* Gout drug works as preventive therapy, fails as treatment
* Co testing the drug in two other preventive trials
* Co sees filing for approval mid-2011
June 9 (Reuters) - Regeneron Pharmaceuticals Inc said a late-stage study of its experimental gout drug met the main trial goal of preventing gout attacks, while a second late-stage study failed to improve gout-related pain.
The late-stage study that tested the drug Arcalyst as a preventive therapy in 241 patients showed 160 milligrams dose of the drug decreased gout flares by 80 percent as compared to a dummy drug, while the 80 mg dose showed a 73 percent reduction.
The second late-stage trial, which evaluated the drug as a treatment for acute gout flares in 225 patients, did not meet the main goal of significantly reducing the average intensity of gout pain, as compared to a common, but potent, painkiller.
The company said pending successful results from two other ongoing studies on the drug as a preventive therapy, it plans to file for regulatory approval by mid-2011.
Gout, a painful type of arthritis in which a build up of uric acid causes swollen joints, affects about 5 million Americans.
Treatment with Arcalyst, in both the studies, was generally well tolerated with no reported drug-related serious adverse events, Regeneron said in a statement.
The most commonly reported adverse event in the preventive study was injection site reaction, and that in the pain treatment study was headache.
Shares of the company closed at $26.50 Tuesday on Nasdaq.
(Reporting by Esha Dey in Bangalore; Editing by Aradhana Aravindan)
((esha.dey@thomsonreuters.com; within U.S. +1 646 223 8780; outside U.S. +91 80 4135 5800; Reuters Messaging: esha.dey.thomsonreuters.com@reuters.net)) Keywords: REGENERON/
* Gout drug works as preventive therapy, fails as treatment
* Co testing the drug in two other preventive trials
* Co sees filing for approval mid-2011
* Shares fall 4 percent
(Adds details, analyst comment, stock movement)
BANGALORE, June 9 (Reuters) - Regeneron Pharmaceuticals Inc said a late-stage study of its experimental gout drug met the main trial goal of preventing gout attacks, while a second late-stage study failed to improve gout-related pain, sending its shares down 4 percent.
However, RBC Capital Markets analyst Michael Yee said he sees Tuesday's news as a 'net positive in general,' and called the prevention data robust.
'The pain study was higher risk, as less data is available there previously,' Yee added.
Gout, a painful type of arthritis in which a build up of uric acid causes swollen joints, affects about 5 million Americans.
The company is developing its drug Arcalyst for preventing or treating gout flares in patients who received uric acid-lowering therapy. The therapy often triggers a rise in frequency of gout attacks in the first several months of treatment.
The late-stage study that tested the drug, generically known as rilonacept, as a preventive therapy in 241 patients showed 160 milligrams dose of the drug decreased gout flares by 80 percent as compared to a dummy drug, while the 80 mg dose showed a 73 percent reduction.
The second late-stage trial, which evaluated the drug as a treatment for acute gout flares in 225 patients, did not meet the main goal of significantly reducing the average intensity of gout pain, as compared to a common, but potent, painkiller.
The company said pending successful results from two other ongoing studies on the drug as a preventive therapy, it plans to file for regulatory approval by mid-2011.
RBC analyst Yee said flare prevention is a few hundred million dollars opportunity, though the challenge for the company will be to get doctors to use the drug upfront even before a flare has happened.
Treatment with Arcalyst, in both the studies, was generally well tolerated with no reported drug-related serious adverse events, Regeneron said in a statement.
The most commonly reported adverse event in the preventive study was injection site reaction, and that in the pain treatment study was headache.
Other U.S. companies developing gout treatments are Savient Pharmaceuticals Inc, Ardea Biosciences Inc and BioCryst Pharmaceuticals Inc. Swiss drugmaker Novartis AG is also developing a treatment for gout.
Shares of Regeneron were down 4 percent at $25.35 on Nasdaq.
(Reporting by Esha Dey in Bangalore; Editing by Aradhana Aravindan) Keywords: REGENERON/ (esha.dey@thomsonreuters.com; within U.S. +1 646 223 8780; outside U.S. +91 80 4135 5800; Reuters Messaging: esha.dey.thomsonreuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2010. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
* Co testing the drug in two other preventive trials
* Co sees filing for approval mid-2011
June 9 (Reuters) - Regeneron Pharmaceuticals Inc said a late-stage study of its experimental gout drug met the main trial goal of preventing gout attacks, while a second late-stage study failed to improve gout-related pain.
The late-stage study that tested the drug Arcalyst as a preventive therapy in 241 patients showed 160 milligrams dose of the drug decreased gout flares by 80 percent as compared to a dummy drug, while the 80 mg dose showed a 73 percent reduction.
The second late-stage trial, which evaluated the drug as a treatment for acute gout flares in 225 patients, did not meet the main goal of significantly reducing the average intensity of gout pain, as compared to a common, but potent, painkiller.
The company said pending successful results from two other ongoing studies on the drug as a preventive therapy, it plans to file for regulatory approval by mid-2011.
Gout, a painful type of arthritis in which a build up of uric acid causes swollen joints, affects about 5 million Americans.
Treatment with Arcalyst, in both the studies, was generally well tolerated with no reported drug-related serious adverse events, Regeneron said in a statement.
The most commonly reported adverse event in the preventive study was injection site reaction, and that in the pain treatment study was headache.
Shares of the company closed at $26.50 Tuesday on Nasdaq.
(Reporting by Esha Dey in Bangalore; Editing by Aradhana Aravindan)
((esha.dey@thomsonreuters.com; within U.S. +1 646 223 8780; outside U.S. +91 80 4135 5800; Reuters Messaging: esha.dey.thomsonreuters.com@reuters.net)) Keywords: REGENERON/
* Gout drug works as preventive therapy, fails as treatment
* Co testing the drug in two other preventive trials
* Co sees filing for approval mid-2011
* Shares fall 4 percent
(Adds details, analyst comment, stock movement)
BANGALORE, June 9 (Reuters) - Regeneron Pharmaceuticals Inc said a late-stage study of its experimental gout drug met the main trial goal of preventing gout attacks, while a second late-stage study failed to improve gout-related pain, sending its shares down 4 percent.
However, RBC Capital Markets analyst Michael Yee said he sees Tuesday's news as a 'net positive in general,' and called the prevention data robust.
'The pain study was higher risk, as less data is available there previously,' Yee added.
Gout, a painful type of arthritis in which a build up of uric acid causes swollen joints, affects about 5 million Americans.
The company is developing its drug Arcalyst for preventing or treating gout flares in patients who received uric acid-lowering therapy. The therapy often triggers a rise in frequency of gout attacks in the first several months of treatment.
The late-stage study that tested the drug, generically known as rilonacept, as a preventive therapy in 241 patients showed 160 milligrams dose of the drug decreased gout flares by 80 percent as compared to a dummy drug, while the 80 mg dose showed a 73 percent reduction.
The second late-stage trial, which evaluated the drug as a treatment for acute gout flares in 225 patients, did not meet the main goal of significantly reducing the average intensity of gout pain, as compared to a common, but potent, painkiller.
The company said pending successful results from two other ongoing studies on the drug as a preventive therapy, it plans to file for regulatory approval by mid-2011.
RBC analyst Yee said flare prevention is a few hundred million dollars opportunity, though the challenge for the company will be to get doctors to use the drug upfront even before a flare has happened.
Treatment with Arcalyst, in both the studies, was generally well tolerated with no reported drug-related serious adverse events, Regeneron said in a statement.
The most commonly reported adverse event in the preventive study was injection site reaction, and that in the pain treatment study was headache.
Other U.S. companies developing gout treatments are Savient Pharmaceuticals Inc, Ardea Biosciences Inc and BioCryst Pharmaceuticals Inc. Swiss drugmaker Novartis AG is also developing a treatment for gout.
Shares of Regeneron were down 4 percent at $25.35 on Nasdaq.
(Reporting by Esha Dey in Bangalore; Editing by Aradhana Aravindan) Keywords: REGENERON/ (esha.dey@thomsonreuters.com; within U.S. +1 646 223 8780; outside U.S. +91 80 4135 5800; Reuters Messaging: esha.dey.thomsonreuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2010. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.