Summit Therapeutics plc Increased Barda Award And Option Exercise

 
TIDMSUMM 
 
   Summit Therapeutics plc 
 
   ('Summit' or the 'Company') 
 
   Summit Announces BARDA Increases Award for Ridinilazole Clinical and 
Regulatory Development to up to $63.7 Million and Exercises Next 
Contract Option 
 
 
   -- Summit Awarded $9.6M under Next Contract Option 
 
   -- Total Committed BARDA Funding Now $53.6 Million 
 
 
   Oxford, UK, and Cambridge, MA, US, 18 June 2019 -- Summit Therapeutics 
plc (NASDAQ: SMMT, AIM: SUMM), a leader in new mechanism antibiotic 
innovation, today announces that the Biomedical Advanced Research and 
Development Authority ('BARDA') has increased the total value of its 
award for the clinical and regulatory development of Summit's precision 
antibiotic ridinilazole for the treatment of C. difficile infection 
('CDI') to up to $63.7 million. Under this award, BARDA has opted to 
exercise the next contract option for $9.6 million, which will support 
patient enrolment and dosing in the ongoing Phase 3 clinical trials of 
ridinilazole. 
 
   "The funding from BARDA is a testament to the promise of ridinilazole to 
address an important public health need in CDI. Through our ongoing 
landmark Phase 3 clinical programme, we aim to show that our microbiome 
preserving antibiotic is superior in sustaining cures compared to the 
current standard of care and so has the potential to be the front-line 
treatment option for patients with CDI," said Mr Glyn Edwards, Chief 
Executive Officer of Summit. "We are pleased with the excellent working 
relationship that has been formed between us over the last two years and 
thank BARDA for its continuing support of ridinilazole." 
 
   The total committed funding from the BARDA award under Contract No. 
HHS0100201700014C is now $53.6 million, with one final option remaining. 
The final option provides funding support for potential applications for 
marketing approvals of ridinilazole. The BARDA contract provides for a 
cost-sharing arrangement with the committed funding drawn down over a 
specified development period. 
 
   This announcement contains inside information for the purposes of 
Article 7 of EU Regulation 596/2014 (MAR). 
 
   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 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 the standard of care, 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, which was believed to be the reason for the improved clinical 
outcome for the ridinilazole-treated patients. In addition, ridinilazole 
preserved the gut microbiome to a greater extent than the marketed 
narrow-spectrum antibiotic fidaxomicin in an exploratory Phase 2 
clinical trial. 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 the Contract with BARDA 
 
   This project has been funded in whole or in part with federal funds from 
the Biomedical Advanced Research and Development Authority, a component 
of the Office of the Assistant Secretary for Preparedness and Response 
within the U.S. Department of Health and Human Services, under contract 
number HHS0100201700014C. 
 
   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, N. gonorrhoeae and Enterobacteriaceae 
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)                                            [phone] 
 
Cairn Financial Advisers LLP (Nominated 
 Adviser)                                       Tel:              [phone] 
Liam Murray / Tony Rawlinson 
 
N+1 Singer (Joint Broker)                       Tel:              [phone] 
Aubrey Powell / Jen Boorer, Corporate Finance 
 Tom Salvesen, Corporate Broking 
 
Bryan Garnier & Co Limited (Joint Broker)       Tel:              [phone] 
Phil Walker / Dominic Wilson 
MSL Group (US)                                  Tel:                  [phone] 
                                                           mailto:[e-mail] 
Jon Siegal                                                        [e-mail] 
                                                       ------------------------------ 
 
Consilium Strategic Communications (UK)         Tel:              [phone] 
Mary-Jane Elliott / Sue Stuart /                       mailto:summit@consilium-comms. 
                                                       com 
                                                       [e-mail] 
                                                       ------------------------------ 
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 the 
BARDA contract, including any potential future payments thereunder, 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 ability of BARDA to 
terminate our contract for convenience at any time, 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

June 18, 2019 07:00 ET (11:00 GMT)

Copyright (c) 2019 Dow Jones & Company, Inc.