Yesterday, tiny drug-delivery expert DURECT
DURECT specializes in reformulating existing drugs into new or longer-lasting dosage forms. It has no compounds currently on the market, but has partnered directly or indirectly with several prominent mid-sized specialty pharmas like Endo Pharmaceuticals
DURECT's lead drug, Posidur, is an injectable longer-lasting version of a popular anesthetic used for post-surgical pain. The drug is partnered with European pharma Nycomed, with DURECT retaining U.S. rights to the compound.
In July, DURECT reported mostly positive phase 2 data for Posidur in a trial testing the drug's ability to help with pain following surgical hernia repair. The highest dose of the compound was successful on the co-primary endpoint of pain reduction and trended toward success on the other co-primary endpoint of reduction in post-surgery opioid use.
Since it was a relatively small phase 2 study, the failure on the latter primary endpoint is excusable. Posidur is set to begin phase 3 testing once a clinical trial protocol is finalized with the FDA.
The compound with the nearest-term potential to bring in recurring revenue to DURECT is its abuse-resistant opioid painkiller Remoxy, which DURECT partnered with Pain Therapeutics, and Pain Therapeutics then out-licensed to King Pharmaceuticals.
I've written here and here about Remoxy and the high likelihood that it will produce positive data in its ongoing phase 3 study. Pain and King expect to present the data from this pivotal study in the fourth quarter, with a possible marketing application filed next year.
If approved, DURECT stands to gain a solid 6% to 11.5% of cost-free royalties on all sales of Remoxy by King Pharmaceuticals. Considering the multibillion market for the drug, these royalties would be meaningful for a drugmaker the size of DURECT, and is why it is worth following.