Roche stakes its claim as the leader in high-risk Alzheimer's R&D

Luca Santarelli, Roche's head of neuroscience

That dark cloud you've been watching form around the late-stage Alzheimer's drug development field has come equipped with a bright silver lining for Roche. Just as J&J/Pfizer's bapineuzumab has been laid to rest as a potential treatment for mild-to-moderate Alzheimer's and Lilly struggles to keep hope alive for its solanezumab program, Roche ($RHHBY) has emerged as the lead company with a late-stage prospect to consider. And it's seizing the moment to stake its claim for the next big attempt at a megablockbuster.

The drug is gantenerumab, which is partnered with MorphoSys AG. Roche has doubled the size of its clinical trial for the drug as it changes the focus from patients with an established case to early-stage disease, reports Reuters

Those failed Phase III studies have created doubts that the experimental drugs in the clinic today can help patients whose brains have been damaged by toxic concentrations of beta amyloid. So Roche will be relying on biomarkers found in spinal fluid to identify pre-symptomatic patients. In a small early-stage study that read out in late 2011, the antibody succcessfully lowered levels of beta amyloid. Now researchers will see if preventing accumulations could delay or prevent the disease. Data from the pivotal study is now expected in 2015.

"The playing field has changed dramatically and gantenerumab is now the most advanced monoclonal antibody in early Alzheimer's and the next big news to read out in this space," Luca Santarelli, Roche's head of neuroscience, tells Reuters' Ben Hirschler.   

Roche and Genentech are also studying crenezumab, an Alzheimer's drug partnered with Switzerland's AC Immune, which is in a Phase II study and is being readied for an innovative study involving high-risk patients. Both programs may represent the best near-term hope of seeing a new therapy that can help patients prevent Alzheimer's, an indication that could be worth billions in annual revenue.

- here's the story from Reuters

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