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AZ takes $381.5m hit on two late-stage trial failures

Will drop ovarian cancer treatment olaparib and scale back ambitions for depression drug TC-5214

AstraZeneca is to discontinue its cancer treatment olaparib and scale back its ambitions for depression drug TC-5214 at a cost of $381.5m after they disappointed in clinical trials.

TC-5214, the most advanced of the drugs, failed to hit its primary endpoint in a phase III trial for major depressive disorder.

TC-5214 currently has four phase III efficacy and tolerability studies trials on-going, but two of these have failed to reach their primary endpoint.

The most recent study to miss its target was investigating the drug as an adjunct therapy to an antidepressant in patients with major depressive disorder who do not respond adequately to initial antidepressant treatment.

However, it failed to show significant improvement over placebo in a patient's measure on the Montgomery-Asberg Depression Rating Scale after eight weeks of treatment.

Meanwhile, phase II studies of olaparib were halted after an interim analysis indicated that previously reported progression free survival benefits were unlikely to translate into an overall survival benefit.

This outcome is the 'definitive measure' of patient benefit in ovarian cancer. A suitable tablet dose of the treatment also proved elusive for the company.

The failure of the study (known as study 19) follows a flexible dose trial of the compound that also failed to meet its primary endpoint.

Olaprib's termination results in a charge of $285m while AstraZeneca will also be hit by a $96.5m fee based on the lower probability of success for the remaining TC-5214 studies.

The costs will be recorded as part of AstraZeneca's R&D expenses for the fourth quarter of 2011.

Two remaining phase III trials of TC-5214 will be continued, as will an additional long-term safety study.

Results from these are expected in the first half of 2012, with a potential new drug application to be submitted to European regulators in 2015, and their US counterparts in the second half of 2012, if results fare better than the other trials.

However, AstraZeneca will face an additional charge of $96.5m if these studies also fail to reach their primary endpoints.

20th December 2011

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