Summit Therapeutics to Receive $1.0 Million Milestone Payment from Eurofarma
06 Février 2020 - 1:00PM
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 RidinilazoleRidinilazole 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 |
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|
Glyn Edwards / Richard Pye (UK office) |
Tel: |
44 (0)1235 443 951 |
Michelle Avery (US office) |
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+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 FinanceTom 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 |
Erin Anthoine |
|
summit@mslgroup.com |
|
|
|
Consilium Strategic Communications (UK) |
Tel: |
+44 (0)20 3709 5700 |
Mary-Jane Elliott / Sue Stuart / Sukaina Virji |
|
summit@consilium-comms.com |
Lindsey Neville |
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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-
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