Zogenix ($ZGNX) is selling off its extended-release painkiller franchise Zohydro to New Jersey's Pernix Therapeutics ($PTX) for $100 million and up to $283.5 million in milestones based on sales. At one point, Zogenix looked at Zohydro as its flagship, but now it appears the company is backing away from pain management altogether.
The FDA approved a tamper-resistant reformulation of Zohydro just a month ago. The extended-release opioid agonist makes use of Zogenix's BeadTek formulation, which is designed to make it more difficult for potential abusers to crush and snort the drug. Instead it forms a viscous gel.
Zohydro originally faced its share of critics as an all-hydrocodone painkiller likely to be abused, leading the company to reformulate with BeadTek. But it turned out the FDA approval didn't allow abuse deterrence as a selling point on the label, making it difficult for the San Diego company to silence its critics until it submitted further data supporting the painkiller's effectiveness, which it had planned to do by the second half of this year.
Now, though, Zohydro is off to Pernix, which will continue to offer the normal extended-release products in the line, as well as the abuse-deterrent option. Pernix said in a statement that it would assume regulatory and financial responsibility for the ongoing efforts to reform the label to include abuse-deterrence claims.
"Zohydro ER is an ideal strategic fit for Pernix, having tremendous synergy with our existing CNS franchise," Pernix CEO Doug Drysdale said in a statement. Pernix plans to hire 100 sales representatives to push Zohydro forward, as well as its insomnia treatment Silenor, the two working in conjunction for patients with pain and sleep issues.
"The submission and recent approval of the supplemental New Drug Application (sNDA) for Zohydro ER with BeadTek was an important catalyst for increasing strategic interest in the brand," Zogenix CEO Roger Hawley said. "We are very pleased to have selected Pernix for this transaction as we believe they are well positioned to continue raising awareness of the important clinical benefits of Zohydro ER for patients suffering with severe chronic pain who are in need of around-the-clock opioid therapy."
- here's the Zogenix release
- and the release from Pernix