Gilead (GILD) Gets Approval For HCV Drug Sovaldi In China

Gilead Sciences, Inc. (NASDAQ:GILD) announced that its blockbuster hepatitis C virus (HCV) infection drug, Sovaldi has now been approved by the China Food and Drug Administration (CFDA) also. The drug was approved for the treatment of adults and adolescents (aged 12-18 years) infected with HCV genotype 1, 2, 3, 4, 5 or 6 as a component of a combination antiviral treatment regimen. We note that Sovaldi is the first Gilead HCV drug approved in China.

We note that HCV is the fourth-most commonly reported infectious disease in China, with approximately 10 million patients. Hence, the approval in the country holds promise for growth.

We note that Sovaldi was approved in the United States in 2013 and in Europe in 2014. The drug is currently approved in 79 countries.

In addition, Gilead is evaluating its HCV single-tablet regimens Harvoni and Epclusa at clinical trials sites across China.

Gilead is known for its presence in the HCV market, thanks to its blockbuster HCV drugs, Sovaldi and Harvoni. The HCV portfolio received a huge a boost with the approval of Epclusa in both the United States (June 2016) and the EU (July 2016) and became the first and only all-oral, pan-genotypic, STR consisting of Sovaldi and velpatasvir (an NS5A inhibitor), for the treatment of adults with genotype 1-6 chronic HCV infection. The FDA approval of Vosevi (Sovaldi, velpatasvir 100 mg/voxilaprevir 100 mg) tablets also boosted the company’s portfolio. The drug is a single-tablet regimen (STR) for the re-treatment of chronic hepatitis C virus infection in adults with genotype 1, 2, 3, 4, 5 or 6, previously treated with an NS5A inhibitor-containing regimen, or with genotype 1a or 3 previously treated with a Sovaldi-containing regimen without an NS5A inhibitor.

However, the HCV franchise is under pressure due to competition and pricing issues. We note that Harvoni, Sovaldi and Epclusa, face competition from AbbVie Inc. (NYSE:ABBV) Viekira Pak and Viekira XR among others. Competition as well as pricing pressure intensified further with the launch of Merck & Co., Inc.’s (NYSE:MRK) Zepatier.

Gilead recently announced plans to acquire Kite Pharma, Inc. (NASDAQ:KITE) to foray in the emerging field of cell therapy. Kite is a pioneer in cell therapy having developed engineered cell therapies that express either a chimeric antigen receptor (CAR) or an engineered T-cell receptor (TCR), depending on the type of cancer. The acquisition will diversify Gilead’s portfolio and poise the company in a dominant position in cellular therapy space. We note that investors were expecting Gilead to announce an acquisition in the near term given the decline in the once lucrative HCV market due to competitive pressure.

More Stock News: This Is Bigger than the iPhone!

It could become the mother of all technological revolutions. Apple (NASDAQ:AAPL) sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market.

Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2020.

Click here for the 6 trades >>