Gilead Sciences ($GILD) enjoys top dog status in the hep C market with Sovaldi and combo drug Harvoni, and the drugmaker wants to keep it that way. The company recently scored FDA approval for new indications for Harvoni in patients with HIV and certain subtypes of hep C, giving Gilead more ammo as it protects its market share from archival AbbVie ($ABBV).
The agency signed off on Harvoni for individuals with genotype 4, 5 and 6 of chronic hep C and for people who are co-infected with HIV and hep C. Regulators based their approval on studies that showed that Harvoni cleared up hep C in patients taking the med. In one study of patients with genotype 4 and 5 who either had or had not received treatment and did not have cirrhosis, Harvoni cleared up hep C in 93% of individuals taking the drug. Another study of people with genotype 6 showed that Harvoni cleared up the virus in 96% of patients, the company said in a statement.
A study of patients co-infected with HIV and hep C showed that Harvoni got rid of the hep C virus in 96% of patients, including those with cirrhosis and who were already treated.
The FDA also cleared the med for use in patients with more advanced forms of the disease who have received treatment. The agency based its approval on a study showing that Harvoni cured the virus in 96% of patients who took the pill along with hep C med ribavirin.Gilead's Norbert Bischofberger
"Harvoni … continues to demonstrate high cure rates and a tolerable side effect profile across a range of patient populations, including those who have historically been considered among the most difficult to cure," Gilead CSO Norbert Bischofberger said in a statement. "We are pleased that the Harvoni label and prescribing information now includes guidance for health care providers on its use in these important HCV patient populations."
The new indications will help the Foster City, CA-based company continue to pile in the money as it faces pricing pressures for its hep C superstars. Last year, sky high prices for Gilead's Sovaldi and Harvoni and AbbVie's rival med Viekira Pak sparked a pricing war when PBMs struck exclusive deals with one or the other of the drugmakers to get their meds covered. Before discounts, Sovaldi runs $85,000 per treatment course and Harvoni rings in at $94,500 for a 12-week course, numbers that still spark the ire of insurers and the public.
As a result, Gilead has stumbled a bit recently with the drugs. In the company's most recent quarter, Harvoni raked in $3.33 billion in sales just ahead of the Street's prediction, and Sovaldi chipped in $1.47 billion, beating analysts' expectations. But hep C revenues on the whole fell short of those reported in Q2, a trend that could be attributed to pricing as well as fewer patient starts.
Gilead doesn't seem worried about the slowdown. The company has only "touched the tip of the iceberg" when it comes to its patient pool, CEO John Martin said in August. And Gilead had some cards dealt in its favor last month after the FDA warned that AbbVie's treatment could cause serious liver injury or death in patients with advanced forms of the disease and demanded that the company change Viekira Pak's label.
Still, Gilead will need all the help it can get as new combo treatments from Merck ($MRK) and Bristol-Myers Squibb ($BMY) inch closer toward approval, potentially putting more pricing pressure on the company in the future.
- read the statement
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