WASHINGTON, D.C., October 9 /PRNewswire/ -- Bavarian Nordic, the Danish-based international biopharmaceutical
company, has received permission from the Department of Health and Human
Services (HHS) to invoice an advance payment of $50 million as allowed under
the recent contract (RFP-3)* to manufacture and deliver 20 million doses of
the company's, IMVAMUNE(R) smallpox vaccine.
HHS approved the advance payment because Bavarian Nordic
fulfilled a number of significant contract milestones relating to the
build-up of security systems, establishment of various procedures and
training, validation of equipment and processes, and a Phase II study report
for preparing the design of Phase III studies.
Anders Hedegaard, President & CEO of Bavarian Nordic, said: "We
are very satisfied that we have already fulfilled several significant
milestones as agreed with the Department of Health and Human Services. With
the advance payment and the future milestone payments, we have created a
solid financial base for our further development."
The advance payment income will be recognised as revenue in the
company's financial statements as the vaccines are delivered. Delivery will
start once an Emergency Use Authorization for IMVAMUNE(R) is granted. Payment
is dependent on Bavarian Nordic's continued fulfilment of the conditions of
the contract.
In addition to the advance payment of $50 million, Bavarian
Nordic expects in 2007 to receive two additional milestone payments of $25
million each for fulfilling activities related to these milestones. The
advance payment does not affect the previously announced guidance for the
company's 2007 result.
IMVAMUNE smallpox vaccine contract
In June 2007, HHS awarded Bavarian Nordic a Bioshield contract to
manufacture and deliver IMVAMUNE, a next-generation smallpox vaccine to the
strategic national stockpile. The contract calls for the registration of
IMVAMUNE as a safe and effective smallpox vaccine in healthy people, but in
the event of a smallpox outbreak, the vaccine would be recommended to protect
people who have weakened immune systems.(1)
The five-year contract is valued at more than $500 million, with
options that if exercised, extend the value to $1.6 billion and the
performance period of the contract. The contract options would allow the
government to procure up to an additional 60 million doses of IMVAMUNE and
support additional clinical studies for extending the license to include
HIV-infected, pediatric, and geriatric populations.
Bavarian Nordic's contract is the first next-generation, or
completely new product procured by HHS under the BioShield program. It is
also is the first contract where HHS has utilized all of its existing and
newly-acquired payment authorities (Advance Payment, Milestone Advance
Payment, and Performance Based Payment) as granted under the Project
Bioshield Act (2004), the Pandemic and All-Hazards Preparedness Act (2006),
and the FAR subpart 32.10.
* This project has been funded in whole with Federal funds from
the Office of the Assistant Secretary for Preparedness and Response,
Biomedical Advanced Research and Development Authority, under Contract No.
HHSO100200700034C.
(1) http://www.hhs.gov/news/press/2007pres/06/pr20070604a.html
About Bavarian Nordic
Bavarian Nordic, headquartered in Denmark, is a leading
international biopharmaceutical company developing and producing innovative
vaccines to prevent and treat infectious diseases and cancer.
In the U.S., Bavarian Nordic operates subsidiary companies, BN
ImmunoTherapeutics, in Mountain View, California developing vaccines against
cancers, and Bavarian Nordic Inc. in Washington, D.C. focused on business
development, marketing, and government relations for the Bavarian Nordic
Group. For more information on Bavarian Nordic visit: www.bavarian-nordic.com
"Safe Harbour" Statement under the Private Securities Litigation
Reform Act of 1995":
Except for the historical information contained herein, this
release contains "forward-looking statements" within the meaning of the
Private Securities Reform Act of 1995. No "forward-looking statement" can be
guaranteed, and actual results may differ materially from those projected.
Bavarian Nordic undertakes no obligation to publicly update any
"forward-looking statement", whether as a result of new information, future
events, or otherwise. Additional information regarding risks and
uncertainties is set forth in the current Annual Report and in Bavarian
Nordic's periodic reports, if any, which we incorporate by reference.