application expected (2007-8) in U.S.
biodefense stockpile (U.S.)
biodefense stockpile, European countries
controlled/gov’t distribution in European counties
controlled/gov’t distribution in U.S.
priority review status
EU666 Biodefense stockpile
UM100 Controlled/Gov't Distribution in US
US666 Biodefense stockpile
US001 FDA application expected
EM160 Controlled/Gov't Distribution in EU
Bavarian Nordic Delivers 1 Million Doses of First Vaccine Developed Under U.S. Biopreparedness Program to the Strategic National Stockpile
- 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.
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.
Anders Hedegaard, President & CEO.
Phone: +45 23 20 30 64