Gilead Sciences Continued Liver Disease Research in 3Q15
Gilead Sciences Beat Revenue Expectations in 3Q15
Liver disease development
On September 21, 2015, Gilead Sciences (GILD) announced positive top-line results from four phase three studies for the combination of sofosbuvir and velpatasvir, also called GS-5816. This single tablet regimen (or STR) is developed as a drug targeting hepatitis C (or HCV) in patients with genotype one to six. This pan genotypic regimen is a part of Gilead Sciences’ strategy to capture market share in developing countries that lack the required apparatuses for genotype testing.
Gilead Sciences expects to file for regulatory approval for sofosbuvir and velpatasvir regimens in the US by the end of 2015. The regimen has also received accelerated assessment in the European Union, which has reduced the review period by four months.
The manufacturing of NS5A inhibitors such as ledipasvir and vepatasvir is a complex process. Gilead Sciences has focused on increasing its production capacity across the world for these NS5A inhibitors to fulfill the demand for its HCV therapies.
Harvoni expanded indications
Gilead Sciences also managed to expand the approved indications of its blockbuster HCV therapy, Harvoni, in Europe. Harvoni has now been approved for patients that are co-infected with HCV and HIV, advanced liver diseases, post liver-transplant recipients, as well as patients who failed to respond to previous sofosbuvir therapies.
The company has also filed applications in the US to expand Harvoni’s label to include HCV/HIV co-infected patients, HCV patients with genotype four to six, patients who failed to respond to previous HCV therapies, post-liver transplant patients, and cirrhotic patients. If approved, Gilead Sciences will be in a better position to compete against other HCV players like AbbVie (ABBV), Merck (MRK), and Roche (RHHBY).
Cardiovascular diseases
In addition to antiviral drugs, Gilead Sciences has been actively diversifying in the cardiovascular disease segments. On October 2, 2015, the Food and Drug Administration (or FDA) approved Gilead Sciences’ Letairis in combination with tadalafil for pulmonary arterial hypertension.
Instead of directly investing in Gilead Sciences and being exposed to excessive company-specific risks, you can invest in the company through the iShares Russell 1000 Growth ETF (IWF). Gilead Sciences accounts for about 1.5% of IWF’s total holdings.
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