Summit Therapeutics plc Summit Announces Barda Expands Ridinilazole Award By $8.8 Million To Include Additional Nda-Enabling ...

 
TIDMSUMM 
 
   Summit Therapeutics plc 
 
   ('Summit' or the 'Company') 
 
   Summit Announces BARDA Expands Ridinilazole Award by $8.8 Million to 
Include Additional NDA-Enabling Work 
 
 
   -- Total Committed BARDA Funding Increased to $62.4 Million 
 
   -- Total Award Increased to up to $72.5 Million 
 
 
   Oxford, UK, and Cambridge, MA, US, 23 January 2020 -- 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 expanded its award for 
the clinical and regulatory development of Summit's precision antibiotic 
ridinilazole for the treatment of C. difficile infection ('CDI') by $8.8 
million. The additional funding is being provided to support a new 
clinical trial in adolescent patients and brings the total value of the 
award to up to $72.5 million. The adolescent clinical trial is expected 
to support a New Drug Application for ridinilazole and also form part of 
a package of work with the potential to provide an additional six months 
market exclusivity for ridinilazole in the US and Europe. 
 
   "BARDA's continued support for ridinilazole is instrumental in helping 
to bring this potential CDI treatment option to patients, whose current 
treatment options fail to sustain cures for one third of the population, 
" said Mr Glyn Edwards, Chief Executive Officer of Summit. "We thank 
BARDA for its commitment to ridinilazole, innovation and public health." 
 
   The total committed funding from the BARDA award under Contract No. 
HHS0100201700014C is now $62.4 million, with one final option of $10.1 
million remaining to be exercised at BARDA's sole discretion. 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). 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 / Ludovico 
 Lazzaretti 
 
N+1 Singer (Joint Broker)                  Tel:                 +44 (0)20 7496 3000 
Aubrey Powell / George Tzimas, 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 6552 
                                                         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 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
January 23, 2020 07:00 ET (12:00 GMT)
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