U.S. Government Supports Phase 3 Study of Bavarian Nordic’s Smallpox Vaccine
Contract modification adds $32 million to the total contract value
KVISTGÅRD, Denmark - May 22, 2012 -Bavarian Nordic A/S (NASDAQ OMX: BAVA) announced today that the U.S. Department of Health and Human Services has supported the initiation of an expanded Phase 3 study of IMVAMUNE® smallpox vaccine. The government is stockpiling 20 million doses of IMVAMUNE® under a Project BioShield contract for use in a potential smallpox emergency. The company's procurement contract was modified, increasing the total value of the contract by $32 million to $544 million.
"This additional $32 million from the Department of Health and Human Services will allow Bavarian Nordic to move forward with our Phase 3 trial of IMVAMUNE® smallpox vaccine," said Anders Hedegaard, President and CEO of Bavarian Nordic A/S. "This study will greatly expand our already promising database and further demonstrate the safety of this important bioterrorism medical countermeasure."
The pivotal Phase 3 trial, which is expected to begin enrollment in the first half of 2013, will include 4,000 subjects and could support a Biologics License Application (BLA) submission to the Food and Drug Administration. Bavarian Nordic has already submitted marketing applications in both Canada and Europe. The design of this study is larger than initially proposed. Therefore, the company had requested modification of the contract to cover the added costs prior to the initiation of the study.
To date, Bavarian Nordic has delivered more than 8 million doses of IMVAMUNE® to the Strategic National Stockpile. The remainder of the 20 million doses are expected to be delivered in 2012 and 2013.
IMVAMUNE® is a MVA-BN® based, third-generation smallpox vaccine candidate. IMVAMUNE® has been shown in clinical trials to be a well tolerated smallpox vaccine in healthy subjects and persons with contraindications to traditional smallpox vaccines. To date, more than 3,400 individuals, including HIV and atopic dermatitis patients, have been vaccinated and none of the serious adverse events normally associated with the traditional smallpox vaccines have been seen, including no cases of myo-/pericarditis.