Expanded Access (EA) policy for Debio 1143

Debiopharm International S.A. is a private Swiss biopharmaceutical company with an ongoing commitment to improve patient outcomes and quality of life in oncology and bacterial infections.

Debiopharm International S.A. is currently developing Debio 1143, a potent, orally available, inhibitor of IAPs (Inhibitor of Apoptosis Proteins).  Debio 1143 presents the potential to enhance both the proapoptotic effect of chemoradiotherapy and the anti-tumor immune response of immuno-oncology agents. Debio 1143 is currently in clinical development in combination with immunotherapy or chemoradiotherapy for the treatment of solid tumors such as Locally-Advanced Squamous Cell Carcinoma of the Head and Neck (LA-SCCHN).

At Debiopharm International S.A, we are focused on enrolling and conducting clinical trials aimed at obtaining the necessary regulatory approvals/marketing authorizations for medicinal products and ensuring that safe and effective medicinal products can be quickly made available for patients. As such, we believe participation in our clinical trial is the most appropriate way to access Debio 1143 at this stage of clinical development. Information about our clinical trials, including eligibility criteria and locations, is available at www.clinicaltrials.gov.

However, Debiopharm International S.A. acknowledges that patients with serious or life-threatening diseases or conditions that cannot be treated satisfactorily with any currently authorized medicinal product, with no other treatment options, may sometimes seek treatment with Debio 1143. In these cases, the treating physician can request Debio 1143 for the patient from Debiopharm International S.A. before regulatory approval has been granted, if allowed by the applicable local laws and regulations.

Debiopharm International S.A. will evaluate these requests case by case on a fair and equitable manner considering  the available safety and clinical data, and provided that the use of Debio 1143 will not interfere with investigational trials that could support the clinical development or marketing approval of Debio 1143 in relevant treatment indications.