1. STATEMENT OF WORK Pylarify FY2027_Redacted.pdf

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 Facility (CC NPF) 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 Facility to NIH Clinical Center patients.

Piflufolastat (F-18 PSMA) F-18 injection (PylarifyTM) is a new imaging drug approved by the FDA 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. Sofie Nuclear Pharmacy is the local authorized commercial pharmacy to provide Pylarify radiopharmaceutical in the DC, Maryland and Virginia areas.

The purpose of the SOW is to procure compounded piflufolasta F-18 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, 2025. This new contract will be issued directly to Progenics Pharmaceuticals, Inc.

starting October 1, 2026 to September 30, 2027 with allowable Economic Price Adjustment for the Lantheus Federal Supply Schedule (FSS) pricing in the calendar 2027 year as allowed by the FSS contract.

A base 12-months performance period from 10/1/2026 to 9/30/2027 will be contracted for the Fiscal Year 2027. Four Option Years will be included as below.

PERIOD OF PERFORMANCE

BASE PERIOD: 10/01/2026 to 09/30/2027 OPTION PERIOD 1: 10/01/2027 to 09/30/2028 OPTION PERIOD 2: 10/01/2028 to 09/30/2029 OPTION PERIOD 3: 10/01/2029 to 09/30/2030 OPTION PERIOD 4: 10/01/2030 to 09/30/2031

(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 Facility at least 30 minutes prior to the administration (calibration time). The contract shall be valid for a period of October 1, 2026 to September 30, 2027 with allowable Economic Price Adjustment for 2027 (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) doses must be delivered directly to the CC

Nuclear Pharmacy Facility in Building 10 of the National Institutes of Health in Bethesda, MD or to NIH Division of Radiation Safety (DRS) if needed. This radiopharmaceutical cannot be procured at one time and must be ordered on demand over a period of time as a task order. The period of performance will be from October 1, 2026 to September 30, 2027.

(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 Facility.

(8) Period of Performance.

October 1, 2026 to September 30, 2027.