Bristol-Myers gets the approval Gilead didn't want: Daklinza + Sovaldi for hep C

Want a window into the future of hepatitis C drug marketing? Keep an eye on Europe. Bristol-Myers Squibb bagged European approval for its hepatitis C fighter Daklinza (daclatasvir) Wednesday, setting the company up for head-to-head competition with Gilead Sciences' upcoming combo drug.

The EU nod covers Daklinza treatment in tandem with Gilead's Sovaldi (sofosbuvir), the heavyweight first entry in a new class of hep C drugs. If you haven't been on sabbatical, you know Sovaldi raged ahead to blockbuster status within one quarter on the market. You also know that Gilead ($GILD) is developing a Sovaldi combo pill, using its own ledipasvir as the companion ingredient--and that Gilead refused to team up with Bristol-Myers ($BMY) to study the Sovaldi-Daklinza combo, despite some eye-popping Phase II data.

Bristol-Myers is running those trials solo. For now, it can say the following in its E.U. approval press release: The Daklinza-Sovaldi cocktail is an "all-oral, once daily regimen that yields cure rates of up to 100%." Plus, it "offers a potential cure" for a broad range of hep C patients, including some hard-to-treat groups, including patients who've failed on previous therapies.

But the FDA didn't allow the company to turn in that Sovaldi-Daklinza data with its current app. That first approval would be for Daklinza and another BMS drug, Sunvepra (asunaprevir)--and that combo hasn't performed quite as well as the Daklinza-Sovaldi team in trials.

After Gilead spurned Bristol-Myers' offer to put Sovaldi alongside Daklinza in Phase III trials, the speculation was that doctors might prescribe the combo off-label. Right now, that prospect looks iffy. Payers are already setting up obstacles to expensive hep C treatments. Off-label use? Patients and doctors would have to jump through many hoops to get there, and physicians are already daunted by the work required to get FDA-approved regimens reimbursed, a recent Decision Resources survey found.

Decision Resources also ID'd which new combo docs are more likely to start with. And what about the potential for price competition? Read more in FiercePharmaMarketing >>