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

Gilead's Sovaldi--Courtesy of Gilead

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. And now, it can say the following in its EU 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, such as patients who've failed on previous therapies.

Like Sovaldi, Daklinza can squeeze out interferon-based treatment cocktails when combined with other oral meds. That's the promise of this new class: regimens that leave the difficult-to-tolerate interferon out. Right now, Sovaldi is the sole "nuc" in the U.S., but AbbVie ($ABBV) and Merck ($MRK) are looking for FDA approval for their own therapies.

And here's where it gets more interesting. We know Gilead will be leaning on its Sovaldi + ledipasvir pill, which is up for FDA approval by Oct. 10. AbbVie's three-drug option is under FDA review for a December decision. Bristol-Myers might want to tout the Daklinza + Sovaldi option when (and if) its FDA nod comes through in November.

But the FDA didn't allow the company to turn in that Sovaldi-Daklinza data with its current app. The 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. Sustained virological response--a common measure in hep C trials--for the latter duo approached 100% in some patients, as Bristol-Myers noted in its EU announcement.

For the Daklinza-Sunvepra team, a recent trial showed response rates of up to 90%. That's way impressive--and gives the duo plenty of opportunity to score sales, as blockbuster analyst projections show. Company execs say the combo has been doing well in Japan, where it won approval in July. Plus, both of those drugs belong to Bristol-Myers, so the company would be collecting sales from two products, rather than one with the other combo. But what might Daklinza do with Sovaldi in the U.S.?

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, once the BMS drug won FDA approval. 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.

The market research firm also found that the hep C-treating specialists surveyed were more likely to know about Gilead's forthcoming combo pill than about Bristol-Myers and AbbVie's options. Half of those docs expect to prescribe Gilead's combination therapy within 6 months after approval and expect the combination of Sovaldi and Johnson & Johnson's ($JNJ) protease inhibitor Olysio to hold its own. Sounds like Bristol-Myers and AbbVie's sales-and-marketing teams have their jobs cut out for them.

But here's the kicker: "[N]ear-term competitors that offer favorable pricing ... will likely be a constraint on the uptake of [Gilead's] regimen," Decision Resources said. Which means that rivals that undercut Gilead's price might move ahead in the prescribing queue. AbbVie has said it's not interested in a price war. Maybe Bristol-Myers will be the one to step up.

- read the Bristol-Myers release
- see the Decision Resources announcement