UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
OF THE SECURITIES EXCHANGE ACT OF 1934
For the month of May 2015
Commission File Number 001-36866
SUMMIT
THERAPEUTICS PLC
(Translation of registrants name into English)
85b Park Drive
Milton
Park, Abingdon
Oxfordshire OX14 4RY
United Kingdom
(Address
of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
FORM
20-F x FORM 40-F ¨
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
¨
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation
S-T Rule 101(b)(7): ¨
Indicate by check mark whether the registrant by furnishing the information
contained in this form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934:
YES ¨ NO
x
If Yes is marked, indicate below the file number assigned to the registrant in
connection with Rule 12g3-2(b): 82-
On April 30, 2015, Summit Therapeutics plc (the Company) issued a press release announcing that
the United States Patent and Trademark Office has issued a patent that protects the use of SMT19969 in the treatment of Clostridium difficile infection. A copy of this press release is attached hereto as Exhibit 99.1 and incorporated by
reference herein.
On May 1, 2015, the Company issued a press release announcing that it would announce its full year financial results for the year
ended January 31, 2015 on Wednesday, May 6, 2015. A copy of this press release is attached hereto as Exhibit 99.2 and incorporated by reference herein.
2
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized.
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SUMMIT THERAPEUTICS PLC |
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By: |
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/s/ Erik Ostrowski |
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Erik Ostrowski |
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Chief Financial Officer |
Date: May 4, 2015
EXHIBIT INDEX
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Exhibit Number |
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Description |
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99.1 |
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Press Release dated April 30, 2015 relating to Grant of U.S. patent |
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99.2 |
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Press Release dated May 1, 2015 relating to Notice of Full Year Financial Results |
Exhibit 99.1
Summit Therapeutics plc
(Summit or the Company)
SUMMIT THERAPEUTICS GRANTED KEY PATENT FOR NOVEL ANTIBIOTIC SMT19969 FOR THE TREATMENT OF C. DIFFICILE INFECTION
Oxford, UK, 30 April 2015 Summit Therapeutics plc (AIM: SUMM, NASDAQ: SMMT), the drug discovery and development company advancing therapies
for Duchenne muscular dystrophy and Clostridium difficile infection (CDI) announces that the United States Patent and Trademark Office has issued a patent that protects the use of SMT19969 in the treatment of CDI.
United States Patent number 8,975,416 is entitled Antibacterial Compounds and will provide a period of exclusivity for the use in the United
States of the small molecule antibiotic SMT19969 in the treatment of CDI through until at least 1 December 2029. Patent protection has previously been granted for SMT19969 in the treatment of CDI in a number of other countries including Japan.
The grant of this key patent for SMT19969 in one of the major commercial markets represents a critical component in our strategy for advancing this
highly selective antibiotic for the treatment of CDI. SMT19969 has the potential to treat initial infection and reduce rates of disease recurrence by being highly sparing of healthy gut flora, commented Glyn Edwards, Chief Executive Officer
of Summit. Through the grant of this patent the intellectual property estate protecting SMT19969 has been significantly strengthened as we continue to evaluate this promising antibiotic in Phase 2 proof of concept patient clinical trials.
Data are expected from the trial in the second half of this year.
- END -
Notes to Editors
About C.
difficile Infection
C. difficile infection 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. The economic impact of CDI is significant with acute care costs
estimated at $4.8 billion in the US alone.
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 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 trial (CoDIFy) is currently being conducted in North
America.
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).
For more information, please contact:
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Summit Therapeutics Glyn Edwards /
Richard Pye (UK office) Erik Ostrowski (US office) |
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Tel: +44 (0)1235 443 951
+1 617 294 6607 |
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Cairn Financial Advisers LLP
(Nominated Adviser) Liam Murray / Tony Rawlinson |
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Tel: +44 (0)20 7148 7900 |
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N+1 Singer (Broker)
Aubrey Powell / Jen Boorer |
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Tel: +44 (0)20 7496 3000 |
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MacDougall Biomedical Communications (US
media contact) Michelle Avery |
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Tel: +1 781 235 3060
mavery@macbiocom.com |
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Peckwater PR (Financial public
relations, UK) Tarquin Edwards |
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Tel: +44 (0)7879 458 364
tarquin.edwards@peckwaterpr.co.uk |
Forward Looking Statements
This announcement contains forward-looking statements, including, but not limited to, statements about the discovery, development and
commercialisation of programme assets. These forward-looking statements are statements based on the Companys current intentions, beliefs and expectations, which include, among other things, the Companys results of operations, financial
condition, prospects, growth, strategies and the industry in which the Company operates. No forward-looking statement is a guarantee of future performance and actual results could differ materially from those expressed or implied in the
forward-looking statements. Accordingly, readers should not place undue reliance on forward-looking statements or information. Forward-looking statements and information by their nature involve known and unknown risks, uncertainties and other
factors which may cause actual results, performance or achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements or information. These
include but are not limited to: adverse results in clinical or preclinical development studies; delays in obtaining regulatory approval; failure to obtain patent protection for inventions; commercial limitations imposed by patents owned or
controlled by third parties; being unable to secure partnership agreements to develop and commercialise programme assets; being unable to secure the necessary funding to conduct any proposed research and development studies; and the ability to
retain and recruit key personnel. The Company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statement contained in this announcement to reflect any changes in expectations
with regard thereto or any changes in events, conditions or circumstances on which any such statement is based, except as required by applicable law.
Exhibit 99.2
Summit Therapeutics plc
(Summit or the Company)
SUMMIT THERAPEUTICS PROVIDES NOTICE OF FULL YEAR FINANCIAL RESULTS
Oxford, UK, 1 May 2015 Summit Therapeutics plc (AIM: SUMM, NASDAQ: SMMT), the drug discovery and development company advancing therapies for
Duchenne muscular dystrophy and C. difficile infection, will be announcing its full year financial results for the year ended 31 January 2015 on Wednesday 6 May 2015.
Summit will host a conference call the same day at 1:00pm BST / 8:00am EST. Conference call information will be included in the full year results press
release and a replay of the call will also be available through the Companys website, www.summitplc.com.
- END -
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).
For more information, please contact:
|
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Summit Therapeutics Glyn Edwards /
Richard Pye (UK office) Erik Ostrowski (US office) |
|
Tel: +44 (0)1235 443 951
+1 617 294 6607 |
|
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Cairn Financial Advisers LLP
(Nominated Adviser) Liam Murray / Tony Rawlinson |
|
Tel: +44 (0)20 7148 7900 |
|
|
N+1 Singer (Broker)
Aubrey Powell / Jen Boorer |
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Tel: +44 (0)20 7496 3000 |
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MacDougall Biomedical Communications (US
media contact) Michelle Avery |
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Tel: +1 781 235 3060
mavery@macbiocom.com |
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Peckwater PR (Financial public
relations, UK) Tarquin Edwards |
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Tel: +44 (0)7879 458 364
tarquin.edwards@peckwaterpr.co.uk |
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