FOSTER CITY, Calif.--(BUSINESS WIRE)--Apr. 7, 2017-- Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved supplemental indications for Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg) tablets and Sovaldi® (sofosbuvir 400 mg) tablets for the treatment of chronic hepatitis C virus (HCV) infection in adolescents without cirrhosis or with compensated cirrhosis, 12 years of age and older, or weighing at least 35kg. Harvoni was approved for pediatric patients with genotype 1, 4, 5 or 6 chronic HCV infection. Sovaldi was approved for pediatric patients with genotype 2 or 3 chronic HCV infection, in combination with ribavirin. There are an estimated 23,000-46,000 pediatric HCV patients in the United States, most of whom were infected with the virus at birth. [More...]
Gilead Notches Pediatric Use For Sovaldi, Harvoni As Sales Fade Among Adults
by Eric Sagonowsky FiercePharma Apr 7, 2017
Amid a tough time for the drugmaker as its hep C sales crash, Gilead scored a win on Friday as the FDA approved the company’s Sovaldi and Harvoni for pediatric patients.
Patients 12 and older with hep C genotypes 1 through 6 will be able to use Sovaldi or Harvoni to treat their disease, which is often transmitted at birth for these young patients. An estimated 23,000 to 46,000 pediatric hep C patients live in the U.S., according to Gilead’s Friday release.
The approvals marked a win for both patients and the Foster City, California, drugmaker, which has been struggling to keep its hep C sales engine churning in recent quarters. That has prompted a call for the company to make big M&A moves, but with its share price slumping, the company has yet to pull the trigger on any major deals.
For patients, the FDA’s Friday decision means they’ll have their first alternative to interferon injections. University of Washington School of Medicine pediatrics professor Karen Murray said in a statement the drugs “represent an important advance” for the patient group.
For Gilead, serving another patient population can’t be a bad thing. Suffering from new competition in hep C from AbbVie and Merck, the drugmaker has seen its dominance of the blockbuster market collapse over the last year, denting its revenues and share price along the way.
Gilead’s 2016 sales came in a $30.39 billion, a 7% slip from the $32.6 billion in turned in back in 2015. The Big Biotech is calling for total 2017 revenues of $22.5 billion to $24.5 billion, a 22% decline from 2016 if it hits the midpoint.
Chiefly contributing to that pain is Gilead’s hep C sales. Harvoni revenues tumbled 34% last year versus the year prior, while Sovaldi fell 24%. Those two meds alone lost $6 billion in sales in 2016 versus 2015. Looking ahead, Gilead is predicting total 2017 hep C sales of $7.5 to $9 billion, a big decline from the $14.8 billion its products turned in last year.
With that considered, industry watchers and analysts have called on the company to make dramatic moves. Barclays analyst Geoff Meacham recently wrote an open letter to management, making his point that Gilead’s “deal parameters should evolve” given its current situation.