J&J Will Seek FDA Approval by 2013 for Alzheimer’s Drug
Johnson & Johnson (JNJ) will seek U.S. regulatory approval of the experimental Alzheimer’s treatment bapineuzumab 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 today. The drug has reduced the growth of plaques in the brain thought tied to the disease, Manji said at the meeting in New Brunswick, New Jersey, where J&J is based.
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. Indianapolis-based Eli Lilly & Co. (LLY) said in August it was suspending development of one such drug. Manji said J&J is moving ahead with trials of bapineuzumab, which the company shares with New York-based Pfizer Inc. (PFE)
“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 at the meeting. “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, Manji said.
The first results from four clinical trials of the treatment are due in mid-2012, he said.
Johnson & Johnson fell 21 cents to $65.51 at 4:01 p.m. in New York Stock Exchange composite trading. Pfizer rose 12 cents to $20.90. Pfizer is the world’s biggest seller of health-care products by annual sales, followed by J&J.
J&J expects a U.S. Food and Drug Administration panel to consider data later this year on Xarelto, an experimental blood thinner to prevent strokes shared with Bayer AG of Leverkusen, Germany, said Martin Fitchet, head of J&J’s cardiovascular research.
The agency will probably rule on the drug’s use in patients with atrial fibrillation, an irregular heartbeat that can lead to stroke, by the end of this year, he said at the conference. Another application, to market Xarelto to prevent blood clots in immobilized patients in the hospital, may be delayed past 2011 because of study data that suggested the medicine may raise the risk of bleeding, Fitchet said.
The agency may rule on a third use for the drug, in orthopedic-surgery patients, in July, said Ernie Knewitz, a J&J spokesman, in an interview. The medicine is also called rivaroxaban.
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 Group Inc. analyst in New York, in a May 11 note to clients. “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 with its 2009 purchase of an 18 percent stake in Dublin-based Elan Corp. for $1 billion. Alzheimer’s affects 5.4 million people in the U.S., and sales of currently approved drugs reached $7 billion last year, Manji said.
The side effects and mixed results in past trials give reason to be skeptical about the drug’s prospects and likely mean additional trials will be needed, said Michael Weinstein, a JPMorgan Chase & Co. analyst based in New York, in a note to clients today.
“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, in a news conference after the meeting.
Bapineuzumab may have “the most potential” of any of J&J’s experimental drugs nearing approval, said Sheri McCoy, vice chairman of the company’s executive committee.
“The science is new and evolving so there’s more risk in that, but at the same time, we have the opportunity” to affect millions of patients, she said.
The company’s pharmaceuticals division expects to seek approvals for 11 new products and expand approved uses for more than 30 existing drugs between 2011 and 2015, J&J said in a statement today.
Prescription drugs accounted for 36 percent of last year’s $61.6 billion in revenue for J&J, which also sells consumer products such as Tylenol and Rolaids and medical devices including heart stents, artificial hips and surgical sutures.
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