Bavarian Nordic today announced the initiation of full commercial operations in the U.S. only eight months after completing the acquisition of the manufacturing and global rights to Rabipur®/RabAvert® (Rabies Vaccine) and Encepur® (Tick-Borne Encephalitis Vaccine) from GlaxoSmithKline plc (GSK). This ensures complete distribution and marketing of RabAvert in the U.S., a major milestone in the commercial transformation at Bavarian Nordic, advancing the company’s robust infectious disease and vaccines franchise.
Every 10 minutes a person in the U.S. starts post-exposure rabies vaccinations after a suspicious animal bite. Left untreated, rabies is almost always fatal. RabAvert is a sterile, freeze-dried rabies vaccine for both pre-exposure and post-exposure vaccination in all age groups.
"At Bavarian Nordic, we have a compelling infrastructure that aligns with the critical vaccine market needs from basic research and development to commercial operations, manufacturing and distribution," stated Paul Chaplin, President and CEO of Bavarian Nordic. "We are proud of the speed at which we managed to establish our commercial presence in the U.S. enabling the full commercial support of RabAvert."
LONG-TERM COMMITMENT TO VACCINE DEVELOPMENT AND DISTRIBUTION
Bavarian Nordic’s concentrated focus in vaccines is exemplified through their proprietary and innovative MVA-BN technology, which drives research and development as well as commercialization of life-saving vaccines including Respiratory Syncytial Virus (RSV), Cancer Immunotherapies, and the first vaccine to treat Equine Encephalitis, currently in clinical trials.
Expanding where there are significant needs, the company continues to seek scientific collaborations that address the most critical world challenges in vaccines. In May 2020, Bavarian Nordic entered into an exclusive agreement with AdaptVac to advance a potential COVID-19 vaccine into clinical trials. Bavarian Nordic also has a history of supply reliability and dedication that has led to key distributions advancements, including a long-term partnership with the U.S. Government, most recently supplying smallpox vaccine to the U.S. Strategic National Stockpile for emergency use.
"Our impressive talent base made the quick transition to commercialization possible and we will continue to do what we do best; develop and distribute life-saving vaccines to protect people at risk," stated Jean-Christophe May, Executive Vice President and Chief Commercial Officer. "We celebrate this milestone as we continue to expand our commercial footprint to include 36 countries around the world, ensuring a reliable supply of our vaccines, wherever and whenever they are needed."
About Bavarian Nordic
Bavarian Nordic is a fully integrated biotechnology company focused on the development, manufacture 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. Strategic National Stockpile of a non-replicating smallpox vaccine, which has been approved by the FDA under the trade name JYNNEOS®. The vaccine is approved as a smallpox vaccine in Europe under the trade name IMVANEX® and in Canada under the trade name IMVAMUNE®. Our commercial product portfolio furthermore contains the market-leading vaccine Rabipur®/RabAvert® against rabies; Encepur® against tick-borne encephalitis and a vaccine against Ebola (ZABDENO® and MVABEA®) that has been licensed to Janssen. 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 therapeutic vaccines against Human Papillomavirus (HPV), Hepatitis B and Human Immunodeficiency Virus (HIV), licensed to Janssen. For more information visit www.bavarian-nordic.com.
About RabAvert (Rabies Vaccine) in the U.S.
RabAvert is indicated for preexposure vaccination, in both primary series and booster dose, and for postexposure prophylaxis against rabies in all age groups.
Important Safety Information about RabAvert
Patients considered to be at risk of a severe hypersensitivity reaction (e.g. anaphylaxis) to RabAvert or any of its components should receive an alternative rabies vaccine if a suitable product is available. However, in view of the almost invariably fatal outcome of rabies, there is no contraindication to post-exposure prophylaxis, including pregnancy.
RabAvert is contraindicated for pre-exposure vaccination in anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to the vaccine or any of its components, which include residues of egg and chicken proteins to which some individuals may be hypersensitive.
Review immunization history for possible vaccine sensitivity and previous vaccination-related adverse reactions, as well as medical history for emergence of clinical symptoms of anaphylaxis after exposure to egg or chicken proteins, which Rabavert contains. Reconstituted RabAvert also contains processed bovine gelatin and trace amounts of neomycin, chlortetracycline, and amphotericin B, to which some individuals may be hypersensitive. Appropriate medical treatment—including immediately available epinephrine injection (1:1,000), and readily available volume replacement, corticosteroids, and oxygen—must be close at hand to manage possible anaphylactic reactions following administration of RabAvert.
Anaphylaxis, meningitis; neuroparalytic events such as encephalitis, transient paralysis; Guillain-Barré Syndrome; myelitis; retrobulbar neuritis; and multiple sclerosis have in very rare cases been reported in temporal association with the use of RabAvert.
For intramuscular use only. Unintentional intravascular injection may result in systemic reactions, including shock.
Syncope (fainting) can occur in association with administration of injectable vaccines, including RabAvert. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.
Development of active immunity after vaccination may be impaired in immune-compromised individuals. Radiation therapy, antimalarials, corticosteroids, other immunosuppressive agents, and immunosuppressive illnesses can interfere with the development of active immunity after vaccination and may diminish the protective efficacy of RabAvert. Preexposure vaccination should be administered to such persons with the awareness that the immune response may be inadequate. If persons receiving corticosteroids or other immunosuppressive therapy, or who are immunosuppressed, are vaccinated post-exposure, it is important that a serum sample on Day 14 (the day of the fourth vaccination) be tested for rabies antibody to ensure that an acceptable antibody response has been induced.
Preexposure vaccination should be postponed in the case of sick and convalescent persons and those considered to be in the incubation stage of an infectious disease.
Administration of Human Rabies Immune Globulin (HRIG), which along with prompt local cleaning of wounds should take place before postexposure prophylaxis, must not exceed the recommended dose, since active immunization to the vaccine may be impaired. HRIG should not be administered to previously vaccinated persons as it may blunt their rapid memory response to rabies antigen.
Because animal reproductive studies or studies in pregnant or lactating women have not been conducted with RabAvert, it is not known whether RabAvert can cause fetal harm when administered to a pregnant woman, whether it can affect reproduction capacity, or whether it is excreted in animal or human milk with consequent risk to breastfed infants (but many drugs are excreted in human milk). Use RabAvert in pregnant or lactating women only if clearly needed.
No data are available regarding the concurrent administration of RabAvert with other vaccines.
The most commonly occurring adverse reactions in clinical trials of RabAvert, were injection site reactions, such as injection site erythema, induration, and pain; flu-like symptoms, such as asthenia, fatigue, fever, headache, myalgia, and malaise; arthralgia; dizziness; lymphadenopathy; nausea; and rash.
Preexposure vaccination does not eliminate the need for additional therapy after a known rabies exposure.
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.
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Rolf Sass Sørensen
Vice President Investor Relations (EU)
Tel: +45 61 77 47 43
Paddock Circle Advisors (US)
Tel: +1 781 686 9600