AbbVie gets an EU green light for its next-gen hep C treatment

AbbVie ($ABBV) is one step closer to challenging Gilead Sciences' ($GILD) dominance in the hepatitis C market, securing a likely European approval for its rival combo treatment as it awaits a U.S. nod.

The European Medicines Agency has recommended approval for AbbVie's three-agent combination, which, like Gilead's competing Harvoni, uses a cocktail of antivirals to halt viral replication and cure more than 90% of hep C patients. The EMA generally approves medicines about three months after such a recommendation, putting AbbVie on track for an early 2015 launch in Europe.

Once approved, AbbVie's drug would be marketed in two parts: once-a-day Viekirax, which combines the NS5A inhibitor ombitasvir with a fixed-dose combo of paritaprevir and ritonavir that blocks NS3/4A; and twice-daily Exviera, which targets NSB5. Each targeted protein is essential to the spread of hep C, and, in pivotal trials on thousands of patients, AbbVie's multi-pill combination has eradicated the virus in patients with all genotypes without the need for painful interferon injections.

Gilead's Sovaldi

In the U.S., AbbVie expects a final FDA decision on its combination by mid December, and the company plans to mount a commercial launch by year's end. That'll put it head to head with Gilead and Harvoni, an all-oral combination of the blockbuster Sovaldi and ‚Äčthe NS5A inhibitor ledipasvir that won stateside approval last month. Gilead's single-pill treatment picked up EU clearance just this week, putting it in line for global sales of up to $10 billion a year, analysts say.

Peak sales estimates for AbbVie's entry hover around $3 billion a year, but the prospect of a price war could well shift the balance of power. Harvoni carries a sticker price of $94,500 for a 12-week regimen, giving AbbVie the chance to chip away at Gilead's market share by undercutting that figure. The company has thus far stayed silent on price, and analysts are divided on whether the company will or should price Viekirax and Exviera at a discount.

Enanta Pharmaceuticals ($ENTA), a Massachusetts biotech, co-developed the cocktail alongside AbbVie and, under a 2006 deal between the two, is guaranteed double-digit royalties on all sales of the combo.

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