Download summit therapeutics plc - corporate

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 July 2015
Commission File Number 001-36866
SUMMIT THERAPEUTICS PLC
(Translation of registrant’s 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 
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 
If “Yes” is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b):
On July 7, 2015, Summit Therapeutics plc (the “Company”) issued a press release announcing that the European Patent Office has
granted a composition of matter patent that protects the use of SMT C1100 in the treatment of Duchenne muscular dystrophy, and that
the period of opposition has expired with no opposition being filed. The press release is attached hereto as Exhibit 99.1 and
incorporated by reference herein.
On July 8, 2015, the Company issued a press release announcing that the U.S. Food and Drug Administration has granted Fast Track
designation for SMT19969, the Company’s novel antibiotic for the treatment of C. difficile infection. The press release is attached
hereto as Exhibit 99.2 and incorporated by reference herein.
The information contained in Exhibits 99.1 and 99.2 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange
Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as
amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
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.
SUMMIT THERAPEUTICS PLC
By: /s/ Erik Ostrowski
Erik Ostrowski
Chief Financial Officer
Date: July 8, 2015
EXHIBIT INDEX
Exhibit
Number
Description
99.1
Press Release dated July 7, 2015 relating to grant of patent by European Patent Office
99.2
Press Release dated July 8, 2015 relating to FDA grant of Fast Track designation
Exhibit 99.1
Summit Therapeutics plc
(‘Summit’ or the ‘Company’)
SUMMIT THERAPEUTICS GRANTED KEY PATENT BY EUROPEAN PATENT OFFICE FOR UTROPHIN
MODULATOR SMT C1100 IN THE TREATMENT OF DMD
•
Patent emerges from opposition period with no opposition filed with EPO
Oxford, UK, 7 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, announces that the European
Patent Office (‘EPO’) has granted a composition of matter patent for the small molecule utrophin modulator SMT C1100 and that the
period of opposition for this patent has now expired with no opposition having been filed. The patent protects SMT C1100 and its use
in the treatment of the fatal muscle wasting disease DMD.
“This is a cornerstone patent for SMT C1100, and its grant and emergence from the opposition period in a major commercial market,
represents a crucial part in our strategy for advancing this promising utrophin modulator therapy for DMD,” commented Glyn
Edwards, Chief Executive Officer of Summit . “The grant of this European patent, combined with its grant in other major
territories including the United States and Japan, ensures strong intellectual property protection for this investigational drug that has
the potential to improve the lives of all patients affected by DMD.”
The patent (European patent number 1986633) is entitled “Treatment of Duchenne Muscular Dystrophy” and will provide a period of
exclusivity for SMT C1100 through until 2027, with the possibility of a longer effective term subject to obtaining a Supplementary
Protection Certificate on marketing approval. The patent has also been validated in all available contracting states to the European
Patent Convention, and so is now in force in all major European states including the United Kingdom, Germany, France, Spain and
Italy.
SMT C1100 is the Company’s most advanced utrophin modulator and forms part of the Company’s wider pipeline of utrophin based
therapies that are in development. SMT C1100 is currently in a Phase 1b clinical trial in patients with DMD with top line results
expected to be reported during Q3 2015.
- END About DMD and Utrophin Modulation
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 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 ).
For more information, please contact:
Summit Therapeutics
Glyn Edwards / Richard Pye (UK office)
Erik Ostrowski (US office)
Tel: +44 (0)1235 443 951
+1 617 294 6607
Cairn Financial Advisers LLP
(Nominated Adviser)
Liam Murray / Tony Rawlinson
Tel: +44 (0)20 7148 7900
N+1 Singer
(Broker)
Aubrey Powell / Jen Boorer
Tel: +44 (0)20 7496 3000
MacDougall Biomedical Communications
(US media contact)
Michelle Avery
Tel: +1 781 235 3060
[email protected]
Peckwater PR
(Financial public relations, UK)
Tarquin Edwards
Tel: +44 (0)7879 458 364
[email protected]
Forward Looking Statements
Any statements in this press release about our future expectations, plans and prospects, including statements about the clinical
development of our product candidates, the timing of clinical results and expectations regarding the sufficiency of our cash balance to
fund operating expenses and capital expenditures, and other statements containing the words “anticipate,” “believe,” “continue,”
“could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar
expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995.
Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors,
including: the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future
clinical trials and the results of such trials, whether preliminary results from a clinical trial will be predictive of the final results of that
trial or whether results of early clinical trials will be indicative of the results of later clinical trials, expectations for regulatory
approvals, availability of funding sufficient for our foreseeable and unforeseeable operating expenses and capital expenditure
requirements and other factors discussed in the “Risk Factors” section of filings that we make with the Securities and Exchange
Commission. In addition, any forward-looking statements included in this press release represent our views only as of the date of this
release and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to
update any forward-looking statements included in this press release.
Exhibit 99.2
Summit Therapeutics plc
(“Summit” or the “Company”)
SUMMIT THERAPEUTICS RECEIVES FDA FAST TRACK DESIGNATION FOR NOVEL ANTIBIOTIC SMT19969 IN
THE TREATMENT OF C. DIFFICLE 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.
- END About Fast Track Status
The FDA established the Fast Track designation process to facilitate the development and expedite the review of drugs intended to
treat serious or life-threatening conditions that demonstrate the potential to address unmet medical needs. Advantages of Fast Track
designation include opportunities for more frequent interactions with the FDA during all aspects of development, submission of a New
Drug Application (‘NDA’) on a rolling basis and eligibility for priority review if supported by clinical data at the time of NDA
submission.
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. A Phase 2 proof of concept trial called 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:
Summit Therapeutics
Glyn Edwards / Richard Pye (UK office)
Erik Ostrowski (US office)
Tel: +44 (0)1235 443 951
+1 617 294 6607
Cairn Financial Advisers LLP
(Nominated Adviser)
Liam Murray / Tony Rawlinson
Tel: +44 (0)20 7148 7900
N+1 Singer
(Broker)
Aubrey Powell / Jen Boorer
Tel: +44 (0)20 7496 3000
MacDougall Biomedical Communications
(US media contact)
Michelle Avery
Tel: +1 781 235 3060
[email protected]
Peckwater PR
(Financial public relations, UK)
Tarquin Edwards
Tel: +44 (0)7879 458 364
[email protected]
Forward Looking Statements
Any statements in this press release about our future expectations, plans and prospects, including statements about the clinical
development of our product candidates, the timing of clinical results and expectations regarding the sufficiency of our cash balance to
fund operating expenses and capital expenditures, and other statements containing the words “anticipate,” “believe,” “continue,”
“could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar
expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995.
Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors,
including: the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future
clinical trials and the results of such trials, whether preliminary results from a clinical trial will be predictive of the final results of that
trial or whether results of early clinical trials will be indicative of the results of later clinical trials, expectations for regulatory
approvals, availability of funding sufficient for our foreseeable and unforeseeable operating expenses and capital expenditure
requirements and other factors discussed in the “Risk Factors” section of filings that we make with the Securities and Exchange
Commission. In addition, any forward-looking statements included in this press release represent our views only as of the date of this
release and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to
update any forward-looking statements included in this press release.