TPOXX JA 2-9-2022-fully signed-2.10.22.pdf

Control No: JA-21-Edg-645 Contractor: SIGA Technologies, Inc.

Program/Equipment: TPOXX

Controlled Unclassified Information

CUI

JUSTIFICATION REVIEW DOCUMENT

FAR PART 6 JUSTIFICATION AND APPROVAL FOR OTHER

THAN FULL AND OPEN COMPETITION

Program/Equipment: Procurement of a smallpox therapeutic to replace expiring stock within the Force Health Protection’s (FHP) current stockpile, manufactured by SIGA Technologies Inc. under the brand name TPOXX, which is an approved treatment of human smallpox disease caused by variola virus (smallpox) in adults and pediatric patients.

Authority:

41 U.S.C. 3304(a)(1) as implemented by FAR Part 6.302-1 -- Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

Amount: $7,469,964.00

Prepared by: Micah Almas Program Manager Email: micah.o.almas.civ@army.mil

DSN:

Date:

Contracting Officer: Richard Totten Branch Chief Email: richard.w.totten2.civ@army.mil

DSN:

Date:

Technical: Rachel Overman Deputy Joint Product Manager Email: rachel.l.overman.civ@army.mil

Requirements: Rachel Overman Deputy Joint Product Manager Email: rachel.l.overman.civ@army.mil

Controlled by: ARMY Controlled by: ACC-APG

CUI Category: General Procurement and Acquisition Distribution/Limited Dissemination Control: FEDCON

POC: Richard Totten, 301-619-2446

Program/Equipment: TPOXX

Controlled Unclassified Information

Reviews: I have reviewed this justification and find it adequate to support other than full and open competition.

Program Manager:

Typed Name: Micah Almas

Signature:

Legal Counsel:

Typed Name:

Program/Equipment: TPOXX

FAR Part 6 Justification and Approval for Other than Full and Open Competition

1. Contracting Activity:

Army Contracting Command Aberdeen Proving Ground Edgewood Division

2. Description of Action:

Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear (JPEO-CBRN) Medical requests a firm-fixed-price contract with SIGA Technologies, Inc. 4575 SW Research Way, Ste 110, Corvallis, OR, 97333 to purchase 10,000 additional doses of a smallpox therapeutic to replenish expiring doses within the existing Department of Defense (DoD) stockpile with a future option to purchase at least 10,000 more doses to increase the available quantity. The Government projects award for March 2022 and FY21 procurement funds will be used.

3. Description of Supplies/Services:

JPEO CBRN Medical requires at least 10,000 treatment courses of a smallpox therapeutic with a future option to purchase at least 10,000 more doses. This is a new procurement to refresh the doses in FHP current stockpile procured under Biomedical Advanced Research Development Authority (BARDA) contract HHSO100201800019C, awarded in FY18. This congressionally funded procurement is required to replenish the smallpox antiviral stockpile. FHP manages the current stockpile for the Department of Defense (DoD), and JPEO-CBRN Medical will partner with them to meet the shared mission of providing the warfighter protection from man-made or natural threats caused by smallpox. This acquisition will extend protection to the warfighter by stockpiling replacement doses so there is not a gap in protection capability.

Period of Performance: 2QFY22 to 4QFY23 or (30 SEPT 2023) Total Value: $7,469,964.00

4. Authority Cited:

41 U.S.C. 3304(a)(1), as implemented by FAR 6.302-1, Only one responsible source and no other supplies or services will satisfy agency 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.

Market research, which included a search of all U.S. Food and Drug Administration (FDA) approved drugs and publication, identified only two drugs approved to treat smallpox infections, TPOXX and brincidofovir. TPOXX, formerly known as tecovirimat, 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 after TPOXX was approved by the FDA as a smallpox therapeutic, prior to TEMBEXA that was approved (in 2021), a competitive contract was awarded to SIGA to acquire TPOXX doses to fill the FHP stockpile with sufficient quantities to meet DoD needs. This current acquisition is intended to replenish product that will expire over the next few years, in addition to an optional requirement to increase the current TPOXX inventory by another 10,000 doses.

On 16 June 2020 an acquisition decision memorandum for JPM CBRN Medical was signed by the MDA authorizing JPM CBRN Medical the ability to execute FY20 BA5 Congressional Mark funds provided in the NDAA to support Antiviral post-exposure prophylaxis (PEP) studies for Smallpox.

Requirement: MDA authorized the JPM CBRN Medical to use up to $11 million (M) in FY20 BA5Congressional Mark funds in the NDAA towards Food and Drug Administration (FDA) approval of TPOXX for a post-exposure prophylaxis indication for smallpox. This memorandum outlines funding allocated for a PEP indication for TPOXX with congressional funding. This requirement is critical to the warfighter to provide a smallpox treatment post exposure prior to symptom onset.

Because smallpox symptoms may not arise until two weeks after exposure to the virus, the DoD has 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. This requirement was identified in 2018, before TEMBEXA was approved. SIGA and the DoD, via the JPEO-CBRND Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical), increased research and development funding to approximately $23 million via an Other Transaction Authority (OTA) agreement, MCDC-1901-001, to support advanced development of TPOXX for PEP against smallpox and to attempt to gain FDA approval for the additional indication, which is currently ongoing. To date, the DoD has expended $3.29 million in funding towards this TPOXX PEP indication and is anticipating submitting to the FDA for approval before FY25. The DoD has also drafted an Expanded Access Protocol (EAP) for TPOXX, which can be used for 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, and 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 warfighter, in addition to delaying replenishment of expiring stock.

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. Its labeling also characterizes TEMBEXA as a potential human carcinogen in instances of extended use. Due to this black box warning and 14 day treatment course, the FDA currently would not approve TEMBEXA for a PEP indication, which is not in the best interest of the warfighter. TPOXX, on the other hand, can be dosed up to 28 days without significant safety concerns. Because of the safety concerns, it is unlikely that TEMBEXA could be dosed in such a way for it to be safe enough to use for the extended treatment required for PEP on asymptomatic patients that have not yet been diagnosed with a smallpox infection.

The PEP indication is vital because if TEMBEXA is used for treatment prior to symptom onset and symptoms do not arise until 14 days after exposure, then the maximum safe dose of TEMBEXA will have been administered at the time of symptom onset. This would exclude additional doses of TEMBEXA due to the FDA black box warning for significant adverse effects leaving the patient experiencing smallpox symptoms without a treatment. If TPOXX was used instead, then the patient in this same scenario would still have 14 days of available treatment courses.

Therefore, TEMBEXA is not a suitable alternative to TPOXX and does not meet the DoD requirement.

The Government has a need for a safe PEP smallpox treatment. It is estimated that investing in development of the only other smallpox therapeutic, TEMBEXA, to meet the DoD requirements for PEP indication, would incur an additional estimated $17.5M, 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 the PEP treatment became available, based on the awarded schedule under the agreement with SIGA. Additional investments would have to be made to overcome the safety issues related to TEMBEXA that would not have been invested to develop TPOXX. This may require a new formulation of TEMBEXA, extended release, or other research and development discoveries of unknown costs and schedule to investigate the current black box warning. There is no guarantee that the safety concerns could ever be overcome.

Market research indicates there are only 2 FDA approved products capable of meeting the existing requirement. Of the 2 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.

6. Efforts to Obtain Competition:

Notice of Intent to Sole Source (W911SR-21-S-TPOX) was published to SAM.gov on 14 September 2021. The only response received was from Chimerix. A separate Sources Sought Notice was issued on 27 Oct 21, W911SR-21-9-TPO2 was posted on SAM.gov, receiving a single response from SIGA. 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: Because this is a sole source action, effective competition is not applicable. Supplies are not available from wholesale supply sources (e.g.

General Services Administration, Defense Logistics Agency, Department of Veterans Affairs, and military control points.) Research identified that SIGA Technologies, Inc. is the only approved manufacturer and the sole distributor of TPOXX and is therefore the most responsible source to replace the stockpile.

b. Subcontracting Competition:

SIGA currently contracts with several contract manufacturing organizations (CMOs) to produce TPOXX. The CMOs currently utilized are:

WR Grace & Co.

Lonza Catalent Pharma Solutions Packaging Coordinators LLC

Development of an FDA approved product requires regulatory approval of all CMO’s, in addition to the product sponsor SIGA. Once approved, there is no opportunity for competition, since the cost and schedule impacts to transfer manufacturing to another subcontractor would be at a minimum $4M and 12 months (6 months to stand up, and 6 months for FDA approval) based on historical data. In addition, the risk of tech transfer of an established/approved process is med/high. A review of SAM confirmed only Packaging Coordinators LLC is the only small business currently utilized by SIGA in the manufacture of TPOXX.

7. Actions to Increase Competition:

The Government will continue to perform market research to determine if a compliant smallpox alternative becomes available and if new insight about TEMBEXA is revealed that make it a more suitable alternative. With any drug product, competition for specific products is limited to the FDA approved sponsor. There is no generic alternative to treat smallpox currently available. The doses procured will have a shelf life of 7 years. It is not anticipated that additional doses of a smallpox therapeutic will be procured until this expiration date nears.

8. Market Research:

In accordance with Defense Federal Acquisition Regulation Supplement (DFARS) 205.205-71, DFARS 206.302-1(d), and DFARS Procedures, Guidance and Information (PGI) 206.302-1(d), a sources sought notice (SSN) was posted to sam.gov on 27 October 2021 for 10 days with the source sought reference number W911SR-21-9-TP02. The only response received was from SIGA Technologies. JPM Bio2 performs ongoing market research to identify performers within their portfolio, in addition to coordination with other Federal agencies with similar requirements and/or alternative products. In the case of a therapeutic meeting the smallpox requirements, no other sources or alternatives exist.

9. Interested Sources:

Chimerix submitted a response to W911SR-21-S-TPOX Notice of Intent to Sole Source . . SIGA Technologies submitted a response to the Sources Sought Notice.

Technical review of the response concluded Chimerix cannot meet the requirements of this procurement. No other sources of an approved therapeutic for the treatment of smallpox have been identified.

10. Other Facts:

a. Procurement History

The initial stockpile was procured by BARDA under contract number HHSO10020180019C, awarded 13 September 2018. This contract was solicited on a full and open competitive basis with SIGA Technologies being selected as the awardee. Subsequently, TPOXX, was selected to pursue a PEP indication in 2020 based on review of the data submitted to the FDA.

b. Continuing and Establish Research and Development of TPOXX

In addition to replacing the DoD stockpile, TPOXX is the subject of continuing U.S.

Government development, including: congressionally funded research to expand tecovirimat’s FDA approved label, to include post-exposure prophylaxis against smallpox. The DoD has also drafted an EAP for tecovirimat, which will have regulatory approval for treatment for smallpox exposure before symptoms arise.

Development of a similar product is cost prohibitive. Generally, advanced development of a therapeutic to FDA licensure can take up to five years with an estimated cost of $45M, assuming the product has reached a Technology Rating Level (TRL) of 5. Limitations of sources is inherent in pharmaceutical products due to the requirement for FDA approval. Considering tecovirimat was approved by the FDA in 2018, any generic products would not be available until the patent has expired.

Technical Certification: I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

Typed Name: Rachel Overman Date:

Title: Deputy Joint Product Manager Signature:

11. Requirements Certification: I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

Typed Name: Rachel Overman Date:

Title: Deputy Joint Product Manager

12. Fair and Reasonable Cost Determination: I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable.

This determination will be made using the following: □ cost analysis X price analysis

□ should cost X IGCE □ audit: □ other:

As a part of this basis, certified cost or pricing data:

X will be required.

□ will not be required and the following exception applies (FAR 15.403):

□ Prices that will be agreed upon are based on adequate price competition.

□ Prices that will be agreed upon are based on prices set by law or regulation.

□ A commercial item is being acquired.

□ A waiver has been granted by the head of the contracting activity (HCA) in accordance with DFARS PGI 215.403-1.

□ The contract action is a modification to a contract or subcontract for commercial item(s).

□ The estimated cost of the contract action is less than the threshold for certified cost or pricing data.

Typed Name: Richard W. Totten Date:

Title: Contracting Officer Signature:

X Right-Click "Signature Setup"

13. Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief.

Typed Name: Richard W. Totten Date:

Title: Contracting Officer Signature:

Approval Based on the foregoing justification, I hereby approve the procurement of the smallpox therapeutic, tecovirimat, for the estimated amount of $7,469,964.00 on an other than full and open competition basis pursuant to the authority of 41 U.S.C.

3304(a)(1), subject to availability of funds, and provided that the deliverables herein described have otherwise been authorized for acquisition.

Lane M. Gary Date:

Command Advocate for Competition Signature: