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Featured Company News - Gilead's Vosevi Receives Positive Opinion from European CHMP; Set to Deliver Advanced Treatment for All HCV Genotypes

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LONDON, UK / ACCESSWIRE / June 26, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Gilead Sciences, Inc. (NASDAQ: GILD), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=GILD. The Company announced on June 23, 2017, that the Committee for Medicinal Products for Human Use (CHMP), and the scientific committee of the European Medicines Agency (EMA) have adopted a positive opinion on the Company's Marketing Authorization Application (MAA). Gilead filed the application for Vosevi, an investigational, once-daily, single tablet regimen of sofosbuvir 400 mg, velpatasvir 100 mg, and voxilaprevir 100 mg, which was intended for the treatment of chronic hepatitis C virus (HCV)-infected patients. For immediate access to our complimentary reports, including today's coverage, register for free now at:


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The Announcement

This update comes at the heels of the announcement made on January 20, 2017, under which the Company announced that the MAA for the single tablet regimen of sofosbuvir 400 mg, velpatasvir 100 mg, and voxilaprevir 100 mg (SOF/VEL/VOX) for the treatment of chronic hepatitis C virus (HCV)-infected patients, was fully validated by the EMA and was under further assessment.

The MAA for SOF/VEL/VOX is supported by data from four Phase-3 studies, which included two studies, namely POLARIS-1 and POLARIS-4, evaluated under 12 weeks of the single tablet regimen in patients with genotypes of 1-6 HCV infection previously treated unsuccessfully with DAA-containing regimens, including NS5A inhibitors. Under these two tests, 97% of the treated patients achieved the primary efficacy endpoint of SVR12.

The other two tests, namely POLARIS-2 and POLARIS-3, evaluated 8 weeks of SOF/VEL/VOX in DAA-naive patients with genotypes 1-6 HCV infection. In POLARIS-2 test, 95% of the patients treated with SOF/VEL/VOX achieved the primary efficacy endpoint of SVR-12. The final test, i.e., POLARIS-3, reported 93% of the patients with genotype-3 infection and cirrhosis treated with SOF/VEL/VOX, achieved the primary efficacy endpoint of SVR12.


Sofosbuvir was granted marketing authorization, as a single agent, in the European Union on January 16, 2014, under the trade name Sovaldi, for use in combination with other agents. Also, the single tablet regimen of sofosbuvir and ledipasvir received marketing authorization in the European Union, under the trade name Harvoni, on November 18, 2014. The single tablet version of sofosbuvir and velpatasvir received marketing authorization in the EU on July 08, 2016, under the trade name Epclusa.

Gilead HCV Treatment Portfolio

According to the Company, the direct-acting antiviral treatment has transformed the ability to treat hepatitis C. However, some patients were unable to be cured with these regimens, effective and well-tolerated therapies are still necessary for them. The Company viewed the submission of this application as a step to deliver enhanced treatment options for the life-threatening disease to the maximum possible patients in Europe and around the world.

Gilead Sciences, Inc. announced on January 12, 2017, a $22 million fund for the HIV cure grants program, which will support 12 new HIV cure research projects. These tests focus on three key segments, namely, translational research, efficacy studies in animal models, and community perspectives of HIV cure.

The SOF/VEL/VOX for the treatment of HCV was initially reviewed by the EMA under the centralized licensing procedure for all 28 member states of the European Union, Norway, and Iceland. The review followed an accelerated procedure reserved for medicinal products expected to be of major public health interest. The Company also submitted a New Drug Application to the FDA for SOF/VEL/VOX on December 08, 2016.

Last Close Stock Review

On Friday, June 23, 2017, the stock closed the trading session at $70.52, marginally rising 0.06% from its previous closing price of $70.48. A total volume of 22.90 million shares have exchanged hands, which was higher than the 3-month average volume of 8.08 million shares. Gilead Sciences' stock price advanced 9.66% in the last one month and 4.46% in the past three months. The stock is trading at a PE ratio of 7.45 and has a dividend yield of 2.95%. The stock currently has a market cap of $92.24 billion.

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