http://www.summitplc.com/
Summit is an Oxford, UK based drug discovery company developing novel drug candidates to treat areas of high unmet medical need. Our strategy has evolved to focus on the development of two high-value clinical-stage programmes that target the fatal genetic disease Duchenne Muscular Dystrophy (DMD) and infections caused by the superbug C. difficile

Summit Therapeutics Receives Fast Track Designa...
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Summit Therapeutics plc
("Summit" or the "Company")

SUMMIT THERAPEUTICS RECEIVES FDA FAST TRACK DESIGNATION FOR NOVEL ANTIBIOTIC SMT19969 IN THE TREATMENT OF C. DIFFICILE INFECTION

Oxford, UK, 8 July 2015 - Summit Therapeutics plc (AIM: SUMM, NASDAQ: SMMT), the drug discovery and development company advancing therapies for Duchenne muscular dystrophy and C. difficile infection ('CDI'), announces that the US Food and Drug Administration ('FDA') has granted Fast Track designation for the Company's novel antibiotic for the treatment of CDI. SMT19969 is a highly selective antibiotic candidate currently being evaluated in a Phase 2 proof of concept trial in CDI patients in North America.

"Fast Track designation recognises the serious healthcare threat posed by C. difficile due to a high rate of disease recurrence, the key clinical issue in treating CDI, and underscores the importance of developing a candidate like SMT19969, which has significant potential to address both the initial infection and recurrence," said Glyn Edwards, Chief Executive Officer of Summit.

Fast Track designation is awarded to expedite the development and regulatory review of drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. SMT19969 is also designated a Qualified Infectious Disease Product ('QIDP') under the Generating Antibiotic Incentives Now Act ('GAIN Act'), which allows Summit to benefit from a number of incentives supporting development of new antibiotics, and if SMT19969 receives marketing approval from FDA, a five year extension of market exclusivity.

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Summit Therapeutics Publishes Preclinical Data ...
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Summit Therapeutics plc
("Summit" or the "Company")

SUMMIT THERAPEUTICS PUBLISHES PRECLINICAL DATA ON DISEASE-MODIFYING POTENTIAL OF UTROPHIN MODULATION IN DMD

Publication in Human Molecular Genetics supports utrophin modulation as mechanism to treat DMD regardless of mutation status
Oxford, UK, 13 July 2015 - Summit Therapeutics plc (AIM: SUMM, NASDAQ: SMMT), the drug discovery and development company advancing therapies for Duchenne muscular dystrophy ('DMD') and C. difficile infection, today announced the publication of preclinical data on the disease-modifying potential of utrophin modulation in the treatment of DMD.

Upon modulation of utrophin protein with the second generation utrophin modulator SMT022357, in vivo models of DMD showed significantly improved muscle stability and a marked reduction of muscle regeneration, necrosis and fibrosis, the hallmark of DMD pathology. Interestingly, researchers found that utrophin was expressed across the entire length of the muscle fibre, likely contributing to its ability to significantly reduce disease progression in animal models. The data were published in the August 1, 2015 issue of Human Molecular Genetics

"These data strongly support utrophin modulation as a potentially valuable mechanism to treat DMD and highlight the importance of the continued development of second-generation, orally available utrophin modulator candidates," said Professor Dame Kay E. Davies of the University of Oxford. "There is tremendous therapeutic potential for utrophin modulation in this devastating disease because there is currently no approved disease modifying therapy applicable to all patients with DMD and many other candidates in clinical development are restricted to a single mutation."

Utrophin is structurally and functionally similar to dystrophin, the protein which is lacking in boys with DMD, and is normally present during muscle development and repair. By modifying utrophin to be continuously produced in boys with DMD, this potentially disease-modifying approach could circumvent the need for dystrophin in all patients with this devastating disease. Summit is currently in Phase 1b clinical studies with SMT C1100, a first-generation utrophin modulator. The paper, "Second-generation compound for the modulation of utrophin in the therapy of DMD," describes the significant disease-modifying potential of SMT022357, a structurally related compound to SMT C1100, which has enhanced pharmaceutical properties.

In the reported study, SMT022357 treatment for five weeks resulted in increased utrophin expression, localized along the entire length of the muscle fibre membrane in both slow- and fast-twitch muscles. This addressed the primary cause of fibre degeneration and increased muscle stability in hind-limb muscles of the mdx mouse, which resulted in reduced regeneration and necrosis, enhanced protection of the muscle against contraction-induced damage and improved muscle function. Utrophin expression in the heart and diaphragm is highly desirable in DMD as loss of function in these organs is life-limiting in DMD. Treatment with SMT022357 resulted in significant increases in utrophin expression in both the heart and diaphragm. Notably SMT022357 treatment resulted in reduced fibrosis in the diaphragm, a significant observation due to the disease pathology in the diaphragm of the mdx model closely resembling that of DMD patients. These data suggest that SMT022357 results in significant improvement in the pathology of DMD and could represent a disease-modifying therapeutic strategy for all patients with DMD.

The paper was authored by Simon Guiraud, Sarah E. Squire, Benjamin Edwards, Huijia Chen, David T. Burns, Nandini Shah, Arran Babbs, Stephen G. Davies, Graham M. Wynne, Angela J. Russell and Kay E. Davies of the University of Oxford, and David Elsey, Francis X. Wilson and Jon M. Tinsley of Summit Therapeutics (reference: Hum. Mol. Genet. (2015) 24 (15): 4212-4224).

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AGM Statement

Summit Therapeutics Announces Phase 1b Modified...
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Summit Therapeutics plc
("Summit" or the "Company")

SUMMIT THERAPEUTICS ANNOUNCES PHASE 1B MODIFIED DIET CLINICAL TRIAL ACHIEVES PRIMARY OBJECTIVE IN DUCHENNE MUSCULAR DYSTROPHY

Primary Objective Met; Plasma Absorption of SMT C1100 Observed at a Level Suitable for Further Development
SMT C1100 to Progress into Phase 2 Open-label Trial
Conference Call Scheduled for 1:00pm BST / 8:00am EDT

Oxford, UK, 17 August 2015 - Summit Therapeutics plc (AIM: SUMM, NASDAQ: SMMT), the drug discovery and development company advancing therapies for Duchenne muscular dystrophy ('DMD') and C. difficile infection, announces that its Phase 1b modified diet clinical trial of SMT C1100 for the treatment of DMD met its primary objective with half of the patients who received the higher dose of SMT C1100 achieving desired plasma levels while following specific dietary guidance. Based on these results, Summit will advance SMT C1100 into a Phase 2 open-label clinical trial.

The Phase 1b clinical trial was designed to increase plasma levels of SMT C1100 in patients by recommending a diet with balanced proportions of fat, proteins and carbohydrates, combined with consuming a small glass of full fat, whole milk at the time of dosing. Initial analysis shows six of 12 patients achieved the desired plasma level after receiving a 2,500 mg dose of SMT C1100 twice daily for 14 days. In a prior Phase 1b trial, only two of 12 patients dosed with SMT C1100 achieved the desired plasma level. SMT C1100 was well tolerated at all doses tested in the modified diet trial with no serious adverse events reported. This outcome increases the human safety database for this investigational drug. SMT C1100 is a small molecule utrophin modulator being developed for the potential treatment of all patients with DMD. SMT C1100 has received orphan drug designation in the US and Europe.

"DMD has a devastating impact on its patients and families, and current treatment options are merely palliative in nature or are only applicable to small subsets of patients. A universal DMD treatment, like SMT C1100 if successfully developed, would have a broad impact for these patients and families, either alone or in combination with other DMD therapies," said Principal Investigator Professor Francesco Muntoni from Great Ormond Street Hospital, London. "I am, therefore, looking forward to future clinical studies with SMT C1100."

"These data clear an important hurdle in the development of SMT C1100 by demonstrating it is a viable drug candidate to bring proof-of-concept for the Company's burgeoning utrophin modulator pipeline and more importantly, hope to all patients and their families living with this devastating disease," said Glyn Edwards, Chief Executive Officer of Summit. "Our priority is advancing SMT C1100 efficiently through future patient clinical trials designed to evaluate the potential clinical benefit of this promising treatment, and this will start with an open-label Phase 2 trial that is expected to start by the end of this year."

The trial also measured enzyme biomarkers of muscle damage, such as creatine kinase. In this modified diet study, there was no change in the enzyme levels when patients received SMT C1100 compared to when they received a placebo. The Company plans to evaluate creatine kinase as well as additional biomarkers over a longer duration of exposure to SMT C1100 in the upcoming Phase 2 open-label trial.

Summit plans to commence the Phase 2 open-label trial during the fourth quarter of 2015. The trial will evaluate the longer-term benefits of SMT C1100 on muscle health, function and safety. Further details of the trial will be provided at a future date.

Conference Call
Summit will host a conference call and webcast to discuss the results of the Phase 1b modified diet trial today 17 August 2015 at 1:00pm BST / 8:00am EDT. To participate in the conference call please dial +44 (0)20 3427 1902 (UK and international participants) or +1 646 254 3360 (US local number) and use the conference confirmation code 6476637. Investors may also access a live audio webcast of the call via the investors section of the Company's website www.summitplc.com. A replay of the webcast will be available shortly after the presentation finishes.

About the Phase 1b Modified Diet Trial
The Phase 1b randomised, placebo controlled clinical trial was designed to evaluate the blood plasma levels of SMT C1100 in paediatric patients with DMD. Patients and their caregivers were provided with specific dietary guidance on recommended balanced proportions of fats, proteins and carbohydrates. The trial enrolled a total of 12 patients aged between 5 and 13 years, divided equally into three dose cohorts, at trial sites in the UK. Patients were randomised to three groups over 14-day treatment periods during which each patient received two different doses of SMT C1100 and a placebo control. There was a wash-out period of at least 14 days in between each of the treatment periods. The Company is still evaluating the full results of the trial. Full data from this trial are expected to be presented at an upcoming medical meeting.

About Utrophin Modulation in DMD
DMD is a progressive muscle wasting disease that affects around 50,000 boys in the developed world. The disease is caused by different genetic faults in the gene that encodes dystrophin, a protein that is essential for the healthy function of all muscles. There is currently no cure for DMD and life expectancy is into the late twenties. Utrophin protein is functionally and structurally similar to dystrophin. In preclinical studies, the continued expression of utrophin has a meaningful, positive effect on muscle performance. Utrophin modulation has the potential to slow down or even stop the progression of DMD, regardless of the underlying dystrophin mutation. It is also expected that utrophin modulation could potentially be complementary to other therapeutic approaches for DMD.

About Summit Therapeutics
Summit is a biopharmaceutical company focused on the discovery, development and commercialization 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).

Summit Therapeutics Reports Financial Results f...
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Summit Therapeutics plc
('Summit' or the 'Company')

SUMMIT THERAPEUTICS REPORTS FINANCIAL RESULTS FOR THE SECOND QUARTER ENDED 31 JULY 2015 AND OPERATIONAL PROGRESS

Oxford, UK, 27 August 2015 - Summit Therapeutics plc (AIM: SUMM, NASDAQ: SMMT), the drug discovery and development company advancing therapies for Duchenne muscular dystrophy ('DMD') and C. difficile infection ('CDI'), today reports its financial results for the second quarter and half-year ended 31 July 2015.

Mr Glyn Edwards, Chief Executive Officer of Summit commented: "We have made very substantial progress with our utrophin modulator programme to treat boys with DMD with the recent announcement that our lead candidate, SMT C1100, achieved its primary objective in a Phase 1b clinical trial, allowing us to advance this molecule into a Phase 2 open-label trial that is expected to start by the end of this year. We further strengthened this programme with the publication of data on a second-generation utrophin modulator demonstrating its disease-modifying potential in animal models of this devastating disease. Importantly, we also received Fast Track designation from the US FDA for SMT19969 in CDI, highlighting the promise of our novel antibiotic treatment with the potential to address disease recurrence, the key clinical issue of CDI. With top-line data from our ongoing Phase 2 proof of concept trial in CDI expected to report in the fourth quarter of 2015, we continue to be excited about progress in both of our clinical programmes."

RECENT OPERATIONAL HIGHLIGHTS

Utrophin Modulation Programme for DMD:

SMT C1100 Highlights

Phase 1b modified diet clinical trial achieved primary objective in DMD
Plasma absorption of SMT C1100 observed at a level suitable for further development
SMT C1100 to progress into Phase 2 open-label clinical trial planned to commence in Q4 2015
Key composition of matter patent granted by European Patent Office for SMT C1100
Utrophin Modulation Pipeline

Positive preclinical data published on second-generation utrophin modulator showing increase in utrophin expression along entire length of muscle fibre, reduction in disease pathology and improvement in muscle function
CDI Programme:

SMT19969 Highlights

Phase 2 proof of concept clinical trial of novel antibiotic SMT19969 against vancomycin on-going with top-line data expected to be reported in Q4 2015
SMT19969 granted Fast Track status by the US Food and Drug Administration
Grant of key patent in the US protecting the use of SMT19969 in the treatment of CDI
FINANCIAL HIGHLIGHTS

Cash and cash equivalents at 31 July 2015 of £26.4 million compared to £11.3 million at 31 January 2015
Loss for the three months ended 31 July 2015 of £4.0 million compared to a loss of £3.3 million for the three months ended 31 July 2014
Initial Public Offering of American Depositary Shares in the US completed in March 2015 raising gross proceeds of $39.3 million

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Proactive investor - Summit Therapeutics PLC (LON:SUMM), up 10% to 140.5p. Said this morning that its treatment for Duchenne muscular dystrophy has received fast-track designation from the US FDA.

Sarepta Therapeutics and Summit Enter into Excl...
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Sarepta Therapeutics and Summit Enter into Exclusive License and Collaboration Agreement for European Rights to Summit's Utrophin Modulator Pipeline for the Treatment of Duchenne Muscular Dystrophy
Sarepta and Summit collaborate to advance the development of novel therapies for patients with Duchenne muscular dystrophy
Summit receives $40 million upfront, with potential future ezutromid-related milestone payments totalling up to $522 million plus royalties
Sarepta and Summit to share research and development costs
Sarepta also receives option for Latin American rights 
Cambridge, MA, and Oxford, UK, 4 October 2016 - Sarepta Therapeutics (NASDAQ: SRPT) and Summit Therapeutics plc (NASDAQ: SMMT, AIM: SUMM) today announced that they have entered into an exclusive license and collaboration agreement granting Sarepta rights in Europe, as well as in Turkey and the Commonwealth of Independent States ('the licensed territory'), to Summit's utrophin modulator pipeline, including its lead clinical candidate, ezutromid, for the treatment of Duchenne muscular dystrophy ('DMD'). As part of the agreement, Sarepta also obtains an option to license Latin American rights to Summit's utrophin modulator pipeline. Summit retains commercialization rights in all other countries.
Utrophin modulation is a potential disease-modifying treatment for all patients with the fatal muscle wasting disease DMD, regardless of their underlying dystrophin gene mutation. Ezutromid is currently in a Phase 2 proof of concept trial called PhaseOut DMD.
"This partnership with Summit Therapeutics furthers our commitment to invest in innovative approaches to treating Duchenne and supports our common goal of improving the lives of patients with DMD," said Edward Kaye, M.D., Sarepta's Chief Executive Officer. "Summit's utrophin modulation technology represents a potentially promising approach to treat DMD, which may complement our current approach of exon skipping therapy."
"Sarepta Therapeutics has paved the way in the development of disease-modifying therapies for DMD with the first FDA-approved drug in this disease area, making them a strong strategic partner to support our utrophin modulator pipeline," commented Glyn Edwards, Chief Executive Officer of Summit. "This agreement provides us with access to Sarepta's development, regulatory and commercialisation expertise for the continued advancement of our promising utrophin modulator pipeline. We look forward to this partnership and working together to bring great advances to patients and families living with DMD."
Under the terms of the agreement, Summit will receive an upfront fee of $40 million. In addition, Summit will be eligible for future ezutromid related development, regulatory and sales milestone payments totalling up to $522 million, including a $22 million milestone upon the first dosing of the last patient in Summit's PhaseOut DMD trial, and escalating royalties ranging from a low to high teens percentage of net sales in the licensed territory. Summit will also be eligible to receive development and regulatory milestones related to its next-generation utrophin modulators. Sarepta and Summit will share specified utrophin modulator-related research and development costs at a 45%/55% split, respectively, beginning in 2018. If Sarepta elects to exercise its option for Latin American rights, Summit would be entitled to additional fees, milestones and royalties.
Sarepta and Summit will host an update call for the Duchenne community on Monday, October 10 at 12:00 EDT. Details of the call can be accessed by visiting http://www.parentprojectmd.org/communitycall. 
This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014 (MAR).
About Utrophin Modulation in DMD
DMD is a progressive muscle wasting disease that is caused by different genetic faults in the gene that encodes dystrophin, a protein that is essential for the healthy function of all muscles. There is currently no cure for DMD and life expectancy is into the late twenties. Utrophin protein is functionally and structurally similar to dystrophin. In preclinical studies, the continued expression of utrophin has a meaningful, positive effect on muscle performance. Summit believes that utrophin modulation has the potential to treat all patients with DMD, regardless of the underlying dystrophin gene mutation. Summit also believes that utrophin modulation could potentially be complementary to other therapeutic approaches for DMD. The Company's lead utrophin modulator, ezutromid, is an orally administered, small molecule. DMD is an orphan disease, and the US Food and Drug Administration ('FDA') and the European Medicines Agency have granted orphan drug status to ezutromid. Orphan drugs receive a number of benefits including additional regulatory support and a period of market exclusivity following approval. In addition, ezutromid has been granted Fast Track designation and Rare Pediatric Disease designation by the FDA.
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 Sarepta
Sarepta Therapeutics is a commercial-stage biopharmaceutical company focused on the discovery and development of unique RNA-targeted therapeutics for the treatment of rare neuromuscular diseases. The Company is primarily focused on rapidly advancing the development of its potentially disease-modifying DMD drug candidates, including EXONDYS 51, designed to skip exon 51 and approved under the accelerated approval pathway. For more information, please visit us at www.sarepta.com.
Contacts

Summit Therapeutics shares shoot up 90% after it inks $522mln Sarepta deal
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16:15 04 Oct 2016
Summit has inked a deal that could potentially be worth more than half a billion dollars.

The company is developing what it hopes is a breakthrough for a hard to treat disease that affects boys.
Shares in Summit Therapeutics (LON:SUMM) shot up 90% after it confirmed it had signed a licensing deal with the US biotech Sarepta Therapeutics (NASDAQ:SRPT) worth up to US$522mln.
The pair will collaborate on Summit’s potentially breakthrough treatment for Duchenne muscular dystrophy (DMD), a muscle wasting disease that affects boys.
The UK drug developer gets an immediate US$40mln and US$22mln when the last patient in the company’s phase II trial is dosed.
Sarepta is a pioneer in the area of DMD with the only disease-modifying treatment out on the market approved by the US Food & Drug Administration.
Access to R&D
The deal, as well as having a massive financial impact, will provide Summit access to the research and development capabilities of the US firm.
DMD is caused by different mutations in the dystrophin gene that result in patients being unable to produce the protein, which is essential for maintaining healthy muscle function. 
The AIM-listed group’s discovery is designed to increase the levels of another, similar, protein call utrophin.
This, it is hoped, will compensate from the lack dystrophin. The system is called utrophin modulation.
Summit chief executive Glyn Edwards said: "This agreement provides us with access to Sarepta's development, regulatory and commercialisation expertise for the continued advancement of our promising utrophin modulator pipeline.
“We look forward to this partnership and working together to bring great advances to patients and families living with DMD."
About DMD
Duchenne Muscular Dystrophy, or DMD, is one of the most common, fatal genetic disorders diagnosed in children around the world. 
It predominantly affects boys and it results in the progressive wasting of muscles throughout the body. 
The disease has an estimated incidence of 1 in 5,000 and a patient population in the developed world of around 50,000. 
Patients typically don’t live beyond their late 20s.
Sarepta’s chief executive, Edward Kaye, said: "Summit's utrophin modulation technology represents a potentially promising approach to treat DMD, which may complement our current approach of exon skipping therapy."
From the conference call 
The deal provides another two years of financing at least, according to Edwards, who was speaking to analysts, investors and journalists on a conference call.
He told them: "We believe our existing cash and the US$40mln upfront payment and the anticipated US$22mln milestone payment for the first dosing of the last patients in our Phaseout DMD study will fund the company through December 31, 2018."
On future partnering, Edwards said: "Our intention for other territories will be to develop  these ourselves but obviously we will keep other options open. In particular, our intention is to keep marketing rights for the USA."
He also noted: "For a new company, just getting going, it's actually easier to market in the US, which is a true single market as opposed to Europe."

Summit Therapeutics Awarded BARDA Contract Worth Up To $62M To Support Development of Ridinilazole for CDI
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Summit Therapeutics plc
('Summit Therapeutics', Summit', or the 'Company')
SUMMIT AWARDED BARDA CONTRACT WORTH UP TO $62 MILLION TO SUPPORT THE DEVELOPMENT OF RIDINILAZOLE FOR THE TREATMENT OF C. DIFFICILE INFECTION
Cambridge MA, Oxford, UK, 11 September 2017 - Summit Therapeutics (NASDAQ: SMMT, AIM: SUMM), the drug discovery and development company advancing therapies for Duchenne muscular dystrophy and C. difficile infection ('CDI'), today announces that the Biomedical Advanced Research and Development Authority ('BARDA'), an agency of the US government's Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response, has awarded Summit a contract worth up to $62 million. The funds will support the clinical and regulatory development of ridinilazole for the treatment of CDI, including Summit's planned Phase 3 development program.
Ridinilazole is a highly selective, novel class antibiotic aimed at both treating the initial infection and reducing recurrent disease, which is the key clinical issue in the treatment of CDI. In a Phase 2 proof of concept clinical trial conducted in North America, ridinilazole was shown to be highly preserving of the microbiome of patients compared with the standard of care, vancomycin, and achieved a substantial reduction in rates of recurrent disease.
The Centers for Disease Control and Prevention highlighted C. difficile as one of three pathogens that pose an immediate public health threat. The economic impact of CDI is significant with one study estimating annual acute care costs at $4.8 billion in the United States.
"CDI is a serious public health threat that is a significant burden on the US population, and BARDA has committed to the development of innovative treatments capable of addressing all aspects of this serious illness, including recurrent disease. BARDA's selection of ridinilazole for an award is testament to ridinilazole's promising clinical and preclinical data package that indicate its potential as a front-line treatment of CDI that could reduce recurrent disease," commented Glyn Edwards, Chief Executive Officer of Summit."This non-dilutive funding award begins to deliver on our strategy of maximizing the value of ridinilazole for patients with CDI, Summit and our shareholders, and we look forward to initiating the Phase 3 clinical program of ridinilazole."
The BARDA contract provides for a cost-sharing arrangement under which BARDA would fund a specified portion of estimated costs for specified activities related to the continued clinical and regulatory development of ridinilazole for CDI. Under the terms of the contract, Summit is initially eligible to receive from BARDA $32 million to fund, in part, obtaining regulatory approval for and commencing enrollment and dosing into Summit's two planned Phase 3 clinical trials of ridinilazole.  In addition, Summit is eligible for additional funding under the contract pursuant to three independent option work segments, which may be exercised by BARDA in its sole discretion upon the achievement of certain development and other milestones for ridinilazole. If the three option work segments are exercised in full, Summit would be eligible for an additional $30 million from BARDA. Activities in these three option work segments include the completion of enrollment and treatment in the two planned Phase 3 clinical trials and other activities related to the preparation for the potential submission of application for marketing approval for ridinilazole in the United States.  
With this contract award, Summit remains on track to initiate two Phase 3 clinical trials of ridinilazole for CDI in the first half of 2018. The Company continues to explore various funding options for completion of its Phase 3 clinical development program, with these including entering into a collaboration with a third party, equity financing or securing additional non-dilutive funding from government entities and philanthropic, non-government and not for profit organizations.
This project will be funded in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201600002C.
Summit will file on Form 6-K with the US Securities and Exchange Commission ('SEC') additional information about the agreement with BARDA. A copy of the Form 6-K will be available to download, from the date of this press release, either from the Investors section of the Company's 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 BARDA
BARDA, within the HHS Office of the Assistant Secretary for Preparedness and Response, makes available medical countermeasures to address public health emergencies arising from natural and intentional threats through an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools. For more information about BARDA, visit www.phe.gov/about/BARDA/Pages/default.aspx.
About C. difficile Infection
C. difficile infection is a serious healthcare threat in hospitals, long-term care homes and increasingly the wider community with over one million estimated cases of CDI each year in the United States and Europe. There are an estimated 29,000 death per year from CDI in the United States alone. The Centers for Disease Control and Prevention highlighted C. difficile as one of three pathogens that pose an immediate public health threat. The economic impact of CDI is significant with one study estimating annual acute care costs at $4.8 billion in the United States.
CDI is a bacterial infection of the colon that produces toxins that cause inflammation and severe diarrhea, 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.
About Ridinilazole
Ridinilazole 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. The Phase 2 trial was conducted in North America with the majority of sites located in the United States. 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 an extension of marketing exclusivity for an additional five years upon FDA approval.
About Summit Therapeutics
Summit Therapeutics is a biopharmaceutical company with operations in the United States and United Kingdom and is focused on the discovery, development and commercialization 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).

Summit Enters Licence and Commercialisation Agreement with Eurofarma for Latin American Rights to Ridinilazole
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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.

dreamcatcher, I guess this is one of yours - pity today's fall from grace - but these things happen in Biotech. Today, sp 48p on News of Trial halting.... that's a massive 78% fall from grace...but I wonder that it ever was worth the higher figure; since the number of patients is relatively small and not all can afford £ots of money to pay-back the Research Costs.
What now, I wonder . . . what's their Cash position and are there any Liabilities, such as Loans outstanding...?
EDIT(12Dec2018)-sp 19p after a serious fall (again). but PE ratio -1.2 DYOR.

No, not held this year.

Another of Jim Mellons favourites, Regent Pacific, which took over Plethora Solutions, and now listed in Hong Kong (ticker 575) is rolling out it's premature ejaculation spray Fortacin right across Europe this year through distributor Recordati.
There has been little PR about this...but according to Recordati they are very excited about Fortacins sales prospects.
And don't forget, Fortacin comes from the stable of Prof. Mike Whiley, and has full EU approval.
A good time to reinvest for some likely big gains.............maybe a better bet than Summit............

P.s. To previous posts, Regent Pacific can be held in an ISA, SIPP, or general trading account.......try iii.