Sarepta Therapeutics Agrees to Sale of Priority Review Voucher for $125M
February 21 2017 - 7:00AM
Business Wire
-- Sale of PRV Provides a Significant Infusion
of Non-Dilutive Capital --
Sarepta Therapeutics, Inc. (NASDAQ:SRPT), a
commercial-stage developer of innovative RNA-targeted therapeutics,
today announced it has entered into an agreement to sell its Rare
Pediatric Disease Priority Review Voucher (PRV). Sarepta received
the PRV when EXONDYS 51TM was approved by the U.S. Food and Drug
Administration (FDA) for the treatment of patients with Duchenne
muscular dystrophy amenable to exon 51 skipping.
The voucher was awarded by the FDA under a provision that
encourages development of new drugs and biologics for the
prevention and treatment of rare pediatric diseases. With the
passage of the 21st Century Cures Act, this PRV program has been
extended through September 30, 2020.
As part of the agreement, Sarepta will receive an upfront
payment of $125M upon the closing of the transaction, which is
subject to customary closing conditions and is expected to occur
following expiration of the applicable U.S. antitrust clearance
requirements. Credit Suisse served as Sarepta’s advisor on this
transaction and conducted an extensive sales process, which
included outreach to multiple pharmaceutical and biotech
companies.
“Our mission at Sarepta Therapeutics is to treat more boys with
Duchenne muscular dystrophy,” said Edward Kaye, Sarepta’s chief
executive officer. “The sale of the PRV provides an important
source of non-dilutive capital to support the rapid advancement of
our follow on exon skipping candidates and next generation RNA
targeted antisense platform.”
About Sarepta TherapeuticsSarepta 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. For more information, please
visit us at www.sarepta.com.
About the Rare Pediatric Disease Priority Review Voucher
ProgramThe program is intended to encourage development of new
drug and biological products for prevention and treatment of
certain rare pediatric diseases. A PRV may be issued to the sponsor
of a rare pediatric disease product application and would entitle
the holder to priority review of a single New Drug Application or
Biologics License Application, which reduces the target review time
and could lead to an expedited approval. The sponsor receives the
PRV upon approval of the rare pediatric disease product application
and it can be sold without limitation, subject to applicable FDA
requirements for filing and use.
Forward-Looking StatementsThis press release contains
forward-looking statements for purposes of the Private Securities
Litigation Reform Act of 1995 (the “Act”) and the protection of the
Act’s Safe Harbor for forward-looking statements. Examples of such
statements include, but are not limited to, statements relating to
Sarepta’s commercialization and development activities, including
the potential for success and timing for the progression of
Sarepta’s drug candidates; current regulatory requirements for
approval of the purchase transaction and the viability of the
priority review voucher sold; and Sarepta’s capital needs. Such
statements are based on management’s current expectations, but
actual results may differ materially due to various risks and
uncertainties, including, whether regulatory requirements may
change that affect the timing for payment and risk of payment under
the royalty agreement with the pharmaceutical company purchaser.
For further information regarding these and other risks related to
Sarepta’s business, investors should consult Sarepta’s most recent
Quarterly Report on Form 10-Q filing with the Securities and
Exchange Commission. Forward-looking statements are not guarantees
of future performance, and Sarepta’s actual results of operations,
financial condition and liquidity, and the development of the
industry in which it operates, may differ materially from the
forward-looking statements contained in this press release. Sarepta
assumes no obligation to update its forward-looking statements
whether as a result of new information, future events or otherwise,
after the date of this press release.
Internet Posting of InformationWe routinely post
information that may be important to investors in the 'For
Investors' section of our website at www.sarepta.com. We
encourage investors and potential investors to consult our website
regularly for important information about us.
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version on businesswire.com: http://www.businesswire.com/news/home/20170221005678/en/
Media and Investors:Sarepta Therapeutics, Inc.Ian Estepan,
617-274-4052iestepan@sarepta.comorW2O GroupBrian Reid,
212-257-6725breid@w2ogroup.com
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