JA-24-Edg-173_TPOXX Mod_07Feb2024_redacted.pdf

CUI//SP-SSEL

Control Number: JA-24-Edg-173

Contractor: SIGA Technologies, Inc.

Program/Equipment: TPOXX

CUI//SP-SSEL

(Source Selection Information - See FAR 2.101 and 3.104-4) requirements.”

5. Reason for Authority Cited: As described at FAR 6.302-1(a)(2), when the supplies or services required by the agency are available from only one responsible source, or, for DoD, NASA, and the Coast Guard, from only one or a limited number of responsible sources, and no other type of supplies or services will satisfy agency requirements, full and open competition need not be provided for.

Only TPOXX meets the Government’s requirement to replenish the current national stockpile.

Market research, including a search of all U.S. Food and Drug Administration (FDA) approved drugs and publications, identified only two drugs approved to treat smallpox infections, TPOXX (approved 2018) also known as tecovirimat and TEMBEXA (approved 2021) also known as brincidofovir. TPOXX is manufactured and marketed by SIGA.

SIGA holds the New Drug Application (NDA) for TPOXX and is the only company with rights to the intellectual property needed to manufacture and sell tecovirimat and TPOXX. Brincidofovir is the active ingredient in TEMBEXA, which is manufactured and marketed by Chimerix. Chimerix holds the NDA for TEMBEXA and is the only company with rights to the intellectual property needed to manufacture and sell brincidofovir and TEMBEXA. No other companies are authorized to manufacture or sell these drugs.

In 2018, TPOXX was approved by the FDA as a smallpox therapeutic, a competitive contract was awarded to SIGA to acquire TPOXX doses to fill the FHP stockpile with enough to meet DoD needs. TEMBEXA was not approved until 2021.TEMBEXA does not meet the DoD’s requirements since there is a “black box” warning issued by the FDA for increased risk for mortality when used for durations longer than that prescribed by its label: two 100 mg doses taken once weekly for two weeks.

According to the United States Center for Disease Control (CDC), based on the favorable safety and efficacy profile of tecovirimat compared with other Medical Counter Measures (MCMs), if only one MCM is administered, it should be tecovirimat, unless there is a contraindication such as a previous adverse event after receiving the drug.

Brincidofovir without tecovirimat should typically only be administered to patients in whom tecovirimat is contraindicated. TEMBEXA's labeling characterizes the drug as a potential human carcinogen in instances of extended use. Due to this black box warning, TEMBEXA’s use is limited to a maximum 14-day treatment course. Should the DoD require doses of TEMBEXA then a separate procurement package would be prepared.

The DoD also has an expanded access program (EAP) for TPOXX, which can be used for Pre-Exposure Prophylactic (PEP) purposes until the FDA approves TPOXX for PEP.

To replace TPOXX with TEMBEXA for the FHP stockpile would require the duplication of effort and cost to develop TEMBEXA for PEP, which would unnecessarily delay the DoD’s requirement to develop PEP for smallpox by at least five years. Any avoidable delay is unacceptable since the PEP indication is a critical tool needed to protect the

CUI//SP-SSEL

Control Number: JA-24-Edg-173

Contractor: SIGA Technologies, Inc.

Program/Equipment: TPOXX

CUI//SP-SSEL

(Source Selection Information - See FAR 2.101 and 3.104-4) warfighter.

TPOXX can be used for a longer duration. TPOXX can be used in combination with other existing treatment options, it is the only product currently capable of meeting the DoD’s requirements. Smallpox symptoms may not arise until two weeks after exposure to the virus, the DoD has separately prioritized development of a PEP that allows treatment to be given to a warfighter who has been exposed to the smallpox virus but is not yet exhibiting any symptoms.

It is estimated that investing in development of TEMBEXA to meet the DoD requirements for safety and future PEP indication, would require minimum of a substantial duplication of cost not expected to be recovered through competition. In addition, an extensive delay estimated at a minimum of five years would be realized before TEMBEXA could be developed to meet TPOXX’s current capability and obtain authorization for use as a PEP.

TPOXX, however, currently has an EAP that allows it to be dosed post smallpox exposure and prior to onset of symptoms and diagnosis and it is anticipated to achieve a license for PEP in FY25. Additional investments would be required to overcome the safety issues related to TEMBEXA that are not needed for the development of TPOXX.

This development of TEMBEXA may require a new formulation of TEMBEXA, including extended release or other research and development discoveries of unknown costs and schedule to overcome the current black box warning and there is no guarantee that the safety concerns could ever be overcome.

Market research indicates there are only two FDA approved products capable of treating smallpox. Of the two products, only one meets the requirements of this procurement. SIGA is the only responsible source, and no other FDA approved products will satisfy agency requirements based on mode of action, the current investment in obtaining a PEP indication for TPOXX and the current safety warnings issued by the FDA for TEMBEXA.

TPOXX is the only product available that will meet the DoD requirement without causing significant delays and expense to the current smallpox therapeutic development program should the alternative TEMBEXA be further developed at DoD expense.

6. Efforts to Obtain Competition: A sources sought notice (W911SR-24-S-TPOX) was published to SAM.gov on 07 Dec 2023, with a closing date of 14 Dec 2023. This resulted in receipt of zero responses. JPM CBRN Medical continually conducts market research to identify medical countermeasures. To date, the only product licensed for smallpox meeting the DoD’s requirements is manufactured by SIGA.

a. Effective Competition: This is a sole source action; effective competition is not possible given the Government’s unique requirement. Equivalent supplies are not available from wholesale supply sources (e.g. General Services