Bavarian Nordic Announces Grant of European Medicines Agency PRIME Eligibility for its RSV Vaccine Candidate for the Prevention of Respiratory Syncytial Virus in the Elderly

Bavarian Nordic A/S

COPENHAGEN, Denmark, June 28, 2022 – Bavarian Nordic A/S (OMX: BAVA) today announced that the European Medicines Agency (EMA) has granted access to its Priority Medicines Program (PRIME) for MVA-BN® RSV in active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults ≥ 60 years of age. There are no approved vaccines for RSV, and access to PRIME was granted after evaluation that the available clinical data collectively show the potential of MVA-BN-RSV to address the unmet medical need in the proposed target population.

PRIME is a program launched by the EMA to strengthen support for the development of drugs targeting an unmet medical need. Through PRIME, the EMA offers early support to drug developers to optimize the generation of robust data on the benefits and risks of a drug and enable accelerated assessment of drug applications. This will help patients benefit as soon as possible from therapies that can significantly improve their quality of life. According to the EMA, only 1 in 4 PRIME eligibility requests are granted.

For more information 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, said, “Following the granting of Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) earlier this year, we are proud to receive PRIME access eligibility for our RSV vaccine candidate, allowing us to pursue accelerated development and review processes with regulatory authorities in the United States and Europe. These grants highlight the potential of our vaccine to address the significant unmet need for preventive treatment, particularly for older adults who may be at risk for serious RSV complications. As we continue to recruit into the vaccine’s global Phase 3 trial, we look forward to working closely with the EMA and FDA to expedite the path to approval.

About respiratory syncytial virus (RSV)
RSV is a common virus that usually causes mild cold-like symptoms, but in severe cases it can lead to serious lung infections, including bronchiolitis and pneumonia, which can ultimately lead to death. Those at risk generally include infants and the elderly/immunocompromised.

It is estimated that each year, RSV-induced infections result in approximately 177,5251 hospitalizations and 14,0001 deaths in adults age 65 and older in the United States, similar to influenza. Therefore, preventing RSV-induced infections is a top priority for governments and healthcare professionals worldwide. There is currently no approved vaccine against RSV. As such, RSV constitutes a significant and critical unmet medical need and a potential vaccine market of billions of dollars per year.

About MVA-BN RSV
MVA-BN RSV, Bavarian Nordic’s candidate vaccine for the prevention of RSV, is being developed for use in the elderly. The vaccine incorporates five distinct RSV antigens to stimulate a broad immune response against both RSV subtypes (A and B), mimicking the immune response seen following a natural response to RSV infection. The incorporation of five antigens differentiates MVA-BN RSV from other RSV vaccine candidates currently in development.

In 2021, Bavarian Nordic reported strong results from a double-blind, placebo-controlled Phase 2 clinical trial, which enrolled healthy adult volunteers, ages 18-50, who were randomized to receive either a single vaccination of MVA-BN RSV, i.e. a placebo. . The volunteers were challenged intranasally with an RSV type A strain 28 days after vaccination. A total of 61 subjects were evaluable.

The study demonstrated a significant reduction in viral load in vaccinated subjects (n=30) compared to placebo (n=31), thereby meeting the primary endpoint of this pivotal study. At the same time, vaccinated subjects showed a significant reduction in clinical symptoms commonly associated with RSV infections. MVA-BN RSV Vaccine Has Demonstrated Vaccine Efficacy of Up to 79% in Preventing Symptomatic RSV Infections2.

Bavarian Nordic also previously reported strong results from a Phase 2 trial of MVA-BN RSV in 421 subjects aged 55 and older, demonstrating that the vaccine was well tolerated and induced both broad and durable antibody responses. and T cells against RSV. , as well as mucosal immune responses that may be important for protection against RSV. The Phase 2 program in elderly subjects involved revaccination of subjects after one year, following which immune responses were rapidly and significantly increased, particularly in subjects with the lowest immunity before the booster vaccination3.

Vaccine candidate is based on Bavarian Nordic’s proprietary MVA-BN® technology platform, also used in the company’s approved vaccines against smallpox, monkeypox and Ebola.

In February 2022, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to MVA-BN RSV, for active immunization for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV). ) in adults aged 60 years or older.

In April 2022, Bavarian Nordic launched a global, randomized, double-blind Phase 3 (VANIR) trial of MVA-BN RSV, planned to enroll 20,000 adults aged 60 and over. The trial is being conducted at approximately 115 sites across the United States and Germany and is designed to run throughout the 2022/2023 RSV season, with initial results expected in mid-2023 if the predefined number of ‘lower respiratory tract disease events occurred.

About Bavarian Nordic
Bavarian Nordic is a fully integrated vaccine company focused on developing, manufacturing and marketing life-saving vaccines. We are a world leader in smallpox vaccines and have long provided the US government with a non-replicating smallpox vaccine, which has been approved by the FDA, also for protection against monkeypox. The vaccine is also approved for protection against smallpox and monkeypox in Canada, and as a smallpox vaccine in Europe. Our commercial product portfolio also contains market-leading vaccines against rabies and tick-borne encephalitis. Through 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 unleashing the power of the immune system, including an Ebola vaccine, which is licensed to the Janssen Pharmaceutical Companies of Johnson & Johnson. We are also engaged in 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 beyond our control, that could cause actual results to differ materially from those discussed in the forward-looking statements. Forward-looking statements include statements regarding 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 that may accompany the forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements to reflect events or circumstances after the date of publication, except as required by law.

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 infection in the elderly 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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