|Siga lands big contract for a smallpox antiviral, but rival protests|
|By Staff and Wire Reports|
|Monday, 16 May 2011 03:34|
Kenneth Moch, the CEO of Chimerix, said his company filed the protest because Siga had utilized an obscure government clause meant to help companies that are in danger of going out of business. "It's hard to justify how a company with a $700 million market cap would go out of business," Moch said.
Siga's CEO, Eric Rose, said in a statement that his company is "uniquely positioned to assist the government in its efforts to protect our nation against the threat of smallpox, and we are confident that the government's decision to award this contract to Siga will be upheld as entirely proper."
According to the Associated Press and both companies, the U.S. Government Accountability Office will decide the dispute. Siga said that the government agency that awarded the contract, the Biomedical Advanced Research and Development Authority, has indicated that it "intends to defend its decision" to choose Siga.
There are FDA-approved vaccines for smallpox, but no FDA-approved treatments. Both Siga and Chimerix say their medicines are on the "fast track" for approval.
The government contract would be a boon for Siga, which hasn't turned an annual profit since its founding in the late '90s. The five-year contract would be worth at least $433 million, and up to $2.8 billion if the government chose to order more of Siga's smallpox medicine. It also represents the first government purchase of the medicine, Siga said. The base contract award also includes options (for the delivery of up to 12 million additional courses of ST-246) that would raise the contract's total value to approximately $2.8 billion, if they are fully exercised.
Under the contract, SIGA is supposed to deliver 1.7 million courses of ST-246. Additionally, SIGA will contribute 300,000 courses manufactured using federal funds provided by HHS under prior development contracts. In addition to the option to purchase up to an additional 12 million courses, the contract will also permit SIGA to continue its work on pediatric and geriatric versions of the drug as well as use of ST-246(R) for smallpox prophylaxis. Dr. Rose added, "We believe that the funding to extend ST-246 to these vulnerable populations is critical to the future success of the U.S. government's smallpox biodefense efforts. There are approximately 64 million children in the United States (through age 15), none of whom is currently vaccinated against this disease."
SIGA's groundbreaking drug, ST-246, is an oral therapeutic agent active against orthopoxviruses including smallpox. While no longer present naturally in the environment, smallpox is considered a formidable bioterrorism threat, and there is currently no FDA-approved treatment for symptomatic individuals. ST-246 works by blocking the ability of the virus to spread to other cells, preventing it from causing disease. The FDA has designated ST-246(R) for "fast-track" status, creating a path for expedited FDA review and eventual regulatory approval.