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Pipeline Setback for Roche

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Roche (RHHBY) recently suffered a setback when it announced the termination of its phase III trial, AleCardio, on pipeline candidate aleglitazar.

The decision to terminate the trial came after the independent Data and Safety Monitoring Board (:DSMB) recommended the company halt the trial due to safety signals and lack of efficacy following a regular safety review.

We note that the trial was being conducted to evaluate the efficacy and safety of aleglitazar in patients with a recent acute coronary syndrome event and type II diabetes.

In addition to scrapping the AleCardio trial, Roche said that it has terminated all other trials related to aleglitazar.

We note that aleglitazar was designed to provide balanced dual peroxisome proliferator-activated receptor (:PPAR) alpha/gamma activation.

We remind investors that companies like AstraZeneca (AZN) and Bristol-Myers Squibb (BMY) had also attempted to develop a diabetes drug using this dual mechanism but failed.

We remind investors that Roche had suffered a setback in 2012 as well when it terminated its phase III trial on dalcetrapib after the independent DSMB cited lack of efficacy.

The trial was evaluating dalcetrapib’s efficacy and safety when added to the existing standard of care for the treatment of patients with stable coronary heart disease (CHD) following an acute coronary syndrome.

Nevertheless, Roche has another candidate, tofogliflozin in phase III, which is being developed to increase renal glucose excretion in patients with type II diabetes.

We expect investor focus on tofogliflozin henceforth.

Roche currently carries a Zacks Rank #4 (Sell). Right now, Santarus, Inc (SNTS) looks attractive with a Zacks Rank #1 (Strong Buy).

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