June 9, 2015
By Alex Keown and Riley McDermid, BioSpace.com Breaking News Staff
BASEL, Switzerland – Roche Holding AG is considering taking a second stab at its failed Alzheimer’s disease drug that was abandoned six months ago following positive data release by Biogen Idec, Inc. ’s, Bloomberg reported.
In December Roche announced it was discontinuing SCarlet RoAD, a phase III study of gantenerumab on pre-dementia Alzheimer’s disease. The company said it canceled the trial “based on results of a pre-planned futility analysis and recommendation by the independent Data Monitoring Committee.” Additionally, the company ended a Phase II trial for crenezumab because the drug did not meet its co-primary endpoints.
But following Biogen’s reports of positive results with its experimental Alzheimer’s drug BIIB037, Roche is considering taking a second shot. Roche researchers said they were more confident in their drugs targeting the plaque. Bloomberg reported Roche could re-run its trial at higher dose levels in order to target the amyloid plaque, which many researchers believe is a primary cause of Alzheimer’s. With Biogen’s success, Roche officials said their drug should work too at higher doses. The company said it will re-evaluate the data from its previous trial and proceed accordingly.
“As expected, there was good dose response across all AD patient subgroups with respect to SUVR (Amyloid) reduction,” wrote Yaron Werber, a closely watched biotech analyst at Citigroup. “However, no CDR-SB or MMSE outcome stratified by subgroup was presented. Biogen expects 6 mg dose to be released later this year and will be releasing Phase III plans soon. Of note, according to presenter, CDR-SB is an approvable endpoint from FDA standpoint, which is good news for Biogen as 10mg demonstrated a clear benefit in CDR-SB. Results of the 6mg arm will be key catalyst for BIIB037.”
In April Biogen announced its drug BIIB037, or aducanumab, led to reductions in brain amyloid plaque by as much as 71 percent. The plaque reduction was more pronounced as the dose of the drug increased and over time and Biogen also announced the drug was able to reduce cognitive decline. Biogen is looking to begin a Phase III trial, which if it proves successful, would then lead the company to seek approval to market the drug.
Developing a treatment that target’s Alzheimer’s disease at the source, something that hasn’t yet successfully been managed, will be an expensive affair for any biotech company. Biogen’s executives speculated bringing the drug to market could cost approximately $2.5 billion, which would include costs of conducting clinical trials as well as construction of a manufacturing facility for the investigational drug.
There are several drugs on the market that help manage Alzheimer’s, but none treat the primary cause, including Eisai Company, Ltd.’s Aracept. According to a Bloomberg report, there have been more than 100 failed efforts to develop a treatment for Alzheimer’s disease since 1998, including two from Roche. A 2014 report in Alzheimer’s Research UK showed 244 Alzheimer’s drugs were tested between 2002 and 2012, but only one was approved – Lundbeck A/S’s Ebixa, Bidness Etc. reported.
Pharmaceutical giants Eli Lilly and Company and Pfizer Inc. have also reported setbacks with their experimental Alzheimer’s treatments. Eli Lilly does have another experimental drug in Phase III trials with results expected sometime in 2016. Lilly’s solanezumab targets the amyloid plaque.
Alzheimer’s disease, a type of dementia, affects 15 million people worldwide, a number that is expected to grow to 75 million by 2030 due, in part, to the lack of effective treatments. In total there are about 50 million people suffering from some form of dementia worldwide. There are currently no drugs that target the cause of Alzheimer’s the most common form of dementia. There is a widespread belief that the buildup of amyloid plaque in the brain is one of the primary causes of the disease.
Genentech , a division of Roche, is currently running an Alzheimer’s study in Colombia, spurred on in part by Biogen’s early successes with BIIB037. Genentech’s Colombian trial involves approximately 300 people, with about 200 being suspected of carrying a rare gene that leads to early onset dementia by age 45. Half of those 200 will receive the anti-amyloid injection, and half will receive a placebo. The remaining 100 are non-carriers who will receive a placebo. Final results of that trial, estimated to cost about $100 million, will not be known until 2020.
When Will Pfizer’s Breakup Happen?
Speculation that the revamping of Pfizer Inc. ’s internal business structure could happen as soon as this year has biotech wondering just when this Big Pharma company could see changes.
Last week an analyst with J.P. Morgan said he thinks there will be a much faster timeline than most of Wall Street had predicted for Pfizer’s stated mission to refocus its efforts on new medicines.
Pfizer initially announced in 2012 that it would be shedding units that were non-essential to that goal. It then promptly sold its nutrition silo to Nestle for $11.85 billion, which was rapidly accompanied by a public spin-off of its animal health business for $2.2 billion.
“While a Pfizer break-up would likely be a 2017 event, we see potential catalysts in 2015-2016,” said Chris Schott, an analyst at J.P. Morgan. “Three years of audited financial statements (2014-2016) are required before any part of Pfizer can be spun off, and we also see 2017 as an attractive time for action as investors see Pfizer’s innovative pipeline clearly contributing to growth and the established business having transitioned to a more stable profile.”
BioSpace wants to know what you think: Will Pfizer be a changed company by the end of 2015?
