Citi: Gilead Sciences, Inc. Sees Blockbuster First Weeks Of Harvoni Launch
October 31, 2014
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
Gilead Sciences, Inc. will likely see a continued strong launch of once-a-day hepatitis C pill Harvoni and will be helped by pent up demand despite its high price tag, said Yaron Werber, head of the biotech analysis team and Citigroup in New York, on Friday.
The U.S. Food and Drug Administration approved Harvoni on Oct. 10. The pill, which is a cocktail of ledipasvir and sofosbuvir (known under the brand name Sovaldi), has been cleared for use in the main subtype of hepatitis, called genotype 1, which accounts for more than two-thirds of the nation’s cases.
Gilead has had high hopes for Harvoni, after clinical trials found that over 90 percent of the patients treated with the drug had no detectable virus in their blood three months after treatment was ended. In medical parlance, that is effectively a cure.
During the second week of launch Harvoni posted had 1,097 new prescriptions, up 147 percent of its first week on the market.
“This is much higher than any other hepatitis C drug launch,” said Werber, who said a corresponding downtick in Sovaldi is being compensated for by Harvoni. “We believe that Harvoni’s launch will be helped by patients’ pent up demand, shorter duration of therapy, growing adoption by a wider physician prescriber base, and less monitoring. Hence volume should expand considerably.”
Harvoni combines the NS5A inhibitor ledipasvir with the nucleotide analog polymerase inhibitor sofosbuvir. Harvoni’s efficacy has been established in patients with chronic hepatitis C virus (HCV) genotype 1 infection, with a treatment duration of eight, 12 or 24 weeks depending on prior treatment history, cirrhosis status and baseline viral load.
Eight weeks of treatment with Harvoni can be considered for treatment-naïve patients without cirrhosis who have baseline HCV viral load below 6 million IU/mL.
The interest in Harvoni may be pushing down the more expensive Sovaldi, however. During the week of Oct. 24, Sovaldi weekly total prescriptions and new prescriptions decreased 12.6 percent and 25.5 percent respectively, said Werber.
The high costs of both drugs remain controversial, however. A 12-week course of Harvoni costs around $94,500, while a similar course of Sovaldi will run as much s $84,000. Those price tags have had insurers and public health plans like Medicaid balking at backing the treatment or offering reimbursement. But the drug will still beat most analyst projections for sales.
“If Sovaldi scrips continue at the same level as the recent weeks without any growth, U.S. sales for 2014 would be around $8.8 billion,” he wrote in a note to investors. “When factoring in ex-US sales, this should lead to much higher sales worldwide compared to Citi $12.5 billion and consensus $11 billion.”