SPECIAL NOTICE
A -- Notice of Intent to use Other than Full and Open Competition
- Notice Date
- 4/13/2015
- Notice Type
- Special Notice
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- Department of Health and Human Services, Office of the Secretary, Acquisitions Management, Contracts, & Grants (AMCG), Office of the Assistant Secretary for Preparedness & Response (ASPR), Department of Health and Human Services, 330 Independence Ave. SW, G640, Washington, District of Columbia, 20201, United States
- ZIP Code
- 20201
- Solicitation Number
- Intent-2015-1-SPXAV
- Point of Contact
- Brooke Bernold, Phone: 2027202823
- E-Mail Address
-
brooke.bernold@hhs.gov
(brooke.bernold@hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Notice of Intent to Use Other than Full and Open Competition Action Code: Intent 2015-1 SPXAV Agency: Department of Health and Human Services Office: Office of the Secretary Location: Acquisitions Management, Contracts, & Grants (AMCG) Contracting Office Address: Office of the Assistant Secretary for Preparedness & Response (ASPR) Department of Health and Human Services 330 Independence Ave. SW G640 Washington, District of Columbia 20201 United States The Department of Health and Human Services (HHS), Office of the Assistant Secretary for Preparedness and Response (ASPR), Biomedical Advanced Research and Development Authority (BARDA) intends to use other than full and open competition to award a sole source contract to Chimerix, Inc. for procurement of brincidofovir for the treatment of smallpox. This notice of intent to award a sole source contract will be posted for 15 calendar days to verify that no other sources can meet this requirement given only one responsible source and no other supplies or services will satisfy the Government requirements. The Government seeks to avoid substantial duplication of cost that is not expected to be recovered through competition. This 15 calendar day notice shall expire on April 28, 2015 at 5:00 PM Eastern Standard Time. If no credible responses to the intent to sole source are received by the Government, a request for proposal will be forwarded to Chimerix, Inc. Following, the Government will amend the intent to sole source by posting the redacted Justification and Approval (J&A) for 30 days. The proposed contract action will support services for which the Government intends to solicit and negotiate with only one source under the authority of the Federal Acquisition Regulation (FAR) 6.302-1. This notice of intent is not a request for competitive proposals. Interested individuals may identify their interest and capability to respond to the requirement by submitting in writing their name, address, telephone number, email, and a statement regarding capability to provide the specified smallpox antiviral. Responses shall be limited to three (3) pages or less, including all attachments. Interested parties will be considered only if they respond to this notice with clear and convincing evidence that competition would be advantageous to the Government, would not be cost or time prohibitive, and would not hinder the mission objective of delivering a second readily-available smallpox antiviral to the Centers for Disease Control and Prevention Strategic National Stockpile (CDC/SNS) with a mechanism of action that differs from the smallpox antiviral already in the CDC/SNS, ST-246. All capability statements, proposals, or quotes received prior to April 28, 2015 at 5:00 PM Eastern Standard Time will be considered by the Government. The Government will not be responsible for any costs incurred by responding to this notice. The Government will notify parties of the outcome of any capability statement, proposals, or quotes submitted in response. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. Anticipated Award Date and Period of Performance: The Government anticipates an award date of fourth quarter FY2015. The estimated period of performance for the 60-month base period is 9/1/2015 - 8/31/2020 for initial deliveries of the second smallpox antiviral treatment courses to the CDC/SNS. Options may be exercised at the Government's discretion to achieve the potential delivery of a maximum of 1.7 million treatment courses. Delivery Schedule: The delivery schedule of the smallpox antiviral treatment courses to the CDC/SNS for the treatment of smallpox will be established during contract negotiations. The first delivery of smallpox antiviral to the CDC/SNS fulfilling requirements established by the FDA to support potential use of the product during a declared emergency is expected to occur in calendar year 2017 of the 60 month base period. The remaining product deliveries will be structured during the remaining 60 month base period. Contract type: The Government proposes the award of a hybrid contract consisting of a firm-fixed price component for purchase of smallpox antiviral and a cost-plus fixed fee component to support final development efforts of the smallpox antiviral. Estimated award amount: The total estimated dollar value for the 60-month base period contract is approximately $100M. If all options are awarded, the total dollar value is estimated to be $435M. Background: BARDA awarded an advanced research and development contract to Chimerix Inc. in February 2011 to support development and approval of brincidofovir for the treatment of smallpox as well as dsDNA virus infections, including cytomegalovirus (CMV). Since that time, significant progress has been made. A data package to support NDA filing for the prevention of CMV is nearing completion. Most non-clinical studies as well as drug manufacturing activities that are required to support approval for both CMV and smallpox indications have been completed. The number of human subjects that have received brincidofovir has increased to more than 1,000 human patients including pediatrics. Therefore, the human safety dataset to support approval and use for both commercial and biodefense indications is robust. During this time, there has also been extensive communication between the FDA, Chimerix, and BARDA about a data package that could support approval of brincidofovir for the treatment of smallpox in accordance with the FDA Animal Rule. These discussions have informed the studies that have been completed to date to demonstrate safety and efficacy in animal models of orthopox infection. Purpose and Objectives: The Government seeks a second smallpox antiviral for delivery to the CDC/SNS with a distinct mechanism of action from the current procurement and delivery of SIGA Technologies smallpox antiviral, ST-246. Procurement of a second smallpox antiviral for the CDC/SNS will achieve the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) smallpox preparedness goal of having two smallpox antivirals with distinct mechanisms of action readily available. The Chimerix smallpox antiviral, brincidofovir, targets orthopox viruses with a distinct mechanism of action when compared to ST-246. In the event of resistance to one smallpox antiviral or if one smallpox antiviral is contraindicated for an individual patient, a second smallpox antiviral option will be available. In addition, the Government desires a product in an advanced stage of development (Phase 2 clinical development or greater) with a commercial indication to enhance sustainability of the smallpox antiviral and potentially reduce total life cycle costs to the Government. The Government desires a smallpox antiviral that has demonstrated activity against variola virus in vitro, and has demonstrated efficacy in the treatment of orthopox virus infection in at least one animal model deemed suitable through correspondence with the U.S. Food and Drug Administration (FDA). Finally, the Government seeks a smallpox antiviral with a robust human safety database in adults and children. Brincidofovir, currently being developed by Chimerix, Inc has been identified as the one candidate smallpox antiviral therapy that has the potential to meet all of the Government's requirements. An understanding of the drug-specific approval pathway for smallpox and significant progress in achieving the milestones along that pathway are unique to Chimerix. The Government considers that an award to any other Offeror would be a duplication of effort and require funding to complete animal model studies and clinical trials to assess safety and efficacy of the product prior to procurement and FDA approval. In addition, this duplication of efforts would significantly delay the time to drug approval for a smallpox indication as well as readiness of the product for procurement and stockpiling.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/OOS/OASPHEP/Intent-2015-1-SPXAV /listing.html)
- Place of Performance
- Address: Chimerix Inc., 2505 Meridian Parkway, Suite 340, Durham, North Carolina, 27713, United States
- Zip Code: 27713
- Zip Code: 27713
- Record
- SN03697478-W 20150415/150413234629-adc39285c4659164c0a0b19b09bc12d2 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |