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Teva and Active Biotech hit by Phase 3 drug failure

pharmafile | May 8, 2017 | News story | Research and Development, Sales and Marketing Active Biotech, Teva 

Teva and Active Biotech have been collaborating on the drug laquinimod since 2004 but it now looks like the work put in may not reap any reward after the companies were forced to admit failure in its most recent trial. The Phase 3 trial sought to determine whether the drug was able to reduce the progression of disability in relapsing-remitting multiple sclerosis (MS).

The drug had once been Teva’s big hope to replace Copaxone as the company’s main revenue driver, however, those hopes have now dimmed – with even commercialisation of the drug beginning to look like a challenge.

The trial involved 2199 patients and compared treatment with laquinimod against a placebo. The number of patients indicates the promise with which the treatment was initially held but the trial failed to meet its primary endpoint, only succeeding in certain secondary endpoints.

“We have learned a great deal from the CONCERTO trial and we will continue our analysis of the data,” said Michael Hayden, President of Global R&D and Chief Scientific Officer at Teva. “Although we are disappointed by not meeting the primary endpoint, we did see positive results on a number of secondary and exploratory endpoints which fuels our belief in the potential of laquinimod as a possible treatment for neurodegenerative diseases. While we have no current plans to further pursue laquinimod in RRMS, we are continuing to study it in two other trials.”

The two other trials mentioned are in primary progressive MS and in Huntington’s disease. Analysts may not hold out much hope for these trials after this failure. The warning signs for the drug were there early on, after it caused cardiovascular side-effects in patients on the highest dose of the drug. Dropping the dose for the most recent trial seems to have eliminated the safety issue but did not provide the results required.

Active Biotech’s shares were down by a third on the news whilst Teva’s also dipped slightly.

Ben Hargreaves

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