JOHNSON & Johnson will seek US regulatory approval for the experimental Alzheimer’s treatment bapineuzumab – being developed with Irish company Elan – in 2012 or 2013, sticking with efforts to treat a disease where other drugmakers have failed.
J&J sees bapineuzumab as the “cornerstone” of its efforts to treat the brain-wasting disease, Husseini Manji, J&J’s global therapeutic area head for neuroscience, said at a company conference.
The drug has reduced the growth of plaques in the brain thought to be tied to the disease, Mr Manji said. At least a dozen potential treatments designed to slow or stop the plaques from forming have failed in mid- to late-stage testing since 2003.
Eli Lilly said in August it was suspending development of one such drug.
Mr Manji said J&J was moving ahead with trials of bapineuzumab, which the company shares with Elan and Pfizer/Wyeth.
“We continue to remain optimistic that bapineuzumab will be the first treatment” to change the course of the disease instead of merely slowing symptoms, he told investors and analysts. “We hope to bear the fruits of these investments.”
The drug was linked to a side effect similar to swelling of the brain when given at high doses in study results released last year. The effects were temporary and ended when patients were taken off the therapy, Mr Manji said. The first results from four clinical trials are due in mid-2012, he said.
Bapineuzumab, if successful, “could yield multi-billions of dollars in sales given the high unmet need in Alzheimer’s disease,” said Jami Rubin, a Goldman Sachs analyst in a note to clients earlier this month. “Drug development in Alzheimer’s disease has also proven to be very risky given the high failure rate” of experimental treatments, she said.
J&J gained its share in the drug when it bought an 18 per cent stake in Elan for $1 billion.
Alzheimer’s affects 5.4 million people in the US, and sales of currently approved drugs reached $7 billion last year, Mr Manji said.
The side-effects and mixed results in past trials give reason to be sceptical about the drug’s prospects and likely mean additional trials will be needed, said Michael Weinstein, a JPMorgan Chase analyst based in New York, in a note to clients. “Yet, the company’s internal enthusiasm and confidence is noteworthy,” he said.
J&J remains confident in the drug after a re-analysis of the data and evidence that bapineuzumab reduces proteins in the brain tied to Alzheimer’s, said Paul Stoffels, J&J’s worldwide co-chairman for pharmaceuticals. – (Bloomberg)
