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Bavarian Nordic A/S (CPH:BAVA) In the first nine months of 2008 Bavarian Nordic generated revenue of DKK 45 million and recorded a loss before tax of DKK 195 million. The expectations for the financial result for the full year 2008 are maintained at revenues in the level of DKK 180 million, and a pre-tax loss in the level of DKK 225 million. The main part of the revenue comprises of a milestone payment under the RFP-3 contract, which is expected in the fourth quarter of 2008. As of 30 September 2008 the Group's net free liquidity was DKK 782 million.
Significant progress was reported in Bavarian Nordic's pipeline during the first 9 months of 2008. Two new projects have entered the pipeline; Anthrax in preclinical development and PROSTVAC(TM) in late Phase II development. With both the HIV multiantigen and the MVA-BN® prostate cancer programme entering Phase I/II trials earlier this year, the number of projects in clinical development has doubled since the beginning of the year. Our most advanced new product, PROSTVAC(TM) - a late stage prostate cancer vaccine candidate, was acquired as part of a newly established partnership with the National Cancer Institute. PROSTVAC(TM), which in clinical studies has shown to extend lives with up to 8.5 months in patients with metastatic prostate cancer, has potential to fulfil an unmet medical need and offers a potential breakthrough and real hope for patients suffering from advanced prostate cancer. Bavarian Nordic is now preparing for Phase III studies with the vaccine, planned for first half 2010.
These recent events have bolstered the Company's strategy to reinforce the cancer business area as announced earlier in 2008.
Key highlights from the period
* In August, Bavarian Nordic announced a scientific partnership with National Cancer Institute in the US. As part of this collaboration, PROSTVAC(TM) - a candidate in late phase II clinical development was obtained.
* More than 2,200 individuals have now been vaccinated with IMVAMUNE® - including more than 750 immune-compromised subjects.
Events after the period
* In October, Bavarian Nordic announced positive Phase II results with PROSTVAC(TM). The results from the Phase II prospective randomized placebo-controlled study of 125 patients with advanced prostate cancer after 4 years of follow-up show that patients receiving PROSTVAC(TM) had a statistically significantly longer median overall survival by 8.5 months (p=0.015) compared to the control group. Currently the only approved treatment for advanced prostate cancer extends median overall survival by an average of approximately 2 months. In addition, PROSTVAC(TM) also had a favourable safety and tolerability profile.
Anders Hedegaard, CEO and President of Bavarian Nordic, commented on the development: "We are successfully on track to complete our primary objectives for 2008 that were established when we announced our updated strategy earlier this year. Our recent acquisition of PROSTVAC(TM) and the exciting Phase II results that were recently reported have created an even stronger and well-balanced platform for Bavarian Nordic's future development. Our pipeline is strengthened in our strategic focus areas and we will now concentrate on taking our most advanced projects, IMVAMUNE® and PROSTVAC(TM) into Phase III within the next couple of years. This will take Bavarian Nordic to a new level and it offers exciting opportunities to the company. The company still expects to initiate delivery of the 20 million doses of IMVAMUNE® under the RFP-3 contract in 2009."
Contact: Anders Hedegaard, President & CEO | +45 23 20 30 64
Webcast In connection with the release of the interim report, a recorded webcast presentation with CEO, Anders Hedegaard will be available on the company' website from Tuesday, November 4th at 09:00 am. The webcast can be accessed from www.bavarian-nordic.com/webcast
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