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, Inc.    GILD

Delayed Quote. Delayed  - 05/24 10:00:00 pm
64.31 USD   -0.59%
05/24 GILEAD SCIENCES : Value Trap?
05/19 GILEAD SCIENCES : considers producing Hep C drug in Egypt
05/19 GILEAD SCIENCES : American “Gilead Sciences” considers p..
SummaryQuotesChartsNewsAnalysisCalendarCompanyFinancialsConsensusRevisions 
News SummaryMost relevantAll newsSector newsTweets 

Gilead Sciences, Inc. : Gilead Provides Update on Hepatitis C Development Programs

share with twitter share with LinkedIn share with facebook
share via e-mail
0
01/07/2013 | 02:40pm CEST

-- Sustained Virologic Response Achieved with Oral Regimen of Sofosbuvir, GS-5885 and Ribavirin in 9/9 Null Responder Genotype 1 Hepatitis C Patients --

-- Second Phase 3 Study Evaluating Fixed-dose Combination of Sofosbuvir and GS-5885 to Begin Later this Month --

Gilead Sciences (Nasdaq:GILD) today announced several updates regarding its late-stage pipeline candidates for the treatment of chronic hepatitis C virus (HCV) infection. The company released new results from an arm of the ongoing Phase 2 ELECTRON study examining the nucleotide sofosbuvir and the NS5A inhibitor GS-5885, and provided a progress report on a range of Phase 2 and 3 clinical trials evaluating a once-daily fixed-dose combination tablet of these medicines. These updates will be highlighted today as part of Gilead's corporate presentation at the 31st Annual J.P. Morgan Healthcare Conference taking place in San Francisco.

"Since the acquisition of Pharmasset only a year ago, we have fully enrolled four Phase 3 studies of sofosbuvir and during the first quarter of this year we will have initiated two Phase 3 studies of the sofosbuvir and GS-5885 fixed-dose combination," said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. "We are on track to submit the initial regulatory filing for sofosbuvir by mid-2013 and to file for approval of the fixed-dose combination of sofosbuvir and GS-5885 in 2014."

Update on Phase 2 ELECTRON Study

Gilead today announced full data from one cohort of the ongoing Phase 2 ELECTRON study examining a 12-week course of all-oral therapy with sofosbuvir, GS-5885 and ribavirin (RBV) among genotype 1 HCV patients who had previously failed to respond to an interferon (IFN)-containing regimen, or "null responders."

Preliminary data, presented in November at the annual meeting of the American Association for the Study of Liver Diseases (AASLD), demonstrated that three of nine patients (3/9) remained HCV RNA undetectable four weeks after completing therapy (SVR4). Today's announcement confirms that all nine patients (9/9) in this cohort achieved SVR4. These patients will continue to be observed to determine sustained virologic response rates at weeks 12 and 24 of follow-up (SVR12 and SVR24).

Results from eight other arms of the ELECTRON study, evaluating sofosbuvir alone and with RBV and/or pegylated IFN, were published earlier this month in the New England Journal of Medicine (N Engl J Med 368;34-44).

Advancing a Fixed-Dose Combination Tablet for HCV

Gilead is currently evaluating a once-daily fixed-dose combination tablet containing sofosbuvir and GS-5885 in several Phase 2 and 3 trials. The studies evaluate sofosbuvir/GS-5885 with and without RBV among a range of genotype 1 HCV patient populations.

  • ION-1: This Phase 3 trial was initiated in October 2012 and is evaluating sofosbuvir/GS-5885 with and without RBV for 12 or 24 weeks among treatment-naïve genotype 1 patients. Pending a review of results from the two 12-week arms (n=50/arm) of an initial enrollment of 200 patients, ION-1 will continue to recruit patients and assess sofosbuvir/GS-5885 in a total of 800 individuals.
  • ION-2: Gilead today announced that a second Phase 3 study for sofosbuvir/GS-5885, ION-2, is expected to begin screening patients in January 2013. This study will evaluate the fixed-dose combination, with RBV for 12 weeks and with and without RBV for 24 weeks of therapy among 400 treatment-experienced genotype 1 HCV patients. Participants in this study will have failed past therapy with regimens containing IFN or IFN plus a protease inhibitor.
  • LONESTAR: Gilead also announced that enrollment is now underway for a new Phase 2 study of sofosbuvir/GS-5885 for 12 weeks and of sofosbuvir/GS-5885 with and without RBV for 8 weeks among genotype 1 treatment-naïve patients. Two additional arms in this trial will evaluate sofosbuvir/GS-5885 with and without RBV for 12 weeks among treatment-experienced genotype 1 patients who had previously received a protease inhibitor-containing regimen. This study, which will enroll 100 patients, is the first trial to evaluate the combination of sofosbuvir and
    GS-5885 for only eight weeks of treatment.

Sofosbuvir, GS-5885 and the fixed-dose combination tablet are investigational products and their safety and efficacy have not yet been established.

Four ongoing Phase 3 studies will support Gilead's initial regulatory filing in mid-2013 for an all-oral therapy with sofosbuvir plus RBV among genotype 2/3 treatment-naïve, treatment-experienced and interferon-intolerant patients, and for sofosbuvir in combination with RBV and peg-IFN among treatment-naïve patients with HCV genotypes 1, 4, 5 and 6. Topline results from the first Phase 3 study, POSITRON, were announced in November 2012, and results from the remaining three studies (FISSION, FUSION and NEUTRINO) are anticipated in Q1 2013. Results from ION-1, ION-2 and LONESTAR are intended to support a regulatory filing for the fixed-dose combination of sofosbuvir/GS-5885 by mid-2014.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Asia Pacific.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the possibility that the proportion of patients who maintain a sustained virologic response 12 and 24 weeks post-treatment in the null responder arm of the ELECTRON study will not be as favorable as the sustained virologic response rates reported in this press release, and the possibility of unfavorable results from additional arms of ELECTRON and other clinical trials involving sofosbuvir and sofosbuvir and GS-5885 with and without RBV. As a result, sofosbuvir and GS-5885 as single agents or as a fixed-dose combination may never be successfully commercialized. In addition, Gilead may make a strategic decision to discontinue development of the compounds or the fixed-dose combination regimen if, for example, Gilead believes commercialization will be difficult relative to other opportunities in its pipeline. Further, Gilead may be unable to file for regulatory approval of sofosbuvir and the fixed-dose combination of sofosbuvir/GS-5885 in the currently anticipated timelines or at all. If marketing approval is granted for any of these products, there may be significant limitations on their use. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended September 30, 2012, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

For more information on Gilead Sciences, please visit the company's website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

Gilead Sciences
Patrick O?Brien, 650-522-1936 (Investors)
Cara Miller, 650-522-1616 (Media)


© Business Wire 2013
share with twitter share with LinkedIn share with facebook
share via e-mail
0
Latest news on GILEAD SCIENCES, INC.
05/24 GILEAD SCIENCES : Value Trap?
05/19 GILEAD SCIENCES : considers producing Hep C drug in Egypt
05/19 GILEAD SCIENCES : American “Gilead Sciences” considers producing new..
05/18 GILEAD SCIENCES, INC. (NASDAQ : GILD) Files An 8-K Submission of Matters to a Vo..
05/18 GILEAD SCIENCES : Submission of Matters to a Vote of Security Holders (form 8-K/..
05/12 GILEAD SCIENCES,INC. (NASDAQ : GILD) Files An 8-K Departure of Directors or Cert..
05/12 GILEAD SCIENCES INC : Change in Directors or Principal Officers, Submission of M..
05/11 GILEAD SCIENCES : to Present at the Bank of America Merrill Lynch Healthcare Con..
05/10 GILEAD SCIENCES : MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AN..
05/09 NATCO PHARMA : launches Hepatitis C drug Velpanat in India
More news
Sector news : Bio Therapeutic Drugs
05/23 UK competition watchdog accuses Merck of obstructing biosimilars
05/22 Cross-border M&A between U.S. and European firms at 10 year high
05/22DJAMGEN : Another Gloomy Day for Amgen
05/09 Sanofi pegs U.S. drug price rises to below healthcare inflation
05/09DJVERTEX PHARMACEUTICALS INCORPORATED : Trump's Pick to Lead FDA Has Backing of Bi..
More sector news : Bio Therapeutic Drugs
News from SeekingAlpha
05/24 How To Double Your Money On A 6% Up Move In Gilead Sciences
05/24 BBP : A Diversified Biotech ETF
05/24 Gilead's Chinese HCV Revenues - How Much To Expect And When
05/24 The No. 1 Stock In The World (Revisited) - Apple Up, Realty Income Down
05/23 10 Attractive High-Yield Blue Chips For Contrarians
Advertisement
Financials ($)
Sales 2017 24 515 M
EBIT 2017 15 036 M
Net income 2017 9 722 M
Debt 2017 4 528 M
Yield 2017 3,32%
P/E ratio 2017 8,63
P/E ratio 2018 9,53
EV / Sales 2017 3,61x
EV / Sales 2018 4,04x
Capitalization 84 036 M
More Financials
Chart GILEAD SCIENCES, INC.
Duration : Period :
Gilead Sciences, Inc. Technical Analysis Chart | GILD | US3755581036 | 4-Traders
Full-screen chart
Technical analysis trends GILEAD SCIENCES, ...
Short TermMid-TermLong Term
TrendsBearishBearishBearish
Technical analysis
Income Statement Evolution
More Financials
Consensus
Sell
Buy
Mean consensus OUTPERFORM
Number of Analysts 27
Average target price 78,6 $
Spread / Average Target 22%
Consensus details
EPS Revisions
More Estimates 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
More about the company
Sector and Competitors
1st jan.Capitalization (M$)
GILEAD SCIENCES, INC.-10.19%84 101
AMGEN, INC.5.74%112 531
CELGENE CORPORATION1.35%90 349
REGENERON PHARMACEUTIC..25.68%48 999
ACTELION LTD24.49%30 824
VERTEX PHARMACEUTICALS..59.90%29 624
More Results