Summit Announces Signing of Revenue Sharing Agreement With the Wellcome Trust for CDI Antibiotic Ridinilazole

OXFORD, United Kingdom, Nov. 06, 2017 (GLOBE NEWSWIRE) -- 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 it has entered into an equity and revenue sharing agreement (the ‘Revenue Share Agreement’) with the Wellcome Trust, covering potential future revenues generated by ridinilazole, its highly selective, novel-class antibiotic for the treatment of CDI.

The Revenue Share Agreement is a follow-on to the October 2012 Translational Award Funding Agreement with the Wellcome Trust (‘TA Agreement’), which provided funding for the now concluded Phase 1 and Phase 2 clinical trials for ridinilazole. The commercial terms in the Revenue Share Agreement summarised below replace those detailed in the TA Agreement. Ridinilazole is currently being prepared to enter Phase 3 clinical trials in the first half of 2018.

“The Wellcome Trust has played a crucial role in supporting the development of our CDI programme, having provided funding to advance ridinilazole from the early stages of discovery through to generating clinical proof of concept in patients with CDI,” commented Dr. David Roblin, Chief Operating Officer and Medical Officer at Summit. “We believe ridinilazole is a precision antibiotic that has the potential to become a front-line therapy for CDI and to deliver real patient benefit. We look forward to commencing our Phase 3 clinical programme in the first half of 2018.”

Under the Revenue Share Agreement, the Wellcome Trust is eligible to receive the following payments if commercialisation of ridinilazole is undertaken by a third-party:

• A mid-single digit percentage share of net revenues received by Summit from sales by the third party.
• A one-time first commercial sale milestone payment of a low single digit percentage of any cumulative pre-commercial payments received by Summit from third party licensees (excluding development funding or grant funding received from the US Government Agency, BARDA, or other third parties, including licensees).
• A one-time milestone payment of a specified amount if cumulative net revenues exceed a specified amount.

If Summit undertakes the commercialisation of ridinilazole, Wellcome Trust is eligible to receive:

• A low-single digit percentage share of net revenues.
• A one-time milestone payment of a specified amount if cumulative net revenues exceed a specified amount.

In addition, under the Revenue Share Agreement, the Wellcome Trust agreed to terminate all of its rights under the TA Agreement to develop or commercialise ridinilazole or the associated intellectual property in the event that Summit was not developing or commercialising ridinilazole.

Separately, the TA Agreement has been novated from Summit Therapeutics plc to its wholly owned subsidiary company, Summit (Oxford) Limited.  The Revenue Sharing Agreement will, unless earlier terminated, expire upon the later of:  the expiration of the last patent or patent application covering ridinilazole; the expiration of any agreement or payment obligations entered into by the Company with a third party relating to the commercialisation of ridinilazole; and the expiration of any payment obligations owed to the Wellcome Trust relating to the commercialisation of ridinilazole.

A Form 6-K has been filed with the US Securities and Exchange Commission (‘SEC’) that contains additional information about the terms of the Revenue Share Agreement with the Wellcome Trust. A copy of this Form 6-K is 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.

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).

Summit Forward-looking Statements
Any statements in this press release about the Company’s future expectations, plans and prospects, including but not limited to, statements about the future operation of the Revenue Sharing Agreement, including any potential future payments thereunder, clinical and preclinical development of the Company’s product candidates, the therapeutic potential of the Company’s product candidates, the sufficiency of the Company’s cash resources, the timing of initiation, completion and availability of data from clinical trials, the potential submission of applications for marketing approvals and other statements containing the words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "would," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials or preclinical studies will be indicative of the results of later clinical trials, expectations for regulatory approvals, laws and regulations affecting government contracts, availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the "Risk Factors" section of filings that the Company makes with the Securities and Exchange Commission, including the Company’s Annual Report on Form 20-F for the fiscal year ended 31 January 2017. Accordingly, readers should not place undue reliance on forward-looking statements or information. In addition, any forward-looking statements included in this press release represent the Company’s views only as of the date of this release and should not be relied upon as representing the Company’s views as of any subsequent date. The Company specifically disclaims any obligation to update any forward-looking statements included in this press release.

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