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Gilead's (GILD) HCV Drug Application Accepted in the EU
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Gilead Sciences, Inc. (GILD - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on the company’s Marketing Authorization Application (MAA) for Vosevi following an accelerated assessment procedure.
Vosevi is an experimental once-daily, single tablet regimen of Sovaldi, velpatasvir 100 mg, and voxilaprevir 100 mg (SOF/VEL/VOX) which is being evaluated for the treatment of chronic hepatitis C virus (HCV)-infected patients.
The data included in the application support the use of SOF/VEL/VOX in patients with or without compensated cirrhosis, with all genotypes (GT1-6) of HCV infection regardless of prior therapy. It includes eight weeks of treatment for HCV direct-acting antiviral (DAA)-naïve patients without cirrhosis, as well as 12 weeks of treatment for patients who have previously failed therapy with a DAA-containing regimen.
The recommendation will now be reviewed by the European Commission. The EMA generally takes into account CHMP’s opinion while reviewing a drug but is not bound by it.
The MAA was filed based on positive data from four phase III studies. We remind investors that Sovaldi was approved in the EU in Jan 2014 for use in combination with other agents while the single tablet regimen of Sovaldi and ledipasvir (90 mg) received marketing authorization in the European Union in Nov 2014 under the trade name Harvoni. On the other hand, the single tablet regimen of Sovaldi and velpatasvir (100 mg) received marketing authorization in the EU in Jul 2016, under the trade name Epclusa..
Meanwhile, Gilead has also submitted a regulatory application for SOF/VEL/VOX in the U.S. as well. The FDA has set a target action date under the Prescription Drug User Fee Act of Aug 8, 2017.
If approved, the combination would be the first once-daily STR available as a salvage therapy for patients infected with HCV genotype 1–6 who have failed prior treatment with DAA regimens including NS5A inhibitors.
Gilead’s HCV franchise is under pressure due to intense competition and pricing issues. HCV product sales were weaker than expected mainly due to fewer new patient starts for Harvoni and lower revenues per patient. Harvoni, Sovaldi and Epclusa has being facing competition from AbbVie’s (ABBV - Free Report) Viekira Pak and Viekira XR, Bristol-Myers’ (BMY - Free Report) Daklinza and Johnson & Johnson’s (JNJ - Free Report) Olysio.
The company expects that the persistent decline in HCV patient starts will be the primary factor behind the year-over-year decrease in revenues in 2017 along with increased competition which will impact patient share and pricing.
Shares of Gilead have underperformed the Zacks classified Medical-Biomedical and Genetics industry in the last one year, with the stock losing 13.4% during this period, against the industry’s gain of 8.2%.
Nevertheless, the HIV franchise of Gilead is performing well and is expected to help the company combat the persistent decline in HCV franchise.
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Gilead's (GILD) HCV Drug Application Accepted in the EU
Gilead Sciences, Inc. (GILD - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on the company’s Marketing Authorization Application (MAA) for Vosevi following an accelerated assessment procedure.
Vosevi is an experimental once-daily, single tablet regimen of Sovaldi, velpatasvir 100 mg, and voxilaprevir 100 mg (SOF/VEL/VOX) which is being evaluated for the treatment of chronic hepatitis C virus (HCV)-infected patients.
The data included in the application support the use of SOF/VEL/VOX in patients with or without compensated cirrhosis, with all genotypes (GT1-6) of HCV infection regardless of prior therapy. It includes eight weeks of treatment for HCV direct-acting antiviral (DAA)-naïve patients without cirrhosis, as well as 12 weeks of treatment for patients who have previously failed therapy with a DAA-containing regimen.
The recommendation will now be reviewed by the European Commission. The EMA generally takes into account CHMP’s opinion while reviewing a drug but is not bound by it.
The MAA was filed based on positive data from four phase III studies. We remind investors that Sovaldi was approved in the EU in Jan 2014 for use in combination with other agents while the single tablet regimen of Sovaldi and ledipasvir (90 mg) received marketing authorization in the European Union in Nov 2014 under the trade name Harvoni. On the other hand, the single tablet regimen of Sovaldi and velpatasvir (100 mg) received marketing authorization in the EU in Jul 2016, under the trade name Epclusa..
Meanwhile, Gilead has also submitted a regulatory application for SOF/VEL/VOX in the U.S. as well. The FDA has set a target action date under the Prescription Drug User Fee Act of Aug 8, 2017.
If approved, the combination would be the first once-daily STR available as a salvage therapy for patients infected with HCV genotype 1–6 who have failed prior treatment with DAA regimens including NS5A inhibitors.
Gilead’s HCV franchise is under pressure due to intense competition and pricing issues. HCV product sales were weaker than expected mainly due to fewer new patient starts for Harvoni and lower revenues per patient. Harvoni, Sovaldi and Epclusa has being facing competition from AbbVie’s (ABBV - Free Report) Viekira Pak and Viekira XR, Bristol-Myers’ (BMY - Free Report) Daklinza and Johnson & Johnson’s (JNJ - Free Report) Olysio.
The company expects that the persistent decline in HCV patient starts will be the primary factor behind the year-over-year decrease in revenues in 2017 along with increased competition which will impact patient share and pricing.
Shares of Gilead have underperformed the Zacks classified Medical-Biomedical and Genetics industry in the last one year, with the stock losing 13.4% during this period, against the industry’s gain of 8.2%.
Nevertheless, the HIV franchise of Gilead is performing well and is expected to help the company combat the persistent decline in HCV franchise.
Gilead currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank stocks here.
Sell These Stocks. Now.
Just released, today's 220 Zacks Rank #5 Strong Sells demand urgent attention. If any are lurking in your portfolio or Watch List, they should be removed immediately. These sinister companies because many appear to be sound investments. However, from 1988 through 2016, stocks from our Strong Sell list have actually performed 6X worse than the S&P 500. See today's Zacks "Strong Sells" absolutely free >>