July 15, 2015
By Alex Keown, BioSpace.com Breaking News Staff
CAMBRIDGE, Mass. –All eyes will be focused on Biogen, Inc. next week as the pharmaceutical company is expected to reveal the latest data in its Alzheimer’s trial – data that could lead to either a breakthrough or another roadblock for Alzheimer’s care.
There is currently no treatment for the primary cause of Alzheimer’s, yet 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 over time and Biogen also announced the drug was able to reduce cognitive decline. The successful trial worked with only 166 patients and before regulatory agents can approve the drug, the drug will likely need to be tested on thousands of patients in late stage trials, the Boston Business Journal noted noted this morning. Still, Biogen is looking to begin a Phase III trial later this year, which if it proves successful, would then lead the company to seek approval to market the drug.
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.
As the clock ticks closer to the July 22 data release, Biogen’s stock is seeing a significant bump. The stock was trading at a morning high of $405.96, up more than $4.64 per share this morning.
Developing a treatment that targets 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.
Biogen plans to release some follow-up data to its Alzheimer’s trials July 22 at the Alzheimer’s Association International Conference in Washington, D.C. Biogen is due to report 12-month data on a 6 milligram dose of the drug, a dose that was added later than the others in an effort to balance efficacy against the amyloid-related imaging abnormalities, Investors.com noted.
The released data will include data on 30 patients who have received a daily 6 milligram dose of the drug for a full year. The 6 milligram group was added to the study after the other four groups, including those receiving a placebo, a 1 milligram dose, a 3 milligram dose and a 10 milligram dose of aducanumab, had already started the study. When the initial results were revealed in April, those patients taking 6 milligrams had only been taking the dosage for 26 weeks.
When the results of the trial were initially released in the spring, the patients taking the 3 milligram doses and 10 milligram doses were the only ones to show a statistically-significant reduction of amyloid plaque and slowing of a decline in brain function.
The release of new information carries risks for investors in the company, the Boston Globe reported. An update on the drug treating amyloid plaque could “substantially alter the probability of success” for upcoming late-stage trials, the Globe noted. The update could swing Biogen’s stock $50 either way, the analysts told the media outlet.
“Should the 6mg cohort further confirm aducanumab’s dose responsiveness ... we think investors might ascribe a 60-70 percent probability of success to the drug and that shares might trade up $50 or more,” Eric Schmidt, a Cowen analyst, told Investors.com. He added that if it fails it could fall by the same amount.
There are several drugs on the market that help manage Alzheimer’s, but none treat the primary cause. According to a Bloomberg report, there have been more than 100 failed efforts to develop a treatment for Alzheimer’s disease since 1998. Roche reported two failed drugs that targeted the amyloid plaque. 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.
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.
Not only will Biogen’s stock be impacted by the July 22 Alzheimer’s drug report, but two days after that, Biogen is expected announce second quarter financial results, which could also cause the stock to move in either a positive or negative direction. First quarter results were somewhat disappointing. Analysts at Alliance Bernstein said Biogen’s first quarterly reports were weaker than expected, primarily due to poor performance from Tecfidera, the company’s multiple sclerosis drug.
As New Jersey Biotech Booms, Will It Overtake Other States As Prime Location?
A week after Celgene Corporation announced it is officially the mystery buyer of Merck & Co. ’s former 1 million-square-foot R&D site in Summit, N.J., it quickly became our most popular story last week.
The company announced last Wednesday that it is buying the space, ending months of speculation about what Big Pharma company might move into the neighborhood.
The Summit, N.J. site is zoned research/office. The New Jersey site would put operations closer to some of the major biotech and pharmaceutical hubs on the East Coast.
But, by far, the most tempting part of doing business in the state remains New Jersey’s operating tax credit, which allows companies to sell their net operating losses to the New Jersey Treasury. One of the state’s most recognizable biotechs, Celgene, used the program until it became profitable, which was key to it staying in the state, said local officials.
That has BioSpace is wondering if New Jersey is becoming the new face of biotech. What do you think? Can the Garden State compete with other longtime stalwarts like California or Boston?
