Eli Lilly & Co. (LLY) said its experimental Alzheimer’s treatment slowed the decline of cognition in some patients while failing to meet the primary goals of two large trials. The shares rose.
Lilly’s drug, solanezumab, delayed the worsening of mental loss in a sub-analysis of patients in the earliest stage of the disease, the Indianapolis-based company wrote in a statement (LLY) today. The medicine didn’t restore thinking, memory or daily activities in any of the groups studied.
The mixed finding wasn’t expected by analysts, who had given the drug a less than 20 percent chance of showing any benefit. Still, doctors and investors said more study is needed to confirm the positive outcome. Earlier this month, a similar- acting medicine from Pfizer Inc. (PFE)and Johnson & Johnson (JNJ) failed to help any group of Alzheimer’s patients in any way.
“People expected nothing, and instead we have some hints of efficacy,” said Mike Krensavage, founder of New York-based Krensavage Asset Management who owns shares of Lilly. “The right thing now is probably to do another trial.”
Lilly rose (LLY) 3.8 percent, or $1.63, to $44.03 at 9:48 a.m. in New York trading, after jumping 18 percent in the past 12 months before today.
The stock is being driven up by “the possibilities now left open,” for the drug and the low expectations investors had before today, Tim Anderson, an analyst with Sanford C Bernstein & Co., wrote in a note to clients.
COMBINED RESULTS
It’s unclear whether the findings will be enough to get U.S. Food and Drug Administration approval since the drug didn’t meet its primary goal in either study. A benefit was only seen when the two trial results were combined and the company did an analysis looking just at patients with the mild and mild-to- moderate stage of the disease.
“All these results ultimately will mean is that they have to do another study,” said David Knopman, a neurologist at the Mayo Clinic in Rochester, Minnesota and head of the trials’ data safety monitoring board. “For patients and families, I don’t think this can be anything but mostly disappointing.”
Lilly said it hasn’t determined yet what steps it will take and is in discussions with U.S. regulators. An outside group of Alzheimer’s researchers will do their own analysis of the findings and the full data will be presented at two medical meetings in October, Lilly said.
NO HOME RUN
“We wish we could have hit the primary endpoint, that would have been the absolute home run for this,” said Anthony Ware, Lilly’s vice president of biomedicines product development, in a telephone interview. “But once we saw the pooled statistical analysis and realized that this was the first agent ever to show a slowing in the cognitive decline in this group of patients, then we were excited by that.”
Even as the shares rose, some analysts cautioned against buying Lilly on the hope he drug will get to market.
“Their studies may continue, but today’s data only reinforces that you should not own Lilly as an Alzheimer’s play,” said Jon Fisher, a fund manager in the Minneapolis office of Fifth Third Asset Management, which manages $17.8 billion, in an e-mail.
“I had always viewed the Alzheimer’s efforts from Lilly and Pfizer as long shots,” Fisher wrote. “After seeing Pfizer discontinue its efforts, I think more of the market moved in this direction with Lilly too.”
DISEASE CAUSE
Despite billions of dollars spent and years of research, the only drugs now on the market only treat symptoms of the disease rather than the underlying cause. None slow its progression. There are 5.4 million Americans with Alzheimer’s and that number is expected to surge as the population ages.
The only other therapy in final-stage testing is Baxter International Inc. (BAX)’s Gammagard. The product is an expensive, scarce treatment derived from donated blood plasma that replaces antibodies in people whose immune systems can’t protect them from infection. Results on whether it could slow or stop Alzheimer’s may be available next year.
“I can predict two possible futures here” on the Lilly finding, said Bill Thies, chief medical and scientific officer for the Chicago-based Alzheimer’s Association. “We can’t replicate it and it becomes a historical anomaly, or we look back 20 years from now and say this is the day we moved toward managing Alzheimer’s disease. It would be nice to know the difference but, to be frank, we just don’t know yet.”
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