Expanded Access Program / Managed Access Program Overview

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

ITM is dedicated to developing new radiopharmaceutical medicines to bring a positive impact on patient health, and to serving patients, patient families and patient communities through research and development, education, empathy, and awareness.

Consistent with ITM’s mission to bring innovative medicines to patients with serious or life-threatening illnesses or conditions, we are focused on enrolling and conducting the clinical trials necessary to gain regulatory approvals to make our medicines available broadly to patients as quickly as possible. We are privileged to collaborate with clinical investigators and with patients who participate in our studies with the goal of developing new, safe and effective targeted radionuclide therapies and diagnostic imaging agents. We believe this approach will serve patients who could be helped by the radiopharmaceutical medicines we are developing.

At the same time, we understand that there are seriously ill patients who will not be eligible for our clinical trials and may not have options for alternative therapies, including investigational therapies in clinical trials being conducted by other sponsors. In these circumstances, ITM will consider providing a requesting physician with pre-approval access to a specific ITM investigational drug for the treatment of an individual patient outside of a clinical trial, under Expanded Access Program/Managed Access Program (EAP/MAP), when certain conditions are met. These conditions include the following:

• The patient has a serious or life-threatening illness or condition and is either no longer responsive to or no longer able to tolerate any available treatment option
• The patient is not eligible to any recruiting clinical study in which an ITM investigational drug is tested
• The investigational drug is in active clinical development with data available to determine an appropriate dose and schedule for the patient’s specific condition
• A benefit-risk analysis, performed by the treating physician on available clinical data as well as on the individual patient's condition and history, supports treatment with the investigational drug
• Making the investigational drug available will not negatively impact or delay the conduct of clinical trials or regulatory review or approval of the investigational drug for broader patient access
• Adequate supply of the investigational drug is available
• Other documentation and information as needed

EAPs /MAPs 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.

ITM continually evaluates the benefit-risk profile of each of our investigational drugs based on evolving clinical data. Each investigational drug product under development is unique and the fact that one investigational drug is made available for the treatment of a particular patient does not mean it will be made available in response to other requests on behalf of other patients whose circumstances and medical histories may be different, or that a different investigational drug will be made available under our policy. Requests will be considered on a case-by-case basis.

ITM is committed to evaluating all requests in a fair and objective manner. All requests must be submitted by the patient’s treating physician. ITM may request more detailed information from the physician in order to fully evaluate a request. The requesting physician must agree to obtain appropriate regulatory and ethics committee approvals and comply with regulatory obligations, including obtaining patient consent, patient monitoring and safety reporting. Each request will be given careful consideration by ITM whose decisions are final.

ITM Contact:

Physicians seeking pre-approval access to ITM’s investigational drugs for patients with no alternative treatment options should submit their requests to Medical Affairs at medical.affairs(at)itm-radiopharma.com. We regularly monitor this mailbox and will use our best efforts to acknowledge each submitted request within 5 business days after receipt.