparison with placebo (n=31), thereby assembly the first endpoint of this pivotal research. On the similar time, vaccinated topics confirmed a big discount in scientific signs generally related to RSV infections. MVA-BN RSV Vaccine Has Demonstrated Vaccine Efficacy of As much as 79% in Stopping Symptomatic RSV Infections2.

Bavarian Nordic additionally beforehand reported sturdy outcomes from a Part 2 trial of MVA-BN RSV in 421 topics aged 55 and older, demonstrating that the vaccine was effectively tolerated and induced each broad and sturdy antibody responses. and T cells towards RSV. , in addition to mucosal immune responses which may be vital for defense towards RSV. The Part 2 program in aged topics concerned revaccination of topics after one yr, following which immune responses had been quickly and considerably elevated, notably in topics with the bottom immunity earlier than the booster vaccination3.

Vaccine candidate relies on Bavarian Nordic’s proprietary MVA-BN® expertise platform, additionally used within the firm’s accredited vaccines towards smallpox, monkeypox and Ebola.

In February 2022, the U.S. Meals and Drug Administration (FDA) granted Breakthrough Remedy Designation to MVA-BN RSV, for lively immunization for the prevention of decrease respiratory tract illness brought on by respiratory syncytial virus (RSV). ) in adults aged 60 years or older.

In April 2022, Bavarian Nordic launched a world, randomized, double-blind Part 3 (VANIR) trial of MVA-BN RSV, deliberate to enroll 20,000 adults aged 60 and over. The trial is being carried out at roughly 115 websites throughout the USA and Germany and is designed to run all through the 2022/2023 RSV season, with preliminary outcomes anticipated in mid-2023 if the predefined variety of ‘decrease respiratory tract illness occasions occurred.

About Bavarian Nordic
Bavarian Nordic is a totally built-in vaccine firm targeted on creating, manufacturing and advertising life-saving vaccines. We’re a world chief in smallpox vaccines and have lengthy offered the US authorities with a non-replicating smallpox vaccine, which has been accredited by the FDA, additionally for defense towards monkeypox. The vaccine can also be accredited for defense towards smallpox and monkeypox in Canada, and as a smallpox vaccine in Europe. Our business product portfolio additionally comprises market-leading vaccines towards rabies and tick-borne encephalitis. By means of our stay virus vaccine platform expertise, MVA-BN®, we now have created a various portfolio of proprietary and partnered product candidates designed to avoid wasting and enhance lives by unleashing the ability of the immune system, together with an Ebola vaccine, which is licensed to the Janssen Pharmaceutical Corporations of Johnson & Johnson. We’re additionally engaged within the growth of a next-generation COVID-19 vaccine. For extra data, go to www.bavarian-nordic.com.

Ahead-looking statements
This announcement contains forward-looking statements that contain dangers, uncertainties and different elements, a lot of that are past our management, that might trigger precise outcomes to vary materially from these mentioned within the forward-looking statements. Ahead-looking statements embrace statements concerning our plans, goals, targets, future occasions, efficiency and/or different data that’s not historic data. All such forward-looking statements are expressly certified by these cautionary statements and every other cautionary statements which will accompany the forward-looking statements. We undertake no obligation to publicly replace or revise any forward-looking statements to replicate occasions or circumstances after the date of publication, besides as required by legislation.

contacts
Europe: Rolf Sass Sørensen, Vice President Investor Relations, tel. : +45 61 77 47 43
United States: Graham Morrell, Paddock Circle Advisors, graham@paddockcircle.comSuch. : +1 781 686 9600

1 Falsey AR, Hennessey PA, Formica MA, Cox C, Walsh EE. Respiratory syncytial virus an infection within the aged and high-risk adults. N Engl J Med. 2005 Apr 28;352(17):1749–59

2 https://www.resvinet.org/uploads/2/2/2/7/22271200/abstract_booklet_rsvvw21.pdf

3 Jordan E et al. 2010. J. Infect, Dis. 28:223(6). 1062-1072

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