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 October 2016
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 ☒ 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):
Collaboration and License Agreement
On October 4, 2016, Summit Therapeutics plc (the
Company
) announced its entry into an exclusive Collaboration and License Agreement
(the
Collaboration Agreement
) with Sarepta Therapeutics Inc. (
Sarepta
), pursuant to which the Company granted Sarepta the exclusive right to commercialize products in the Companys utrophin modulator
pipeline in the European Union, Switzerland, Norway, Iceland, Turkey and the Commonwealth of Independent States (the
Licensed Territory
). Such products include the Companys lead product candidate, ezutromid, for the
treatment of Duchenne muscular dystrophy (
DMD
) and its second generation and future generation small molecule utrophin modulators (collectively, the
Licensed Products
). The Company also granted Sarepta an option
to expand the Licensed Territory to include Latin America. The Company retains commercialization rights in the rest of the world.
Financial
. Under
the terms of the Collaboration Agreement, the Company is entitled to receive an upfront payment of $40.0 million from Sarepta within 10 days of entry into the Collaboration Agreement. In addition, the Company will be eligible to receive up to $42.0
million from Sarepta in specified development milestones for ezutromid, including a $22.0 million milestone, payable on or after April 1, 2017, following the first dosing of the last patient in the Companys ongoing Phase 2 clinical trial
of ezutromid, which is referred to as PhaseOut DMD, and up to $150.0 million from Sarepta in specified regulatory milestones related to ezutromid in the Licensed Territory. The Company will also be eligible to receive up to $65.0 million in
specified development milestones and up to $225.0 million in specified regulatory milestones from Sarepta for its second generation and future generation small molecule utrophin modulators in the Licensed Territory. In addition, the Company will
also be eligible to receive up to $330.0 million from Sarepta in specified sales milestones on a product-by-product basis, as well as tiered, escalating royalties ranging from a low to high teens percentage of net sales on a product-by-product basis
in the Licensed Territory. The royalties are subject to potential reductions, including for a specified portion of royalty payments that Sarepta may become required to pay under any third-party license agreements, subject to a maximum royalty
reduction.
Research and Development
. Under the Collaboration Agreement, the Company and Sarepta have agreed to collaborate on the research and
development of the Licensed Products pursuant to a joint development plan through a joint steering committee comprised of an equal number of representatives from each of the Company and Sarepta. Sarepta has the final decision making authority with
respect to commercialization decisions of the Licensed Products in the Licensed Territory. If the joint steering committee elects not to pursue development of a second generation (or future generation) small molecule utrophin modulator candidate,
then the Company may engage, under certain circumstances, in the development of such candidate for commercialization outside of the Licensed Territory and outside of the Collaboration Agreement, subject to Sareptas option, exercisable at
Sareptas discretion and only available to Sarepta under certain specified circumstances, to bring such candidate under the Collaboration Agreement.
Under the Collaboration Agreement, the Company will be solely responsible for all research and development costs for the Licensed Products until
December 31, 2017. Thereafter, the Company will be responsible for 55.0% of the budgeted research and development costs related to the Licensed Products in the Licensed Territory, and Sarepta will be responsible for 45.0% of such costs. Any
costs in excess of 110.0% of the budgeted amount are borne by the party that incurred such costs. The Company is also obligated to spend a specified minimum amount on the research and development of certain Licensed Products prior to the end of
2019.
Manufacture and Supply of Licensed Products
. The Company has agreed to use commercially reasonable efforts
to supply to Sarepta active pharmaceutical ingredient, finished drug product and placebo for Sarepta to conduct research, development and commercialization activities for the Licensed Products in accordance with the Collaboration Agreement. Sarepta
also will have the right to establish back up and second source suppliers under certain circumstances.
Intellectual Property
. Under the terms of
the Collaboration Agreement, each party will own the entire right, title and interest in and to all know-how and patent rights first made or invented solely by the employees or consultants of such party in the course of the collaboration, and all
such know-how and patent rights will be included in the licenses granted to the other party under the Collaboration Agreement. The parties will jointly own all rights, title and interests in and to all know-how and patent rights first made or
invented jointly by employees or consultants of the parties in the course of the collaboration.
Latin America Option
. Under the Collaboration
Agreement, Sarepta has an exclusive option (the
Latin America Option
) to expand the Licensed Territory to include specified countries in South and Central America (the
Option Territory
). Sarepta may exercise the
Latin America Option at any time prior to the date that is three months following the first receipt of regulatory approval for a Licensed Product in the United States or the European Union. Sarepta is required to pay the Company up to an aggregate
of $17.0 million for the exercise of the Latin America Option and the achievement of certain regulatory milestones. If Sarepta exercises the Latin America Option, it will be solely responsible for all research, development and commercialization
costs of the Licensed Products that are specific to the Option Territory. The Company will also be eligible to receive up to $82.5 million in specified sales milestones on a product-by-product basis in the Option Territory, as well as royalties at
the same rates as elsewhere in the Licensed Territory.
Commercialization
. Under the Collaboration Agreement, Sarepta will be solely responsible
for all commercialization activities and associated costs, relating to Licensed Products in the Licensed Territories. Sarepta has agreed to use commercially reasonable efforts to commercialize Licensed Products in specified countries within the
Licensed Territories and, if the Latin America Option is exercised, to use commercially reasonable efforts to commercialize Licensed Products in certain specified countries within the Option Territory.
Termination
. Unless earlier terminated, the Collaboration Agreement will expire on a Licensed Product-by-Licensed Product and country-by-country basis
upon the expiration of the royalty term in such country for such Licensed Product. The Collaboration Agreement may be terminated by Sarepta upon six months prior written notice in its entirety or on a Licensed Product-by-Licensed Product and
country-by-country basis. Either party may, subject to a cure period, terminate the Collaboration Agreement in the event of the other partys uncured material breach. Sarepta may also terminate the Collaboration Agreement under specified
circumstances relating to the safety or regulatory approvability of ezutromid. Except with respect to a second generation (or future generation) small molecule utrophin modulator candidate that the joint steering committee elects not to pursue, as
described above, during the term of the Collaboration Agreement the parties are prohibited from commercializing small molecule utrophin modulators anywhere in the world outside of the collaboration. Such exclusivity commitment may survive for one
year following termination with respect to one party depending upon the circumstances of termination.
Standstill
. The Collaboration
Agreement also contains a standstill provision pursuant to which, among other things, each party has agreed that, for a period from the execution of the Collaboration Agreement until the date that regulatory approval is first received for a Licensed
Product, subject to certain exceptions, or unless invited in writing by the other party to do so, neither party nor its respective affiliates will, directly or indirectly: (i) effect or seek, offer or propose to effect, or cause or participate
in any acquisition of securities or assets of the other party; any tender or exchange offer, merger, consolidation or other business combination involving the other party; any recapitalization, restructuring, liquidation, dissolution or other
extraordinary transaction with respect to the other party; or any solicitation of proxies or consents to vote any voting securities of the other party, or in any way advise or, assist any other person in doing so;
(ii) form, join or in any way participate in a group with respect to any securities of the other party; (iii) act in concert with any person in relation to voting securities of the other party; (iv) otherwise act to seek
to control or influence the management, board of directors or policies of the other party; (v) take any action reasonably expected to force the other party to make a public announcement regarding any such matters; or (iv) enter into any
agreements, discussions or arrangements with any third party with respect to any of the foregoing.
The foregoing description of certain terms of the Collaboration Agreement does not purport to be complete and is
qualified in its entirety by reference to the Collaboration Agreement that the Company intends to file as an exhibit to its annual report on Form 20-F for the period ending January 31, 2017. The press release announcing the Collaboration
Agreement is attached hereto as Exhibit 99.1.
Cash Guidance
The Company believes that its existing cash and cash equivalents, and the receipt of a $40.0 million upfront payment in connection with its entry into the
Collaboration Agreement and an anticipated $22.0 million payment for a near-term regulatory milestone under the Collaboration Agreement, will be sufficient to enable the Company to fund its operating expenses and capital expenditure requirements
through December 31, 2018.
Forward-looking Statements
Any statements in this press release about the Companys future expectations, plans and prospects, including but not limited to, statements about the
potential benefits and future operation of the collaboration with Sarepta, including any potential future payments thereunder, clinical and preclinical development of the Companys product candidates, the therapeutic potential of the
Companys product candidates, the sufficiency of the Companys cash resources, and the timing of initiation, completion and availability of data from clinical trials, 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, availability of funding sufficient for the Companys 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 Companys Annual Report on Form 20-F for the fiscal year ended January 31, 2016. 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 Companys views only as of the date of this release and should not be relied upon as representing the
Companys views as of any subsequent date. The Company specifically disclaims any obligation to update any forward-looking statements included in this Report on Form 6-K.
The information in this Report on Form 6-K, including Exhibit 99.1, 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.
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
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Date: October 4, 2016
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 October 4, 2016
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