On November 1, 2010, the Pharmaceutical Research and Manufacturers of America (PhRMA) issued a press release discussing new treatments in development for Alzheimer’s disease. Alzheimer’s is a progressive, degenerative brain disease that causes memory loss, personality changes, dementia, and ultimately death. While the greatest risk factor for Alzheimer’s is age—as the majority of patients diagnosed with Alzheimer’s are 65 or older—the disease is not a result of aging. Rather, researchers believe that a combination of genetic, lifestyle, and environmental factors trigger the onset of Alzheimer’s.
The portion of the U.S. population aged 65 and older is expected to more than double by 2050, increasing from 40.2 million in 2010 to over 88.5 million in 2050 (Source: the U.S. Department of Health and Human Services’ Administration on Aging). The number of individuals affected by Alzheimer’s is also forecast to double. Presently, 5.1 million of the 5.3 million individuals diagnosed with Alzheimer’s are 65 or older—a figure that could be between 11 million and 16 million by 2050, unless effective therapies that prevent or treat Alzheimer’s are established. Moreover, the Alzheimer’s Association estimates that the costs to treat and care for Alzheimer’s patients could rise from $172 billion dollars in 2010 to nearly $1.1 trillion by 2050.
To date, only five medications are FDA-approved for Alzheimer’s patients to date—all of which treat the symptoms of the disease and do not stop or slow the disease’s progression. Nevertheless, in recent years, improved imaging technologies (e.g., PET scans) and data collected through the Alzheimer’s Disease Neuroimaging Initiative (a collaboration between biopharmaceutical companies, nonprofits, universities, the NIH, and the FDA) have allowed researchers to gain a better understanding of the complex mechanisms that cause Alzheimer’s patients to develop plaque and tangles in the brain. As well, technology is now available that facilitates the identification of biomarkers associated with the disease’s progression. As a result of these scientific and technological advances, PhRMA estimates that there are roughly 98 therapies currently in clinical trials or under regulatory review in the U.S.
Several companies within our Research Coverage are developing novel products and technologies to address Alzheimer’s disease. BELLUS Health Inc. (BLU-TSX), a Québec-based health company, is currently conducting a Phase I clinical study with NRM8499, a prodrug of tramiprosate, which is designed to increase the exposure of tramiprosate to the brain to improve the agent’s effect on cognitive function and other Alzheimer’s symptoms. BELLUS Health expects to complete the 84-patient study in the fourth quarter 2010, with results available in the first quarter 2011. In addition to developing NRM8499, BELLUS Health also supplies VIVIMIND™, oral tablets containing homotaurine (a natural amino acid found in seaweed), to protect memory function. VIVIMIND™ has demonstrated its ability to protect memory in clinical tests of more than 2,000 patients. In September 2010, BELLUS Health received a natural health product number for VIVIMIND™, indicating that the product is formally authorized for sale in Canada.
As well, Neuralstem, Inc. (CUR?-NYSE Amex)?, a Maryland-based stem cell research and biotherapeutics company, is developing neurogenic compounds designed to stimulate the growth of stem cell neurons, a function that may be suppressed in individuals who have Alzheimer’s, major depression, stroke, or traumatic brain injury.
Further coverage on BELLUS Health, Neuralstem, and other biopharmaceutical companies is available through our Research Library.