Alzheimer’s trial setback spurs an argument on ethics

The recent snafu regarding Eli Lilly's experimental Alzheimer's drug is causing some researchers to take a hard second look at how they communicate with people who sign up for drug trials. Do future participants in Alzheimer's studies need to be told about the new data indicating that patients who took the Lilly drug got worse? The New York Times' Gina Kolata discussed the issue with a few different ethicists who specialize in clinical trials. "We realize drugs can cause side effects and that...

Does Lilly need Genzyme more than Sanofi?

Eli Lilly's latest pipeline setback for Alzheimer's is adding extra pressure on CEO John Lechleiter to do something dramatic to quickly improve the pharma company's product mix. And that has BNET's Jim Edwards speculating that Lilly should jump in with a better offer for Genzyme, shoving Sanofi aside. After all, over the next four years Lilly faces the loss of patents on drugs that account for 60 percent of its revenue. And Effient has been a bust. The reasoning may be based on nothing but a...

Lilly’s Alzheimer’s disaster spells trouble for entire class

Eli Lilly's latest pratfall in the Alzheimer's arena could cause plenty of sleepless nights in the burgeoning research field. As Bloomberg reports, Lilly's Alzheimer's therapy works much like a number of other therapies in the pipeline--and a disaster for one could spell big trouble for all. For decades many researchers have operated under the assumption that the buildup of amyloid in the brain causes Alzheimer's, a memory-wasting disease that is claiming millions of new victims. But the...

Lilly halts Phase III Alzheimer’s program

The challenging field of Alzheimer's has claimed another drug development program. Eli Lilly (NYSE: LLY) said today that it's halting all Phase III trials of semagacestat after preliminary results showed the drug did not slow disease progression and was associated with worsening of clinical measures of cognition and the ability to perform activities of daily living. After reviewing preliminary results from 2,600 patients enrolled in two Phase III trials, researchers found that...

Data-sharing breeds Alzheimer’s progress

A 2003 venture to bring together the NIH, FDA, industry, universities and nonprofits is paying dividends for Alzheimer's biomarker research. There have been advancements in using imaging for early disease detection, and about 100 clinical studies are in progress for Alzheimer's. The Alzheimer's Disease Neuroimaging Initiative, as it is called, doesn't just raise money or conduct trials: one of the major goals when the group first set out in 2003 was to share information. All data on the...

Merck commits up to $289M for new Alzheimer’s collaboration

Undaunted by its mixed results trying to come up with a new therapy for Alzheimer's, Merck has struck a $289 million deal with Canada's Alectos Therapeutics to collaborate on new molecules for the memory-wasting ailment and other disorders. The pact includes an upfront payment and milestones, but there was no breakout on the payments. The collaboration will target that modulate O-linked N-acetylglucosaminidase, an enzyme that is believed to be involved in the development of Alzheimer's disease....

Elan, Transition push ahead with troubled Alzheimer’s drug

Elan and Transition Therapeutics have reported fresh trouble with their partnered Alzheimer's drug, noting that it failed to hit its mid-stage primary endpoints. Late last year the deaths of nine patients in the study prompted investigators to drop the highest dose being used in the trial. But the two developers say they're committed to pushing ahead into Phase III, despite a considerable amount of flak coming from analysts following their progress. Elan reported that the ELND005 study's...

‘Longevity’ gene cures Alzheimer’s in mice

A group of biologists at MIT say they have found solid evidence from an animal study that the SIRT1 pathway can be used to successfully treat Alzheimer's. In a study of mice modeled to suffer from Alzheimer's while producing higher levels of sirtuin one, the scientists found that the rodents retained both memory and learning abilities, warding off the disease....

Can Eisai’s new Alzheimer’s drug fill blockbuster shoes?

Eisai and Pfizer rolled out a new set of clinical trial numbers on their long-acting version of Aricept (donepezil), with the experimental 23 milligram extended-release formulation besting the 10 milligram immediate-release drug that the Japanese company relies on for the lion's share of its U.S. revenue. In a study which enrolled 1,476 patients, researchers said that the once-daily 23 milligram therapy proved more effective in maintaining and improving brain function than the...

Biomarkers promise to revolutionize Alzheimer’s research

A slate of new biomarkers developed to diagnose Alzheimer's at an early stage may revolutionize drug development work in the field. After years of study investigators have concluded that the dementia associated with the disease comes at the end of a lengthy process. But biomarkers that can be detected through brain scans, MRIs and spinal taps present a new opportunity to identify the disease early on, creating a big opening to slow or even stop disease progression before it blights a patient's...