Merck KGaA has entered into a global in-licensing agreement with Debiopharm, a Lausanne, Switzerland-based biopharmaceutical company, for the development and commercialization of xevinapant, a treatment for locally advanced squamous cell carcinoma of the head and neck, in a EUR 898-million ($1.08-billion) deal.

Xevinapant is an oral inhibitor of an apoptosis proteins (IAP) antagonist in Phase III development. It is being studied to treat previously untreated high-risk locally advanced squamous cell carcinoma of the head and neck (LA SCCHN), in combination with platinum-based chemotherapy and standard fractionation intensity-modulated radiotherapy. In February 2020, the US Food and Drug Administration granted breakthrough therapy designation to xevinapant for this indication.

Under the licensing agreement, Merck KGaA gains exclusive rights to develop and commercialize xevinapant globally, including in the US. Merck KGaA will co-fund with Debiopharm the ongoing Phase III registrational TrilynX study, a global double-blind, placebo-controlled, 700-patient randomized clinical trial to evaluate the efficacy and safety of xevinapant. Merck KGaA will also initiate a second global Phase III study to evaluate xevinapant in patients with LA SCCHN who are unable to tolerate high-dose cisplatin in combination with radiotherapy.

The agreement also includes development rights for preclinical follow-on compounds to xevinapant. Debiopharm will receive EUR 188 million ($227 million) in upfront payments and up to EUR 710 million ($855 million) in regulatory and commercial milestones, as well as royalty payments. The companies anticipate the closing of the transaction in the early second quarter of 2021.

Source: Merck KGaA and Debiopharm