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DURECT Says FDA Accepts NDA For REMOXY With June 23 Goal Date

DURECT Corp. (DRRX) said Thursday that the U.S. Food and Drug Administration has accepted the resubmission of the New Drug Application for REMOXY by King Pharmaceuticals, Inc. (KG) and the PDUFA goal date is June 23.

REMOXY, based on DURECT's ORADUR technology, is an investigational drug that is a unique, controlled release formulation of oxycodone for moderate-to-severe chronic pain designed to reduce potential risks of unintended use.

In December 2002, DURECT licensed to Pain Therapeutics, Inc. (PTIE) the right to develop and commercialize on a worldwide basis REMOXY and other oral sustained release drug candidates using the ORADUR technology which incorporate four specified opioid compounds.

Under the license agreement, DURECT is reimbursed for formulation and other work performed under its agreement, and will receive additional payments if certain development and regulatory milestones are achieved with respect to the licensed drug candidates.

In addition, if commercialized, DURECT will receive royalties for REMOXY and the other licensed drug candidates of between 6.0% to 11.5% of net sales of the drug candidate depending on sales volume as well as a mark-up on DURECT's supply of key excipients used in the manufacture of the licensed drug candidates.

Pain Therapeutics sublicensed the commercialization rights of REMOXY and other licensed drug candidates to King Pharmaceuticals in November 2005.

In October 2010, Pfizer Inc. (PFE) agreed to buy King Pharmaceuticals. Should that deal be completed, Pfizer would assume the development and commercialization rights and obligations to REMOXY and to the other licensed ORADUR-based opioids.

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