JERUSALEM Teva Pharmaceutical Industries Ltd. said the trial of its oral formulation of glatirameracetate, Copaxone, Teva’s drug for relapsing-remitting multiple sclerosis, failed due to a strong placebo effect.
Results released this week during a teleconference call of fourth-quarter results indicate that oral Copaxone did not achieve a statistically significant effect on relapse rate compared to placebo. But the company is not calling this a failure because the main trial criterion, reduction of relapses, was not significant against a surprisingly low number of relapses in the trial group.
“We have done the final analysis of the Phase III study of 5- and 50-mg doses of Copaxone, the CORAL trial, in enteric coated tablets. It looks like neither of these doses had a significant effect, similar to interim results published earlier this year, although the treatment showed a positive trend on redacting relapses,” Aharon Schwartz, Teva’s vice president, Global Products Division, told BioWorld International.
Schwartz said the trial of 1,650 patients produced an unexplained placebo effect.
“Over 1,000 patients, including 60 percent of the patients receiving placebo, did not make any relapses during the trial, so we could not measure a decrease in relapse rate,” he said. “If the usual placebo effect in previous trials with immunomodulatory agents ranged between 10 [percent] and 40 percent, here it was 60 percent.”
Teva stressed that the company still is studying all the results of the trial and considering its alternatives, together with partner H. Lundbeck A/S, of Copenhagen, Denmark, which had signed a two-year development and cooperation agreement to work on multiple sclerosis and Parkinson’s disease.
Schwartz added, “The unanticipated excess placebo effect follows in the footsteps of Myoral, another oral drug for multiple sclerosis in a clinical trial by AutoImmune Inc. This gives us hope that at a different treatment protocol, the oral regimen may still prove highly effective.”
Separately, Teva said it appointed Israel Makov as the company’s next president and CEO. Makov, chief operating officer since January 2001 and with Teva since 1995, will begin his term upon retirement of incumbent Eli Hurvitz, to take effect April 22 at Teva’s annual general shareholder meeting.
Hurvitz is anticipated to continue in a leadership role. Teva Chairman Meir Heth said, “We hope that Eli Hurvitz will become the next chairman” as soon as the general meeting elects him a director.
Hurvitz, who finishes 25 years as Teva’s president and CEO, said, “I am passing the baton to my colleague, Israel Makov, who for the past seven years has been a strong and influential leader and a major contributor to Teva’s success. Based on our experience, Teva will be led by a CEO, management team and an organization that will continue to implement the company’s strategy and lead it to new horizons.”
Makov, as executive vice president of business development, is credited with leading the company’s expansion and globalization strategy and developing Teva’s M&A and integration activities, which contributed significantly to the company’s top- and bottom-line growth during those seven years.
At the same time, Teva reported that revenue in the fourth quarter reached a record $567 million, beating all analysts’ expectations by $15 million. Revenue from Copaxone totaled $102 million in the fourth quarter, an increase of 42 percent from the same period last year, and 7.3 percent higher than in the preceding quarter.