A decision (or the lack of it) by the US federal government may imperil viability of the Swedish company known as Barvarian Nordic — and the development of Prostvac VF, now in development for treatment of advanced prostate cancer.
Bavarian Nordic makes a smallpox vaccine known as Imvamune. This vaccine is manufactured for potential use in men and women who are known to be at risk for severe adverse reactions to the standard smallpox vaccine.
According to a report on Bloomberg.com:
- In 2007, the US Department of Health and Human Services (HHS) awarded Barvarian Nordic a $500 million health contract for 20 million doses of Imvamune.
- Barvarian Nordic and HHS agree that the current vaccine is beginning to lose potency (i.e., it is reaching its “past due” date) and needs to be replaced.
- The company has been expecting HHS to order replacement vaccine since June.
What does this have to do with Prostvac VF?
Well … 95 percent of Barvarian Nordic’s annual revenue comes from this one product — Imvamune. No sales of Imvamume, no income for Barvarian Nordic, no money to invest in the development of Prostvac VF, and Barvarian Nordic has to shut its doors.
The theoretical moral of this story: Nothing new … Just don’t put all of your eggs in one basket!
Since Prostvac VF is one of the more promising (and advanced) investigational, immunotherapeutic agents in Phase III clinical trials for the treatment of advanced prostate cancer, this is not good news for the prostate cancer community in general … and most specifically for the patients and the researchers involved in execution of this Phase III trial (quite apart from the effects on Barvarian Nordic). On the other hand, even if the worst was to happen, it is not impossible that another company would purchase the assets of Barvarian Nordic and continue the trial. We’ll just have to keep an eye on the smallpox vaccine market through next January.
This may all be a high-powered game of “chicken” … but we don’t think so. We suspect it has more to do with the ability of Congress to come to decisions regarding the funding of the federal government (including the Project BioShield program that is funded through HHS and through which HHS pays for Imvamune and other, similar products).