• Merck has signed an agreement with Debiopharm.
  • This is a € 900 million agreement is for the development of Xevinapant.

Germany-based healthcare and chemicals group Merck KGaA has signed a € 900 million (equal to US $ 1 billion 70 million 541 thousand) global licensing agreement with Switzerland-based Debiopharm to develop and commercialize Xevinapant. Xevinapant is useful for the treatment of head and neck cancer.

Under the terms of agreement, Merck KGaA will pay Swiss-based Debiopharm € 188 million (equal to $ 223 million 624 thousand 120) upfront and up to € 710 million (equal to $ 844 million 537 thousand 900) in regulatory payments, commercial milestones, and royalty payments. The business partners may close the transaction in early Q2 of 2021.

Merck and Debiopharm are going fund an ongoing 700-patient Phase 3 clinical trial together. This trial will evaluate the efficacy and safety of Xevinapant against placebo when added to definitive chemoradiotherapy (CRT) in cisplatin-eligible patients who are suffering from high-risk Locally Advanced Squamous Cell Carcinoma of the Head and Neck (LA SCCHN). Xevinapant is a potent oral Inhibitor of Apoptosis Proteins (IAP) antagonist. Merck said that IAP antagonist was the only medicine in its class that was in late-stage clinical development.

The results of a Phase 2 trial results showed that the combination of Xevinapant and chemoradiotherapy lowered the risk of death by 51% against standard of care. On the basis of the Phase 2 study, the US Food and Drug Administration (FDA) granted Xevinapant Breakthrough Therapy Designation a status in combination with standard of care for the treatment of patients with previously untreated LA SCCHN, in FEB 2020.