6505--Intent to Sole Source PYLARIFY (piflufolastat F 18)
Closed Special Notice Posted
- Solicitation number
- 36C25225Q0655
- Agency
-
Veterans Integrated Service Network 12
Veterans Health Administration, Department of Veterans Affairs
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 325412 Pharmaceutical Preparation Manufacturing
- PSC
- 6505 Drugs And Biologicals
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 12 has published a special notice announcing its intent to award a sole source contract for PYLARIFY (Piflufolastat F 18), a specialized radiopharmaceutical injection. The procurement will be conducted by the VHA Regional Procurement Office Central, Great Lakes Acquisition Center, Network Contracting Office 12 in Milwaukee, Wisconsin. The sole source award is intended for Progenics Pharmaceuticals, Inc., located in N. Billerica, Massachusetts, to supply the Edward J. Hines, Jr. VA Medical Center in Hines, Illinois. PYLARIFY is a highly specialized radioactive diagnostic agent used for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer patients. The procurement falls under NAICS code 325412 for Pharmaceutical Preparation Manufacturing and represents a firm-fixed-price delivery order arrangement.
The purpose of this special notice is to satisfy federal procurement transparency requirements while announcing the VA's intent to proceed with sole source procurement due to PYLARIFY being manufactured exclusively by Progenics Pharmaceuticals as the only FDA-approved vendor for this specific radiopharmaceutical. The contract covers a base period from September 1, 2025, through August 31, 2026, with one 12-month option period, at a unit price of $3,789.16 per injection under Federal Supply Schedule contract 36F79719D0170. Interested parties have until 5:00 PM Eastern Time on August 26, 2025, to submit written notice to Stacy.Massey@va.gov demonstrating their capability to meet the requirement, though this is not a request for competitive proposals. Any responses must include supporting evidence provided at no cost to the government, and the VA retains sole discretion regarding whether to proceed with competition. The radiopharmaceutical offers unique clinical advantages including longer decay half-life and reduced radiation exposure compared to alternative PSMA imaging agents, making it particularly valuable for prostate cancer diagnosis and monitoring.
Notice text
The Department of Veterans Affairs, VHA Regional Procurement Office Central, Great Lakes Acquisition Center, Network Contracting Office 12, located at 115 S. 84th Street, Suite 101, Milwaukee, WI 53214-1476 intends to award a sole source, firm-fixed-price delivery order to Progenics Pharmaceuticals, Inc. 331 Treble Cove Road, N. Billerica, MA 01862, for the purchase of Pylarify Injection (Piflufolastat F 18). The associated North America Classification Systems (NAICS) Code is 325412, Pharmaceutical Preparation Manufacturing.
The Edward J. Hines, Jr. VA Medical Center, 5000 South 5th Avenue, Hines, IL, 60141-3030, has a requirement for the purchase of Pylarify Injection (Piflufolastat F 18). Pylarify (piflufolastate F18) is highly specialized radiopharmaceutical. Pylarify is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy and or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. Pylarify combines the accuracy of PET imaging, the precision of PSMA targeting, and the clarity of F18 radioisotope. Per the FDA website https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm. Pylarify is manufactured for and a trademark of Progenics Pharmaceuticals, Inc.
This notice satisfies the requirement at FAR 5.201(b)(1), to publicize the proposed contract action. This notice of intent is not a request for competitive proposals. No solicitation documents are available at this time. Interested parties may give written notice to Stacy.Massey@va.gov by 5:00pm e.s.t. on 08/26/2025. Supporting evidence must be furnished in sufficient detail to demonstrate the ability to meet the subject requirement. This information shall be provided at no cost or obligation to the Government. Responses will be considered by the Government; however, a determination by the Government not to compete the proposed acquisition based upon responses of this notice is solely within the discretion of the Government.
Inquiries shall be emailed to Stacy.Massey@va.gov. No telephone requests will be accepted. Any response to this notice must show clear and convincing evidence that competition would be advantageous to the Government in future procurements.
Files
| File | Type | Posted |
|---|---|---|
| LSJ_OVER_SAT Pylarify_Redacted.pdf | ||
| 36C25225Q0655.docx | DOCX document |
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