Log in
E-mail
Password
Remember
Forgot password ?
Become a member for free
Sign up
Sign up
Settings
Settings
Dynamic quotes 
OFFON

4-Traders Homepage  >  Equities  >  Nasdaq  >  Gilead Sciences    GILD

GILEAD SCIENCES (GILD)
Mes dernières consult.
Most popular
Report
SummaryQuotesChartsNewsAnalysisCalendarCompanyFinancialsConsensusRevisions 
News SummaryMost relevantAll newsSector newsTweets

Gilead Sciences : China Food and Drug Administration Approves Gilead's Sovaldi® Sofosbuvir for Treatment of Chronic Hepatitis C Virus Infection

share with twitter share with LinkedIn share with facebook
share via e-mail
0
10/05/2017 | 05:57pm CET

By a News Reporter-Staff News Editor at Drug Week -- 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 (see also Liver Diseases and Conditions - Chronic Hepatitis C Virus).

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.

Keywords for this news article include: Asia, Antivirals, Pharmaceutical Companies, China, Genetics, Cytokines, Ribavirin, Interferons, Purine Nucleosides, Respiratory Agents, Drugs and Therapies, Gilead Sciences Inc., Inhaled Antiinfectives, Respiratory Inhalant Products, Government Agencies Offices and Entities, Intercellular Signaling Peptides and Proteins.

Our reports deliver fact-based news of research and discoveries from around the world. Copyright 2017, NewsRx LLC

(c) 2017 NewsRx LLC, source Health Newsletters

share with twitter share with LinkedIn share with facebook
share via e-mail
0
Latest news on GILEAD SCIENCES
09:12a GILEAD SCIENCES : adds to CAR-T assets with Cell Design Labs buyout
01:31a GILEAD SCIENCES : Kite Announces Data From ZUMA-3 Study of KTE-C19 in Adult Pati..
12/11 GILEAD SCIENCES : Today’s Research Reports on Stocks to Watch: Gilead Sciences a..
12/11 GILEAD SCIENCES : and Kite to Acquire Cell Design Labs
12/11 GILEAD SCIENCES : Hookipa raises EUR 50 million series C
12/11 GILEAD SCIENCES : acquires CDL for $567m
12/11 GILEAD SCIENCES : US stocks end higher on Friday on the back of strong jobs data
12/11 GILEAD : Kite Reveals Long-Term Data From Pivotal ZUMA-1 Study Of Yescarta
12/10 GILEAD SCIENCES : acquires CDL for $567m
12/10 GILEAD SCIENCES : Kite Announces Long-Term Data From Pivotal ZUMA-1 Study of Yes..
More news
News from SeekingAlpha
12/11 YOUR DAILY PHARMA SCOOP : Celgene Upside, Erytech Tumbles, Novartis Neulasta Bio..
12/10 GILEAD DOUBLES DOWN ON CAR-T : Updates To Thesis
12/10 BIOTECH IN 2018 : Will Repatriated Cash Fuel A Feeding Frenzy?
12/08 GILEAD SCIENCES : Going Down When It Should Go Up
12/08 CRISPR THERAPEUTICS : Analysis Of And Update On The B-Thalassemia Franchise
Financials ($)
Sales 2017 25 816 M
EBIT 2017 15 661 M
Net income 2017 10 511 M
Debt 2017 12 742 M
Yield 2017 2,71%
P/E ratio 2017 9,75
P/E ratio 2018 12,72
EV / Sales 2017 4,33x
EV / Sales 2018 4,91x
Capitalization 99 094 M
Chart GILEAD SCIENCES
Duration : Period :
Gilead Sciences Technical Analysis Chart | GILD | US3755581036 | 4-Traders
Technical analysis trends GILEAD SCIENCES
Short TermMid-TermLong Term
TrendsBullishNeutralNeutral
Income Statement Evolution
Consensus
Sell
Buy
Mean consensus OUTPERFORM
Number of Analysts 29
Average target price 85,7 $
Spread / Average Target 13%
EPS Revisions
Managers
NameTitle
John F. Milligan President, Chief Executive Officer & Director
John C. Martin Executive Chairman
Kevin B. Young Chief Operating Officer
Robin L. Washington Chief Financial Officer & Executive Vice President
Norbert W. Bischofberger Chief Scientific Officer & Executive VP-Research
Sector and Competitors
1st jan.Capitalization (M$)
GILEAD SCIENCES1.55%99 094
REGENERON PHARMACEUTICALS1.43%40 911
VERTEX PHARMACEUTICALS87.81%36 319
GENMAB1.62%11 562
EXELIXIS, INC.79.28%8 021
BLUEBIRD BIO INC163.61%7 844