Emergent BioSolutions Buys FDA-Approved Smallpox Oral Antiviral

Maryland-based Emergent BioSolutions Inc. announced yesterday that it had completed its acquisition of exclusive worldwide rights to TEMBEXA® (brincidofovir) from Chimerix. This oral antiviral was approved by the U.S. FDA in 2021 for all age groups to treat smallpox caused by the variola virus.

The effectiveness of TEMBEXA for treating smallpox disease has not been determined in humans because adequate and well-controlled field trials have not been feasible, and inducing smallpox disease in humans to study the drug’s efficacy is not ethical.

Furthermore, TEMBEXA is not indicated for treating diseases other than human smallpox.

Despite the successful eradication of smallpox in the 1970s, there is considerable concern that the variola virus could reappear.

According to the U.S. Centers for Disease Control and Prevention, the variola virus is ranked in Category A due to its ease of transmission and high mortality rate.

“The addition of TEMBEXA to our smallpox medical countermeasure franchise, which consists of our smallpox vaccine and therapeutic for smallpox vaccine complications, creates a more comprehensive offering to combat this deadly public health threat,” said Paul Williams, SVP government/MCM business at Emergent, in a press release issued on September 26, 2022.

This transaction includes a 10-year contract to supply up to 1.7 million treatment courses of tablet and suspension formulations of TEMBEXA to the U.S. government valued at up to $680 million, which was awarded to Chimerix on August 29, 2022.

TEMBEXA is formulated as 100 mg tablets and 10 mg/mL oral suspension dosed once weekly for two weeks.

The oral suspension formulation is essential for patients with difficulty swallowing due to age or medical status.

TEMBEXA is not indicated for treating diseases other than human smallpox disease.

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