Work towards manufacturing scale-up of a smallpox antiviral has been suspended after a protest was filed against award of the US government contract.
On May 13 Siga Technologies revealed the US Biomedical Advanced Research and Development Authority (BARDA) had awarded it a five-year, $433m (€306m) contract. However, two days later Siga was forced to suspend work on the contract after Chimerix filed a protest.
"We are undaunted by what we believe will be a brief delay in starting work on this important bioterrorism defense contract and will make every effort to deliver our smallpox antiviral drug to the strategic national stockpile as soon as possible”, said Eric Rose, CEO of Siga.
Having received the protest the US Government Accountability Office (GAO) will make a decision on the award of the contract. Siga said the US government intends to defend its decision, adding that GAO protests are generally resolved in fewer than 100 days.
Chimerix is also developing an antiviral smallpox medical countermeasure, CMX001, and in February 2011 won a BARDA contract worth an initial $24.8m. The contract supports expanded human safety trials and other development activities.
The contract awarded to Siga supports the final stages of ST-246 development. Activities covered by the contract include development of techniques for scale-up manufacturing and a Phase III safety study.
Siga will also manufacture 1.7m treatment courses of the drug within five years. Options in the contract allow BARDA to source an extra 12m courses. If this and other options are exercised the contract could be worth up to $2.8bn.
“[The] contract represents an important milestone in the path from discovery to approval of a medical countermeasure against a potentially deadly bioterrorism threat”, said Robin Robinson, deputy assistant secretary for preparedness and response and BARDA director.