The oral Copaxone trials conducted by Teva Pharmaceuticals (Nasdaq:TEVA) have failed, and capital market sources estimate that the drug giant will not carry out further trials.
Copaxone is used in the treatment of relapsing-remitting multiple sclerosis, and is administered via injections.
On September 17 Teva released interim results from trials of oral Copaxone, Coral, which indicated that patients who received high-dose Coral for over a year showed a positive response. But the results were not statistically significant.
An independent committee monitoring the trials recommended the trials continue through completion in October 2001.
The trials were carried out together with Danish drug manufacturer Lundbeck, and cost of millions of dollars. They began in mid-2000 and included 1,600 patients who were divided into three groups, receiving the treatment over a 56 week period.
After the September announcement Teva shares plunged 10% on a day Nasdaq lost 7%.
Teva ended the trials in December, and was due to release the results at the beginning of this year. However, to date the company hasn't released the results to investors or to the U.S. Food & Drug Administration, neither has it announced a date for additional trials.
Investec Securities analyst Kobby Finkelstein on Tuesday speculated about the reasons Teva hasn't released the results. The analyst said that either Teva is looking for a strategic partner to replace Lundbeck, or it is waiting for the right opportunity for such an announcement, for instance, when releasing its financial reports, due in two days.
In response, Teva said the oral Copaxone trials have recently ended and the trial code was cracked. The company said the final results are in line with the interim results. Teva noted that like past results, the present results also point to a positive effect in the trials' critical test, but as expected, the results are not statistically significant. The company said it is still studying the results, and examining the options with Lundbeck.