Gilead Sciences, Inc. (GILD) Obtains CFDA Approval for Sovaldi for Treatment of Chronic Hepatitis C Virus Infection


Gilead Sciences, Inc. (NASDAQ:GILD) announced that the China Food and Drug Administration (CFDA) has approved Sovaldi® (sofosbuvir 400mg), a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C virus (HCV) infection. Sovaldi was approved for the treatment of adults and adolescents (aged 12 to 18 years) infected with HCV genotype 1, 2, 3, 4, 5 or 6 as a component of a combination antiviral treatment regimen. Sovaldi is the first Gilead HCV medicine approved in China.

The approval of Sovaldi is supported by a Phase 3 study conducted in China, presented earlier this year at the Asian Pacific Association for the Study of the Liver (APASL) meeting. SVR12 (HCV RNA undetectable 12 weeks after completing therapy) rates for Chinese HCV patients with genotype 1, 2, 3 or 6 ranged from 92-100 percent. The study evaluated Sovaldi in combination with ribavirin (RBV) or pegylated interferon+ribavirin (PegIFN+RBV) across a range of difficult-to-cure patient populations, including treatment-experienced patients and those with compensated cirrhosis. In this study, the safety profiles of the regimens were consistent with the known side effects of pegylated interferon and/or ribavirin. The most common adverse events were hematological abnormalities and pyrexia.

Professor Lai Wei, the principal investigator of Sovaldi’s Phase 3 study and former Chairman of the Chinese Society of Hepatology of the Chinese Medical Association said, “The approval of sofosbuvir in China provides more treatment options for Chinese HCV patients. The clinical trials in China and around the world provide evidence that the treatment is effective for multiple genotypes, which offers HCV patients in China a better chance at curing their disease.”

HCV is the fourth-most commonly reported infectious disease in China, with approximately 10 million people infected. HCV genotypes 1, 2, 3 and 6 account for more than 96 percent of all cases. Less than one percent of HCV patients are currently treated, using interferon-based regimens that have lower efficacy, longer treatment duration and less favorable safety profiles than more recent regimens that contain direct-acting antiviral medicines.

“With the approval of Sovaldi, there is now the potential opportunity to transform treatment for HCV patients in China,” said John F. Milligan, PhD, Gilead’s President and Chief Executive Officer. “Medicines are one part of the solution but, as we have seen in other countries around the world, there are many other challenges that impact diagnosis, linkage to care and treatment. Gilead is committed to working with the government and other stakeholders with the goal to help reduce the significant burden of HCV disease in China.”

Sovaldi received marketing approval from the U.S. Food and Drug Administration (FDA) in 2013 and the European Commission in 2014. It is also approved for use in 79 countries including Australia, India, Indonesia, the Philippines, New Zealand, Canada, Egypt, Switzerland and Turkey.

Gilead Sciences in China

Gilead has been present in China since 2007, starting with manufacturing and growing over time to include the establishment of commercial operations based in Shanghai in 2016.

Beyond the approval of Sovaldi, Gilead is studying its HCV single-tablet regimens Harvoni®(ledipasvir/sofosbuvir) and Epclusa® (sofosbuvir/velpatasvir) at clinical trials sites across China, with the aim of providing important new treatment options to Chinese HCV patients.

Shares of Gilead closed last Friday at $83.27, up $0.65 or 0.79%. GILD has a 1-year high of $86.27 and a 1-year low of $63.76. The stock’s 50-day moving average is $78.33 and its 200-day moving average is $70.66.

On the ratings front, GILD has been the subject of a number of recent research reports. In a report issued on September 15, Baird analyst Brian Skorney reiterated a Buy rating on GILD, with a price target of $87, which represents a slight upside potential from current levels. On September 14, RBC’s Brian Abrahams initiated coverage with a Buy rating on the stock and has a price target of $94.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Brian Skorney and Brian Abrahams have a yearly average return of 10.7% and 9.8% respectively. Skorney has a success rate of 62% and is ranked #335 out of 4653 analysts, while Abrahams has a success rate of 59% and is ranked #354.

Overall, 5 research analysts have assigned a Hold rating and 10 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $87.40 which is 5.0% above where the stock closed last Friday.