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

4-Traders Homepage  >  Equities  >  Nasdaq  >  Regeneron Pharmaceuticals Inc    REGN

Delayed Quote. Delayed  - 09/30 10:14:59 pm
402.02 USD   -1.07%
09/30 NASDAQ 100 MOVE : Ctsh, nxpi
09/30 REGENERON PHARM : Announces Phase 2 Study of Aflibercept Co-Formulat..
09/27 FDA GRANTS PRIO : REGN), Sanofi SA (NYSE:SNY)
SummaryQuotesChartsNewsAnalysisCalendarCompanyFinancialsConsensusRevisions 
News SummaryMost relevantAll newsSector news 

FDA: Regeneron Drug Offers 'Small' Benefit In Gout

share with twitter share with LinkedIn share with facebook
share via e-mail
0
05/04/2012 | 05:24pm CEST

--Regeneron seeks wider FDA approval for drug Arcalyst in gout patients

--Arcalyst is now on the market for rare disease

--Arcalyst will be reviewed by FDA advisory panel on Tuesday

--Agency is concerned about small treatment effect, possible increased cancer risk

(Adds information on cancer imbalance, and on similar drug from Novartis, in the third, eighth and ninth paragraphs.)

 
   By Jennifer Corbett Dooren 
   Of  
 

The U.S. Food and Drug Administration said that the treatment effect from a proposed Regeneron Pharmaceuticals Inc. (>> Regeneron Pharmaceuticals Inc) treatment for gout was "small," and the agency raised concerns that the product might increase the risk for cancer.

Regeneron is seeking FDA approval for short-term use of a drug called Arcalyst to treat gout, a form of arthritis. Arcalyst, also known by its generic name rilonacept, is already on the market to treat a rare disease called Cryopyrin-Associated Periodic Syndromes.

The product is an injection that is designed to block a protein called interleukin-1, which is secreted by infection-fighting cells in the body. Too much interleukin-1 can be harmful and is linked with several inflammatory diseases, including gout. But many drugs that block proteins in the body can also increase the risk of serious infections and possibly cancer. The FDA has so far refused to approve a similar drug, Ilaris, from Novartis AG (NVS, NOVN.VX) that Novartis has proposed to use as a long-term treatment in certain gout patients, partly because of concerns about infections.

Regeneron is proposing to use Arcalyst as a short-term, 16-week treatment for gout in combination with other drugs. Gout is caused by a build-up of uric acid, which causes pain, redness, tenderness and a feeling of warmth in joints, often in the joint at the base of the big toe. Patients are treated with a drugs such as allopurinol to lower uric acid. However, during the first few months of treatment, gout can often become worse while uric acid is being lowered. Arcalyst is meant to be used as a temporary treatment while uric-acid levels stabilize.

Arcalyst will be reviewed by the FDA's arthritis drugs advisory committee--made up of non-FDA medical experts--on Tuesday. The FDA released a staff review of the product on Friday in preparation for the meeting.

The agency said clinical studies of the drug showed more patients receiving Arcalyst had a reduction in gout flares compared to those who didn't receive the drug. "However, the treatment effect was small," FDA said. The agency explained that patients in the placebo group had an average of only one gout flare during the 16-week period while those receiving an 80-milligram dose of Arcalyst had about 0.3 flare.

The agency also said that, in the "studied gout population, rilonacept appears to be associated with an increased risk of malignancy," although the FDA also noted that people in the study were already at an increased risk of cancer. The agency said the risk "is small but may be real."

The FDA said there were six cancers in the gout studies seen in patients taking Arcalyst compared to none in the placebo group. In at least two of those cases, Regeneron said, the cancer was diagnosed soon after starting treatment with Arcalyst and it was determined that the cancer had been present before treatment had started.

The agency noted that treatment with the drug lasted only for 16 weeks and most cancers take far longer to develop. However, the FDA said long-term safety data for Arcalyst was lacking.

The panel will be asked to vote on a series of questions such as whether the data submitted support the safety and effectiveness of the drug. The outcome of the votes will amount to a recommendation about whether the panel thinks the FDA should approve the product. The FDA isn't required to follow the advice of its panels but usually does.

Regeneron, in a document prepared for the Tuesday meeting, said the drug is safe and effective for treating gout "and would provide a new option for physicians" to manage the disease.

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com

Stocks mentioned in the article : Regeneron Pharmaceuticals Inc
share with twitter share with LinkedIn share with facebook
share via e-mail
0
Latest news on REGENERON PHARMACEUTICALS
09/30 NASDAQ 100 MOVERS : Ctsh, nxpi
09/30 REGENERON PHARMACEUTICALS : Announces Phase 2 Study of Aflibercept Co-Formulated..
09/29 REGENERON PHARMACEUTICALS : and Teva Announce Global Collaboration to Develop an..
09/29 REGENERON PHARMACEUTICALS : Assigned Patent
09/27 FDA GRANTS PRIORITY REVIEW FOR DUPIL : REGN), Sanofi SA (NYSE:SNY)
09/26DJSANOFI : FDA Accepts Sanofi's, Regeneron's Dermatitis Treatment for Priority Rev..
09/22 REGENERON PHARMACEUTICALS : Assigned Patent
09/20 REGENERON PHARMACEUTICALS : Teva buys rights to Regeneron chronic pain drug for ..
09/20 REGENERON PHARMACEUTICALS INC : Entry into a Material Definitive Agreement (form..
09/20 Bayer raises sales targets for top-selling drugs after Monsanto deal
More news
Sector news : Bio Therapeutic Drugs
09/29DJARROWHEAD PHARMACEUTICALS : Amgen, Arrowhead Pharma Agree to Cardiovascular Coll..
09/27DJAMGEN : Myeloma Treatment Study Fails to Meet Primary Endpoint
09/23DJAMGEN : FDA Approves Amgen's Biosimilar Version of Humira -- 2nd Update
09/23DJAMGEN : FDA Approves Amgen's Biosimilar Version of Humira -- Update
09/23DJAMGEN : FDA Approves Amgen's Biosimilar Version of Humira
More sector news : Bio Therapeutic Drugs
News from SeekingAlpha
09/30 BIOTECH FORUM DAILY DIGEST : A Volatile Few Days, Some Small Caps Blow Up, Spotl..
09/30 AMGEN GETS BUSY; MANY NEWS ITEMS : Anything Good Yet?
09/30 Regeneron's failed mid-stage study of rinucumab weights on Ophthotech; shares..
09/30 Sanofi announces thematic call on Dupilumab
09/30 Regeneron's Eylea combo no better than Eylea alone in mid-stage study in wet ..
Advertisement
Financials ($)
Sales 2016 5 073 M
EBIT 2016 1 798 M
Net income 2016 731 M
Finance 2016 961 M
Yield 2016 -
P/E ratio 2016 66,74
P/E ratio 2017 45,81
EV / Sales 2016 8,25x
EV / Sales 2017 6,85x
Capitalization 42 787 M
More Financials
Chart REGENERON PHARMACEUTICALS
Duration : Period :
Regeneron Pharmaceuticals  Technical Analysis Chart | REGN | US75886F1075 | 4-Traders
Full-screen chart
Technical analysis trends REGENERON PHARMAC...
Short TermMid-TermLong Term
TrendsBullishBullishBearish
Technical analysis
Income Statement Evolution
More Financials
Consensus
Sell
Buy
Mean consensus OUTPERFORM
Number of Analysts 26
Average target price 468 $
Spread / Average Target 15%
Consensus details
EPS Revisions
More Estimates Revisions
Managers
NameTitle
Leonard S. Schleifer President, CEO & Class I Director
P. Roy Vagelos Chairman
Robert E. Landry Chief Financial Officer & Senior VP-Finance
George Damis Yancopoulos Class I Director & Chief Scientific Officer
Charles A. Baker Independent Class III Director
More about the company
Sector and Competitors
1st jan.Capitalization (M$)
REGENERON PHARMACEUTIC..-25.15%42 787
AMGEN, INC.1.92%123 816
GILEAD SCIENCES, INC.-23.06%102 749
CELGENE CORPORATION-14.19%79 659
VERTEX PHARMACEUTICALS..-32.45%21 061
ACTELION LTD21.70%18 780
More Results