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A Pivotal Year for Alzheimer's Disease Drug Development


Eli Lilly, Johnson & Johnson, Pfizer, and Elan Corporation are all poised to benefit.

Alzheimer's disease ("AD") is named after the German physician Alois Alzheimer, who in 1906 discovered amyloid plaques and neurofibrillary tangles in the brain of a 51-year-old female patient, Auguste D, who died from severe dementia. After more than a century, the exact causes of AD are not yet understood.

According to the Alzheimer's Association, AD is the sixth-leading cause of death in the country and the only cause of death among the top 10 in the United States that cannot be prevented, cured, or even slowed. Estimates vary, but experts suggest that as many as 5.4 million Americans may have AD.

A fatal form of dementia, AD is a chronic neurogenetic disorder that results in a progressive decline in cognitive functions including memory, judgment, decision-making, orientation to physical surroundings, and language. With the increasing life expectancy and the accelerated aging of the population, there is an urgent need to develop treatments for AD.

As of 2010, there are an estimated 36 million people in the world with dementia, and this number is expected to increase to 66 million in 2030 and 115 million in 2050. As many as 28 million of the world's 36 million people with dementia have yet to receive a diagnosis, and therefore do not have access to treatment, information, and care.

Most people with dementia will be cared for at home by a family member. Caring for a person with such a disease can cause emotional, psychological, and physical problems.

Due in part to the high projected cost of the treatment, supportive care, and the emotional stress on families, in 2011 the US Congress passed and President Obama signed the National Alzheimer's Project Act that instructs the US government to develop a strategic plan to slow the progression, delay the onset, and prevent AD by 2025.

New federal funding has been committed prior to the completion of the strategic plan. In February 2012, the Obama administration announced its plans to spend an additional $50 million this year and will seek an extra $80 million in fiscal 2013 to bolster research for AD9. An additional $26 million will be allocated to goals outside pure research, including public awareness and support for caregivers. The National Alzheimer's Project Act also established an Advisory Council on AD research, which brings together some of the foremost experts in the field. The next meeting for the Advisory Council is scheduled for April 17, 2012, and the plan is expected to be completed in 2012.

Beyond the government initiatives, 2012 represents a pivotal year for AD drug development, especially in view of expected results from ongoing Phase 3 trials, including solanezumab by Eli Lilly & Co. (LLY), bapineuzumab by Johnson & Johnson (JNJ), Pfizer Inc. (PFE), and Elan Corporation plc (ELN), and tideglusib by Noscira/Grupo Zeltia.

Positive results from other ongoing clinical trials, the introduction of new tools for detection, such as Eli Lilly's Amyvid™ imaging agent, and advances in understanding the causes and biology of AD could also enhance interest and much-needed investment in the life science companies developing treatments for this disease.

New data in the field will be reported at the two main AD conferences in 2012. The first event is the Alzheimer's Association International Conference ("AAIC") annual meeting being held July 14-19, 2012 in Vancouver, British Columbia, Canada. The second is the International Conference on Alzheimer's' Disease ("ICAD") annual meeting being held October 8-9, 2012 in Dubai, United Arab Emirates.

In view of recent progress, we believe that therapeutic success in AD could indeed occur as early as this year. Accordingly, we produced a white paper titled "2012: A Pivotal Year for Alzheimer's Disease Drug Development" to provide an overview of product candidates in clinical trials and the more than 30 life science companies developing novel therapies for AD.

To request a free copy of the white paper, please click here.
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