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  >  Nyse  >  Johnson & Johnson    JNJ

SummaryQuotesChartsNewsAnalysisCalendarCompanyFinancialsConsensusRevisions 
News SummaryMost relevantAll newsSector newsTweets 

J&J's Simponi Helps Colitis Patients In Clinical Trial

share with twitter share with LinkedIn share with facebook
share via e-mail
0
05/21/2012 | 08:45pm CET
   By Peter Loftus 
   Of  
 

Johnson & Johnson (>> Johnson & Johnson) said its drug Simponi improved symptoms in a majority of patients with an inflammatory-bowel disease in a new clinical trial.

The results, released at a medical conference Monday, could support expansion of the approved uses of Simponi to include treating the bowel condition, known as ulcerative colitis, which J&J estimates affects about 700,000 people in the U.S.

Simponi, which was introduced in 2009, is currently approved to treat signs and symptoms of moderate to severe rheumatoid arthritis, active psoriatic arthritis and active ankylosing spondylitis.

Simponi is known as an anti-tumor necrosis factor, or anti-TNF, a category that also includes J&J's older drug, Remicade, which is already approved to treat ulcerative colitis. Simponi can be self-administered by patients as an injection, while Remicade requires intravenous infusion by a health-care provider.

J&J recorded $410 million in Simponi sales for 2011; Merck & Co. (MRK), which markets the drug in certain countries outside the U.S., recorded $264 million in Simponi sales for 2011.

J&J tested Simponi in a late-stage clinical trial of more than 770 patients with moderately to severely active ulcerative colitis who had failed to respond to or tolerate certain other treatments.

Some patients received Simponi--at two different dose levels--and some received a placebo, and researchers tracked how many experienced a clinical response at six weeks after the start of treatment. Clinical response included improvements in various symptoms of ulcerative colitis such as diarrhea.

According to J&J, 51.8% and 55% of patients in the two Simponi groups, respectively, achieved a clinical response at week 6, versus 29.7% of placebo patients. The results were presented Monday at the Digestive Disease Week medical meeting in San Diego.

In a secondary measure in the trial, roughly 18.7% and 17.8% of patients in the Simponi groups had clinical remission, versus 6.3% in placebo patients.

The rates of adverse events were comparable among the Simponi and placebo groups, and J&J said the safety of Simponi in the colitis study was consistent with the drug's safety profile in the diseases for which it's already approved.

As a class of drugs, Simponi and other anti-TNFs are associated with increased risk of infections and certain forms of cancer such as lymphoma.

The data suggest Simponi could be a new treatment option for ulcerative colitis patients who don't respond to other drugs, or who prefer the convenience of a subcutaneous injection, said William Sandborn, chief of the division of gastroenterology at the University of California, San Diego, and lead investigator of the J&J-funded study.

J&J also has studied Simponi over a longer treatment duration in colitis patients, and results are expected later this year.

J&J plans to apply for U.S. and European regulatory approval of Simponi as a treatment for ulcerative colitis this year, said J&J spokesman Brian Kenney.

Abbott Laboratories (>> Abbott Laboratories) also has applied for regulatory approval of its anti-inflammatory drug, Humira, as a treatment for ulcerative colitis. European regulators have approved the new indication.

Last year, the FDA declined to approve J&J's requests to market Simponi's ability to inhibit progression of structural damage in both rheumatoid arthritis and psoriatic arthritis.

-By Peter Loftus, Dow Jones Newswires; +1-215-982-5581; peter.loftus@dowjones.com

Stocks mentioned in the article : Johnson & Johnson, Abbott Laboratories
share with twitter share with LinkedIn share with facebook
share via e-mail
0
Latest news on JOHNSON & JOHNSON
02/24 JOHNSON & JOHNSON : Remarks by President Trump at Signing of Executive Order on ..
02/24 JOHNSON & JOHNSON : Fourth Talcum Powder Lawsuit Heads to Trial in Missouri Ovar..
02/24 JOHNSON & JOHNSON : ex-dividend day
02/23 JOHNSON & JOHNSON : S&P upgrades Google's owner to its second-highest ranking
02/23 JOHNSON & JOHNSON : Anti-diarrhea medication ripe for abuse by opioid addicts, a..
02/22 Genmab and J&J's cancer drug set for blockbuster sales this year
02/21 Icahn buys Bristol-Myers shares, adding to activist pressure
02/21 JOHNSON & JOHNSON : Ford Still Can Repair its Brand in South Africa but it Needs..
02/21 JOHNSON & JOHNSON : Ford still can repair its brand in South Africa but it needs..
02/20 MEDTRONIC : Global High Speed Surgical Drill Market- Medtronic, Johnson and John..
More news
Sector news : Pharmaceuticals - NEC
02/24DJSHIRE : Files 8K - Other Events
02/24DJASTRAZENECA : Hyperkalaemia Drug Clears Scientific Hurdle for European Approval
02/24DJASTRAZENECA : Gets Approval for Drug Treating Hyperkalaemia
02/24 Exclusive - Trump says Republican border tax could boost U.S. jobs
02/23DJPFIZER : Files 8K - Changes Executive Management
More sector news : Pharmaceuticals - NEC
News from SeekingAlpha
02/24 UPCOMING EVENTS : J&J And NeuroDerm Put New Delivery Routes To The Test
02/24 A Dividend Portfolio Built From The World's Best Dividend ETFs
02/24 ValueAct Capital Is Going Risk-Off. Right Or Wrong?
02/24 SYNERGY : 3 Scenarios, 1 Choice
02/24 Europe's CHMP backs expanded use of Janssen Biotech's Darzalex
Advertisement
Financials ($)
Sales 2017 74 655 M
EBIT 2017 23 131 M
Net income 2017 18 272 M
Finance 2017 22 793 M
Yield 2017 2,73%
P/E ratio 2017 18,40
P/E ratio 2018 17,25
EV / Sales 2017 4,17x
EV / Sales 2018 3,94x
Capitalization 333 891 M
More Financials
Chart JOHNSON & JOHNSON
Duration : Period :
Johnson & Johnson Technical Analysis Chart | JNJ | US4781601046 | 4-Traders
Full-screen chart
Technical analysis trends JOHNSON & JOHNSON
Short TermMid-TermLong Term
TrendsBullishBullishNeutral
Technical analysis
Income Statement Evolution
More Financials
Consensus
Sell
Buy
Mean consensus OUTPERFORM
Number of Analysts 22
Average target price 125 $
Spread / Average Target 2,1%
Consensus details
EPS Revisions
More Estimates Revisions
Managers
NameTitle
Alex Gorsky Chairman & Chief Executive Officer
Dominic J. Caruso Chief Financial Officer & Vice President
Paulus Stoffels Chief Scientific Officer & Executive VP
Charles O. Prince Independent Director
William David Perez Independent Director
More about the company
Sector and Competitors
1st jan.Capitalization (M$)
JOHNSON & JOHNSON5.63%333 891
ROCHE HOLDING LTD.5.98%210 192
PFIZER INC.4.86%207 902
NOVARTIS AG4.72%202 648
MERCK & CO., INC.11.86%182 412
SANOFI4.79%109 848
More Results