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jbog

04/11/11 6:22 PM

#118073 RE: DewDiligence #118069

Dew,


NEW YORK, April 11 (Reuters) - An experimental oral multiple sclerosis drug being developed by Teva Pharmaceutical Industries Ltd <TEVA.TA> reduced the disease's relapse rate by 23 percent over a placebo in a late stage study, according to data released on Monday.

Researchers said the Teva drug, laquinimod, proved to be effective, safe and well tolerated in the study that will be presented later this week at the American Academy of Neurology meeting in Honolulu, Hawaii.

Laquinimod was also associated with a 36 percent reduction in disability progression compared with placebo, while the progression of brain atrophy was reduced by 32.6 percent with the Teva drug.

The results were deemed to be statistically significant, researchers said.

Adverse side effects, such as headache and back pain, were similar in patients who took laquinimod and those who got a placebo.

There were elevations of liver enzymes seen with the Teva pill. But researchers said the enzyme elevations were transient, reversible and there were no signs of liver dysfunction. (Reporting by Bill Berkrot; editing by Andre Grenon)
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flatlander_60048

04/11/11 6:36 PM

#118074 RE: DewDiligence #118069

At first glance they seem similar to the results from Gylenia. However, I believe that Marth made comments that Gylenia was not a good drug due to side effects. I thought he had alluded that Laquinimod would have a much cleaner SE profile. The elevated liver enzymes may be a problem when long term usage are considered. The fact these elevated enzyme levels were noted to be reversible suggest that they reversed when treatment with Laquinimod was suspended. Did any of the discontinuations occur as a result of abnormal enzyme levels?

In any case, Teva is under pressure to show that they have a blockbuster replacement for copaxone, so one has to take Marth's statements with a grain of salt (especially when they are made before clinical testing has been fully completed).

FL
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Bio_pete

04/11/11 7:28 PM

#118081 RE: DewDiligence #118069

"The 23% and 36% reductions in relapse rate and disability progression, respectively, are in line with what Teva has been hinting at for the past few months. "

How do these rates compare to Copaxone?