November 11, 2014
By Mark Terry, BioSpace.com Breaking News Staff
Foster City-based Gilead Sciences, Inc. , announced today positive results from several Phase II and Phase III trials focused on Harvoni (ledipasvir/sofosbuvir) for the treatment of hepatitis C virus (HCV).
The data will be presented this week at the 65th Annual Meeting of the American Association for the Study of Liver Diseases in Boston.
Harvoni was released for treatment last month and is breaking sales records previously held by Gilead’s blockbuster HCV treatment Sovaldi. Gilead has a strong portfolio of HCV drugs and is expected to continue with record sales. Analysts with Citigroup Inc. predict Gilead’s HCV portfolio will reach $13 billion for 2014, up from $9.33 billion in 2013.
The sales haven’t been without their speed bumps, however. Sovaldi was approved in December 2013 and hit sales figures of $9 billion by September of this year. But in the third quarter of 2014, Gilead reported Sovaldi sales of $2.8 billion, a drop of 20 percent quarter-over-quarter. Investors reacted with a 4 percent drop in share prices.
Analysts feel that decrease in Sovaldi sales was the result of physicians holding back on prescribing the drug because they anticipated the launch of Harvoni, a once-a-day oral mix of Sovaldi and ledipasvir. It probably shouldn’t be a surprise that Harvoni was going to eat away at Sovaldi sales.
Sovaldi cut the length of standard treatment for HCV from 24 weeks to 12 weeks. Priced at $1,000 per pill, with the additional cost of interferon, the full treatment per patient ran to about $94,000. Harvoni is a single-regimen treatment. Harvoni’s treatment usually runs about eight weeks, so although it too costs about $94,500, with the shorter treatment duration the costs are closer to $63,000.
The new clinical trial results for Harvoni are likely to cement Gilead’s place in the HCV market. “Chronic hepatitis C patients with advanced liver disease are among the most difficult to cure and traditionally have had limited or no treatment options,” said Norbert Bischofberg, executive VP of R&D and chief scientific officer of Gilead in a statement. “The data presented this week demonstrated that Harvoni provides high cure rates for patients with advanced liver disease, as well as for those who failed prior treatment with other antivirals, including sofosbuvir-based regimens.”
Gilead has applied for approval for Harvoni in the European Union, Japan and New Zealand.
