Summit Therapeutics has entered into an exclusive license and commercialization agreement granting Eurofarma Laboratórios rights in Latin America to its precision antibiotic ridinilazole in development for the treatment of C. difficile (CDI). Summit retains rights in all other countries.

Ridinilazole is a targeted antibiotic that has the potential as a frontline therapy to treat initial infection and preserve patients’ microbiomes to reduce the rate of recurrent CDI. In a Phase II trial in CDI patients, ridinilazole demonstrated statistical superiority in sustained clinical response rates compared to the standard of care, vancomycin. Ridinilazole is expected to enter Phase III trials in 1H18.

Summit will receive an upfront payment of $2.5 million, and is eligible to receive a further $25.2 million in development, commercial, and one-time sales milestones in the Licensed Territory. The agreement also provides for product supply transfer payments. Eurofarma will be responsible for obtaining regulatory approval for ridinilazole in the Licensed Territory. Summit retains full responsibility for the clinical development of ridinilazole in all countries, and is responsible for regulatory approvals outside Latin America.

“Eurofarma’s established infrastructure and expertise in Latin America are ideally placed to commercialize our novel antibiotic, ridinilazole,” said Glyn Edwards, chief executive officer of Summit. “This agreement, combined with the recent contract award of up to $62 million from the US Government agency BARDA, will further support the Phase III clinical program and regulatory development of ridinilazole.

“CDI is a serious global healthcare threat including in Latin America,” said Martha Penna, P&D vice-president of Eurofarma. “Through our interest in bringing innovative products to the region, we were impressed by the efficacy data from the ridinilazole Phase 2 programme and the differentiated profile of the drug. We believe it has the potential to address a major unmet need in CDI, and we look forward to working with Summit to bring ridinilazole to market for the benefit of patients.”