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DURECT Announces Launch of First FDA Approved SABER™-Injectable Peptide Product
Date:2/8/2011

CUPERTINO, Calif., Feb. 8, 2011 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today reported that its collaborator, CreoSalus, Inc., has launched commercial sales of its Food and Drug Administration (FDA) approved product known as SucroMate™ Equine, an injectable animal health drug utilizing DURECT's SABER™ technology to deliver the peptide deslorelin.  DURECT will receive a royalty on net sales of SucroMate and will supply one of the key excipients in SucroMate.  Although this product represents a modest revenue opportunity for DURECT by itself, the SABER technology is the basis for our POSIDUR program currently in a pivotal Phase III clinical trial as well as multiple on-going feasibility projects seeking to deliver proteins and peptides for periods of up to one month from a single injection.

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"This is the launch of the first FDA approved SABER-Injectable product and as such it represents a regulatory milestone for DURECT because of the similarities between New Drug Application (NDA) and New Animal Drug Application (NADA) Chemistry, Manufacturing and Controls (CMC) section requirements," stated James E. Brown, DVM, President and CEO.  

SucroMate Equine regulates ovulation in mares through a single injection of deslorelin, increasing the likelihood of conception during breeding for both naturally bred and artificially inseminated horses.  CreoSalus has signed a U.S. distribution agreement for SucroMate Equine with Bioniche Life Sciences.  

About SABER™ Technology

The SABER system is a patented controlled-release technology that can be formulated for systemic or local administration of active agents.  DURECT believes that its SABER system can provide the basis for the
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SOURCE DURECT Corporation
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