It has entered into an agreement to sell the Rare Paediatric Disease PRV it received when EXONDYS 51TM was approved by the US Food and Drug Administration (FDA) for the treatment of patients with Duchenne muscular dystrophy amenable to exon 51 skipping.
The PRV program is intended to encourage development of new drug and biological products for prevention and treatment of certain rare paediatric diseases. A PRV entitles the holder to a 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.
Sarepta will receive an advance payment of US$125mln upon the closing of the transaction, which is subject to customary closing conditions and is expected to occur following expiration of the applicable US antitrust clearance requirements.
“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,” he added.
Sarepta shares were up 2.6% at US$29 in pre-market trading.
Story by ProactiveInvestors