|Bavarian Nordic CEO Paul Chaplin|
Though it's been eradicated, the threat of a smallpox outbreak is taken very seriously by public health officials, an ongoing concern that's helped Bavarian Nordic pay its bills through the years.
With an announcement Wednesday trumpeting two successful late-stage tests, the company has reason to believe it can advance its business with smallpox vaccine Imvamune.
In a Phase III study of liquid-frozen Imvamune, the vaccine met its primary endpoint while confirming its safety profile in its largest study to date--4,000 total patients. And, in a Phase II study of freeze-dried Imvamune, the formulation demonstrated an equivalent antibody response to the liquid-frozen version--good news for Bavarian Nordic execs, as those results are the final clinical data needed to support stockpiling of the freeze-dried formulation in the U.S. Strategic National Stockpile.
In a project funded through a $22 million Biomedical Advanced Research and Development Authority (BARDA) contract, the company is transferring its freeze-drying process to a new manufacturing line with a larger capacity. That work is expected to be finalized this year, and it's the final step for the company to meet regulatory stockpiling requirements, it said in a statement. In its Q1 2015 results, Bavarian Nordic said it's planning to submit a freeze-dried version of the vaccine this year for FDA review, and procurement would be conducted through a new contract with the U.S. government.
Paul Chaplin, Bavarian Nordic CEO, said the freeze-dried version "provides a number of advantages for the future procurement and stockpiling, thereby broadening the commercial potential." He said deliveries should start next year.
Bavarian Nordic isn't alone in the smallpox vaccine space, though, as it's joined by Sanofi Pasteur--which, through a 2008 purchase of Acambis, received ACAM2000 and a 10-year, $425 million U.S. government contract. In its statement, Bavarian Nordic said Imvamune's Phase III trial had no serious adverse reactions, demonstrating an advantage against ACAM2000's 5.73 events per 1000 immunizations.
Since 2010, Bavarian Nordic has delivered 28 million doses of liquid-frozen Imvamune to the U.S. stockpile as protection against renegade stocks and re-engineered viruses; the vaccine accounted for more than 80% of the company's revenue last year.
- here's the release
- and the Q1 statement (PDF)