Summit Therapeutics Granted Key European Patent for Novel Antibiotic Ridinilazole for Treatment of C. Difficile Infection
19 Janvier 2016 - 1:00PM
Summit Therapeutics plc (NASDAQ:SMMT) (AIM:SUMM), the drug
discovery and development company advancing therapies for Duchenne
muscular dystrophy and Clostridium difficile infection (‘CDI’),
announces that the European Patent Office (‘EPO’) has granted a key
patent covering the novel antibiotic, ridinilazole, and that the
opposition period has expired with the patent having faced no
challenge. The patent covers the use of ridinilazole for the
treatment of infections caused by the bacterium Clostridium
difficile.
“This is a key patent protecting the use of
ridinilazole for the treatment of CDI and its grant and emergence
from the period of opposition means this patent is now effective in
Europe, in addition to the other major commercial markets including
the United States and Japan,” commented Glyn Edwards, Chief
Executive Officer of Summit. “The robust patent portfolio
for ridinilazole, together with the strong Phase 2 clinical data
showing statistical superiority over vancomycin, the current
standard of care, further strengthens the potential commercial
value of this novel product candidate in the treatment of CDI.”
The patent (European patent number EP2373631) is
entitled “Antibacterial Compounds” and will provide a period of
exclusivity for the use of ridinilazole in the treatment of CDI
through until 1st December 2029, with the possibility of patent
term extension through to 1st June 2035 subject to the obtaining of
Supplementary Protection Certificates and a paediatric
investigation plan on marketing approval. The patent has also been
validated in all available contracting countries to the European
Patent Convention, and so is now in force in over 30 European
states including the United Kingdom, Germany, France, Spain, Italy,
Switzerland and Norway. Patent protection has previously been
granted for ridinilazole for the treatment of CDI in other
countries including the United States, Australia, New Zealand,
Japan, Russia and China, in addition to other territories.
Ridinilazole is a novel class small molecule
antibiotic that Summit is developing for the treatment of
CDI. Top-line results from a Phase 2 proof of concept trial
reported in late 2015 showed that ridinilazole was statistically
superior to vancomycin, the current standard of care, in the
endpoint of sustained clinical response (‘SCR’). SCR was
measured as cure at the end of treatment and no recurrence of CDI
within 30 days of the end of treatment.
About C. difficile InfectionC.
difficile infection is a serious healthcare threat in hospitals,
long-term care homes and increasingly the wider community with
between 450,000 and 700,000 cases of CDI in the US annually. It is
caused by an infection of the colon by the bacterium C. difficile,
which produces toxins that cause inflammation, 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. Existing CDI treatments
are predominantly broad spectrum antibiotics, and these cause
further damage to the gut flora and are associated with high rates
of recurrent disease. Recurrent disease is the key clinical issue
as repeat episodes are typically more severe and associated with an
increase in mortality rates and healthcare costs. The economic
impact of CDI is significant with one study estimating annual acute
care costs at $4.8 billion in the US.
About RidinilazoleRidinilazole
(SMT19969) is an orally administered small molecule antibiotic that
Summit is developing specifically for the treatment of CDI. In
preclinical efficacy studies, ridinilazole exhibited a narrow
spectrum of activity and had a potent bactericidal effect against
all clinical isolates of C. difficile tested. 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 this 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 has
received Qualified Infectious Disease Product (‘QIDP’) designation
and has been granted Fast Track status by the US Food and Drug
Administration. The QIDP incentives are provided through the
US GAIN Act and include an extension of marketing exclusivity for
an additional five years upon FDA approval.
About Summit Therapeutics
Summit is a biopharmaceutical company focused on the discovery,
development and commercialisation of novel medicines for
indications for which there are no existing or only inadequate
therapies. Summit is conducting clinical programs focused on the
genetic disease Duchenne muscular dystrophy and the infectious
disease C. difficile infection. Further information is available at
www.summitplc.com and Summit can be followed on Twitter
(@summitplc).
For more information, please contact:
Summit |
|
Glyn Edwards / Richard Pye (UK office) |
Tel: +44 (0)1235 443 951 |
Erik Ostrowski / Michelle Avery (US office) |
+1 617 225 4455 |
|
|
Cairn Financial Advisers
LLP |
|
(Nominated Adviser) |
|
Liam Murray / Tony Rawlinson |
Tel: +44 (0)20 77148 7900 |
|
|
N+1 Singer |
|
(Broker) |
|
Aubrey Powell / Jen Boorer |
Tel: +44 (0)20 7496 3000 |
|
|
Peckwater PR |
|
(Financial public relations, UK) |
Tel: +44 (0)7879 458 364 |
Tarquin Edwards |
tarquin.edwards@peckwaterpr.co.uk |
|
|
MacDougall Biomedical
Communications |
|
(US media contact) |
Tel: +1 781 235 3060 |
Chris Erdman |
cerdman@macbiocom.com |
|
|
Forward-looking StatementsAny statements in
this press release about Summit’s future expectations, plans and
prospects, including but not limited to, statements about the
clinical and preclinical development of Summit’s product
candidates, the therapeutic potential of Summit’s product
candidates, and the timing of initiation, completion and
availability of data from clinical trials, 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
on-going 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, availability of funding sufficient for Summit’s
foreseeable and unforeseeable operating expenses and capital
expenditure requirements and other factors discussed in the "Risk
Factors" section of filings that Summit makes with the Securities
and Exchange Commission including Summit’s Annual Report on Form
20-F for the fiscal year ended January 31, 2015. 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 Summit’s views
only as of the date of this release and should not be relied upon
as representing Summit’s views as of any subsequent date. Summit
specifically disclaims any obligation to update any forward-looking
statements included in this press release.
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