Gilead Warns After Nine Hepatitis Patients Taking Heart Drug Develop Condition, One Dies From Cardiac Arrest
March 23, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Foster City, Calif.-based Gilead Sciences, Inc. sent an email warning to health care providers on Friday regarding nine patients who developed cardiac problems related to its hepatitis C drugs.
According to the company, nine patients taking Harvoni or Sovaldi along with another drug, amiodarone, were treated for abnormally slow heartbeats. One of the patients died of cardiac arrest. Three of the nine patients required a pacemaker.
Six of the cases of symptomatic bradycardia were identified within 24 hours of treatment. The remaining three showed symptoms in the first two to 12 days.
All of the patients were being treated with amiodarone. Three were also being treated with Harvoni and five were being treated with Sovaldi along with Bristol-Myers Squibb Company ’s daclatasvir. One of the patients on Sovaldi was also taking Johnson & Johnson ’s Olysio. Gilead indicated in the statement that these drug combinations were not recommended and it will update its product labeling.
In the fourth quarter of 2014, Sovaldi sold $1.73 billion. In the same period, Harvoni sales hit $2.1 billion. The drugs are noted for their price as well, costing more than $1,000 per day for a full round of treatment reaching $94,500.
The company has been in a pricing and distribution war with Chicago-based AbbVie over hepatitis C treatments since late last year. On Jan. 6, 2015 Gilead announced an exclusive rights deal with CVS Health Corp. to exclusively sell Harvoni and Sovaldi.
On Dec. 22, 2014, AbbVie inked an exclusive agreement with Express Scripts Inc., the largest pharmacy benefit manager in the U.S., for AbbVie’s hepatitis C treatment Viekira Pak.
“We have said before that a price war in the HCV market, with only two major competitors, Gilead and AbbVie, does not make sense for either competitor or for the future market potential of the category,” said Geoffrey Porges, a biotech analyst with Sanford Bernstein, in a December note. “However, it appears that AbbVie has indeed chosen to start a price battle. AbbVie is likely to have had to pay dearly for the privilege of exclusive access plus no restrictions based on fibrosis scores.”
The warning email caused Gilead stock to drop about 2.7 percent in premarket trading, but it’s unlikely to be long-term, according to analysts. Brian Abrahams, an analyst with Wells Fargo, views it as a buying opportunity and notes that hepatitis C patients being treated with both Harvoni or Sovaldi and amiodarone is pretty low. “As such we would not expect this to have any material impact on uptake of [Gilead’s] HCV drugs or on the company’s future revenue stream.”
Gilead stock is currently selling for $102.29. It had a high of $107.18 on Feb. 3, 2015, but sold for $102.61 on Friday.