SAM #36C24226F0064

Sole Source Procurement of Lenalidomide Oral Capsules for VA VISN 02

This notice details the Department of Veterans Affairs' intent to award a sole-source contract for Lenalidomide oral capsules to Exelan Pharmaceuticals, supporting cancer and blood disorder treatments for VA patients. - Sole-source procurement to Exelan Pharmaceuticals for Lenalidomide, an immunomodulatory drug - Used to treat multiple myeloma, anemia in myelodysplastic syndromes (MDS), and certain lymphomas - Products include Lenalidomide oral capsules in 2.5MG, 5MG, 10MG, 15MG, 20MG, and 25MG dosages - Part numbers: 76282-0696-48, 76282-0697-48, 76282-0698-48, 76282-0699-47, 76282-0700-47, 76282-0701-47 - Estimated annual contract value is $26,272,218 - Vendor must comply with federal regulations, current Good Manufacturing Practices (cGMP), FDA requirements, and the REMS program - The contract ensures a continuous supply through REMS-certified pharmacies to maintain patient access and safety - No other vendors identified due to the specialty nature and regulatory requirements of the drug - Place of performance and contracting office: Samuel S. Stratton VA Medical Center / VISN 02 Contracting Office, 113 Holland Avenue, Albany, NY 12208

Description

This is a notice of intent to award a Sole-Source only contract and is not a request for quotes.

Name of Proposed Contractor Exelan Pharmaceuticals Street Address: 370 W. Camino Gardens, Suite 204 City, State, Zip: Boca Raton, FL 334432

The objective of this action is the procurement for:

The purpose of this contract is to establish a reliable and continuous supply of Lenalidomide, an immunomodulatory drug used primarily to treat multiple myeloma, anemia in myelodysplastic syndromes (MDS) in adults, and certain types of lymphoma. Lenalidomide works by enhancing the immune system s ability to fight cancer cells. It inhibits the growth of new blood vessels in tumors and alters the immune response to target and destroy malignant cells. It comes with serious risks that require careful management and monitoring.

Contractor shall provide all materials, labor, and equipment necessary to supply Lenalidomide in accordance with all applicable federal regulations, Good Manufacturing Practices (cGMP) and the Food and Drug Administration (FDA) requirements. This is an emergent need to ensure continuous supply, to meet regulatory obligations (Risk Evaluation and Mitigation Strategy REMS) program, and to support patient access.

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