Two names come to mind when we think of a new smallpox drug - Oregon-based Siga Technologies Inc. (SIGA) and North Carolina-based privately held biotech company Chimerix Inc. These two companies continue to be in the news not only for landing a federal contract but also for the standoff between them.
Smallpox eradication efforts by the WHO began in 1967 and the world was officially declared free of this highly contagious disease in 1980. At present, there is no effective drug with which to treat or prevent smallpox infections. In September 2007, the FDA approved ACAM2000 made by Acambis plc., the first smallpox vaccine in over 75 years. Although smallpox has been eradicated from the world, it still poses potential bioterrorism threat as there is a risk of deliberate release of smallpox virus for use as a bio-warfare agent.
To address the bioterrorism threat, Siga Technologies is developing ST-246, an orally active, smallpox antiviral, to treat individuals exposed to the smallpox virus in the event of an outbreak. According to Siga, ST-246 works by blocking the ability of the virus to spread to other cells, preventing it from causing the disease. The FDA has designated ST-246 for "fast-track" status, creating a path for expedited FDA review and eventual regulatory approval.
In clinical trial, ST-246 has been found to be well-tolerated in healthy human volunteers at all tested orally administered doses. In addition, ST-246 is the first drug ever to demonstrate 100% protection against human smallpox virus in a primate trial conducted at the CDC (U.S. Centers for Disease Control and Prevention), according to Siga.
In order to supplement and re-supply health agencies with antibiotics, chemical antidotes, antitoxins or life-support medications if there is a public health emergency due to terrorist attack, flu outbreak or earthquake, the CDC maintains a national repository of life-saving pharmaceuticals known as Strategic National Stockpile or SNS.
Usually, the Department of Health and Human Services or HHS for short, through the Biomedical Advanced Research and Development Authority or BARDA issues an RFP (request for proposal) to eligible bidders to supply medicines to the nation's stockpile. Under the RPF, BARDA seeks responses from qualified small business sources only.
Last October, Siga was selected for the procurement of smallpox antiviral drug by the U.S. Department of Health and Human Services relating to the company's May 2009 response to a Request for Proposal issued by BARDA. Under the contract, Siga was asked to deliver 1.7 million courses of a smallpox antiviral for the strategic national stockpile, pending resolution of issues regarding Siga's status with the Small Business Administration. Only those companies that qualify as a small business concern are eligible for the award.
Siga's eligibility for award of the government contract was questioned by Chimerix , an unsuccessful contender for the strategic national stockpile. Chimerix is also developing CMX001 as a medical countermeasure for the treatment of smallpox. According to Chimerix, since the SBA (Small Business Administration) had determined that Siga is not a small business concern as it is controlled by and affiliated with MacAndrews & Forbes, owned by billionaire Ron Perelman, Siga did not qualify for a small-business set-aside.
Last November, Siga appealed the adverse small business size determination of the SBA. However, in February of this year, the Small Business Administration Office of Hearings and Appeals affirmed the ruling of the SBA Area Office that Siga was other than small at the time of its submission in response to a Request for Proposal from the BARDA.
Meanwhile on February 16, 2011 Chimerix was awarded a contract worth a total value of $81.1 million by the BARDA for the development of its antiviral drug candidate, CMX001, as a medical countermeasure in the event of a smallpox release.
On February 18, 2011, the 2009 BARDA Smallpox RFP was canceled and a new Request for Proposal, seeking to procure 1.7 million courses of a smallpox antiviral was issued on February 21, 2011. Siga responded to the 2011 BARDA Smallpox RFP, and on May 13, secured the contract with the BARDA to deliver two million courses of its smallpox antiviral, ST-246, to the Strategic National Stockpile. The 5-year base contract award is worth $433 million and includes options that would raise the contract's total value to about $2.8 billion, if these options are fully exercised. Contract options include the delivery of up to 12 million additional courses of ST-246, according to the company.
Shares of Siga gained more than 12% in after-hours trading on Friday (May 13) to close at $15.98, following the news of the contract award.
But this time too, Chimerix is back with its deliberate ploy to delay the contract as it has filed a protest with the U.S. GAO (Government Accountability Office) over Siga's contract.
On May 15, Siga announced that it has been notified by the BARDA of the post-award protest filed by Chimerix. With work under the contract to be suspended until further notice pursuant to the applicable protest rules, there is going to be a delay in the award of the contract to Siga.
Commenting on the developments, Eric Rose, SIGA's Chairman and Chief Executive Officer, said, "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.
SIGA says it is uniquely positioned to assist the government in its efforts to protect the nation against the threat of smallpox. Will the government's decision to award the contract to Siga be upheld as entirely proper?
Usually the GAO issues a decision on a protest within 100 days after it is filed. Stay tuned...
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December 19, 2025 15:10 ET U.S. inflation data and interest rate decisions by major central banks were the highlights of this busy week for economics news flow. Employment data and survey results on the housing markets also gained attention in the U.S. In Europe, the European Central Bank and Bank of England announced their policy decisions and macroeconomic projections.