Investors Excited Over Eli Lilly and Biogen's Upcoming Alzheimer’s Drug Data

July 20, 2015
By Mark Terry, BioSpace.com Breaking News Staff

Eli Lilly and Company and Biogen, Inc. will be presenting data regarding their drugs for Alzheimer’s disease at this week’s Alzheimer’s Association International Conference, and the buzz is building for positive results.

Lilly will be presenting data on a clinical trial of its drug solanezumab. The drug has been marked by disappointing clinical trials in 2012, failing to show the symptoms of Alzheimer’s compared to placebo. But in the last two to three years, Lilly researchers began to analyze a subgroup of AD patients that had a mild form of the disease that responded to the drug.

Solanezumab is a transfused antibody that binds to amyloid, one of the proteins found in the brain of Alzheimer’s patients, and removes it from the brain. The company has estimated that about 25 percent of the patients in previous trials were not appropriate for the drug and now their Phase III trials utilize brain imaging technology to verify that all patients have the amyloid plaque.

“This year is different,” said Reisa Sperling, director of the Center for Alzheimer’s Research at Harvard Medical School in a Reuters article, “because multiple mechanisms are being explored and there’s a tremendous revival of faith in the anti-amyloid approach.”

On Wednesday, Biogen will present data on its drug aducanumab, specifically regarding dosages of six milligrams. On March 20, 2015, Biogen announced the results of a Phase IIb trial for aducanumab, which showed a significant decrease in amyloid plaque in AD patients.

Like the Lilly trials, Biogen has been in the process of identifying and narrowing the subpopulation of AD patients that can benefit from its drug. “We’re at a stage now where we understand the appropriate patient populations,” said Biogen’s George Scangos, chief executive officer in a conference call.

In previous clinical trials, Biogen studied four different doses, a placebo group, and a one milligram, three milligram and 10 milligram dosage study. In data disclosed in March, the three milligram and 10 milligram groups showed statistically-significant decrease in amyloid accumulation, with evidence that the decline in brain function slowed. The data of the six milligram dosage will be new.

Although it seems that the higher the dosage, the slower the brain function decline, there are safety issues. Approximately 35 percent of the patients in the 10 milligram group that had a specific gene known as ApoE4 discontinued the trial due to adverse side effects, compared to about eight percent with those that did not have the ApoE4 gene. The hope is that the six milligram dosage will split the difference between effectiveness and safety.

If several companies come up with slightly different viable approaches, researchers believe potential drug cocktails can be developed as “a 1-2-3 punch,” said Sperling.

“Another five to eight years down the road,” said Ronald Peterson, director of the Mayo Clinic’s Alzheimer’s Disease Research Center in the Reuters article, “even before symptoms appear, we will be treating with a cocktail of therapies.”

A lot rests on the possible success. About 123 drugs for Alzheimer’s have failed in the past. Although the companies haven’t disclosed specifics about the costs of their AD drug development, large drug studies often cost more than $100 million. The payoff would be considerable for any company developing a viable Alzheimer’s drug. Jeffrey Holford, analyst with Jefferies and Co. , predicted that if the Lilly drug was approved, it could create top annual sales of more than $3 billion worldwide.

With the Baby Boomers aging, estimates are that the annual costs related to Alzheimer’s care will increase five-fold to $1.2 trillion over the next 40 years. Any company developing a good AD therapy is going to be a leader in the industry for years.