WASHINGTON, December 20 /PRNewswire-FirstCall/ -- Bavarian Nordic has received permission from the Department of Health and Human Services (HHS) to invoice another milestone payment of $25 million as allowed under the RFP-3* contract to manufacture and deliver 20 million doses of the company's IMVAMUNE(R) next-generation smallpox vaccine candidate. HHS granted permission because the company has fulfilled a number of significant milestones in the contract. The income will be recognised as revenue in the company's financial statements for 2007.
Anders Hedegaard, President & CEO of Bavarian Nordic, said: "Receiving another milestone payment from the RFP-3 contract concludes a successful year for Bavarian Nordic. We have fulfilled the ambitious goals set for 2007 in the contract with the Department of Health and Human Services. We find this very satisfactory and encouraging for our ongoing collaboration. "
Bavarian Nordic has already received an advance payment of $50 million and a milestone payment of $25 million. With this payment of $25 million, the company has received a total of $100 million in 2007 for fulfilling significant milestones in the RFP-3 contract. In 2008 Bavarian Nordic expects to receive another milestone payment of $25 million from the contract.
About the smallpox vaccine contract
In June 2007, HHS awarded Bavarian Nordic a BioShield contract to manufacture and deliver IMVAMUNE(R), a next-generation smallpox vaccine candidate, to the strategic national stockpile. According to HHS, the vaccine would be recommended in the event of a smallpox outbreak to protect people in the United States who have weakened immune systems.(1)
The contract requires the registration of IMVAMUNE(R) as a safe and effective smallpox vaccine in healthy people. The five-year contract is valued at more than $500 million, with an option that if exercised, increases the total value of the contract to $1.6 billion and extends the performance period. The option allows HHS to procure up to an additional 60 million doses of IMVAMUNE(R) and to support additional clinical studies for extending the product license to include the 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.
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: http://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.
SOURCE Bavarian Nordic A/S