Exhibit 99.1
Summit Therapeutics plc
(‘Summit’ or the ‘Company’)
Summit Therapeutics to Receive $1.0 Million Milestone Payment from Eurofarma
| | • | | Milestone Based on Achievement of Patient Enrolment Target in Phase 3 Clinical Trials of Ridinilazole |
Oxford, UK, and Cambridge, MA, US, 6 February 2020 –Summit Therapeutics plc (NASDAQ: SMMT, AIM: SUMM) today announced that it achieved the first milestone under its license and collaboration agreement with Eurofarma Laboratórios SA (‘Eurofarma’). The $1.0 million milestone payment was triggered by Summit achieving its initial patient enrolment target at trial sites in Latin America in the Phase 3 clinical trials of ridinilazole forC. difficile infection (‘CDI’).
“CDI is a global issue caused largely by broad spectrum antibiotic-induced imbalances in the healthy gut microbiome. By being precisely targeted toC. difficileand therefore preserving the microbiome to protect against CDI recurrence, ridinilazole has the potential to significantly improve patient outcomes through sustaining cures,”said Mr Glyn Edwards, Chairman and CEO of Summit.“Eurofarma is an ideal partner for us with the necessary expertise to successfully market ridinilazole in Latin America, should it receive approval. We’re pleased with the progress we have made in enrolling our Phase 3 clinical trials, and we look forward to the results of the trials expected in the second half of 2021.”
The global Phase 3 clinical trials, initiated in February 2019, aim to show superiority of ridinilazole over the standard of care, vancomycin, in sustained clinical response, a measure that encompasses both the initial cure and the key unmet need of reducing recurrences.
Under the terms of its licence and commercialisation agreement with Eurofarma, Summit is entitled to receive a further $2.75 million upon the achievement of additional staged patient enrolment targets in Latin America in the Phase 3 clinical trials, along with other development, commercial and sales milestones and product supply transfer payments.
The clinical and regulatory development of ridinilazole is being funded in part with Federal funds from the US Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (‘BARDA’), under Contract No. HHS0100201700014C.
This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014 (MAR). The person responsible for arranging for the release of this announcement on behalf of the Company is Richard Pye, Vice President, Investor Relations and Corporate Affairs.
About C. difficile Infection
C. difficile infection is a serious healthcare threat in hospitals, long-term care homes and increasingly in the wider community with over one million estimated cases of CDI annually in the United States and Europe. CDI is caused by an infection of the colon by the bacterium C. difficile, which produces toxins that cause inflammation and severe diarrhoea, and in the most serious cases can be fatal. Patients typically develop CDI following the use of broad-spectrum antibiotics that can cause widespread damage to the natural gastrointestinal (gut) flora and allow overgrowth of C. difficile bacteria. The vast majority of patients are treated with broad-spectrum antibiotics, which cause further damage to the gut flora and are associated with high rates of recurrent disease. Reducing disease recurrence is the key clinical issue in CDI as repeat episodes are typically more severe and associated with an increase in mortality rates and healthcare costs. A study estimated that the total costs attributable to the management of CDI were approximately $6.3 billion per year in the United States.
