Intent to Sole Source PYLARIFY (piflufolastat F 18)

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.