Alzheimer’s Imaging Agents Offer Progress in Diagnosis of an Elusive Disease
While most doctors, patients, employers and the majority of Americans try to sift through over 2,000 confusing pages of the recently passed health care legislation, one group is wasting no time taking action—the same group that has improved health care innovation and treatment for patients for decades—the medical device industry.
Specifically, as a recent Wall Street Journal article highlighted, “companies specializing in medical imaging are pushing to develop chemical agents to detect Alzheimer's disease from brain scans.” Such a breakthrough would certainly help numerous patients and their families because this technology may “one day make it possible to predict who will suffer from the progressive ailment before symptoms appear.”
In particular, “Avid Radiopharmaceuticals Inc., a tiny imaging company based in
WSJ noted that “the market for diagnosing and treating Alzheimer's is estimated to grow to nearly $10 billion globally in 2014 from $8 billion in 2009, according to BCC Research, a technology market research firm based in Wellesley, Mass. The diagnostics and biomarker segment alone is expected to climb to $2.8 billion in 2014 from $1.1 billion in 2009.”
This increase in market should not surprise anyone because with the recently passed reform putting 31 million more patients into the system, it is inevitable that more patients will be diagnosed and treated. Instead, this opportunity for investment should be applauded and supported overwhelmingly considering the average cost to get a drug from research to the market is around $1 billion, and usually can take almost seven years. In fact, it will probably be another decade before companies developing such compounds see any profit, but likely the clinical trials and research would help save the lives and memories of thousands affected by the ailment.
Accordingly, this kind of breakthrough—created by industry funded research and support—is significant because “currently, Alzheimer's disease can be diagnosed definitively only by taking samples of brain tissue after death and looking for signs of sticky substances called amyloid plaques.” Using the new chemical compounds, which are injected into the brain, scanning devices would detect regions of the brain that take on color, “showing where the chemical has adhered and presumably indicating Alzheimer's-related plaque.”
This kind of innovation is critical because today’s “available treatments only work to treat symptoms, such as memory loss, but don't actually slow the course of the disease.” The new compounds would “increase early detection for Alzheimer's patients,” which is extremely important considering “15% to 20% of people labeled as Alzheimer's patients are misdiagnosed, which can lead to inappropriate treatments.” As a result, Richard Pither, head of research and development for GE's diagnostics division asserted that these imaging agents will give doctors the first chance “to definitively look inside someone's brain and say, 'Yeah, this is an Alzheimer's patient.'”
So far, it seems like the evidence is pointed in the right direction. Last week, Avid “presented preliminary data from a late-stage clinical trial showing that the company's compound, called florbetapir, binds to indicators of Alzheimer's in the brain and correctly identified which patients had the disease.” WSJ reported that “these results, presented at the American Academy of Neurology annual conference in Toronto, were the first for this type of experimental compound in a Phase 3 trial, a key step before applying to regulators for approval of a new treatment.” Final results from the study are expected late this year.
Another positive sign of evidence presented last week came from Bayer, who is testing florbetaben, a molecule licensed from Avid. Bayer’s “preliminary data on 150 patients in a midstage trial, showed that the compound correctly identified those whose doctors had also diagnosed them as having Alzheimer's disease compared with healthy patients. Results are expected near the end of 2011, according to Bayer. Additionally, Bayer “is looking to develop molecular imaging targets for cancer, particularly certain solid tumors, as well as other neurodegenerative diseases.”
Consequently, “a midstage trial of GE's product, flutemetamol, have also been promising, in which brain scans of patients using flutemetamol were found to have more amyloid plaques while healthy participants had virtually none.”
Despite some concerns about the “cost of and access to diagnostic scanning devices,” industry always has and continues to support patients in financial need. The companies developing this science and carrying out trials will use their resources to bring access to those that need it the most through clinical trials, educational grants, non-profit organizations, and government run programs. This noble goal is essential for America’s future because approximately 7.7 million Americans older than 65 are expected to have the disease by 2030, according to the Alzheimer's Association. As a result, the evidence from these companies demonstrates that industry is making great strides at reducing that number through innovations that help with early detection of the disease and proper diagnosis, both of which will be important to developing new treatments as well.