Gilead Sciences, Inc. (NASDAQ:GILD) announced that the European Commission has granted marketing authorization for Vosevi® (sofosbuvir 400mg/velpatasvir 100mg/voxilaprevir 100mg), as a once-daily single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection.
Vosevi was authorized as a 12-week treatment regimen for patients with any genotype of chronic HCV infection, without cirrhosis or with compensated cirrhosis, who have previously failed therapy with a direct-acting antiviral (DAA)-containing regimen. A 12-week regimen was also authorized for use in DAA-naïve patients with compensated cirrhosis infected with any HCV genotype, with an option to shorten therapy to 8 weeks for those infected with genotype 3. For DAA-naïve patients without cirrhosis, the recommended treatment duration is 8 weeks.
“DAA-based therapies have transformed our ability to treat hepatitis C. However, until now we have had limited options for patients who have failed to achieve cure with these regimens,” said Professor Michael Manns, Director of the Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany. “Vosevi has demonstrated high cure rates across a range of DAA-experienced patients, with a simple 12-week single tablet regimen. Availability of Vosevi will have a significant impact for this group of patients, offering them the opportunity to be cured of this disease.”
Gilead also today announced an extension of the marketing authorization for Harvoni® (ledipasvir 90mg/sofosbuvir 400mg). Previously authorized for the treatment of adults with chronic HCV genotype 1, 3, 4, 5 or 6 infection, the indication for Harvoni has been extended to include the treatment of chronic HCV genotype 1, 3, 4, 5 and 6 infection in adolescents aged 12 to < 18 years. Harvoni is the first direct-acting antiviral regimen to receive marketing authorization in the European Union extended for use in the adolescent population.
“The authorization of Vosevi and the extended indication for Harvoni demonstrate our ongoing commitment to bring therapies with high cure rates to all HCV-infected patients,” said John Milligan, PhD, Gilead’s President and Chief Executive Officer. “We look forward to working with healthcare providers and governments to ensure Vosevi is made available to patients who would benefit the most from it, while continuing to expand the benefits of our other approved medicines for patients with chronic HCV infection across Europe.”
Sofosbuvir-based regimens are recommended by global guidelines across HCV genotypes and disease severities and have been used to treat more than 1.5 million patients worldwide. Vosevi is Gilead’s fourth sofosbuvir-based treatment to be granted marketing authorization by the European Commission for the treatment of chronic HCV infection. The marketing authorization of Vosevi follows an accelerated review procedure by the European Medicines Agency, reserved for medicinal products expected to be of major public health interest. It allows for the marketing of Vosevi in all 28 countries of the European Union. Gilead will now work diligently with national pricing and reimbursement agencies across Europe to make Vosevi available to patients.
The approval of Vosevi is supported by data from four Phase 3 studies. Two studies (POLARIS-1 and POLARIS-4) evaluated 12 weeks of the single tablet regimen in patients with hepatitis C genotypes 1-6 previously treated unsuccessfully with DAA-containing regimens, including NS5A inhibitors. Two other studies (POLARIS-2 and POLARIS-3) evaluated 8 weeks of Vosevi in DAA-naïve patients with hepatitis C genotypes 1-6. Across POLARIS-1 and POLARIS-4, 97 percent of patients treated with Vosevi (n=431/445) achieved the primary efficacy endpoint of SVR12. In POLARIS-2, 95 percent of patients with hepatitis C genotypes 1-6 with and without cirrhosis treated with Vosevi (n=477/501) achieved the primary efficacy endpoint of SVR12. In POLARIS-3, 96 percent of patients with genotype 3 infection and compensated cirrhosis treated with Vosevi (n=106/110) achieved the primary efficacy endpoint of SVR12. The most common adverse drug reactions among patients who received Vosevi in the POLARIS studies were headache, diarrhea and nausea.
Sofosbuvir as a single agent was granted marketing authorization in the European Union on January 16, 2014, under the trade name Sovaldi®, for use in combination with other agents for the treatment of adults with chronic HCV infection. The single tablet regimen, Harvoni, received marketing authorization in the European Union on November 18, 2014. The single tablet regimen of sofosbuvir (400mg) and velpatasvir (100mg) received marketing authorization in the European Union on July 8, 2016, under the trade name Epclusa® for the treatment of adults with chronic HCV infection.
Vosevi was approved by the U.S. Food and Drug Administration on July 18, 2017 for the re-treatment of adults with genotype 1-6 chronic HCV infection.
Shares of Gilead Sciences closed yesterday at ִ$74.96, up $0.77 or 1.04%. GILD has a 1-year high of $82.10 and a 1-year low of $63.76. The stock’s 50-day moving average is $69.49 and its 200-day moving average is $68.59.
On the ratings front, Gilead has been the subject of a number of recent research reports. In a report released yesterday, J.P. Morgan analyst Cory Kasimov maintained a Buy rating on GILD, with a price target of $85, which represents a potential upside of 13% from where the stock is currently trading. Separately, on the same day, Maxim Group’s Gabrielle Zhou reiterated a Hold rating on the stock.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Cory Kasimov and Gabrielle Zhou have a yearly average return of 2.8% and 1.4% respectively. Kasimov has a success rate of 44% and is ranked #1249 out of 4160 analysts, while Zhou has a success rate of 49% and is ranked #2031.
Overall, 3 research analysts have assigned a Hold rating and 11 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 $84.00 which is 12.1% above where the stock closed yesterday.
Gilead Sciences, Inc. is a biopharmaceutical company, which discovers, develops and commercializes therapeutics for unmet medical need. It focuses on human immunodeficiency virus and liver diseases, such as chronic hepatitis C virus infection & chronic hepatitis B virus infection, hematology & oncology, and cardiovascular & inflammation as well as respiratory diseases. The company’s products include Descovy, Odefsey, Genvoya, Stribild, Complera, Atripla, Truvada, Viread, Emtriva, Tybost, Vitekta, Vemlidy, Epclusa, Harvoni, Sovaldi, Viread, Hepsera, Zydelig, Letairis, Ranexa, Lexiscan, Cayston, Tamiflu, AmBisome and Macugen.