Bavarian Nordic signs first smallpox vaccine deal in the EU
This article was originally published in Scrip
Bavarian Nordic has signed its first contract with the military of an EU country for the delivery of a small order of its smallpox vaccine, Imvamune. The Danish vaccine firm would not disclose the identity of the buyer (who has bought the vaccine for preparedness stockpiles) or the value of the deal, adding that the delivery will occur this year.
This will be the third country that has signed a smallpox vaccine deal with the firm, following orders from the US authorities for 20 million doses at a value of $500 million (the company has received $125 million of this to date) and the Canadian authorities' order for 20,000 doses last year (there is an option to raise this to 180,000 doses; value not disclosed).
Although the company would not disclose the cost price of the two-injection viral vaccine – which is live but not replicating and is given subcutaneously a few months apart – Anders Hedegaard, its president and CEO, told Scrip that: "The US got a decent price because they paid for a lot of the development of the vaccine."
The firm has had a few teething problems regarding the delivery of the vaccine to the US. It has now been delayed after the FDA's good manufacturing practices inspection of the firm's Kvistgaard facility and at IDT, the company's contract filling partner, in May 2009.
"There was no warning letter. Just standard GMP observations. They are all workable and within reach and without heavy investment," he said.
The company says the corrective actions triggered by the inspections will be implemented within a short time, and expects to deliver Imvamune to the US government between the fourth quarter of 2009 and the end of the second quarter of 2010.
It is keen to point out that there is a need for governments to hold stockpiles of the vaccine in the event of bioterrorism. Smallpox was officially eradicated in 1980, with natural disease killing 30% of those infected. "The old [smallpox] vaccine is not good enough. The threat level depends on intelligence, but in Russia in the 1980s some 60,000 people were working on biological weapons," says Mr Hedegaard.
A Phase III clinical trial with the vaccine is planned for late 2010, involving between 2,000 and 5,000 people, primarily in the US. Phase II trial development has so far exposed the vaccine to 2,700 patients, again mostly US citizens. Separately, the US authorities have initiated talks with Bavarian Nordic for a new contract to develop a freeze-dried formulation of Imvamune, which would offer increased shelf-life and improved stability of the vaccine compared with the current liquid-frozen formulation.
As the company is awaiting the timing of the delivery of the vaccine to the US, the expectations for its full year 2009 financial results are expressed as a range. The expected revenue of DKK375 million was based on the delivery of two million doses of Imvamune in 2009, but the revenue is now in the range of DKK100-3000 million, based on a maximum delivery of 1.5 million doses.
Last month, the company reported unaudited half year revenue (ending June 30th, 2009) of DKK33 million (down from DKK23 million the previous year) and a loss before tax of DKK188 million (DKK119 million). The firm's net free liquidity has fallen from DKK882 million to DKK489 million for the same period.
The firm has a number of other vaccines in development: the one with "blockbuster potential" is Prostvac, a therapeutic vaccine for advanced prostate cancer, where a Phase III is planned for next year; others target anthrax (preclinical), breast cancer (Phase I/II), HIV (Phase I/II) and measles/RSV (Phase I).