January 13, 2016
By Alex Keown, BioSpace.com Breaking News Staff
SAN FRANCISCO – While some investor analysts have reported being underwhelmed by some presentations at the J.P. Morgan Healthcare Conference, analysts at the Motley Fool report that Gilead Sciences ’ 2015 successes should continue through 2016 and into the foreseeable future.
Due to the phenomenal success of its Hepatitis C treatments Sovaldi and Harvoni, Gilead is poised to report earnings of more than $32 billion in 2015—more than three times what the company generated in 2012.
“But, what’s really scary for its peers—and great for its investors—is that Gilead looks practically unstoppable,” Sean Williams, writing for Motley Fool, said in an analysis.
Williams highlights several key reasons why Gilead should continue to dominate the HCV market, as well as advances in treating HIV, which will lead to the continuation of strong revenue streams. The first point is that with about 4 million people diagnosed with HCV in the United States, Gilead’s Sovaldi and Harvoni, a combination of Sovaldi and ledipasvir, have only been used to treat about 300,000 patients. Globally, there are approximately 180 million people diagnosed with HCV, which means “Gilead‘s HCV franchise looks to have a multi-decade growth opportunity on its hands,” Williams said.
The growth will be due to Gilead’s continued developments of hepatitis treatments, including hepatitis B. On Tuesday, Gilead submitted a New Drug Application to the U.S. Food and Drug Administration for tenofovir alafenamide, an investigational, once-daily treatment for adults with chronic hepatitis B virus infection. The company is also continuing to use Sovaldi in combination with other drugs, including “a triplet drug comprised of Sovaldi, velpatasvir, and a protease inhibitor” for the treatment of genotype 3 HCV patients, Williams said. Also, in the waning days of 2015, Harvoni was approved for expanded use in patients with genotype 4, 5 and 6 chronic hepatitis C virus (HCV) infection and in patients co-infected with HIV by the U.S. Food and Drug Administration. In addition, Harvoni plus ribavirin (RBV) for 12 weeks was approved as an alternate therapy to 24 weeks of Harvoni for treatment-experienced, genotype 1 patients with cirrhosis.
Additionally, Gilead announced that the U.S. Food and Drug Administration granted priority review to the company’s New Drug Application for an investigational, once-daily fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir, better known as Sovaldi, and velpatasvir , an investigational pan-genotypic NS5A inhibitor, for the treatment of chronic genotype 1-6 hepatitis C virus infection. Gilead filed the NDA for SOF/VEL on Oct. 28 and FDA has set a target action date under the Prescription Drug User Fee Act of June 28, 2016. The FDA has assigned SOF/VEL a Breakthrough Therapy designation, which is granted to investigational medicines that may offer major advances in treatment over existing options, Gilead said.
Gilead is also looking to speed up approval for a new HIV treatment by the FDA. In July, Gilead used a $125 million voucher to accelerate potential approval of the drug. The company acquired the voucher from Montreal-based Knight Therapeutics Inc. The FDA can take up to 10 months to approve a new drug, but the voucher would trim that down by four months. Gilead is hoping to see approval for its once-daily tablet HIV-1 drug that combines Gilead’s emtricitabine and tenofovir alafenamide (TAF) with Janssen Pharmaceutical’s rilpivirine for the treatment of HIV-1 in adults and pediatric patients in January 2016 rather than May 2016.
Although Williams laid out his opinion of why Gilead will continue to show strong revenue streams for years to come, Gilead’s stock had a rough Tuesday, jumping to $98.37 per share in the morning, then falling to $95.26 per share in the afternoon before finally rallying to a closing price of $97.10 per share.
Gilead has been criticized for the price of its hepatitis treatments, which can reach $95,000 for a 12-week regimen. A U.S. Senate report said the high cost of the drugs has also been damaging to Medicaid programs. According to the investigation, Medicaid programs spent $1.3 billion before rebates for the hepatitis C drugs to treat fewer than 2.4 percent of enrollees diagnosed with the liver disease. More than 700,000 hepatitis C patients on state Medicaid programs are still waiting to receive their medications.
Despite the price, Gilead’s hepatitis C treatments have proven to be highly effective since they were launched. Sovaldi has had a 90 percent efficacy in curing, not treating, but curing, the liver disease when used with other treatments —surpassing older treatments. It was because of that high rate of efficacy that Gilead was able to command such a high price for Sovaldi.
