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At June 30, 2008, DURECT had cash and investments of $47.6 million,compared to cash and investments of $62.0 million at December 31, 2007; thesefigures include restricted investments of $1.0 million at June 30, 2008 and atDecember 31, 2007.
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"The major event for us since the end of the first quarter was the filingof the New Drug Application (NDA) for Remoxy(TM), which represents the firstNDA filing for a product candidate based on one of DURECT's platformtechnologies," stated James E. Brown, D.V.M., President and CEO of DURECT."We also continued to make progress in our dialogue with the FDA with respectto POSIDUR(TM) and, relevant to ELADUR(TM), received orphan drug designationfor bupivacaine for post-herpetic neuralgia. In addition, our balance sheethas been strengthened by the elimination of all of our $23.6 million ofconvertible debt which was exchanged into common stock per the original termsof our indenture."
Recent Highlights:
-- Remoxy and other Abuse-Resistant Opioids. In June 2008, an NDA forRemoxy (ORADUR(TM)-based oxycodone) was submitted to the U.S. Food and DrugAdministration (FDA). Pursuant to Prescription Drug User Fee Act (PDUFA)guidelines, the FDA is expected to determine whether to accept the NDA forfiling within 90 days. At that time Pain Therapeutics (the NDA sponsor) willalso learn if the NDA filing was granted priority review. A priority reviewdesignation is given to drugs that offer real advances in treatment, orprovide a treatment where no adequate therapy exists. A Priority Review meansthat the time it takes the FDA to review a NDA is reduced from 12 months toapproximately 6 months. In addition, during the second quarter of 2008 DURECTmade its first shipment of certain key components that are included in Remoxyto meet the production requirements of King Pharmaceuticals, which has rightsto commercialize Remoxy upon approval.
Remoxy, an investigational drug, is a long acting oral formulation ofoxycodone intended to treat moderate to severe pain. Based on DURECT's ORADURtechnology, which is covered by issued and pending patent applications ownedby DURECT, Remoxy is designed to resist common methods of prescription drugmisuse and abuse.
In addition to Remoxy, there are three other ORADUR-based abuse-resistantopioids covered in our collaboration with Pain Therapeutics. PainTherapeutics has previously announced positive results from a Phase I clinicaltrial for one of these drug candidates, and they have stated that they expectto file an Investigational New Drug application (IND) for a newabuse-resistant opioid in 2008.
-- POSIDUR (SABER(TM)-Bupivacaine) Post-Operative Pain Relief Depot. Wecontinue to be in dialogue with the FDA regarding the Phase III program andbelieve we are making progress in defining our plans.
POSIDUR is our post-operative pain relief depot that utilizes our patentedSABER technology to deliver bupivacaine to provide up to three days of painrelief after surgery. POSIDUR is licensed to Nycomed for commercialization inEurope and select other countries, and DURECT has retained commercializationrights in the US, Canada and Asia.
-- ELADUR (TRANSDUR(TM)-Bupivacaine). The FDA recently gran
