The litany of clinical trial failures for Eli Lilly's pipeline programs is likely to force the company to start carving up its R&D budget as the pharma giant enters a 7-year drought on the sales side, according to a group of analysts tracked by the Indianapolis Business Journal.
The long and frustrating search for something--anything--that can treat Alzheimer's or blunt its symptoms ran into yet another Phase III roadblock this morning as Baxter International reported that its Phase III study of the immune-bolstering treatment Gammagard ended in failure.
There has been growing buzz among Alzheimer's researchers that they need to shift their attention to early-stage patients, whose brains are not yet severely damaged by the disease. The FDA added its voice to the move, offering a new draft guidance today aimed at shooing investigators toward a more realistic goal.
Even as failures in the field pile up, Merck CEO Kenneth Frazier is pushing ahead with a massive development program for a drug to boost HDL or "good" cholesterol.
Eli Lilly's ($LLY) solanezumab has secured an endorsement from Alzheimer's researchers, who will study the experimental drug as a preventive therapy against the memory-robbing disease in patients before symptoms emerge.
After meetings with top regulators, Eli Lilly has opted to wait on filing for U.S. and European approvals of its closely watched Alzheimer's candidate solanezumab. Instead, the Indianapolis-based drug giant will embark on a new Phase III study to further investigate whether the antibody therapy slows cognitive declines in patients with the memory-robbing disease.
Alzheimer's research has been dominated for years by the amyloid beta hypothesis: Toxic loads of the protein build up in the brain, blighting its ability to retain memories. Cut amyloid levels, say advocates, and you can delay or prevent the disease.
In the two pivotal Phase III studies of the drug, investigators determined that there was a noticeable effect on the level of beta amyloid found in patients' blood, suggesting that solanezumab had reduced levels of the toxic protein in the brain.
Washington University School of Medicine in St. Louis has pieced together a pioneering new study that will help put a new theory on preventing Alzheimer's to a definitive test. And the outcome could help pave the way for a megablockbuster approach to treating a disease that afflicts millions.
Shares of Eli Lilly surged today after investigators spelled out the encouraging solanezumab data they plucked out of a secondary analysis of a group of patients with a mild form of the memory-wasting disease.