1. STATEMENT OF WORK Pylarify FY2026 without price.docx

NIH Department of Radiology & Imaging Sciences Radiopharmacy, Nuclear Medicine

STATEMENT OF WORK

Procurement of Piflufolastat F-18 (PylarifyTM) Unit Doses Nuclear Pharmacy, Nuclear Medicine Department of Radiology and Imaging Sciences Clinical Center National Institutes of Health Bethesda, MD 20892

(1) Introduction and Scope of Work

The NIH Clinical Center Nuclear Pharmacy (CC NP) purchases and compounds radiopharmaceuticals (radioactive drugs) on a daily basis for life-saving clinical nuclear medicine procedures which are 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 NIH Nuclear Medicine clinic performs imaging and therapy procedures for all patients admitted to the NIH Clinical Center. These procedures are essential and necessary for the NIH clinical staff to save patients’ lives and minimize their sufferings. These nuclear medicine procedures must use radiopharmaceuticals that are administered to the patients in order to produce the required images or therapeutic results. Radiopharmaceuticals are radioactive drugs that are regulated by both FDA and US NRC. Procurement and use of these radiopharmaceutical drugs must meet federal regulations from both of these agencies. 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.

Piflufolastat F-18 injection (PylarifyTM) is a new imaging drug approved by the FDA this year for use in scintigraphic localization of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer. It is the first and only commercially available approved imaging agent to identify suspected metastasis or recurrence of prostate cancer. Progenics Pharmaceuticals, Inc. (a wholly own subsidiary of Lantheus Holdings, Inc.) is the only manufacturer with an exclusive patent authorized by FDA to provide this new drug in the United States (US). Based on this diagnostic test and patient disease conditions, the patient will be treated appropriately. For each patient study, the dose activity (calibrated dose) is unique at a specific time (calibrated time). Lantheus Holdings, Inc. has authorized regional commercial nuclear pharmacies to compound and prepare this radioactive drug and invoice customers on behalf of the company.

The purpose of the SOW is to procure compounded piflufolasta F-18 in patient ready unit doses (UDs) from Progenics Pharmaceuticals, Inc. (a Lantheus company) through 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 missions. Progenics Pharmaceuticals, Inc. (A Lantheus Company) is currently the sole manufacturer authorized by the FDA to provide this new radioactive drug. This contract will be a continuation of IDIQ #36F79719D0170 issued to an Authorized Agent and will be completed as of September 30, 2024. This new contract will be issued directly to Progenics Pharmaceuticals, Inc. starting October 1, 2025 to September 30, 2026 with allowable Economic Price Adjustment for the new Lantheus Federal Supply Schedule (FSS) pricing in the new calendar 2026 year as allowed by the FSS contract.

A base 12-months period will be initially funded with a purchase order. It is predicted that additional funding will be added in separate orders as funding becomes available.

(2) Requirements.

The NIH Clinical Center Nuclear Medicine Clinic is seeking to procure Piflufolastat F-18 injection (PylarifyTM) unit dose from Progenics Pharmaceuticals, Inc. (A Lantheus Company). The Piflufolastat F-18 injection (PylarifyTM) unit doses that are ordered must arrive at the NIH Clinical Center Nuclear Pharmacy at least 30 minutes prior to the administration (calibration time). The contract shall be valid for a period of October 1, 2025 to September 30, 2026 with allowable Economic Price Adjustment for 2026 (price increases cannot exceed 10% unless receiving approval from the NIH Chief of the Contracting Office). The vendor must submit a written request for Economic Price Adjustment to the Contracting Officer within ten (10) days of the price change.

(3) References.

a) Piflufolastat F-18 injection (PylarifyTM) Prescribing Information. Lantheus, May, 2021.

b) Piflufolastat F-18 injection (PylarifyTM) Imaging Guidelines. Lantheus, May, 2021.

c) Piflufolastat F-18 injection (PylarifyTM) is solely manufactured and supplied by Lantheus Holdings, Inc. June, 2021.

d) Lantheus Pylarify FSS 36F79725D0093 Price Quote, March 27, 2025.

(4) Delivery.

Piflufolastat F-18 injection (PylarifyTM) unit doses must be delivered directly to the CC Nuclear Pharmacy 1C437 in Building 10 of the National Institutes of Health in Bethesda, MD or to Radiation Safety Office in Building 21 if needed. This radiopharmaceutical cannot be procured at one time and must be ordered over a period of time as a task order. The period of performance will be from October 1, 2025 to September 30, 2026.

(5) Quality Assurance Surveillance Program (QASP)

The vendor performance will be evaluated based on the following parameters:

a) Errors/mistakes of the delivered doses (wrong activity, wrong calibration time, etc).

b) Presence of contaminations detected by radiation monitors and wipe testing.

c) Evidence of compliance with all applicable regulations (US FDA and US NRC websites for warning letters and notices of incompliance actions.

(6) Security Consideration.

None. No requirements are included that could lead to security breaches. The vendor will not have access to NIH patient protected data on NIH property.

(7) Place of Performance

At the vendor’s facility and deliver to the NIH Nuclear Pharmacy.

(8) Period of Performance.

October 1, 2025 to September 30, 2026.