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DURECT Corporation Q1 2010 Earnings Call Transcript

For REMOXY, we continue to support King's progress towards resubmission of the NDA in the fourth quarter this year. ELADUR started a large Phase II study in chronic lower back pain, and we continued activity in the licensing front with multiple programs.

Let us now go through our major programs in a little more detail.

Starting with REMOXY. REMOXY is a 12-hour extended release and tamper-resistant form of oxycodone. Our ORADUR technology is resistant to snorting, smoking, injecting, high-heat exposure, and dissolving in drinks. Regulatory history on this product shows us that the NDA was submitted in June of 2008 and it was granted priority review. However, a Complete Response letter was received in December of 2008. King then assumed control of the NDA from Pain Therapeutics in March last year and King met with the FDA in July of 2009, and they stated after that meeting that they had established a path to address the FDA's comments. King expects to resubmit the NDA in the fourth quarter of this year, with an expected PDUFA date six months after re-submission.

If you look at the potential financial impact of REMOXY to DURECT, it is significant. The oxycodone sales in 2009 were $3.2 billion, and DURECT will receive a royalty on King sales that start at 6% and go to 11.5%, with the 11.5% being close to about $1 billion. So, we take and make some assumptions – we assume that the REMOXY annual sales are somewhat in the range of $500 million to $900 million. That would represent about 16% to 28% market penetration. DURECT would yield royalties that would range between $36 million and $72 million. That will make a big difference to a company that has an average burn rate over the last five years of $14 million.

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