What if you had a new drug, but no one to sell it? That's the predicament faced by Depomed, whose shingles-pain drug Gralise won FDA approval Friday. The company had a licensing deal with Solvay Pharmaceuticals, but Abbott Laboratories bought the Belgian drugmaker. And just two weeks before Gralise got the regulatory nod, Abbott said it wasn't obligated to follow through on a launch.
The two companies are in mediation now, which is expected to take about eight weeks; if that doesn't resolve their differences, binding arbitration follows. Analysts tend to think Abbott is out of the picture, irrespective of how the talks pan out. And frankly, why would Depomed want Abbott to market a drug it clearly doesn't want to sell?
But there's another view. Abbott may not like the terms of the Gralise license. It may want access to Gralise's sister drug Serada, which is in late-stage development for the treatment of hot flashes. The mediation could end with a new marketing deal that's simply more favorable to Abbott than Solvay's deal was.
If Depomed does need a new partner, here are some potential selling points. Gralise's FDA-approved label specifies that the drug isn't interchangable with other gabapentin meds, which could protect it against generic rivals. Pfizer's Neurontin, for instance, is a gabapentin drug, and copycat versions are available. Then there's the fact that FDA blessed a 30-day dosage-titration pack, to relieve doctors of writing the complicated instructions on a prescription pad. So, it's easier to prescribe than it otherwise would have been.