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Alzheimer's

At a time when nearly 300,000 Pennsylvanians suffer from Alzheimer's disease and about a million other state residents serve as Alzheimer's caregivers, the nation's biopharmaceutical research companies are developing 98 medicines for the fatal brain condition.

Thirty-eight of the medicines are being created by companies with facilities in Pennsylvania. And new Alzheimer's medicines are being tested in patients in 96 clinical trials being conducted around the state.Three of the companies developing new Alzheimer's treatments are headquartered in Pennsylvania, with Avid Radiopharmaceuticals located in Philadelphia, QR Pharma in Radnor and Cephalon in Frazer.Avid, in collaboration with Bayer Health Care Pharmaceuticals of Wayne, New Jersey, is working on an Alzheimer's disease diagnostic agent while QR Pharma is developing a treatment for advanced Alzheimer's. The Avid/Bayer agent is in the third and final phase of human clinical testing before submission of an application for approval.QR Pharma is in the first phase of human trials. Cephalon is working on a product to treat cognition disorders such as memory loss and difficulty thinking. It too is in the first phase of human clinical testing.These companies, and other American biopharmaceutical research companies, are stepping up to the plate just in time. The first of 76 million baby boomers turns 65 in January and there are going to be many more Alzheimer's disease patients the deeper we go into the 21st Century.It's been estimated that the number of Americans with Alzheimer's could increase from 5.3 million today to 13.5 million 40 years from now in 2050. The cost of treating this condition, which causes a progressive loss of memory and destroys the ability to think, could skyrocket from $172 billion a year to in excess of $1 trillion annually, including a 600 percent increase in Medicare costs to $627 billion. The Medicaid cost of treating Alzheimer's could increase 400 percent to $178 billion.In Pennsylvania, businesses throughout the state today spend several billion dollars a year to help treat the disease.America's biopharmaceutical research companies are trying to create the treatments needed to put a dent in the relentless progression of Alzheimer's. The new drugs they are developing today include cutting-edge medicines that reflect new technologies. In one case, a gene therapy is being developed to insert a gene into the brain to prevent the death of cells and memory loss. In another instance, researchers are working on a vaccine designed to induce a specific powerful immune response.If one of the new medications delays the onset of the disease just five years, it would save the nation's health care system about $447 billion and prolong quality of life for a number of patients.It will be no easy task, however, to achieve that kind of progress and a daunting challenge to create a preventive vaccine or cure. It takes 10 to 15 years to develop a new medicine and get it approved at an average expense of $1.3 billion. Most medicines that enter human clinical testing fail and sometimes companies spend millions of dollars before stopping a research project.For those medicines that are ultimately approved, tens of thousands of pages of clinical and scientific data must be generated to prove safety and effectiveness. Companies have to hire a wide range of scientists to conduct years of complex research, including chemists, biologists, toxicologists and epidemiologists.With only five medicines approved today to treat the symptoms of Alzheimer's disease, we've got a long way to go in the search for prevention and a cure. But our nation's biopharmaceutical research companies, including Avid, Cephalon and QR Pharma, have clearly demonstrated their determination to fight this debilitating, fatal scourge with nearly 100 new medicines in development.Sharon Brigner, MS, RNDeputy Vice President, PhRMA950 F St NW, #300Washington, D.C. 20004Special to The TIMES NEWS