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

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Contract Opportunity

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 (Sofie 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.

Justification:

The product is owned and developed by Lantheus Medical/Progenics Pharmaceuticals (now merged as one company). Sofie Co. has been authorized by Lantheus to manufacture and distribute the product and is allowed to use Lantheus’ Federal Supply Schedule contract on contract 36F79719D0170. Sofie Co. was originally the company that received awards. However, Lantheus Medical/Progenics Pharmaceuticals has shifted to taking awards directly under Progenics Pharmaceuticals Inc. via their GSA contract 36F79719D0170.

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.

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. Sofie Nuclear Pharmacy (known as Sofie Co.) was authorized authorized by Lanthesus Medical Imaging to compound, prepare, delivery and invoice for these drugs. Lantheus now accepts awards directly through their GSA contract instead of accepting it through Sofie Co.

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, this requirement should be sole sourced to Progenics Pharmaceuticals Inc.

Requirement:

96x Qty for PYLARIFY piflufolastat F-18 injections

4x Qty for PYLARIFY unused doses fees

***This notice cannot be posted on GSA Ebuy due to the SIN category for drugs & pharmaceuticals having errors/incompatibilities with posting notices.***

Place of Performance or Delivery:

The contract period of performance is 10/01/2025 to 09/30/2026

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 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-CC-26-000012) by 11:00 AM eastern standard time on 09/29/2025 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.

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