Sarepta Therapeutics Agrees to Sale of Priority Review Voucher for $125M
02/21/17 7:00 AM EST
-- Sale of PRV Provides a Significant Infusion of
The voucher was awarded by the
As part of the agreement, Sarepta will receive an upfront payment of
“Our mission at
About Sarepta Therapeutics
About the Rare Pediatric Disease Priority Review Voucher Program
The 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
This 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
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Media and Investors:
Sarepta Therapeutics, Inc.
Ian Estepan, 617-274-4052
Brian Reid, 212-257-6725
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