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Summit Corporation PLC (SUMM)     

dreamcatcher - 11 Sep 2012 21:55

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



Chart.aspx?Provider=EODIntra&Code=SUMM&SChart.aspx?Provider=EODIntra&Code=SUMM&S

js8106455 - 23 May 2014 18:29 - 174 of 213

LISTEN:
Summit Corporation - Phase 1b clinical trial in DMD patients

Click here to listne

skinny - 03 Jun 2014 07:14 - 175 of 213

Notice of AGM and Proposed Capital Reorganisation

NOTICE OF ANNUAL GENERAL MEETING
AND PROPOSED CAPTIAL REORGANISATION

Oxford, UK, 3 June 2014 - Summit (AIM: SUMM), a drug discovery and development company advancing therapies for Duchenne Muscular Dystrophy and C. difficile infection, announces that its Annual Report and Accounts for the year ended 31 January 2014 together with the Notice of Annual General Meeting (the 'Notice') have been posted to shareholders. Copies of both documents are available on the Company's website, www.summitplc.com.

Also to be considered by shareholders at the meeting and detailed in the Notice are proposals for a capital reorganisation that will simplify the share capital structure of the Company (the 'Capital Reorganisation'). The proposals are subject, inter alia, to shareholder approval and, following their implementation, will result in the Company having a single class of Ordinary Shares in issue.

The Capital Reorganisation will consist of three elements:

a Consolidation of every 20 Existing Ordinary Shares into one Consolidated Ordinary Share;
an immediate Sub-Division of each of those Consolidated Ordinary Shares into one New Ordinary Share and 19 New Deferred Shares; and
a Capital Reduction to cancel the Existing and New Deferred Shares and a reduction in the Company's Share Premium Account.
Full details of the Capital Reorganisation are included in the Notice along with an explanation why the Directors consider this activity to be in the best interests of the Company and its shareholders.

The Annual General Meeting will be held at 10:00am on Thursday, 3 July 2014 at the Milton Park Innovation Centre, 99 Park Drive, Milton Park, Abingdon, Oxfordshire, OX14 4RY, UK.

more...

skinny - 17 Jun 2014 07:08 - 176 of 213

Summit Establishes US Office and Strengthens its Drug Development Team

SUMMIT ESTABLISHES US OFFICE IN CAMBRIDGE, MASSACHUSETTS AND STRENGTHENS ITS DRUG DEVELOPMENT OPERATIONS TEAM

Oxford, UK, 17 June 2014 - Summit (AIM: SUMM), a drug discovery and development company advancing therapies for Duchenne Muscular Dystrophy ('DMD') and C. difficile infection ('CDI'), announces it has established US operations in Cambridge, Massachusetts and strengthened its drug development operations team following the recruitment of new clinical and preclinical employees. The US operations are being formed to facilitate greater interactions with academic, clinical and business leaders in Summit's areas of therapeutic development.

Located at the new US office will be key members of the clinical development team: Dr Michael Boss, the overall leader of the utrophin modulation programme for DMD, and Dr Bindu Tejura who recently joined Summit as Vice President of Clinical Development and will be involved in both the DMD and CDI programmes.

"Summit's expansion to the US supports our strategy to continue to strengthen the investor base and allows for greater access to academic and industry key opinion leaders in North America, in order to advance our clinical programmes that will have a significant proportion of their development undertaken there," commented Glyn Edwards, Chief Executive Officer of Summit. "With our DMD and CDI programmes reaching key inflection points, it is important that we continue to strengthen the team supporting their development."

The operations and undertaking in the US will be conducted through a wholly owned subsidiary company, Summit Therapeutics Inc., which is incorporated in Delaware.

About Dr Michael Boss
Dr Michael Boss is a senior executive with broad operating experience in the biotechnology industry that includes biomedical product development, business development, identification and licensing of new technologies, intellectual property and project management. During his career, Dr Boss has held a number of positions including Chief Operating Officer and Chief Business Officer at the cancer and autoimmune biotechnology company Xanthus Pharmaceuticals Inc. At Xanthus he led a number of activities including the successful sale of the company to Antisoma, after which he continued to lead the autoimmune business. Dr Boss has experience of DMD and disease biomarkers from his time as Vice President of R&D and Vice President of Operations at Athena Diagnostics Inc. which developed the first test for DMD, along with the development of tests for many genetic and neurological diseases. Earlier in his career at Celltech Ltd he was the lead investigator on a landmark patent that enabled for the first time the genetic engineering and manufacture of recombinant monoclonal antibodies. Dr Boss holds a PhD in immunology (University of London), an MBA (London Business School) and he completed his postdoctoral fellowship with the Nobel Laureate Dr David Baltimore (Massachusetts Institute of Technology).

About Dr Bindu Tejura
Dr Bindu Tejura is a Medical Director and Clinical Research Investigator with over 10 years of experience in the development of new drugs and has an excellent understanding of drug development. She has been responsible for the design and interpretation of many Phase 1 and 2 clinical trials as well as several large Phase 3 studies. Prior to joining Summit, Dr Tejura was Medical Director at Millennium Pharmaceuticals Inc. where she gained broad clinical experience including being lead clinician on a large Phase 3 oncology study. She has held a number of previous roles at Cubist Pharmaceuticals, Dyax Inc. and Antisoma plc. Dr Tejura is a qualified clinician having undertaken her medical training at a number of hospitals and medical centres in the UK and the US. She holds a Bachelor of Medicine degree as well as a Bachelor of Pharmacology degree from the University of Wales, College of Medicine (Cardiff).

- END -

dreamcatcher - 03 Jul 2014 07:25 - 178 of 213


Summit Announces First Patients Dosed in a Phas...

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Summit Corporation plc
('Summit' or the 'Company')

SUMMIT ANNOUNCES FIRST PATIENTS DOSED IN A PHASE 2 CLINICAL TRIAL OF THE NOVEL ANTIBIOTIC SMT19969 FOR THE TREATMENT OF C. DIFFICILE INFECTION

Oxford, UK, 3 July 2014 - Summit (AIM: SUMM), a drug discovery and development company advancing therapies for Duchenne Muscular Dystrophy and C. difficile infection ('CDI'), announces that the first patients have been dosed in its Phase 2 proof of concept clinical trial that is evaluating the novel oral antibiotic SMT19969 for the treatment of CDI.

"SMT19969 is a new and differentiated antibiotic that combines excellent potency with unprecedented selectivity for C. difficile meaning it has a minimal antibiotic effect against bacteria that comprise the healthy gut flora. This profile is expected to be important in treating initial infection and reducing the high rates of disease recurrence, the major clinical issue that effects up to 30% of patients," commented Glyn Edwards, Chief Executive Officer of Summit. "The enrolment and dosing of the first patients in this Phase 2 trial achieves another important development milestone on the path towards establishing proof of concept for this highly promising treatment."

About the Phase 2 Clinical Trial
The Phase 2 trial, named CoDIFy, is a randomised, double-blind, active comparator study that will evaluate the efficacy of SMT19969 relative to vancomycin, the current standard of care in the treatment of CDI following ten days of dosing. The primary endpoint of the trial will measure the sustained clinical response, which is defined as cure from the initial infection with no recurrence within 30 days post end of treatment. The safety and tolerability of SMT19969 will also be evaluated. The study will recruit approximately 100 patients randomised into two equally sized treatment arms receiving SMT19969 and vancomycin respectively.

The study is being performed in North America and will involve approximately 25 trial sites in the US. Summit has now received clearance from Health Canada regarding its Clinical Trial Application which adds up to five additional study sites in Canada. Top line data from this trial is expected to be reported in the first half of 2015. Further information about this study is available on www.clinicaltrials.gov.

The development of SMT19969 is being supported by a Translational Award from the Wellcome Trust.

About C. difficile Infection
C. difficile infection ('CDI') is a serious healthcare threat in hospitals, long-term care homes and increasingly the wider community. It is a serious illness caused by infection of the colon by the bacteria 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 disrupt the normal gastrointestinal (gut) flora and so allow C. difficile to flourish. Existing CDI antibiotics cause further damage to the gut flora and are associated with high rates of recurrent disease. This is the key clinical issue as repeat episodes are typically more severe and associated with an increase in mortality rates and healthcare costs.

Recent years have seen a significant increase in CDI and it is estimated that there are approximately 900,000 cases across Europe and North America per annum. This rise means CDI has a high economic burden with the annual cost of care in the US alone estimated at over $4.8 billion.

- END -

dreamcatcher - 04 Jul 2014 20:38 - 179 of 213

consolidation of the shares @20/1

dreamcatcher - 07 Jul 2014 16:23 - 180 of 213

Summit to unveil promising new results for its DMD treatment

By John Harrington

July 07 2014, 7:59am
A poster presentation reporting these additional findings from the Phase 1b clinical trial will be presented at ICNMD at 11:30am CET on Monday 7 July 2014.
A poster presentation reporting these additional findings from the Phase 1b clinical trial will be presented at ICNMD at 11:30am CET on Monday 7 July 2014.


Summit (LON:SUMM) is to present promising new data from its recently completed Phase 1b clinical trial of SMT C1100, its treatment for Duchenne Muscular Dystrophy (DMD).

The company will unveil the data at the 13th International Congress on Neuromuscular Diseases (ICNMD) being held between 5-10 July in Nice, France.

The results of this study showed a statistically significant decrease in key enzymes associated with muscle damage and support the proposed mechanism of action of SMT C1100.

DMD is a rare but fatal muscle wasting disease that occurs in boys.

The latest study results cover the impact of dosing with SMT C1100 on blood levels of the enzymes creatine kinase (CK), aspartate aminotransferase (AST) and alanine aminotransferase ('ALT').

In healthy people, the levels of these enzymes are normally very low but in patients with DMD, muscle cells are weakened by the lack of dystrophin, causing these enzymes to leak out and accumulate in the blood.

During dosing with SMT C1100, a statistically significant reduction in CK, AST and ALT levels was observed when compared to pre-dose baseline levels. Blood levels of these enzymes increased towards pre-dosing levels after dosing stopped.

Summit said the results are consistent with the proposed mechanism of action of the utrophin modulator SMT C1100, whereby its effect would result in lower muscle damage and lead to lower levels of these key markers in the blood. The data from this Phase 1 study are encouraging and clearly support further evaluation in a placebo-controlled study.

skinny - 09 Jul 2014 07:19 - 181 of 213

FDA Grants QIDP Designation to Summit's Novel Antibiotic for the Treatment of C. difficile Infection

FDA GRANTS QIDP DESIGNATION TO SUMMIT'S NOVEL ANTIBIOTC SMT19969 FOR THE TREATMENT OF C. DIFFICILE INFECTION

Oxford, UK, 9 July 2014 - Summit (AIM: SUMM), a 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 designated the Company's novel antibiotic SMT19969 for the treatment of CDI as a Qualified Infectious Disease Product ('QIDP').

The QIDP designation allows Summit to benefit from a number of incentives supporting the development of new antibiotics including eligibility for Priority Review and Fast Track status and, if SMT19969 receives marketing approval from the FDA, a five-year extension of market exclusivity. The QIDP incentives are provided through the Generating Antibiotics Incentives Now Act ('GAIN Act') that was signed into US law in 2012 as part of the FDA Safety and Innovation Act. SMT19969 is currently in a Phase 2 proof of concept trial that is being conducted in North America.

"Summit is delighted that our novel antibiotic SMT19969 for the treatment of C. difficile infection has received QIDP designation from the FDA under the GAIN Act," commented Glyn Edwards, Chief Executive Officer of Summit. "This status recognises the serious healthcare threat posed by pathogens such as C. difficile and it will confer a number of advantages that will accelerate the development of this promising and differentiated antibiotic with the potential to treat initial CDI and reduce the high rates of disease recurrence, the major clinical issue."

About the GAIN Act
The GAIN Act was signed into law in 2012 and provides pharmaceutical and biotechnology companies with incentives to develop new antibacterial and antifungal drugs for the treatment of life-threatening infectious diseases. The GAIN Act lists specific qualifying pathogens, including C. difficile and means new therapeutics to treat CDI are eligible for designation as QIDPs. A drug that receives QIDP designation is eligible for: i) Fast Track designation. This is intended to facilitate the development and expedite the review of new drugs intended to treat serious or life-threatening conditions through more frequent meetings with the FDA and a rolling review of trial findings; ii) Priority Review that reduces to only six months the time taken by the FDA to review a drug marketing application; and iii) an additional five years of marketing exclusivity under the Hatch-Waxman Amendments upon the approval of a new drug application by the FDA.

About C. difficile Infection
C. difficile infection ('CDI') is a serious healthcare threat in hospitals, long-term care homes and increasingly the wider community. It is a serious illness caused by infection of the colon by the bacteria 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 disrupt the natural balance of the gastrointestinal (gut) flora allowing C. difficile to flourish. Existing CDI antibiotics cause further damage to the gut flora and are associated with high rates of recurrent disease. This is the key clinical issue as repeat episodes are typically more severe and associated with an increase in mortality rates and healthcare costs. Recent years have seen a significant increase in CDI and means the disease has a high economic burden with the annual cost of care in the US alone estimated at over $4.8 billion.

About SMT19969
SMT19969 is a novel, oral small molecule antibiotic that is being developed specifically for the treatment of CDI. Results from non-clinical efficacy studies show that SMT19969 combines potent bactericidal activity against C. difficile with high levels of antibacterial selectivity. A Phase 1 trial conducted in healthy volunteers showed SMT19969 to be safe and well tolerated at all doses tested. In addition, a significant reduction in total clostridia but not in other bacterial groups was reported which demonstrated that SMT19969 was highly sparing of gut flora. The Phase 2 proof of concept CoDIFy trial is currently being conducted in North America.

- END -

dreamcatcher - 04 Sep 2014 07:10 - 182 of 213


Summit Corporation PLC : Half-yearly report

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Summit Corporation plc
('Summit' or 'the Company')

INTERIM RESULTS FOR THE SIX MONTHS ENDED 31 JULY 2014

Oxford, UK, 4 September 2014, Summit (AIM: SUMM), the drug discovery and development company advancing therapies for Duchenne Muscular Dystrophy ('DMD') and C. difficile infection ('CDI'), today reports its interim financial results for the six months ended 31 July 2014.

HIGHLIGHTS

Product Development

Duchenne Muscular Dystrophy
- SMT C1100 met its primary endpoints in a Phase 1b clinical trial in DMD patients with the utrophin modulator shown to be safe and well tolerated at all doses tested
- Potential indicator of SMT C1100 activity in the Phase 1b trial with a statistically significant reduction observed in the levels of three enzymes associated with muscle damage
- Next clinical trial in DMD patients to monitor dietary impact on SMT C1100 uptake expected to start in Q4 2014; it is planned to then enrol these patients into a Phase 2 open-label study

C. difficile Infection
- First patients enrolled and dosed in a Phase 2 clinical trial of the novel antibiotic SMT19969
- SMT19969 designated as a Qualified Infectious Disease Product ('QIDP') by the US FDA to provide accelerated development and market exclusivity benefits
- £1.9 million milestone payment received as part of the Wellcome Trust Translational Award

Corporate

- US operations established through opening of Cambridge, Massachusetts office
- Mr Erik Ostrowski appointed Chief Financial Officer, bringing experience in finance, operations and investment banking in the biotechnology and healthcare sector
- Mr Leopoldo Zambeletti appointed as a Non-Executive Director, adding additional experience in healthcare investment banking and product licensing and other strategic transactions

Financial

- Cash position at 31 July 2014: £17.4 million (31 January 2014: £2.0 million)
- £22.0 million (£20.7 million net of costs) financing completed in March 2014
- Increase in operational expenditure in-line with expectation and reflects the increase in product development activities
- Loss for the six months ended 31 July 2014 of £5.9 million (31 July 2013: £2.1 million)

Glyn Edwards, Chief Executive Officer of Summit commented: "Strong progress has been made during the first half of the year in the development of our DMD and CDI programmes as they are evaluated in patient clinical trials. Encouraging results were reported from the Phase 1b trial of the utrophin modulator SMT C1100 while the Phase 2 trial on our C difficile antibiotic SMT19969 enrolled and dosed its first patients."

"We look forward to an exciting period as we generate more data from clinical trials that we hope will provide a fuller understanding about the potential of these life-changing treatments for two serious diseases."

An analyst briefing conference call will be held at 12:30pm BST (07:30am ET) on Thursday, 4 September 2014. The call will be hosted by N+1 Singer and the dial-in details are as follows: +44 (0) 330 336 0007, access code: 428647.

- END -

dreamcatcher - 04 Sep 2014 17:13 - 183 of 213

UPDATE - Summit plc looking forward to trials results

By John Harrington

September 04 2014, 1:36pm
'We look forward to an exciting period as we generate more data from clinical trials,” said Glyn Edwards, chief executive officer.
"We look forward to an exciting period as we generate more data from clinical trials,” said Glyn Edwards, chief executive officer.


---ADDS BROKER COMMENT AND SHARE PRICE---

Drug developer Summit (LON:SUMM) enters the second half of the year with a healthy cash position to support the execution of its clinical development plans.

Cash at the end of July stood at £17.4mln, up from £2.0mln a year earlier, following its massively oversubscribed £22mln fund raising in March.

The company is entering an important stage of its development, as reflected by the ramping up of research & development (R&D) expenditure in the first half of the year; spending on R&D rose to £4.9mln from £2.1mlm and was a major factor in a deeper loss of £5.9mln, versus a loss the year before of £2.1mln.

Such losses are par for the course for early stage drug development companies, and the focus of the results statement was understandably on progress made to date on the company’s two clinical programmes for Duchenne Muscular Dystrophy (DMD) and C. difficile infection (CDI).

Patient trials are either on-going or expected to start in the near future and will generate further data that should provide a fuller understanding of the potential of these life-changing treatments for two serious diseases, Summit said.

Regarding SMT C1100, Summit’s treatment for DMD, the next clinical trial in DMD patients to monitor dietary impact on Summit’s SMT C1100 uptake is expected to start in before the end of this year.

On the CDI front, the first patients have been enrolled and dosed in a phase II clinical trial of the novel antibiotic SMT 19969, and the drug was designated as a Qualified Infectious Disease Product earlier this year by the US Food & Drug

A £1.9 million milestone payment received as part of the Wellcome Trust Translational Award was also received in respect of the CDI programme.

Glyn Edwards, chief executive officer of Summit, said he is looking forward to an exciting period for Summit, and commented: "Strong progress has been made during the first half of the year in the development of our DMD and CDI programmes as they are evaluated in patient clinical trials. Encouraging results were reported from the Phase 1b trial of the utrophin modulator SMT C1100 while the Phase 2 trial on our C difficile antibiotic SMT19969 enrolled and dosed its first patients."

N+1 Singer described the results as “solid”, saying they highlight the strong progress being made by the company with its lead programmes.

“SMT C1100 is the first utrophin modulator to enter clinical trials in DMD, with the next clinical trial on track to commence in Q4 2014. There is currently no cure for DMD, a fatal muscle wasting disease that affects around 1 in 3,500 male births, and unlike other approaches in development, SMT C1100 can potentially be used by 100% of boys with DMD and in combination with other agents,” the broker noted, as it indicated it would not be making any major changes to its forecasts based on the interim results.

“SMT 19969 is currently in Phase II and on track to deliver top line data in H1 2015. C difficile infection is established as a major healthcare threat, with around 900,000 cases per annum in Europe and North America, and responsible for acute care costs of $4.8bn per annum in the USA alone.

“We remain highly positive on the group’s future prospects,” it added.

Shares in Summit were down 3.5p at 166p in afternoon trading.

skinny - 08 Sep 2014 07:23 - 184 of 213

Summit Presents New Positive Preclinical Data on SMT19969 for C. difficile at ICAAC 2014

Oxford, UK, 8 September 2014 - Summit (AIM: SUMM), the drug discovery and development company advancing therapies for Duchenne Muscular Dystrophy and C. difficile infection ('CDI'), reports new positive preclinical efficacy data on SMT19969, a novel and selective antibiotic for the treatment of CDI, at the 54th Interscience Conference on Antimicrobial Agents and Chemotherapy ('ICAAC 2014') held in Washington DC, USA from September 5-9 2014.

The data being presented is from a series of preclinical in vivo and in vitro efficacy studies whose results show that SMT19969 continues to display superiority over vancomycin, the current standard of care for the treatment of CDI. In comparison to vancomycin, SMT19969 provided increased survival rates and prevention of recurrent disease in vivo, displayed superior C. difficile killing, and reduced toxin B production.

Infectious diseases expert and hospital epidemiologist with a specialist interest in C. difficile disease, Dale Gerding MD, Professor of Medicine at Loyola University Stritch School of Medicine commented, "C. difficile infection is associated with high levels of recurrent disease and, to reduce this, it is imperative that antibiotics which minimise impact on the natural bacterial flora of the gut are used. The gut flora and its protective role are typically disrupted in CDI patients. Antibiotics that have a targeted spectrum of activity, such as SMT19969, could allow restoration of the protective flora to happen sooner and so reduce disease recurrence. The results on SMT19969 are encouraging and it warrants further evaluation in patient clinical trials."

Glyn Edwards, Chief Executive Officer of Summit added, "These results further illustrate that SMT19969 has potential to be a new and differentiated antibiotic for the treatment of initial CDI infection and for the prevention of recurrent disease, the key clinical issue. It is an exciting time in the development of SMT19669 with patients now being enrolled into a Phase 2 proof of concept trial as we work towards establishing the potential of this highly selective antibiotic for the treatment of CDI."

The results were detailed in five poster presentations given by Summit and its collaborators that include Dr Joseph Blondeau (Royal University Hospital and the University of Saskatchewan, Canada), Professor Kevin Garey (University of Houston College of Pharmacy, Houston, US) and Professor Nigel Minton (School of Life Sciences, University of Nottingham, UK). The details of the presentations were as follows:

skinny - 08 Oct 2014 07:28 - 185 of 213

SUMMIT REPORTS POSITIVE DATA ON ITS UTROPHIN MODULATION PROGRAMME FOR THE TREATMENT OF DMD AT 2014 WMS CONGRESS

Phase 1b clinical trial data on lead utrophin modulator SMT C1100
Positive preclinical data unveiled on second generation candidates
Oxford, UK, 8 October 2014 - Summit (AIM: SUMM), the drug discovery and development company advancing therapies for Duchenne Muscular Dystrophy ('DMD') and C. difficile infection, reports clinical data on SMT C1100, the Company's lead utrophin modulator, highlighting its safety profile and further detailing the observed reduction in enzymes associated with muscle damage in a Phase 1b study in boys with DMD. In addition, Summit is unveiling new positive preclinical data on its second generation utrophin modulator programme for the treatment of DMD.

All data are being presented at the 19th International World Muscle Society Congress ('WMS') being held in Berlin Germany from 7-11 October 2014.

Glyn Edwards, Chief Executive Officer of Summit commented, "SMT C1100 is paving the way in the clinic for utrophin modulation and the initial signs of activity point to this mechanism as a potential treatment for all boys with DMD. Our second generation utrophin modulators build on this mechanism with the new data illustrating how they increase utrophin protein levels and improve muscle health, while having enhanced drug properties compared to the first generation drug SMT C1100."

"This exciting progress shows SMT C1100 has the potential to become the first utrophin modulator drug to treat all DMD patients, to be followed by second generation candidates with improved properties, as we seek to change the treatment paradigm for this devastating condition."

The data on the second generation programme comprise results from in vivo and in vitro studies that highlight the promising profile of two lead candidates as potential disease modifying treatments:

Significant improvement in systemic exposure in vivo compared to first generation utrophin modulator SMT C1100 with blood plasma levels 10-40 times higher following oral dosing;
Modulation of utrophin expression in vivo with an increase in protein levels observed in skeletal muscle, diaphragm and heart compared to the control;
Significant improvement in disease pathology with reduction in muscle fibre fibrosis ('scarring') and membrane damage;
Improvement in muscle health indicated by a significant reduction in the number of regenerating muscle fibres;
Protection of muscle function with the increased utrophin protein levels resulting in significant improvement in muscle membrane stability and resistance to damage.
These studies were conducted as part of the UtroDMD Alliance, a collaboration to develop utrophin modulator drugs for the treatment of DMD.

dreamcatcher - 25 Nov 2014 19:32 - 186 of 213

BioMarin deal is positive for Summit, says N+1 Singer

By Giles Gwinnett

November 25 2014, 12:04pm
BioMarin said it would pay US$17.75 for each Prosensa share or around US$680mln - a 55.2% premium on Friday's closing price



The planned acquisition of Dutch pharma group Prosensa by rare disease giant BioMarin is positive for Summit Corp (LON:SUMM) and highlights the potential value of Duchenne Muscular Dystrophy (DMD)-focused firms, says N+1 Singer.

BioMarin said it would pay US$17.75 for each Prosensa share or around US$680mln - a 55.2% premium on Friday's closing price.

Analyst Sheena Berry noted there was currently no cure for DMD, which is classed as an orphan disease in the US and Europe, and affects around 1 in 3,500 male births.

Prosensa’s lead drug candidate can potentially treat 13% of the DMD population whereas Summit’s lead DMD programme - utrophin modulator SMT C1100 - can potentially be applied to 100% and in combination with other agents," she added.

Prosensa's lead candidate is drisapersen, which has completed phase III trials and the firm is targeting a filing for a new drug with the FDA by the end of this year.

DMD is caused by mutations in the dystrophin gene, which contains the instructions for making dystrophin, which acts as a shock absorber to prevent damage when muscles contract.

It is thought that utrophin, a protein naturally present in the body in small amounts, may be able to make up for the lack of dystrophin in boys with DMD since both proteins appear to have very similar functions.

Berry said the broker continues to be positive on the utrophin modulation programme for DMD.

"The compound completed a Phase Ib trial earlier in the year, meeting its primary endpoint as well as having a positive impact on enzyme markers.

"SMT C1100 is expected to enter its next clinical trial in DMD imminently and we anticipate results during the course of 2015. Our forecasts assume peak sales in SMT C1100 of around US$2bn four years after market entry and assume a significant partnering deal in the group’s 2017 financial year."

The broker estimates Summit's revenue of £2.3mln in 2015, rising to £50.5mln in 2017.

Summit shares added 0.39% to 128.5p on Tuesday.

dreamcatcher - 11 Dec 2014 17:40 - 187 of 213

Summit gets go-ahead for DMD dietary trial

By Philip Whiterow

December 11 2014, 7:58am
'The initiation of this trial means our DMD and CDI programmes have the potential to achieve important clinical milestones in the near-term.'
"The initiation of this trial means our DMD and CDI programmes have the potential to achieve important clinical milestones in the near-term."


Summit (LON:SUMM) has received approval from the UK authorities to start a Phase 1b modified diet trial of SMT C1100, its treatment for muscle wasting disease Duchenne Muscular Dystrophy (DMD).

The new trial will assess specific dietary guidance to improve drug absorption and test the drug on enzyme markers of muscle health in 12 boys aged between 5-13. Top-line data from the trial is expected in mid-2015.

Glyn Edwards, chief executive, said: "We believe it is possible to enhance absorption of SMT C1100 through dietary means and this new patient trial is designed to test this so that we can confidently evaluate the efficacy of utrophin modulation in subsequent clinical trials."

“We believe that utrophin modulation has the opportunity to benefit all boys with DMD and we are working to ensure this molecule has the best chance to reach the market through a well-designed clinical path.

"The initiation of this trial means our DMD and CDI programmes have the potential to achieve important clinical milestones in the near-term with both expected to report top-line data in mid-2015."

The modified diet trial will be conducted at four NHS hospitals and, if successful, will be followed by a Phase 2 open label trial to generate longer-term efficacy and safety data on SMT C1100.

dreamcatcher - 19 Dec 2014 15:57 - 188 of 213


Summit Considering Potential US Registered Publ...

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Summit Corporation plc
('Summit' or 'the Company')

SUMMIT CONSIDERING POTENTIAL U.S. REGISTERED PUBLIC OFFERING AND STOCK EXCHANGE LISTING

Oxford, UK, 19 December 2014 - Summit (AIM: SUMM) announces that it is considering the possibility of a registered public offering of its ordinary shares in the United States under the U.S. Securities Act of 1933, as amended, and a related listing on a U.S. stock exchange to supplement its current listing on the AIM market of the London Stock Exchange. Summit has not made any decision regarding the timing or the terms of the potential offering, and there is no certainty that the offering will take place.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any securities.

- END -

dreamcatcher - 02 Feb 2015 15:04 - 189 of 213

Summit Corporation PLC : Third Quarter Results ...
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NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, IN OR INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OF SUCH JURISDICTION

Summit Corporation plc
('Summit' or the 'Company')

THIRD QUARTER RESULTS FOR THE NINE MONTHS ENDED 31 OCTOBER 2014

Oxford, U.K., 2 February 2015 - Summit (AIM: SUMM), the drug discovery and development company advancing therapies for Duchenne Muscular Dystrophy ('DMD') and C. difficile infection ('CDI'), announces financial results for the third quarter and nine months ended 31 October 2014. The Company has also separately announced today its proposed offering of American Depositary Shares in the United States, on the NASDAQ Global Market, to complement the continuing trading of Summit's ordinary shares on AIM.

HIGHLIGHTS

DUCHENNE MUSCULAR DYSTROPHY PROGRAMME

Received regulatory and ethics committee approval to commence Phase 1b modified diet clinical trial of lead utrophin modulator SMT C1100; Top-line data expected to be reported in mid-2015
If successful, plan to initiate Phase 2 Open Label clinical trial in H2 2015 and placebo controlled Phase 2 clinical trial of SMT C1100 in early 2016
On-going development of second generation utrophin modulators with positive preclinical data unveiled at the 19th World Muscle Society Congress
C. DIFFICILE INFECTION PROGRAMME

Phase 2 Proof of Concept clinical trial on-going in U.S. and Canada
Enrolment and dosing of patients underway; top line data now expected in H2 2015
Positive preclinical efficacy data presented at the 54th ICAAC conference
OPERATIONAL HIGHLIGHTS

Proposed offering of American Depositary Shares in the United States and listing on the NASDAQ Global Market to complement the Company's current AIM listing, subject to shareholder approval (see separate announcement)
Proposed change of registered name to Summit Therapeutics plc
Appointment of Valerie Andrews as a Non-Executive Director
FINANCIAL HIGHLIGHTS

Cash and cash equivalents at 31 October 2014 of £15.0 million compared to £2.0 million at 31 January 2014
Operational expenditure in-line with expectation and reflects the increase in product development activities
Loss for the nine months ended 31 October 2014 of £8.3 million compared to £3.8 million for the nine months ended 31 October 2013
Mr Glyn Edwards, Chief Executive Officer of Summit commented, "Summit continues to make progress on a number of fronts. The announcement today of a proposed listing on NASDAQ is intended to provide greater access to a wider set of healthcare investors, generate greater liquidity in the Company's shares, and increase awareness of Summit in geographies outside of the U.K., particularly in the United States. As a complement to Summit's current quotation on AIM, the proposed NASDAQ listing and U.S. public offering are also expected to support the on-going development of our DMD and CDI programmes. We expect to report top line data from patient clinical trials in each of these programmes during 2015."

Notes to Editors

About Summit
Summit is an Oxford, U.K. based drug discovery and development company targeting high-value areas of unmet medical need including Duchenne Muscular Dystrophy and C. difficile infection. Summit is quoted on the AIM market of the London Stock Exchange and trades under the ticker symbol SUMM. Further information is available at www.summitplc.com and Summit can be followed on Twitter (@summitplc).

//////////////////////////////////////////////////////////////////////////////////////////////////



Summit shares climb as unveils US listing plans

By Giles Gwinnett

February 02 2015, 10:47am
Shares in drug developer Summit (LON:SUMM) jumped over 10% on Monday as it told investors it continues to make progress on a number of fronts and unveiled plans to list on the NASDAQ exchange in the US
Shares in drug developer Summit (LON:SUMM) jumped over 10% on Monday as it told investors it continues to make progress on a number of fronts and unveiled plans to list on the NASDAQ exchange in the US


Shares in drug developer Summit (LON:SUMM) jumped over 10% on Monday as it told investors it continues to make progress on a number of fronts and unveiled plans to list on the NASDAQ exchange in the US.

The firm has filed for a proposed offering of American Depository shares to be listed on the exchange under the symbol 'SMTT'. The size of the offering and final timing has yet to be determined.

Summit is developing treatments for muscle wasting disease Duchenne Muscular Dystrophy (DMD) and C. difficile infection.

Chief executive Glyn Edwards told investors the proposed listing was aimed at providing greater access to a "wider set of healthcare investors, generate greater liquidity in the company's shares, and increase awareness of Summit in geographies outside of the UK".

"As a complement to Summit's current quotation on AIM, the proposed NASDAQ listing and US public offering are also expected to support the on-going development of our DMD and CDI programmes," he said.

"We expect to report top line data from patient clinical trials in each of these programmes during 2015," he added.

Highlights of the nine months to end October last year saw the company receive approval to commence a Phase 1b clinical trial of lead utrophin modulator SMT C1100 for Duchenne's and top line data is expected in mid-2015.

On the C-diff programme, a phase 2 Proof of Concept clinical trial IS on-going in the US and Canada and enrolment and dosing of patients is underway with top line data expected in the second half of 2015.

Operational expenditure for the nine months was in-line with expectations, Summit said, reflecting the increase in product development activities.

Research and development costs increased to £7.6 million from £4.4 million for the comparable period in 2013.

The loss for the period came in at £8.3 million compared to £3.8 million in 2013.

Cash and equivalents as at October 31 last year were of £15 million compared to £2 million on Jan 31, 2014.

Broker N+1 Singer noted the acquisition of Prosensa at the end of last year for up to US$840mln highlighted the "significant value" in DMD companies and provides a positive read-across to Summit and its utrophin modulation programme.

Prosensa is a company developing a compound for Duchenne Muscular Dystrophy that was previously listed on NASDAQ.

!Its lead drug candidate can potentially treat 13% of the DMD population where Summit’s lead DMD programme, SMT C1100, can potentially be used by 100% of boys with DMD and in combination with other agents," noted N+1.

"Summit’s third quarter results indicate that the group’s two clinical programmes continue to progress with data expected from mid-2015.

“We continue to be upbeat about Summit’s future prospects and believe 2015 could be a very positive year for the group."

Summit shares added 10.59% to 141p.

dreamcatcher - 20 Feb 2015 07:08 - 190 of 213

Summit Announces First Patients Dosed in Phase ...
HUG
Summit Therapeutics plc
('Summit' or the 'Company')

SUMMIT ANNOUNCES THE FIRST PATIENTS DOSED IN PHASE 1B MODIFIED DIET CLINICAL TRIAL OF SMT C1100 FOR TREATMENT OF DMD


Oxford, UK, 20 February 2015 - Summit Therapeutics plc (AIM: SUMM), the drug discovery and development company advancing therapies for Duchenne Muscular Dystrophy ('DMD') and C. difficile infection, announces that the first patients with DMD have been enrolled and dosed in a Phase 1b modified diet clinical trial of the orally administered, small molecule utrophin modulator SMT C1100.

"We believe that utrophin modulation has the potential to benefit all patients with DMD, irrespective of the underlying fault in the dystrophin gene causing the disease, and this new trial forms part of our broader clinical development path that seeks to provide this drug with the best chance of reaching the market," commented Glyn Edwards, Chief Executive Officer of Summit. "We look forward to reporting data from this study in Q3 2015."

About the Phase 1b Modified Diet Clinical Trial
The Phase 1b trial is a randomised, placebo controlled study being conducted in paediatric patients with DMD. This new trial aims to increase the blood plasma levels of SMT C1100 compared to those observed in the previous open label Phase 1b trial completed in 2014 by providing patients with specific dietary guidance on recommended balanced proportions of fat, protein and carbohydrates. The trial is also evaluating the potential impact of SMT C1100 on enzyme biomarkers that are related to muscle health, and further evaluating the safety and tolerability of the drug.

The trial is being conducted in the UK and is enrolling a total of 12 patients aged between 5 and 13 years, divided equally into three dose cohorts. The trial will include three randomised 14-day treatment periods during which each patient will receive two different doses of SMT C1100 and a placebo control. There will be a 14-day wash-out period between each of the three treatment periods.

Top-line data from the Phase 1b modified diet trial are expected to be reported in Q3 2015. If successful, Summit plans to initiate a Phase 2 open label trial in DMD patients designed to evaluate the longer-term effects of SMT C1100 on muscle health, function and safety. Summit also plans to conduct a larger multinational Phase 2 placebo controlled trial.

- END -

dreamcatcher - 23 Feb 2015 16:11 - 191 of 213

UPDATE - Summit Therapeutics hires new director as pursues US listing

By Giles Gwinnett

February 23 2015, 10:15am
Broker N+1 Singer said: 'Top line data from the group’s two clinical programmes is expected in H2 2015. We continue to be upbeat about Summit’s future prospects and believe 2015 could be a very positive year for the group.'
Broker N+1 Singer said: "Top line data from the group’s two clinical programmes is expected in H2 2015. We continue to be upbeat about Summit’s future prospects and believe 2015 could be a very positive year for the group."


---Adds share price and broker comment---

Pharma and biotech specialist David Wurzer has been hired as a non-exec director at drug developer Summit Therapeutics (LON:SUMM) as it continues to pursue a NASDAQ listing in the US.

Summit chairman Frank Armstrong said: "David's expertise in financial matters and experience in working for US listed companies will be extremely valuable in supporting the future growth of the company."

Wurzer was executive vice president, treasurer and CFO of NASDAQ listed biotechnology company CuraGen Corporation between 1997 and 2008. He also held a number of positions at Value Health Inc from 1991 to 1997.

The 56-year-old is currently the executive vice president and chief investment officer at Connecticut Innovations - a state funded venture capital fund.

As reported on February 2, the group has filed for a proposed offering of American Depository shares to be listed on the exchange under the symbol 'SMTT'.

Today, it said it filed on Friday an amended registration statement, which included a preliminary prospectus for the offering.

Summit is advancing therapies for Duchenne Muscular Dystrophy (DMD) and C. difficile infection (CDI).

Broker N+1 Singer said: "Top line data from the group’s two clinical programmes is expected in H2 2015. We continue to be upbeat about Summit’s future prospects and believe 2015 could be a very positive year for the group."

Shares added 2.37% to 151p.

dreamcatcher - 05 Mar 2015 20:19 - 192 of 213

UPDATE - Summit NASDAQ listing begins as unveils US$34.2mln fundraise

By Giles Gwinnett

March 05 2015, 3:22pm
The initial public offering will see 3.45mln American Depositary shares offered at a price of US$9.90 each to raise around US$34mln
The initial public offering will see 3.45mln American Depositary shares offered at a price of US$9.90 each to raise around US$34mln


Drug developer Summit (LON:SUMM) reached another milestone on Thursday as it listed on the NASDAQ exchange in the US and brought in US$34.2mln alongside the IPO to fund its research.

The initial public offering (IPO) saw 3.45mln American Depositary shares (ADS) offered at a price of US$9.90 each to raise around US$34.2mln. Shares began trading under the symbol SMMT and were unchanged at the time of writing.

The group's shares continue to trade on AIM and the offer price is equivalent to around £1.30p a share - about 20% lower than Wednesday night's London closing price of 161p.

"Today's successful listing on NASDAQ achieves a significant milestone that we believe will support the company's future growth and development," said Summit chief executive Glyn Edwards.

"We believe being dual-listed will enhance the profile of Summit amongst the investment community and will mean we are better able to continue advancing our mid-stage clinical programmes in Duchenne muscular dystrophy [DMD] and C. difficile infection [CDI]."

Edwards believes the proposed listing will provide greater access to a "wider set of healthcare investors, generate greater liquidity in the company's shares, and increase awareness of Summit in geographies outside of the UK".

"As a complement to Summit's current quotation on AIM, the proposed NASDAQ listing and US public offering are also expected to support the on-going development of our DMD and CDI programmes," he said.

Summit is developing treatments for muscle wasting disease Duchenne Muscular Dystrophy and hospital super-bug C. difficile infection. It has received approval to start a Phase 1b clinical trial of lead utrophin modulator SMT C1100 for Duchenne's and top line data is expected in mid-2015.

On the C-diff programme, a phase 2 proof of concept clinical trial is on-going in the US and Canada and enrolment and dosing of patients is underway with top line data expected in the second half of 2015.

Broker N+ 1 Singer highlighted that another Duchenne Muscular Dystrophy firm - Prosensa - was previously listed on Nasdaq and snapped up at the end of 2014 for up to US$840mln.

It believes the deal revealed the significant value in DMD companies and provides a "positive read-across" to Summit.

"There is currently no cure for DMD, a fatal muscle wasting Orphan disease in the US and Europe, which affects around 1 in 3,500 male births. Prosensa’s lead drug candidate can potentially treat 13% of the DMD population where Summit’s lead DMD programme, SMT C1100, can potentially be used by 100% of boys with DMD and in combination with other agents," it said.

"We continue to be upbeat about Summit’s future prospects and believe 2015 could be a very positive year for the group."

On AIM, summit shares eased 8.39% to stand at 147.5p.

js8106455 - 29 Apr 2015 11:47 - 193 of 213

Watch: Summit plc - Master Investor 2015

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