Bavarian Nordic Interim Report for the Period 1 January to 30 June 2007
KVISTGARD, Denmark, August 9 /PRNewswire-FirstCall/ --
- In June, the U.S. Department of Health and Human Services (HHS) awarded a contract to Bavarian Nordic for the manufacture and delivery of 20 million doses of the company's MVA based smallpox vaccine, IMVAMUNE(R), for the protection of persons considered to be at risk for smallpox. The total value of the deal, including contractual options, is USD 1.6 billion. The company has hedged USD 300 million at at the exchange rate of DKK 5.56.
- Advanced and milestone payments in 2007 and 2008 from the RFP-3 contract amount to approx. USD 125 million. Revenue and result before tax and the group's net liquidity depend on the upfront and milestones payment schedule in the RFP-3 contract, which is determined by the planning and design of clinical trials under the contract.
- Bavarian Nordic's subsidiary, BN ImmunoTherapeutics, has initiated Phase I/II clinical trials with its breast cancer vaccine candidate in the U.S. and Europe
- In April, Anders Hedegaard was appointed new CEO of Bavarian Nordic A/S. He took up this position on 1 August 2007. Former CEO, Peter Wulff, who wished to step down, will stay on in Corporate Management as Head of Business Development including existing and new scientific commercial activities and projects.
- During the first six months of 2007, Bavarian Nordic realised revenues of DKK 51.4 million and a loss before tax of DKK 127.8 million. Based on the planned clinical activities and related milestone payments, the expectations for the full year 2007 result are as previously stated at revenues of DKK 380 million and a loss before tax of DKK 50 million.
- Guidance for the full year result is maintained as previously stated in stock exchange announcement no. 23/2007 of 4 June 2007. Based on the planned activities and milestone payments, the company expects revenue of around DKK 380 million and a loss before tax of DKK 50 million.
- The group's net liquidity was DKK 573.9 million as per 30 June 2007. At year-end the company's net liquidity is expected to amount approximately DKK 900 million.
Commenting on the interim report, Bavarian Nordic's new CEO, Anders Hedegaard said: "The first half of 2007 has been an exciting and eventful period for Bavarian Nordic. We were awarded the entire RFP-3 contract for 20 million doses of our MVA based smallpox vaccine, and with the recent settlement with Acambis on the legal disputes on the MVA technology, we can now focus on other projects in our pipeline. Our HIV, cancer and measles programmes are all on track and at year-end the number of projects in clinical development will have doubled to six."
IMVAMUNE(R) - third generation smallpox vaccine
The safety and initial immunogenicity data from the Phase II placebo controlled study in 745 healthy subjects has been completed. Smallpox vaccines based on replicating vaccinia viruses have been reported to be associated with serious heart complication (e.g. myopericarditis) in every 145 people that are vaccinated. One of the primary objectives of this Phase II study was to compare the IMVAMUNE(R) vaccinated subjects to the placebo group with regard to ECG changes and cardiac symptoms that have been reported for traditional smallpox vaccines. No abnormal cardiac symptoms were associated following the vaccination with IMVAMUNE(R) and this large amount of safety data has confirmed the excellent safety and tolerability profile of IMVAMUNE(R) and revealed no particular safety concerns in this healthy study population.
The clinical study report including the initial immunogenicity data is planned to be submitted to the FDA during third quarter 2007.
The Phase II study in HIV infected patients in a total of 450 subjects is on-going in the US with finalization of enrolment on-track for the end of 2007. No serious adverse events have been recorded in this study.
HIV vaccines
MVA HIV nef
The analysis of the T cell responses to Nef from HIV is on-going in the Phase II study investigating the safety of various doses of MVA HIV nef in comparison to a control arm receiving IMVAMUNE(R). Immunogenicity data are expected during third quarter 2007.
MVA-BN(R) HIV polytope
The first Phase I study in 36 healthy subjects is progressing as planned with the completion of enrolment and all vaccinations. All vaccinations were well tolerated and the first immunogenicity data from this novel vaccine concept are expected during fourth quarter 2007.
The second Phase I study is in 30 HIV infected subjects and is also progressing on schedule. Enrolment has been completed with the majority of subjects having already been vaccinated twice with the vaccine against HIV.
A third Phase I study that is sponsored by NIH as part of a joint RFP together with Epimmune-Pharmexa was initiated in second quarter 2007. This study will evaluate the MVA-BN(R) HIV polytope vaccine in conjugation with a DNA vaccine in healthy subjects.
Measles vaccine
A Phase I clinical trial in adults evaluating the safety and immunogenicity of the measles vaccine is progressing with a planned initiation during third quarter 2007.
Cancer Immunotherapy
As planned, Bavarian Nordic's subsidiary, BN ImmunoTherapeutics has initiated Phase I/II clinical studies with the MVA-BN(R)-HER2 vaccine against breast cancer. Enrolment of patients for two studies in the U.S. and Europe is ongoing and proceeding according to schedule.
The company's programme for a prostate cancer vaccine is also proceeding as planned and clinical studies are expected to be initiated around the turn of 2007/2008.
Bavarian Nordic A/SCONTACT: Bavarian Nordic A/S, Tel. +45-33-26-83-83, Fax. +45-33-26-83-80