Expanded Access Program

Expanded access is a general term used to refer to a variety of regulatory mechanisms available to provide treatment access to patients with life threatening or severely debilitating disease for whom commercially available therapies or diagnostics have failed or are not available.

Curium’s decision to open an Expanded Access Program is based on regulatory guidance only when all the following criteria are met:

• Patient has a serious disease or condition, or whose life is immediately threatened by their disease or condition
• There is no comparable or satisfactory alternative therapy to diagnosis, monitor, or treat the disease or condition
• Patient enrollment in a clinical trial is not possible
• The potential patient benefit justifies the potential risks of the treatment use and those potential risks are not unreasonable in the context of the disease or condition to be treated; and
• Providing the investigational drug for the requested use will not interfere with the initiation, conduct, or completion of clinical investigations that could support marketing approval of the expanded access use or otherwise compromise the potential development of the expanded access use.

NOTE: the term “treatment” is used interchangeably to refer to use of an investigational drug when the primary purpose is to diagnose, monitor, or treat a patient’s disease or condition.

The EAP will provide access in a manner that:

• Does not threaten enrollment in or conduct of controlled clinical trials for the product
• Meets all regulatory requirements
• Does not pose added risk to patient safety
• Can be financially sustained

EAPs are not set up to support commercial objectives nor are they meant to support analysis or test a hypothesis though the data may be used in a supplementary fashion.

Treating physicians may request information about Expanded Access for a Curium product by contacting Curium at CuriumEAP@curiumpharma.com.

Each physician request will be assessed for inclusion in the EAP on an individual basis, dependent upon the EAP specific procedures and applicable regulations by the Curium EAP Selection committee for the specific program.

Curium may provide physician requested Expanded Access product for patients with no other available therapies and for patients who are not eligible to participate in a current Curium clinical trial. Curium will acknowledge receipt of the request via telephone call or email within 5 business days of receipt of the request.

If the site is not eligible to participate in the EAP, but the patient is eligible for screening, Curium may provide the physician with a list of participating physicians who may be contacted to assist with patient participation the EAP.

If the site is selected to participate in the EAP, Curium will provide the physician with the appropriate start-up packet to assist with physician registration.

Pursuant to the 21st Century Cures Act: the posting of applicable policies by Curium shall not serve as a guarantee of access to any specific product by any individual patient.