SUMM Summit Therapeutics Plc

 
TIDMSUMM 
 
   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 for C. 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 to C. difficile and 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. 
 
   About Ridinilazole 
 
   Ridinilazole is an investigational oral small molecule new mechanism 
antibiotic that is designed to selectively kill C. difficile, thereby 
preserving patients' protective gut microbiome and leading to sustained 
CDI cures. In a Phase 2 proof of concept trial in CDI patients, 
ridinilazole showed statistical superiority in sustained clinical 
response ('SCR') rates compared to vancomycin. In that trial, SCR was 
defined as clinical cure at end of treatment and no recurrence of CDI 
within 30 days of the end of therapy. Ridinilazole was also shown to be 
highly preserving of the gut microbiome in the Phase 2 proof of concept 
trial. The gut microbiome is known to be important in protecting against 
CDI. Ridinilazole has received Qualified Infectious Disease Product 
('QIDP') designation and has been granted Fast Track designation by the 
US Food and Drug Administration. The QIDP incentives are provided 
through the US GAIN Act and include a potential extension of marketing 
exclusivity for an additional five years upon FDA approval. 
 
   About Summit Therapeutics 
 
   Summit Therapeutics is a leader in antibiotic innovation. Our new 
mechanism antibiotics are designed to become the new standards of care 
for the benefit of patients and create value for payors and healthcare 
providers. We are currently developing new mechanism antibiotics for 
infections caused by C. difficile, Enterobacteriaceae and N. gonorrhoeae 
and are using our proprietary Discuva Platform to expand our pipeline. 
For more information, visit www.summitplc.com and follow us on Twitter 
@summitplc. 
 
   Contacts 
 
 
 
 
Summit 
Glyn Edwards / Richard Pye (UK office)     Tel:                  44 (0)1235 443 951 
Michelle Avery (US office)                                          +1 617 225 4455 
 
Cairn Financial Advisers LLP (Nominated 
 Adviser)                                  Tel:                 +44 (0)20 7213 0880 
Liam Murray / Tony Rawlinson 
 
N+1 Singer (Joint Broker)                  Tel:                 +44 (0)20 7496 3000 
Aubrey Powell / Jen Boorer, Corporate 
 Finance 
 Tom Salvesen, Corporate Broking 
 
Bryan Garnier & Co Limited (Joint Broker)  Tel:                 +44 (0)20 7332 2500 
Phil Walker / Dominic Wilson 
MSL Group (US)                             Tel:                     +1 781 684 6652 
                                                         mailto:summit@mslgroup.com 
Erin Anthoine                                                   summit@mslgroup.com 
                                                  --------------------------------- 
 
Consilium Strategic Communications (UK)    Tel:                 +44 (0)20 3709 5700 
Mary-Jane Elliott / Sue Stuart / Sukaina          mailto:summit@consilium-comms.com 
 Virji                                             summit@consilium-comms.com 
                                                  --------------------------------- 
Lindsey Neville 
 
 
   Summit Forward-looking Statements 
 
   Any statements in this press release about the Company's future 
expectations, plans and prospects, including but not limited to, 
statements about the potential benefits and future operation of our 
license and commercialization agreement with Eurofarma Laboratórios 
SA, the clinical and preclinical development of the Company's product 
candidates, the therapeutic potential of the Company's product 
candidates, the potential commercialisation of the Company's product 
candidates, the sufficiency of the Company's cash resources, the timing 
of initiation, completion and availability of data from clinical trials, 
the potential submission of applications for marketing approvals and 
other statements containing the words "anticipate," "believe," "continue, 
" "could," "estimate," "expect," "intend," "may," "plan," "potential," 
"predict," "project," "should," "target," "would," and similar 
expressions, constitute forward-looking statements within the meaning of 
The Private Securities Litigation Reform Act of 1995. Actual results may 
differ materially from those indicated by such forward-looking 
statements as a result of various important factors, including: the 
uncertainties inherent in the initiation of future clinical trials, 
availability and timing of data from ongoing and future clinical trials 
and the results of such trials, whether preliminary results from a 
clinical trial will be predictive of the final results of that trial or 
whether results of early clinical trials or preclinical studies will be 
indicative of the results of later clinical trials, expectations for 
regulatory approvals, laws and regulations affecting government 
contracts and funding awards, availability of funding sufficient for the 
Company's foreseeable and unforeseeable operating expenses and capital 
expenditure requirements and other factors discussed in the "Risk 
Factors" section of filings that the Company makes with the Securities 
and Exchange Commission, including the Company's Annual Report on Form 
20-F for the fiscal year ended 31 January 2019. Accordingly, readers 
should not place undue reliance on forward-looking statements or 
information. In addition, any forward-looking statements included in 
this press release represent the Company's views only as of the date of 
this release and should not be relied upon as representing the Company's 
views as of any subsequent date. The Company specifically disclaims any 
obligation to update any forward-looking statements included in this 
press release. 
 
   -END- 
 
 
 
 

(END) Dow Jones Newswires

February 06, 2020 07:00 ET (12:00 GMT)

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