KVISTGARD, Denmark, November 6 /PRNewswire/ -- Bavarian Nordic A/S - Interim Report for the period 1 January to 30 September 2007
This document contains a summary of Bavarian Nordic's interim report for the period 1 January to 30 September 2007.
The full results statement can be found on the company's website: http://www.bavarian-nordic.com.
Commercial organisation strengthened
- Bavarian Nordic has established a new commercial function in order to strengthen the company's commercial activities and increase the sales promotion for its third generation smallpox vaccine, IMVAMUNE(R), and future vaccines including HIV and cancer vaccines. To lead this new commercial function, the company has appointed Nicolai Buhl Andersen as Executive Vice President Commercial Affairs.
IMVAMUNE(R) third generation smallpox vaccine
- The clinical development is proceeding as planned with Phase III studies expected to be initiated in 2008. Before year-end Bavarian Nordic expects to invoice two additional milestone payments each of USD 25 million as part of the RFP-3 contract. With the already received advance payment, the total amount to be invoiced adds up to USD 100 million in 2007.
Refocused HIV strategy
- Bavarian Nordic announces Phase II data from the MVA HIV nef programme, showing proof of concept for the MVA technology's ability to control HIV replication.
- The present data indicate that a broader immune response is desirable in terms of optimizing the control of the HIV replication.
- As a result of the recommendations by international Scientific Advisory Boards, the MVA HIV nef data will be incorporated into the MVA-BN(R) HIV multiantigen approach, as this provides an excellent opportunity to generate a broad immune response. Thus the company will focus on its MVA-BN(R) HIV multiantigen programme going forward.
- A Phase I/II trial, investigating the safety and immunogenicity of the MVA-BN(R) HIV multiantigen in HIV infected patients will be initiated during first half of 2008.
- The company's two programmes in cancer immunotherapy are proceeding as planned. The company expects to report the first clinical safety and immunogenicity data from its breast cancer programme in first half of 2008, where also Phase I studies with the prostate cancer vaccine candidate are expected to be initiated.
Measles vaccine enters clinical phase
- The company has initiated Phase I clinical studies with its vaccine candidate against measles.
Full year results are maintained
- During the first nine months of 2007, Bavarian Nordic realised revenues of DKK 64.0 million and a loss before tax of DKK 218.9 million. Based on the planned clinical activities and related milestone payments, the expectations for the full year 2007 result are as previously stated at a loss before tax of approximately DKK 50 million despite lower revenue of approx. DKK 350 million compared to the previously guided revenue at DKK 380 million. This is due to delays in the RFP-2 contract and the revenue is now expected in 2008.
Commenting on the interim report, Bavarian Nordic's CEO, Anders Hedegaard said: "Third quarter has been an exciting and very active period for Bavarian Nordic. The positive development in the RFP contracts with the U.S. government creates a solid foundation for the further development of our pipeline. With the initiation of Phase I with our measles vaccine candidate we have taken an important step into the development of childhood vaccines, and furthermore we have taken another important step towards an even more focused strategy for HIV vaccines."
Key highlights after the close of the fiscal period (1 October - 6 November 2007)
U.S. government extends RFP-2 contract with Bavarian Nordic
- The U.S. government has extended the RFP-2 contract that was awarded to Bavarian Nordic in 2004. Within the scope of the extension, Bavarian Nordic will initiate a larger Phase II study with IMVAMUNE(R) in people diagnosed with atopic dermatitis. The contract extension has a value of USD 15 million. The additional clinical studies will be performed within the contract period, which has been extended until 2010. However the main part of the revenue is expected in the end of 2008 and beginning of 2009.
Advance payment of USD 50 million from RFP-3 contract
- Bavarian Nordic has received an advance payment of USD 50 million as allowed under the RFP-3 contract to manufacture and deliver 20 million doses of the company's, IMVAMUNE(R) smallpox vaccine. Permission has been granted because the company has fulfilled a number of significant milestones in the contract.
Development pipeline Programme Status Next milestone IMVAMUNE(R) II(i) Phase III (2008) (smallpox) HIV multiantigen Preclinical Phase I/II (H1, 2008) Breast cancer I/II Safety and immunogenicity data (H1, 2008) Prostate cancer Preclinical Phase I (H1, 2008) Measles I Initial immunogenicity data (H2,2008) RSV Preclinical Phase I (2008) (i) Sold to governments as a vaccine under development
Bavarian Nordic's two projects in tropical diseases, dengue fever and Japanese encephalitis, have been temporarily discontinued pending discussions with a potential external partner on clinical development and funding.
Webcast and conference call
In connection with the release of the interim report, the company will hold a conference call/webcast presentation on Tuesday 6 November at 09:00 am (CET), with the participation of Anders Hedegaard, CEO, Paul Chaplin, CSO and Rolf Sass Sørensen, VP Investor Relations. The presentation and conference call will be held in English. Dial-in numbers and further details are found on the company's website: http://www.bavarian-nordic.com/webcast.
About Bavarian Nordic
Bavarian Nordic (CSE: BAVA) is a leading international biopharmaceutical company developing and producing innovative vaccines to prevent and treat infectious diseases and cancer. With operations in Denmark, Germany, the USA, and Singapore, Bavarian Nordic employs over 250 people. Bavarian Nordic's patented technology, MVA-BN(R), is as been demonstrated in clinical studies, one of the world's safest, multivalent vaccine vectors for the development of vaccines against various infectious diseases such as smallpox, HIV/AIDS, as well as against breast and prostate cancer. Several MVA-BN(R)-based HIV and smallpox vaccines are in clinical Phase I and Phase II trials. Bavarian Nordic has ongoing development contracts with the US government to develop IMVAMUNE(R) as a safe third-generation smallpox vaccine. Bavarian Nordic has supplied several other governments with smallpox vaccines.
For more information please visit http://www.bavarian-nordic.com
Contacts: Anders Hedegaard, President & CEO, Telephone: +45-33-26-83-83