After Failed Trials, Johnson & Johnson Turns to Early Stage Alzheimer's

A little over a year ago, Dr. Husseini Manji, global head of neuroscience drug development at Johnson & Johnson, predicted that brain researchers were on the cusp of a golden age. That was before J&J's highly anticipated Alzheimer's drug, bapineuzumab, failed to improve memory and thinking skills in closely watched clinical trials of people with mild to moderate forms of the disease. Had it worked, the drug would have been the first to alter the course of Alzheimer's, a fatal brain-wasting disease that affects 36 million people worldwide. It also would have meant billions of dollars in annual sales. Instead, J&J and its partners, Pfizer and Elan, pulled the plug on the intravenous treatment after years of development. Nevertheless, Manji, the Kenyan-born scientist who spent 15 years researching neuropsychiatric diseases for the National Institutes of Health, stands by his prediction. The former chief of the NIH's Mood and Anxiety Disorders Program, who recently met with computer experts at NASA to understand how best to untangle the web of disparate information on brain science, says there is nothing more complex than brain disorders. "We shouldn't expect it to be easy," Manji, 53, who leads the company's research efforts in Alzheimer's, mood disorders, schizophrenia and pain conditions, said in an interview. Like its rivals, J&J is preparing to pivot from testing drugs in people who already have dementia to early-stage patients, when drugs may have a better shot at working. In November, J&J partnered with Japan's Shionogi to gain access to Shionogi's oral beta secretase, or BACE, inhibitor, a promising new class of drugs that aims to prevent the production of the Alzheimer's-linked protein beta amyloid before it can form toxic clumps in people's brains. While J&J and its partners are retooling bapineuzumab into a more convenient shot formulation - instead of an IV - the company is also working on other approaches, including an amyloid-attacking antibody similar to bapineuzumab, called AAB003, and a vaccine that would enlist the help of an individual's immune system to fight the disease.