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2019-09-24

Bavarian Nordic A/S: Bavarian Nordic Announces U.S. FDA Approval of JYNNEOST (Smallpox and Monkeypox Vaccine, Live, Non-re...

* First FDA approved non-replicating smallpox vaccine
* Only FDA approved vaccine for prevention of monkeypox
* Company granted Priority Review Voucher
* Conference call and webcast tomorrow at 3:00 PM CEST

COPENHAGEN, Denmark, September 24, 2019 ? Bavarian Nordic A/S (OMX: BAVA,
OTC: BVNRY) today announced that the U.S. Food and Drug Administration
(FDA) has approved JYNNEOS? (Smallpox and Monkeypox Vaccine, Live,
Non-replicating) (MVA-BN®, liquid-frozen) for prevention of smallpox and
monkeypox disease in adults 18 years of age and older determined to be at
high risk for smallpox or monkeypox infection. JYNNEOS is the only approved
non-replicating smallpox vaccine in the U.S. and the only approved
monkeypox vaccine anywhere in the world.

JYNNEOS is approved for use broadly, including in people with weakened
immune systems and those with eczema or with household members with eczema.
This approval is a major breakthrough in meeting the U.S. government?s
long-standing commitment to developing a vaccine that can be administered
to people who are at high risk of adverse reaction to traditional,
replicating smallpox vaccines.

?The licensure of this vaccine not only enhances domestic biodefense and
global health security but also demonstrates what can be accomplished for
the American people through public-private partnerships,? said Rick Bright,
Ph.D., HHS deputy assistant secretary for preparedness and response and
director of the Biomedical Advanced Research and Development Authority
(BARDA). ?The years of dedication working with Bavarian Nordic on this
vaccine ultimately mean that the U.S. is better prepared to save lives if
an emergency occurs involving one of the deadliest diseases the world has
ever known.?

?The FDA approval of JYNNEOS is a tremendous milestone for both our company
and the U.S. Department of Health and Human Services,? said Paul Chaplin,
President and Chief Executive Officer of Bavarian Nordic. ?Together, we
have shown that it is possible to develop a safe and effective medical
countermeasure for national security threats like smallpox. JYNNEOS is the
culmination of a fifteen-year partnership that started with a call from the
NIH for a safer smallpox vaccine, successfully transitioned to BARDA and
was delivered to the Strategic National Stockpile for use in an emergency.
We are committed to the continued supply of vaccines to the U.S. and thank
them for their global leadership on biodefense. We are also particularly
pleased with the additional indication to protect against monkeypox that
creates new commercial opportunities for JYNNEOS.?

Concurrent with the approval, FDA granted Bavarian Nordic a Priority Review
Voucher (PRV) under the Material Threat Medical Countermeasure PRV program.
A PRV can be used to accelerate the FDA?s review of a future human drug
application and is also transferrable. The Company intends to sell the
voucher to a third party.

Conference call and webcast
The management of Bavarian Nordic will host a conference call tomorrow,
September 25, 2019 at 3 pm CEST (9 am EST) to discuss the FDA approval of
JYNNEOS. Dial-in numbers and further details will be provided in advance of
the call on:
http://www.bavarian-nordic.com/investor/events.aspx?event=5713

.

About monkeypox
Monkeypox is a rare viral zoonotic disease (transmission from animals to
humans) similar to human smallpox, whose causative agent, variola virus, is
also a member of the Orthopoxvirus genus. However, monkeypox infection is
less transmissible human-to-human than smallpox and also less deadly (case
fatality estimates for monkeypox are up to 10%). Orthopoxvirus infections
produce antibody responses that are cross-protective against other viruses
within the genus. It is this property of orthopoxviruses that allows
JYNNEOS to be used as a vaccine against both smallpox and monkeypox.

Until recently, infections of monkeypox in humans had mostly been limited
to central and western regions of Africa, where the virus is naturally
occurring. However, during the ongoing monkeypox outbreak in Nigeria,
increased human-to-human transmission has been observed and the wide
geographic spread, predominantly in urban areas, has raised concerns over
the disease. The recent cases of monkeypox observed in the UK, Israel and
Singapore all originated from Nigeria, demonstrating that the virus is no
longer a domestic challenge only. Nigeria is Africa?s largest country by
both population and economy, including the large oil and gas industry,
which employs a significant number of local and foreign employees. It is
estimated that more than five million people travel to countries affected
by monkeypox in Central Africa each year, suggesting a market potential for
a monkeypox vaccine for travelers.

About smallpox
Smallpox is a highly contagious and deadly disease, which was eradicated
worldwide by 1980 after a global vaccination campaign, and no longer occurs
naturally. Unique to humans, the disease is caused by the variola virus,
and is transmitted from person to person through direct contact with
contaminated fluids and objects, as well as through the air. Historically,
about 30% of those who became infected with smallpox died from the illness.

Despite being eradicated, smallpox is considered by many governments to be
a significant bioterrorism threat and as routine vaccination stopped in the
1970?s, the majority of the world?s population today are highly vulnerable.
Re-emergence of smallpox could occur as result of deliberate or accidental
release of samples that are kept for research purposes or may be
synthesized in a lab.

About JYNNEOS?
JYNNEOS is a suspension for subcutaneous injection (0.5 mL) based on a
live, attenuated vaccinia virus (Modified Vaccinia Ankara, MVA-BN),
incapable of replicating in the body, yet still capable of eliciting a
potent immune response. The vaccine was developed in partnership with the
U.S. Government to ensure all populations can be protected from smallpox,
including people with weakened immune systems or who are at high risk of
adverse reactions to traditional smallpox vaccines, which are based on
replicating vaccinia virus strains. Typical severe adverse reactions known
for replicating vaccinia virus strains, such as myocarditis, encephalitis,
generalized vaccinia or eczema vaccinatum, were not observed during the
clinical development program of JYNNEOS.

The approval of JYNNEOS for smallpox is based on a comprehensive
development program, comprising a total of 7871 individuals aged 18 through
80 years who received at least 1 dose (7109 smallpox vaccine-naïve and 762
smallpox vaccine-experienced individuals) in 22 clinical trials, including
two Phase 3 studies, the latter of which showed non-inferiority in terms of
immunogenicity measured by plaque reduction neutralization test of JYNNEOS
compared to ACAM2000, the other U.S. licensed, replicating smallpox
vaccine.

The approval for monkeypox is based on survival data obtained in lethal
monkeypox virus challenge studies in non-human primates. Overall survival
in various models ranged from 80% to 100% of JYNNEOS-vaccinated animals
compared to 0-40% in control animals.

The safety of JYNNEOS was evaluated in smallpox vaccine-naïve healthy
adults, in healthy adults previously vaccinated with a smallpox vaccine, in
HIV-infected adults, and in adults with atopic dermatitis.

The most common (>10%) adverse reactions associated with JYNNEOS were
injection site reactions (pain, redness, swelling, induration, itching) and
systemic adverse reactions such as muscle pain, headache, fatigue, nausea,
myalgia and chills. Serious adverse reactions were reported in 0.05% of
subjects who received JYNNEOS and included Crohn?s disease, sarcoidosis,
extraocular muscle paresis and throat tightness. Cardiac adverse reactions
of special interest were reported in 0.08% of subjects who received JYNNEOS
and included tachycardia, electrocardiogram T wave inversion,
electrocardiogram abnormal, electrocardiogram ST segment elevation,
electrocardiogram T wave abnormal, and palpitations.

For full Prescribing Information, visit http://www.jynneos.com

.

Bavarian Nordic has received significant support during the development of
JYNNEOS from the Biomedical Advanced Research and Development Authority
(BARDA), part of the Office of the Assistant Secretary for Preparedness and
Response at the U.S. Department of Health and Human Services, the National
Institutes of Health (NIH), the Department of Defense (DoD) and the Centers
for Disease Control and Prevention (CDC).

Bavarian Nordic has to-date delivered 28 million doses of liquid-frozen
MVA-BN to the U.S. Strategic National Stockpile for emergency use. The
Company has an ongoing ten-year contract with BARDA to replenish and
potentially expand the stockpile, which has expired, with a freeze-dried
formulation of the vaccine. A Phase 3 lot consistency study of the
freeze-dried formulation is currently ongoing to support the approval of
this formulation.

MVA-BN is also approved in the EU under the trade name IMVANEX® for active
immunization against smallpox of the general adult population, including
people with weakened immune systems (people diagnosed with HIV or atopic
dermatitis), and in Canada under the trade name IMVAMUNE® for active
immunization against smallpox in a public health emergency for persons 18
years of age and older who are contraindicated to replicating smallpox
vaccines.

About Bavarian Nordic
Bavarian Nordic is a fully integrated biotechnology company focused on the
development of innovative therapies against infectious diseases and cancer.
Using our live virus vaccine platform technology, MVA-BN®, we have created
a diverse portfolio of proprietary and partnered product candidates
intended to unlock the power of the immune system to improve public health
with a focus on high unmet medical needs. In addition to our long-standing
collaboration with the U.S. government on the development and supply of
medical countermeasures, including the only FDA-approved, non-replicating
smallpox vaccine, our infectious disease pipeline comprises a proprietary
RSV program as well as vaccine candidates for Ebola, HPV, HBV ...

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