Bavarian Nordic Delivers 1 Million Doses of First Vaccine Developed Under U.S. Biopreparedness Program to the Strategic National Stockpile
13 July 2010
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- Smallpox Vaccine Represents the Company's First
Major U.S. Product Sale
KVISTGÅRD, Denmark -July 13, 2010 -
Bavarian Nordic A/S (NASDAQ OMX: BAVA) announced today that
it has delivered 1 million doses of its smallpox vaccine
IMVAMUNE® to the U.S. Strategic National Stockpile for use in
the event of a smallpox bioterrorism attack on the U.S.
IMVAMUNE® is the first vaccine successfully developed under
Project BioShield, a U.S. program created by Congress in 2004 to
develop and purchase medicines and vaccines to protect the American
public from bioterrorism attacks. Bioterrorism experts are
concerned about the possibility of an attack on the US that exposes
the population to the smallpox virus.
IMVAMUNE® was clinically developed and manufactured under
contracts with the Biomedical Advanced Research and Development
Authority (BARDA), a division of the U.S. Department of Health
& Human Services (HHS), as well as the National Institutes of
Health (NIH). Under the BARDA contract, Bavarian Nordic will
deliver 20 million doses of IMVAMUNE® to the U.S. Strategic
National Stockpile, with an option for 60 million more
doses.
"We are gratified that the U.S. Government has added our vaccine
to the Strategic National Stockpile. This represents a
significant milestone for our company, our first major sale to the
U.S.," said Bavarian Nordic President and CEO Anders
Hedegaard. "Our partnership with NIH, BARDA and HHS over the
recent years is a case study in successful public-private
partnerships to combat bioterrorism. We look forward to
continuing that partnership through other contracts with the U.S
government."
IMVAMUNE® is a non-replicating strain of vaccinia virus
that, unlike conventional smallpox vaccines, does not have the
ability to replicate in human cells, thereby eliminating risk of
accidental infection. Currently stockpiled smallpox vaccines
are based on a replicating form of the vaccinia virus, and are
therefore considered inappropriate for up to 25 percent of the
population that may be immunocompromised or have other medical
conditions that contraindicate a replicating viral vaccine.
While studies indicate that IMVAMUNE® is likely to be well
tolerated in a broad population, it is currently being stockpiled
for emergency use specifically in people with compromised immune
systems, e.g. HIV/AIDS patients.
Mr. Hedegaard said the delivery authorization marks Bavarian
Nordic's "transformation from a fledgling biotech to a
fully-integrated research innovator with proven manufacturing and
regulatory experience." On March 17, FDA concluded that
Bavarian Nordic has fulfilled all requirements to support the
delivery of IMVAMUNE® to the U.S. Government.
The Need for a Non-Replicating Smallpox
Vaccine
Security experts-including the U.S. Commission on the Prevention
of Weapons of Mass Destruction Proliferation and Terrorism-expect
that an act of biological terrorism is more likely than nuclear
terrorism. Compared to a nuclear weapon, a biological weapon
is much cheaper to produce, the starting materials are more
accessible, and less diversity of technological experience is
required. HHS considers smallpox a high-priority
threat.
Because vaccination against smallpox is no longer standard, an
increasing proportion of the population is unprotected and
vulnerable to a bioterrorism attack. Smallpox presents a
continued global threat for which countries need to be
prepared.
The U.S. Strategic National Stockpile includes stocks of
conventional smallpox vaccines made from a live, replicating form
of the vaccinia virus. These vaccines were used in a global
effort to wipe out the disease and resulted in worldwide
eradication by 1980.
Conventional smallpox vaccines have been associated with high
rates of serious adverse events, including death and severe
disability. The 2003 U.S. smallpox vaccination program for health
care workers, which involved more than 37,000 individuals,
confirmed these severe side effects.
IMVAMUNE® (MVA-BN®) is a non-replicating smallpox
vaccine derived from the modified vaccinia virus Ankara.
Since IMVAMUNE® does not have the ability to replicate in human
cells, clinical trial data from 2,800 people in 15 ongoing or
completed studies indicates that IMVAMUNE® has a favorable
safety profile and is well tolerated, including in individuals with
compromised immune systems who are currently not eligible for
conventional smallpox vaccines.
BARDA highlighted the need to protect this vulnerable population
in its 2010 Broad Agency Announcement for Medical Countermeasure
Development, in which it noted the need for "attenuated smallpox
vaccine - sufficient quantity to protect 66 M [million] people,
comprising those for whom smallpox vaccine is contraindicated and
their household contacts," which includes immunocompromised and
atopic dermatitis patients.
About Bavarian Nordic's Contracts with the U.S.
Government
Bavarian Nordic initiated the development of IMVAMUNE® in
1999 and began the first clinical study in 2001. In 2003,
Bavarian Nordic was awarded a contract, valued at $29 million, from
the U.S. National Institutes of Health (NIH), for the further
development of IMVAMUNE®. In 2004, Bavarian Nordic was
awarded its second U.S. Government contract, valued at $115
million, to continue advanced development of IMVAMUNE®
including clinical trials in individuals with compromised immune
systems. In parallel, Bavarian Nordic invested $100 million
in the construction of an industrialized manufacturing facility
specifically designed to meet the potential demands for
IMVAMUNE® by the U.S. Government.
In June 2007, the U.S. Government awarded Bavarian Nordic its
third contract for $500 million to manufacture and deliver 20
million doses of IMVAMUNE® for the Strategic National
Stockpile. This contract includes an option to purchase
an additional 60 million doses. In November 2009, BARDA
awarded another contract with a prospective value of up to $40
million to Bavarian Nordic for development of a freeze-dried
version of IMVAMUNE®. IMVAMUNE® is the first entirely
new biodefense vaccine developed under Project BioShield for
inclusion in the Strategic National Stockpile.
BARDA, a division of HHS, manages Project BioShield and is
responsible for working with biotechnology and pharmaceutical
companies to develop and stockpile effective medicines and vaccines
against bioweapons, pandemic influenza, and other emerging
infectious diseases.
This release will have no impact on the company's financial
guidance for 2010.
Bavarian Nordic: An Established Biodefense
Leader
Founded in 1994, Bavarian Nordic is a leading industrial
biotechnology company working to target unmet medical needs by
developing and producing vaccines for the prevention and treatment
of life-threatening diseases. With more than a decade of
experience manufacturing smallpox vaccines and working with the
U.S. Government, Bavarian Nordic has grown from a biotechnology
company to a fully integrated biopharmaceutical company with proven
manufacturing and regulatory expertise.
Forward-looking statements
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. 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.
Contact:
Anders Hedegaard, President & CEO.
Phone: +45 23 20 30 64