Shares of Pain Therapeutics shot up 23% this morning after the biotech outlined Pfizer's plans to complete the work needed to resubmit the tamper-proof pain med Remoxy to the FDA. The pharma giant ($PFE) also handed back three assets to Pain, which is pondering whether it will keep the rights to abuse-resistant formulations of hydrocodone, hydromorphone and oxymorphone or try to license them back out.
A cloud has been hanging over Remoxy ever since the FDA rejected the therapy--for the second time--back in 2011, causing Pain's stock ($PTIE) to tumble from heights it's never approached since. Back in the summer, Pfizer, which has undergone a massive R&D restructuring, helped soothe some of Pain's concerns when it elected to move ahead on a Phase I study.
The progress also helped bolster Durect ($DRRX), which had supplied some of the technology used. Its shares were up 11% in premarket trading.
Remoxy is an extended-release version of oxycodone altered to leave a bad taste if chewed, as well as just make it harder to chew. Researchers felt that the makeover would reduce the potential for abuse. And Pfizer agreed, inspired to pay $3.6 billion for King Pharmaceuticals back in 2010, when Jeff Kindler ran the pharma giant, even though Remoxy had already been rejected in 2008. The new regime at Pfizer, though, took its time in considering whether it would mount yet another campaign for approval.
"We … were informed that, following guidance received from the U.S. Food and Drug Administration earlier this year, Pfizer will proceed with the additional clinical studies and other actions required to address the Complete Response Letter received in June 2011," reported Pain. "These new clinical studies will include, in part, a pivotal bioequivalence study with the modified Remoxy formulation to bridge to the clinical data related to the original Remoxy formulation, and an abuse-potential study with the modified formulation."
That won't be easy, though. A complete response isn't expected until mid-2015, a full 7 years after the first FDA rejection for King and Pain. If the FDA ever gets around to approving Remoxy, which Pfizer obtained in its deal to acquire King Pharmaceuticals, the biotech will get a $15 million milestone and a 20% royalty stream on the net sales.
- here's the release