Summit Therapeutics plc Summit Enters Licence And Commercialisation Agreement With Eurofarma For Latin American Rights To Rid...

 
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)                                                       [phone] 
 
Cairn Financial Advisers LLP 
 (Nominated Adviser)                 Tel:                  [phone] 
Liam Murray / Tony Rawlinson 
 
N+1 Singer (Joint Broker)            Tel:                  [phone] 
Aubrey Powell / Jen Boorer 
 
Panmure Gordon (Joint Broker)        Tel:                  [phone] 
Freddy Crossley, Corporate Finance 
Tom Salvesen, Corporate Broking 
 
MacDougall Biomedical 
 Communications (US)                 Tel:                      [phone] 
Karen Sharma                                             [e-mail] 
 
Consilium Strategic Communications 
 (UK)                                Tel:                  [phone] 
Mary-Jane Elliott / Jessica Hodgson /       [e-mail] 
Philippa Gardner/ Rosie Phillips 
 
Eurofarma 
Emilio Maganha Neto, Portfolio &     Tel:   + 55 11 5090-8493 
 Licensing                                  [e-mail] 
Silvia Marconato, Corporate Communications  + 55 11 5090-8526 
                                            [e-mail] 
 
 
 
   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)

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