Early Access to Meabcos Investigational Medicinal Products

Meabco‘s primary focus is to develop new medicines that make a meaningful difference to patients’ lives. In our pursuit to develop highly effective and safe therapies, the successful completion of a clinical trial program and subsequent availability of data to support the safety and efficacy of an Investigational Medicinal Products (IMP) is the most effective way of ensuring timely review and decision making by Health Authorities on a given product. This will ultimately result in access to new, safe, and effective approved medicines for the broadest patient population.

However, we recognize that there are circumstances wherein patients with serious or life- threatening diseases have exhausted all available therapeutic options and may not be able to enroll in one of our trials.

In such circumstances, subject to the criteria set forth below and country specific regulations, individual patients may be eligible for Early Access to a Meabco IMPs outside of a clinical trial. IMP designates any product in active development that is not approved for marketing.

Any use of an IMP outside a clinical trial must be administered by a licensed and appropriately qualified physician, in accordance with local laws and regulations governing such programmes.

Named Patient Program

Named Patient Supply describes the process in which Meabco makes an IMP available to a single patient in accordance with country-specific regulations. It includes treatment under an Investigational New Drug (IND) for individual patients in the US as defined by the US Food and Drug Administration (FDA). The treating physician contacts Meabco for the IMP and is responsible for securing any required institutional and Health Authority authorization, administering the treatment, coordinating the patient’s care and reporting any safety events. In some cases NPS may be managed by an external vendor appointed by Meabco. The information provided here primarily describes NPS.