Expanded Access

Intercept Pharmaceuticals (“Intercept”) believes the best way for patients to access medicines prior to approval is through participation in clinical trials. In some specific situations when enrollment into a clinical trial is not feasible, physicians caring for patients with serious or life-threatening conditions or diseases may seek special access to investigational medicines (referred to as compassionate use or also known as expanded access, pre-approval access and emergency use).

Intercept may consider individual compassionate access requests to an investigational medicine outside of a clinical trial only when all the following criteria are met:

• The patient’s condition is believed to be life-threatening or potentially debilitating
• All available therapies normally used to treat the disease or condition have been exhausted
• No other viable options including participation in clinical trials are available
• There is sufficient evidence that the potential benefit to the patient would likely outweigh the potential risks based on what is known at the time
• Compassionate access will not compromise the clinical development program of the investigational medicine
• Adequate supply exists to support both the ongoing clinical trials and prior approved compassionate use requests
• There is a plan by Intercept Pharmaceuticals to make the medicine, once approved, available commercially in the country from which the request was received
• The request to Intercept Pharmaceuticals for compassionate access to the investigational medicine arises from the patient's treating physician unsolicited

Treating physicians for patients that meet these criteria, may submit a request by contacting: global@idispharma.com

If all these criteria are met, Intercept may consider the compassionate use requests from the treating physician. Intercept strives to acknowledge requests within 5 business days of receipt of the request and completed application documentation. All eligible requests will be evaluated by a review committee in a fair, unbiased manner. Any compassionate access to investigational medicine must comply with the applicable country-specific laws and regulations, including approvals from regulatory bodies and by an Institutional Review Board or Ethics Committee from the treating hospital if applicable. If the request is approved, the treating physician must be responsible for his / her patient’s care. The physician’s duty is to understand the risks and benefits of the investigational medicine, be prepared to follow all legal and regulatory authority requirements, and be willing to conduct all necessary medical monitoring, safety reporting and data collection. The patient (or his or her guardian) must also provide informed consent.

Information about Intercept clinical trials can be found at https://clinicaltrials.gov/

This policy is not a guarantee of access to any Intercept investigational drug. Intercept reserves the right to revise or revoke this policy at any time.