Summit Therapeutics plc Summit Enters Licence And Commercialisation Agreement With Eurofarma For Latin American Rights To Rid...
21 December 2017 - 6:00PM
UK Regulatory
TIDMSUMM
Summit Therapeutics plc
("Summit" or the "Company")
SUMMIT ENTERS INTO LICENCE AND COMMERCIALISATION AGREEMENT WITH
EUROFARMA FOR LATIN AMERICAN RIGHTS TO RIDINILAZOLE, SUMMIT'S PRECISION
ANTIBIOTIC IN DEVELOPMENT FOR THE TREATMENT OF CDI
-- Summit to receive $2.5 million upfront payment
-- Up to $25 million in development, regulatory, pricing and initial sales
milestones
-- Summit retains commercial rights to ridinilazole in rest of the world
Oxford, UK, 21 December 2017 - 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 it has entered into an exclusive
licence and commercialisation agreement granting Eurofarma
Laboratórios SA ('Eurofarma') rights in Latin America (the
'Licensed Territory') to Summit's precision antibiotic ridinilazole in
development for the treatment of CDI. Summit retains commercialisation
rights in all other countries.
Ridinilazole is a targeted antibiotic that has the potential as a
frontline therapy to treat initial infection and preserve patients'
microbiomes to reduce the rate of recurrent CDI. In a Phase 2 proof of
concept trial in CDI patients, ridinilazole demonstrated statistical
superiority in sustained clinical response ('SCR') rates compared to the
standard of care, vancomycin. Ridinilazole is expected to enter Phase 3
clinical trials in the first half of 2018.
"Eurofarma's established infrastructure and expertise in Latin America
are ideally placed to commercialise our novel antibiotic, ridinilazole,"
commented Glyn Edwards, Chief Executive Officer of Summit. "This
agreement, combined with the recent contract award of up to $62 million
from the US Government agency BARDA, will further support the Phase 3
clinical programme and regulatory development of ridinilazole. These
partnerships endorse the potential of ridinilazole in the treatment of
CDI, and move us a step closer to bringing this antibiotic to patients."
Eurofarma is a multinational pharmaceutical company with headquarters in
Brazil and operations in over 20 countries in South and Central America,
the Caribbean and Africa. Eurofarma has a broad portfolio of products
across multiple therapeutic areas including a focus in infectious
diseases where it markets a number of antibiotics.
"CDI is a serious global healthcare threat including in Latin America,"
added Martha Penna, P&D Vice-president of Eurofarma. "Through our
interest in bringing innovative products to the region, we were
impressed by the efficacy data from the ridinilazole Phase 2 programme
and the differentiated profile of the drug. We believe it has the
potential to address a major unmet need in CDI, and we look forward to
working with Summit to bring ridinilazole to market for the benefit of
patients."
Under the terms of the licence and commercialisation agreement, Summit
will receive an upfront payment of $2.5 million, and is entitled to
receive a further $3.75 million in development milestones upon the
achievement of staged patient enrolment targets in the planned Phase 3
clinical trials of ridinilazole. Summit is eligible to receive up to an
additional $21.4 million through other development milestones,
commercial milestones, and one-time sales milestones based on cumulative
net sales up to $100 million in the Licensed Territory. Further, the
agreement provides for product supply transfer payments expected to
provide a return equivalent to a high single digit to low double-digit
percentage of net sales. For each incremental $100 million in cumulative
net sales achieved, Summit is entitled to a further milestone payment
which, when combined with the aforementioned product supply transfer
payments, is expected to provide a return equivalent to a mid- to
high-teens percentage of net sales.
Eurofarma will be responsible for obtaining regulatory approval for
ridinilazole in the Licensed Territory. Summit retains full
responsibility for the clinical development of ridinilazole in all
countries, and is responsible for obtaining regulatory approvals outside
of the Eurofarma licensed territories.
A Form 6-K will be filed with the US Securities and Exchange Commission
('SEC') that contains additional information about the terms of the
licence and commercialisation agreement with Eurofarma. A copy of this
Form 6-K will be available to download either from the Investors section
of the Company website at www.summitplc.com or from the SEC website at
www.sec.gov.
This announcement contains inside information for the purposes of
Article 7 of EU Regulation 596/2014 (MAR).
About Ridinilazole
Ridinilazole is a small molecule precision antibiotic that Summit is
developing for the treatment of CDI. In preclinical efficacy studies,
ridinilazole exhibited a targeted spectrum of activity that combined a
potent bactericidal effect against all clinical isolates of C. difficile
tested with minimal impact on other bacteria that are typically found in
the gut microbiome. 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, an orally administered
small molecule, 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 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 programmes 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).
About the Eurofarma Group
As the first 100% Brazilian-owned multinational pharmaceutical company,
Eurofarma has been in existence for 45 years, has 6,500 employees, and
has operations in 20 Latin American countries. With 12 manufacturing
plants in the region, the company has more than 280 products in its
portfolio. In 2016, it produced more than 290 million units and reached
revenues of R$3.3 billion, 15.7% higher than the previous year. The
Group invests approximately 5.5% of its net sales in Research &
Development and maintains a pipeline of more than 175 projects.
About Eurofarma Brazil
Considered one of the best companies to work for, Eurofarma Brazil is
also considered the most sustainable pharmaceutical company in the
country based on an analysis by the Exame Sustainability Guide. With
operations in all main pharmaceutical segments including Medical
Prescriptions, Generics, Hospital, Oncology, Veterinary, and Bids and
Services to Third Parties, Eurofarma has the largest medical advertising
salesforce in Brazil with more than 2,000 representatives that together
perform 450,000 medical contacts per month. The company has the 4th
largest pharmacy system in the country and has a portfolio of medicines
that is the 2nd largest by prescription volume.
For more information, visit www.eurofarma.com.br or visit us in social
media (Facebook: @eurofarma LinkedIn: @eurofarma; Instagram:
@eurofarma_br).
Contacts
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) 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
Panmure Gordon (Joint Broker) Tel: +44 (0)20 7886 2500
Freddy Crossley, Corporate Finance
Tom Salvesen, Corporate Broking
MacDougall Biomedical
Communications (US) Tel: +1 781 235 3060
Karen Sharma ksharma@macbiocom.com
Consilium Strategic Communications
(UK) Tel: +44 (0)20 3709 5700
Mary-Jane Elliott / Jessica Hodgson / summit@consilium-comms.com
Philippa Gardner/ Rosie Phillips
Eurofarma
Emilio Maganha Neto, Portfolio & Tel: + 55 11 5090-8493
Licensing emilio.neto@eurofarma.com.br
Silvia Marconato, Corporate Communications + 55 11 5090-8526
silvia.marconato@eurofarma.com.br
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 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, 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 2017. 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-
This announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the information
contained therein.
Source: Summit Therapeutics plc via Globenewswire
http://www.summitplc.com/
(END) Dow Jones Newswires
December 21, 2017 02:00 ET (07:00 GMT)
Copyright (c) 2017 Dow Jones & Company, Inc.
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