Depomed has big plans for the Nucynta franchise it picked up last week from Johnson & Johnson for $1.05 billion, and they start with a relaunch.
Earlier this week, once-skeptical Johnson & Johnson CEO Alex Gorsky seemed to be fully on-board pharma's slim-down bandwagon, telling presentation-watchers at the JP Morgan Healthcare Conference he was willing to jettison pieces of the J&J puzzle if they didn't present a "path to achieving leadership." Now, he's followed up with another divestment that will send U.S. rights to pain med Nucynta to California's Depomed.
The FDA says it will abide by a court ruling stating it has to grant orphan drug exclusivity to Depomed's Gralise. But the agency has drawn a line in the sand, saying it does not intend to extend the same benefit to any other drugmakers under the same circumstances.
On Tuesday, Depomed announced that it won its patent lawsuit against Actavis, which wanted to market a generic version of Depomed's shingles pain drug Gralise. Depomed's shares surged more than 13% in after-hours trading to $14.94.
Mallinckrodt scored FDA approval for its Xartemis XR oxycodone and acetaminophen tablet, known in development as MNK-795, an opioid treatment for acute pain. The approval is also a win for Depomed, which owns the controlled-release technology and collected $10 million in a milestone payment.
Mallinckrodt and Depomed welcomed the FDA's priority review acceptance of an application for the companies' new oral pain drug that makes use of Depomed's controlled-release Acuform technology.
Depomed took a 10% hit on its stock price mid-day Monday after FDA advisers turned thumbs down on their drug to ease symptoms of hot flashes in a lopsided "no" vote. By a vote of 12 to 2 the outside advisers voted against recommending an approval for Sefelsa, concluding that the company had failed to demonstrate that the drug worked as billed.
Depomed shares spiked yesterday as the company races with Hisamitsu to garner the first FDA approvals of non-hormonal drugs for tempering hot flashes, even though Depomed's drug fell short of efficacy goals in trials.
Depomed chalked up a couple of much-needed wins in its ongoing fight to protect its shingles pain drug Gralise from generic competition.
Depomed has released full data from its Phase III Breeze 3 trial of Serada, a controlled-release, oral, non-hormonal treatment for menopausal hot flashes (or hot flushes, if you are from the U.K.). This includes a new statistical analysis of the data, which the company carried out after a discussion with the FDA.