AbbVie ($ABBV) has won European Commission approval for its oral hepatitis C cocktail, offering some positive news after some disappointments for the U.S. drugmaker in recent months. It also sets the stage for the drugmaker to take its marketing battle with Gilead Sciences ($GILD) to another continent.
The interferon-free treatment, branded as Viekira Pak in the U.S., will be branded as Viekirax + Exviera in Europe. And it is a substantial market. AbbVie said about 9 million people in Europe are infected with the disease, 60% of those with genotype 1. The treatment was approved under an accelerated process for use with or without ribavirin in patients with genotype 1 chronic HCV, including those with compensated liver cirrhosis, HIV-1 co-infection, patients on opioid substitution therapy and liver transplant recipients. Viekirax has also been approved for use with ribavirin in genotype 4 HCV, the company said. In trials its cure rate was 95% to 100%.
|AbbVie CEO Richard Gonzalez|
"The approval of AbbVie's hepatitis C treatment in the European Union, following the recent approvals in the U.S. and Canada, offers patients across Europe a new and effective treatment to cure this serious disease," AbbVie CEO Richard Gonzalez said in a statement.
The approval comes just a month after the FDA approved the treatment, which immediately led to a flurry of exclusivity deals with payers as the two battle for market share. Gilead's hep C franchise, which began with approval of Sovaldi and last year added approval for its cocktail Harvoni, has been raking in billions and billions of dollars. It was first to market and is a single daily pill regimen, giving it an advantage over AbbVie's multi-pill treatment.
To take some of the edge off that marketing advantage, AbbVie priced its combo at just over $83,000, for a 12-week course, compared with Gilead's $94,500 for a 12-week course of Harvoni, then immediately struck an exclusivity deal with benefits manager Express Scripts ($ESRX) to discount it even further to get access to the 25 million people covered under Express Scripts' national formulary. Because AbbVie's drugs are only approved for genotype 1 disease, Express Scripts will cover Gilead's meds in patients with other genotypes. Gilead responded with its own agreements with Express Scripts' biggest rival, CVS Health ($CVS), to make its Harvoni and Sovaldi available on the payer's main drug list and then another deal with Anthem ($ANTM), the biggest provider of health coverage to U.S. businesses. It announced two new deals with payers today.
CEO Richard Gonzalez has been working hard to reposition AbbVie, which will take a huge financial hit when biosimilar competition arrives for its rheumatoid arthritis drug Humira. Currently the best-selling drug in the world, it rakes in $11 billion in revenues for AbbVie. The CEO had hoped to significantly expand the company's offering with a $55 billion buyout of Ireland's Shire ($SHPG) but pulled the plug on the deal when the U.S. made tax changes that undercut some of the cost benefits that would have helped pay for it. Just this month, the company released 2015 guidance of $4.25 to $4.45 a share, which Bloomberg figured would come in at the low end of analyst estimates that averaged $4.42.
- here's the AbbVie release