Dec 12 (Reuters) - Eli Lilly & Co plans to conduct a big new trial of its experimental Alzheimer's disease treatment among patients with mild symptoms, keeping alive a drug that failed two earlier large studies among patients with mild to moderate Alzheimer's.
Lilly said on Wednesday it decided, after talks with health regulators, not to seek U.S. approval of the drug, solanezumab, at least for now, based on data from the earlier trials. The data showed solanezumab helped some patients with mild Alzheimer's but fell short in the wider group.
Instead, Lilly plans to begin another late-stage trial that only enrolls those with mild symptoms. Additional details, including the study's design and duration, are still being determined.
"We remain encouraged and excited by the solanezumab data," David Ricks, president of Lilly Bio-Medicines said.
In premarket trading, Lilly shares fell 3.2 percent to $49.
The company plans to begin the new Phase III study by no later than the third quarter of 2013. Industry analysts have predicted a big new trial in patients with mild Alzheimer's could take three years.
They say solanezumab could generate annual sales of $2 billion to $7 billion, if proven safe and effective in that population as no drug has been able to stave off progression of the disease.
Other analysts, however, have been less impressed with the solanezumab data and predicted Lilly would not go to the trouble and expense of conducting another trial.
An estimated 5 million Americans have Alzheimer's, the biggest cause of dementia. More than 35 million people worldwide are believed to have dementia, including Alzheimer's disease, and those numbers are expected to rise as more countries see lifespans increase.
Lilly badly needs new medicines because its earnings will plunge through 2014 as its biggest products face competition from cheaper generics.
Solanezumab could play a big role in reviving company results, should it win approval, Leerink Swann analyst Seamus Fernandez said.
Lilly said in August its experimental drug, given by intravenous infusion, appeared safe but failed to prevent progression of mental and physical decline in two big studies that enrolled patients with mild to moderate Alzheimer's.
But combined results of the two Phase III studies showed the drug reduced progression of cognitive declines by more than 30 percent in patients with only mild symptoms. It did not slow the loss of physical function, such as the ability to dress and other activities of daily living.
A similar, closely watched drug from Pfizer Inc, bapineuzumab, earlier this year also failed in big studies. Researchers did not cite any benefits to patients with mild symptoms.
Both drugs work by blocking beta amyloid - protein fragments that form toxic plaques in the brain that are considered a hallmark of Alzheimer's disease.
Lilly, along with Merck & Co Inc and others, is developing another type of treatment that blocks amyloid through a different route - by inhibiting production of an enzyme called beta secretase.
Leerink Swann's Fernandez said the BACE inhibitors may be "closer to the Holy Grail" in treating Alzheimer's than drugs like solanezumab, and that a safe and effective one could capture annual sales of $10 billion or more.
Lilly research chief Jan Lundberg, in an interview with Reuters last week, predicted the company will do for Alzheimer's patients what it did almost a century ago for diabetics - find a breakthrough treatment, even though skeptics say it could take years. (Reporting by Ransdell Pierson; Editing by Jeffrey Benkoe)
Our 2024 Coverage Needs You
It's Another Trump-Biden Showdown — And We Need Your Help
The Future Of Democracy Is At Stake
Our 2024 Coverage Needs You
Your Loyalty Means The World To Us
As Americans head to the polls in 2024, the very future of our country is at stake. At HuffPost, we believe that a free press is critical to creating well-informed voters. That's why our journalism is free for everyone, even though other newsrooms retreat behind expensive paywalls.
Our journalists will continue to cover the twists and turns during this historic presidential election. With your help, we'll bring you hard-hitting investigations, well-researched analysis and timely takes you can't find elsewhere. Reporting in this current political climate is a responsibility we do not take lightly, and we thank you for your support.
Contribute as little as $2 to keep our news free for all.
Can't afford to donate? Support HuffPost by creating a free account and log in while you read.
The 2024 election is heating up, and women's rights, health care, voting rights, and the very future of democracy are all at stake. Donald Trump will face Joe Biden in the most consequential vote of our time. And HuffPost will be there, covering every twist and turn. America's future hangs in the balance. Would you consider contributing to support our journalism and keep it free for all during this critical season?
HuffPost believes news should be accessible to everyone, regardless of their ability to pay for it. We rely on readers like you to help fund our work. Any contribution you can make — even as little as $2 — goes directly toward supporting the impactful journalism that we will continue to produce this year. Thank you for being part of our story.
Can't afford to donate? Support HuffPost by creating a free account and log in while you read.
It's official: Donald Trump will face Joe Biden this fall in the presidential election. As we face the most consequential presidential election of our time, HuffPost is committed to bringing you up-to-date, accurate news about the 2024 race. While other outlets have retreated behind paywalls, you can trust our news will stay free.
But we can't do it without your help. Reader funding is one of the key ways we support our newsroom. Would you consider making a donation to help fund our news during this critical time? Your contributions are vital to supporting a free press.
Contribute as little as $2 to keep our journalism free and accessible to all.
Can't afford to donate? Support HuffPost by creating a free account and log in while you read.
As Americans head to the polls in 2024, the very future of our country is at stake. At HuffPost, we believe that a free press is critical to creating well-informed voters. That's why our journalism is free for everyone, even though other newsrooms retreat behind expensive paywalls.
Our journalists will continue to cover the twists and turns during this historic presidential election. With your help, we'll bring you hard-hitting investigations, well-researched analysis and timely takes you can't find elsewhere. Reporting in this current political climate is a responsibility we do not take lightly, and we thank you for your support.
Contribute as little as $2 to keep our news free for all.
Can't afford to donate? Support HuffPost by creating a free account and log in while you read.
Dear HuffPost Reader
Thank you for your past contribution to HuffPost. We are sincerely grateful for readers like you who help us ensure that we can keep our journalism free for everyone.
The stakes are high this year, and our 2024 coverage could use continued support. Would you consider becoming a regular HuffPost contributor?
Dear HuffPost Reader
Thank you for your past contribution to HuffPost. We are sincerely grateful for readers like you who help us ensure that we can keep our journalism free for everyone.
The stakes are high this year, and our 2024 coverage could use continued support. If circumstances have changed since you last contributed, we hope you'll consider contributing to HuffPost once more.
Support HuffPostAlready contributed? Log in to hide these messages.