Bavarian Nordic Delivers Smallpox Vaccine to England in Response to Current Monkeypox Cases

COPENHAGEN, Denmark, September 19, 2018 - After the confirmation on Friday 7^th September 2018 of the first case of human monkeypox in England, Public Health England (PHE), as part of their response, engaged Bavarian Nordic to assist in the supply of its IMVANEX^® smallpox vaccine, which is approved in the European Union. The vaccine has now been used to vaccinate healthcare workers treating the patients and those involved in their care. IMVANEX is not approved for monkeypox, however, in the past when smallpox vaccines were routinely administered, they were shown also to be highly efficacious in preventing monkeypox. 

Only a few days after the first case, a second, unrelated case was reported in the UK. According to PHE, both patients are believed to have acquired the infection in Nigeria, which recently experienced a large outbreak of monkeypox. Bavarian Nordic continues to work closely with PHE to ensure a sufficient and rapid supply of additional vaccines, should the need arise. 

Monkeypox is similar to human smallpox, although it is less transmissible human-to-human and less deadly with an estimated fatality rate of 1-10%. There are no approved vaccines for the prevention of monkeypox.

Currently, a field study is ongoing to evaluate IMVANEX (also known as IMVAMUNE) for the prevention of monkeypox in the Democratic Republic of the Congo, where the virus is naturally occurring, and is known to infect humans. The study, which is conducted in collaboration between Bavarian Nordic, local health authorities and the U.S. Centers for Disease Control and Prevention (CDC) who is also sponsor of the study, has enrolled over 1,000 healthcare and frontline workers who in their daily work are at high risk of being infected with the virus. 

"We are pleased to assist the PHE in this emergency situation, which has required the prompt action from all involved parties, and I am happy that we have been able to respond with such short notice," said Paul Chaplin, President and CEO of Bavarian Nordic. 

Additional information on monkeypox, the reported cases in England, and the ongoing study in DR Congo is available at the following sources:

Public Health England updates: https://www.gov.uk/government/news/monkeypox-case-in-england
WHO fact sheet on monkeypox: http://www.who.int/news-room/fact-sheets/detail/monkeypox
CDC study of IMVAMUNE: https://clinicaltrials.gov/ct2/show/study/NCT02977715

About Bavarian Nordic
Bavarian Nordic (OMX: BAVA, OTC: BVNRY) is a fully integrated biotechnology company focused on the development of innovative and safe therapies against cancer and infectious diseases. Using our live virus vaccine platform technology, MVA-BN^®, we have created a diverse portfolio of proprietary and partnered product candidates intended to improve the health and quality of life for children and adults. We supply our IMVAMUNE^® non-replicating smallpox vaccine to the U.S. Strategic National Stockpile and other government stockpiles. The vaccine is approved in the European Union (under the trade name IMVANEX^®) and in Canada. Registration studies are currently underway in the U.S. In addition to our long-standing collaboration with the U.S. government on the development of IMVAMUNE^® and other medical countermeasures, our infectious disease pipeline comprises a proprietary RSV program as well as vaccine candidates for Ebola, HPV, HBV and HIV, which are developed through a strategic partnership with Janssen. Additionally, in collaboration with the National Cancer Institute, we have developed a portfolio of active cancer immunotherapies, designed to alter the disease course by eliciting a robust and broad anti-cancer immune response while maintaining a favorable risk-benefit profile. Through multiple industry collaborations, we seek to explore the potential synergies of combining our immunotherapies with other immune-modulating agents, e.g. checkpoint inhibitors. For more information visit www.bavarian-nordic.com or follow us on Twitter @bavariannordic.

Contacts
Rolf Sass Sørensen
Vice President Investor Relations (EU)
Tel: +45 61 77 47 43 

Graham Morrell
Paddock Circle Advisors (US)
graham@paddockcircle.com
Tel: +1 781 686 9600

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