Biogen’s Alzheimer’s Drug - Could Be One of Most Valuable in History - Has Critical Ties to Brown
Friday, November 01, 2019
Biotech firm Biogen could double its market cap if it receives approval from the Food and Drug Administration (FDA) for its experimental Alzheimer’s drug, aducanumab, said CNBC’s "Mad Money" host Jim Cramer Wednesday.
Creamer reports that Biogen, with a $54.1 billion market cap as of Wednesday’s close, “could be worth twice that if all goes well” with the FDA. The implications for the drug -- medically and financially -- are groundbreaking.
Brown University physician and researcher Dr. Stephen Salloway at the Warren Alpert Medical School has played a critical in the development and clinical research on aducanumab.
GET THE LATEST BREAKING NEWS HERE -- SIGN UP FOR GOLOCAL FREE DAILY EBLASTSalloway is a leading Alzheimer's researcher in America, and recent investments made at Brown University, including the $100 million gift for its brain science institute from alumnus Robert and Nancy Carney, are part of the efforts to quicken the pace of scientific discovery and help find cures for diseases such as ALS and Alzheimer's.
Approximately 5.5 million Americans suffer from Alzheimer's and of these, around 5.3 million are 65 and older, and 200,000 are younger and suffer from early-onset Alzheimer's disease. It is estimated that about two-thirds of Americans with Alzheimer's disease are women.
The Comeback
In March, the aducanumab clinical trials that Salloway worked on were suspended -- and then two weeks ago, Biogen announced that new analysis of the research had shown the drug was having a positive impact on slowing Alzheimer’s.
“This is really exciting news. We’ve been testing a medicine that has a funny name -- aducanumab -- that’s been developed by Biogen up in Cambridge for a number of years for patients with early Alzheimer’s disease,” said Salloway, on GoLocal LIVE on Thursday.
“It had some encouraging results which we published in 2016. It was covered around the world because it looked really good — many people were very interested, we had 60 patients with early Alzheimer’s on this medicine over at Butler Hospital in our memory and aging program, and from our point of view, they seem to be doing well, so we were encouraged,” said Salloway.
"Then all of a sudden in March, I got an email that the drug looked like it didn't meet an outcome analysis — an interim analysis — and Biogen was going to stop testing it. We were blown away, how could that be, it was looking good and our patients were really devastated. They had to come off the drug — some had been on [it] for years and actually doing well," said Salloway, who is the Martin M. Zucker Professor of Psychiatry and Human Behavior and Professor of Neurology at Brown, and Chief of Neurology and Director of the Memory and Aging Program at Butler Hospital.
"Then last week, we got the news — the comeback of the year — that additional data came in and actually looked like the drug was having a positive effect, and Biogen has been speaking with the FDA, and the FDA has given them the green light to submit for approval," added Salloway.
Potential FDA Approval
Now, the drug aducanumab moves forward. The drug, if approved, will be the first new Alzheimer's drug to the market in 16 years, according to Salloway. And, the drug could clearly be the most important in the treatment of the disease.
“So the drug, which we thought was not going forward, is now back online and being considered for approval — this would be the first drug approved for Alzheimer’s in 16 years and the first drug to actually target the key elements of the disease, actually — removing the amyloid plaques that build up in the brain, and hopefully slowing down memory loss. So this is a major development,” said Salloway.
2020 Registry
In addition, Sallow is leading the development to grow an Alzheimer's Prevention Registry to 2,020 participants by the start of 2020. “We have an Alzheimer’s prevention registry where people can either sign up online or over the phone to find out what’s going on with the research and see if that’s something they’re interested in doing,” said Salloway in an interview with GoLocal in June.
The registry says, "Effective treatment - and even prevention - of Alzheimer's is closer than ever before, and we're at the forefront of that effort right here in Rhode Island. But we can't get there without the help of thousands of people with normal memory or mild memory loss who are willing to participate in research. That's why we're on a mission to grow our Alzheimer's Prevention Registry."
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