Durect to supply two excipients to King Pharma for Remoxy manufacturing
Durect Corporation has signed an exclusive long term excipient supply agreement with respect to Remoxy with King Pharmaceuticals, Inc. This agreement stipulates the terms and conditions under which Durect will supply to King, based on Durect's manufacturing cost plus a specified percentage mark-up, two key excipients used in the manufacture of Remoxy.
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 mid-2008, an NDA for Remoxy was accepted by the FDA and was granted Priority Review. In December 2008, the FDA issued a Complete Response Letter related to Remoxy. In July 2009, King Pharmaceuticals met with the FDA to discuss the Complete Response Letter and King Pharmaceuticals has stated that it anticipates that the resubmission of the NDA could occur mid-year 2010.
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