Piflufolastat F-18 injection drugs (Pylarify) from Lantheus (Notice of Intent to sole source)

Acquisition Description:

This is a Notice of Intent, not a request for proposal.  The National Institute of Health, Clinical Center (NIH-CC) intends to negotiate on an other than full and open competition basis with Progenics Pharmaceuticals Inc.

The National Institute of Health, Clinical Center (NIH-CC)’s has the Nuclear Pharmacy (CC NP) department (collectively “Program”) that purchases and compounds radiopharmaceuticals (radioactive drugs) on a daily basis for life-saving clinical nuclear medicine procedures. This is essential for the NIH Clinical Center to achieve optimal patient care. These radiopharmaceuticals are United States Food and Drug Administration (FDA) approved drugs for use in patients. They are also radioactive materials that are regulated by the United States Nuclear Regulatory Commission (US NRC) through the NIH radioactive material license (RAM) administered by the NIH Radiation Safety Office (RSO). Only RSO certified Nuclear Medicine personnel can order these radiopharmaceuticals directly for patient use. Each radiopharmaceutical is time sensitive because of the rapid radiation decay. Because of their short useful half-lives, they cannot be ordered in advance for storage. They must be properly compounded, dispensed, calibrated and delivered for a specific patient at a specific time on a specific date on a daily basis.

The purpose is to procure compounded piflufolasta F-18 in patient ready unit doses (UDs) from an authorized nuclear pharmacy for the use by the NIH Nuclear Medicine, Department of Radiology and Imaging Sciences to diagnose and treat diseases as required by necessary patient care protocols at the NIH Clinical Center. This new radioactive drug is vital to the NIH Clinical Center mission.

The product is owned and developed by Lantheus Medical/Progenics Pharmaceuticals (now merged as one company). Progenics Pharmaceuticals Inc uses Lantheus’ Federal Supply Schedule contract on contract 36F79719D0170.

Justification and other information:

This requirement will be sole sourced to Progenics Pharmaceuticals Inc. under FAR 8.405-6 (b): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized. This notice is being made on SAM.gov instead of GSA Ebuy because the GSA Ebuy category “65 I B PHARMACEUTICALS AND DRUGS” states that “This SIN is not available through GSA Advantage.”

Lantheus Medical Imaging (a company of Lanntheus Holding, Inc.) is the developer and intellectual property owner of Piflufolastat F-18 injection drugs (Pylarify) in the United States. More specifically, Progenics Pharmceuticals had been developing this drug and Lantheus merged Progenics Pharmaceuticals. Progenics Pharmaceuticals Inc is the only local authorized commercial nuclear pharmacy authorized by Lanthesus Medical Imaging to compound, prepare, delivery and invoice for these drugs. They use the Federal Supply Schedule contract on contract 36F79719D0170, and they are the designated authorized vendor for our area.

Only this drug can be used for Program’s patient care and research and Program has been using these drugs for years in ongoing projects and patient care. Only qualified vendors that meet the FDA and US NRC regulations can provide these radiopharmaceuticals for compounding and dispensing at NIH Nuclear Pharmacy to NIH Clinical Center patients. Thus, only Progenics Pharmaceuticals Inc. is the sole authorized provider of these drugs.

Indefinite Delivery/Indefinite Quantity (IDIQ) Requirement:

150x to 230x Qty of PYLARIFY piflufolastat F-18 injections

4x Qty for PYLARIFY unused doses fees

Base Year

Option Year 1

Option Year 2

Option Year 3

Option Year 4

Place of Performance or Delivery:

The contract period of performance is 10/01/2026 – 09/30/2027 for the base year.

Option Years:

10/01/2027 – 09/30/2028

10/01/2028 – 09/30/2029

10/01/2029 – 09/30/2030

10/01/2030 – 09/30/2031

This requirement will be awarded on GSA Contract #36F79719D0170.

Place of Performance: NIH Clinical Center in Bethesda, MD

The statutory authority for this sole source requirement is 41 U.S.C. 1901 (a) (1) as implemented by FAR 13.106-1 and/or FAR 8.405-6 - only one responsible source and no other supply of service will satisfy agency requirements. THIS IS NOT A REQUEST FOR PROPOSAL.  All responsible sources that could provide the required may submit a capability statement that will be considered by email (subject line to reference NOI-000004) by 10:00 AM eastern standard time on 09/29/2026 to: lu-chang.lu@nih.gov

All responses received by the closing date of this synopsis will be considered by the Government.  A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.