Sarepta Therapeutics (NASDAQ:SRPT) and Summit Therapeutics plc
(NASDAQ:SMMT) (AIM:SUMM) today announced that they have entered
into an exclusive license and collaboration agreement granting
Sarepta rights in Europe, as well as in Turkey and the Commonwealth
of Independent States (‘the licensed territory’), to Summit’s
utrophin modulator pipeline, including its lead clinical candidate,
ezutromid, for the treatment of Duchenne muscular dystrophy
(‘DMD’). As part of the agreement, Sarepta also obtains an option
to license Latin American rights to Summit’s utrophin modulator
pipeline. Summit retains commercialization rights in all other
countries.
Utrophin modulation is a potential
disease-modifying treatment for all patients with the fatal muscle
wasting disease DMD, regardless of their underlying dystrophin gene
mutation. Ezutromid is currently in a Phase 2 proof of concept
trial called PhaseOut DMD.
"This partnership with Summit Therapeutics
furthers our commitment to invest in innovative approaches to
treating Duchenne and supports our common goal of improving the
lives of patients with DMD," said Edward Kaye, M.D., Sarepta’s
Chief Executive Officer. "Summit’s utrophin modulation technology
represents a potentially promising approach to treat DMD, which may
complement our current approach of exon skipping therapy.”
“Sarepta Therapeutics has paved the way in the
development of disease-modifying therapies for DMD with the first
FDA-approved drug in this disease area, making them a strong
strategic partner to support our utrophin modulator pipeline,”
commented Glyn Edwards, Chief Executive Officer of Summit. “This
agreement provides us with access to Sarepta’s development,
regulatory and commercialisation expertise for the continued
advancement of our promising utrophin modulator pipeline. We look
forward to this partnership and working together to bring great
advances to patients and families living with DMD.”
Under the terms of the agreement, Summit will
receive an upfront fee of $40 million. In addition, Summit will be
eligible for future ezutromid related development, regulatory and
sales milestone payments totalling up to $522 million, including a
$22 million milestone upon the first dosing of the last patient in
Summit’s PhaseOut DMD trial, and escalating royalties ranging from
a low to high teens percentage of net sales in the licensed
territory. Summit will also be eligible to receive development and
regulatory milestones related to its next-generation utrophin
modulators. Sarepta and Summit will share specified utrophin
modulator-related research and development costs at a 45%/55%
split, respectively, beginning in 2018. If Sarepta elects to
exercise its option for Latin American rights, Summit would be
entitled to additional fees, milestones and royalties.
Sarepta and Summit will host an update call for
the Duchenne community on Monday, October 10 at 12:00pm EDT.
Details of the call can be accessed by visiting
http://www.parentprojectmd.org/communitycall.
About Utrophin Modulation in
DMD DMD is a progressive muscle wasting disease that 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 a meaningful, positive effect
on muscle performance. Summit believes that utrophin modulation has
the potential to treat all patients with DMD, regardless of the
underlying dystrophin gene mutation. Summit also believes that
utrophin modulation could potentially be complementary to other
therapeutic approaches for DMD. The Company’s lead utrophin
modulator, ezutromid, is an orally administered, small molecule.
DMD is an orphan disease, and the US Food and Drug Administration
(‘FDA’) and the European Medicines Agency have granted orphan drug
status to ezutromid. Orphan drugs receive a number of benefits
including additional regulatory support and a period of market
exclusivity following approval. In addition, ezutromid has been
granted Fast Track designation and Rare Pediatric Disease
designation by the FDA.
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).
About Sarepta Sarepta
Therapeutics is a commercial-stage biopharmaceutical company
focused on the discovery and development of unique RNA-targeted
therapeutics for the treatment of rare neuromuscular diseases. The
Company is primarily focused on rapidly advancing the development
of its potentially disease-modifying DMD drug candidates, including
EXONDYS 51, designed to skip exon 51 and approved under the
accelerated approval pathway. For more information, please visit us
at www.sarepta.com.
Contacts
For Sarepta Therapeutics:
SareptaIan Estepan |
Tel:
617-274-4052 iestepan@sarepta.com |
W2O GroupBrian Reid |
Tel:
212-257-6725breid@w2ogroup.com |
For Summit:
Summit Glyn Edwards / Richard Pye
(UK office)Erik Ostrowski / Michelle Avery (US office) |
Tel: +44 (0)1235 443 951 +1 617 225 4455 |
Cairn Financial Advisers LLP(Nominated
Adviser)Liam Murray / Tony Rawlinson |
Tel: +44 (0)20 77148 7900 |
N+1 Singer (Broker)Aubrey Powell / Jen
Boorer |
Tel: +44 (0)20 7496 3000 |
MacDougall Biomedical Communications(US media
contact)Chris Erdman / Karen Sharma |
Tel: +1
781 235 3060cerdman@macbiocom.comksharma@macbiocom.com
|
Consilium
Strategic Communications (Financial public relations,
UK)Mary-Jane Elliott / Sue Stuart / Jessica Hodgson / Lindsey
Neville |
Tel: +44 (0)20 3709 5700
Summit@consilium-comms.com |
|
|
Sarepta Forward-looking StatementsThis press
release contains statements that are forward-looking. Any
statements contained in this press release that are not statements
of historical fact may be deemed to be forward-looking statements.
Words such as "believes," "anticipates," "plans," "expects,"
"will," "intends," "potential," "possible" and similar expressions
are intended to identify forward-looking statements. These
forward-looking statements include statements about the terms of
the license and collaboration agreement Sarepta has entered into
with Summit (Oxford) LTD, including the rights, obligations and
benefits of each party under the agreement such as Sarepta’s
commercialization rights for certain product candidates in
specified territories and Sarepta’s payments associated with those
rights to Summit; the potential of ezutromid and utrophin
modulation as a disease-modifying treatment for all patients with
DMD regardless of their dystrophin gene mutation; the potential
benefits to the parties and the DMD community resulting from the
agreement; the partnership between the parties furthering their
common goal of improving the lives of patients with DMD; the
potential of utrophin modulation technology to complement Sarepta’s
current approach of exon skipping therapy; Summit’s plans to access
Sarepta’s expertise for the continued advancement of their
promising utrophin modulator pipeline and working together to bring
great advances to patients and families living with DMD.
These forward-looking statements involve risks
and uncertainties, many of which are beyond Sarepta's control.
Known risk factors include, among others: the expected benefits and
opportunities related to the license and collaboration and
agreement may not be realized or may take longer to realize than
expected due to challenges and uncertainties inherent in product
research and development; the partnership between Sarepta and
Summit may not result in any viable treatments suitable for
clinical research or commercialization due to a variety of reasons
including the results of future research may not be consistent with
past positive results or may fail to meet regulatory approval
requirements for the safety and efficacy of product candidates or
may never become commercialized products due to other various
reasons including any potential future inability of the parties to
fulfill their commitments and obligations under the agreement,
including any inability by Sarepta to fulfill its financial
commitments to Summit; and even if the agreement results in
commercialized products the parties may not achieve any significant
revenues from the sale of such products.
Any of the foregoing risks could adversely
affect Sarepta's business, results of operations and the trading
price of Sarepta's common stock. For a detailed description of
risks and uncertainties Sarepta faces, you are encouraged to review
Sarepta's 2015 Annual Report on Form 10-K and most recent Quarterly
Report on Form 10-Q for the quarter ended June 30, 2016 filed with
the Securities and Exchange Commission (SEC) as well as other SEC
filings made by Sarepta. We caution investors not to place
considerable reliance on the forward-looking statements contained
in this press release. Sarepta does not undertake any obligation to
publicly update its forward-looking statements based on events or
circumstances after the date hereof.
Summit Forward-looking Statements
Any statements in this press release about
Summit’s future expectations, plans and prospects, including but
not limited to, statements about the potential benefits and future
operation of the collaboration with Sarepta Therapeutics, including
any potential future payments thereunder, clinical and preclinical
development of Summit’s product candidates, the therapeutic
potential of Summit’s product candidates, 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 Summit’s foreseeable and unforeseeable operating
expenses and capital expenditure requirements and other factors
discussed in the "Risk Factors" section of filings that Summit
makes with the Securities and Exchange Commission including
Summit’s 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 Summit’s views only as of the date of this release and
should not be relied upon as representing Summit’s views as of any
subsequent date. Summit specifically disclaims any obligation to
update any forward-looking statements included in this press
release.
-END-
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