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US pharma: "299 heart disease/stroke drugs now in R&D"
  "Awareness and adherence to prescribed therapies are potential lifesavers, yet only 48% of Americans with high blood pressure are aware of the condition and have it under control" World News | February 02, 2011
Lynne Taylor
US biopharmaceutical research companies currently have 299 medicines in development for the prevention and treatment of heart disease and stroke, says a new report.
Drug discoveries played a major role in reducing deaths in the US from heart attacks and stroke by 28% during 1997-2007, yet cardiovascular disease still kills one American every 39 seconds and more than 82 million people in the US have a least one type of the disease, says the report, which was issued yesterday by the Pharmaceutical Research and Manufacturers of America (PhRMA) on the first day of American Heart Month.
The industry's 299 potential new medicines for the treatment and prevention of cardiovascular disease, all of which are now in clinical trials or awaiting review by the Food and Drug Administration (FDA), are the following (some are listed in more than one category): - 22 for acute coronary syndrome; - five adjunctive therapies; - 15 for arrhythmia/atrial fibrillation; - 15 for atherosclerosis; - nine for coronary artery disease; - 17 for heart attack; - 36 for heart failure; - 27 for hypertension; - 11 imaging agents; - 23 for ischemic disorders; - 43 for lipid disorders; - 20 for peripheral vascular disease; - 17 for pulmonary vascular disease; - 27 for stroke; - 28 for thrombosis; and - 35 others.
PhRMA points out that many of these products use cutting-edge technologies and new scientific approaches including: - human stem cells that restore cardiac function by forming new heart muscle; - a new anticoagulant that regulates clot formation to prevent deep vein thrombosis; - a gene therapy that uses a patient's own cells to treat heart failure; and - a drug that blocks the transfer of high-density lipoprotein (HDL or "good") cholesterol to low-density lipoprotein (LDL or "bad") cholesterol.
"Medicines developed for cardiovascular health over the last three decades are in large measure responsible for preventing more than a million American deaths a year," said PhRMA president John Castellani.
The National Center for Health Statistics reports that heart disease has topped the US list of killer diseases every year since 1900 except for 1918, when an influenza epidemic killed over 450,000 people. However, says PhRMA, death rates from heart disease and stroke are falling, thanks in large part to new drug treatments, with stroke having dropped to the fourth leading cause of death in 2008 after being third for over 50 years. According to the National Heart, Lung and Blood Institute (NHLBI), if death rates were the same as those of 30 years ago, 815,000 more Americans would die of heart disease annually and 250,000 more would die of stroke.
Many people who survive heart attacks develop heart failure, a chronic disease affecting 5.7 million Americans. The cost of these diseases to US society currently stands at over $503 billion a year, and this is expected to triple in the next 20 years, due in large measure to the aging population, the American Heart Association (AHA) reported recently.
Moreover, women and minorities suffer disproportionately from cardiovascular disease; over 42 million US women have the disease compared to nearly 38 million men, says the AHA, which will, on February 27, sponsor National Wear Red Day to alert women to their special risks.
And African Americans, who have the highest prevalence of high blood pressure in the world, suffer a 1.8 times greater rate of fatal stroke than other Americans and a 1.5 times greater rate of heart disease death, the Assocation adds.
Awareness and adherence to prescribed therapies are potential lifesavers, yet only 48% of Americans with high blood pressure are aware of the condition and have it under control, says PhRMA. Adds Ralph Brindis, president of the American College of Cardiology: "we know that people who have been diagnosed with this disease and do not take their medications as prescribed are almost five times more likely to suffer from a heart attack, stroke, aneurysm, dementia or premature death."
"In order to maximise the potential of advancing science and newly-developed drugs, we must continue identifying strategies that successfully help patients follow their treatment plans. This effort in itself has the potential to significantly improve the quality of care for cardiovascular disease and save another million lives every year," says Dr Brindis.
Personalised medicine "shaping the way R&D is done"
World News | November 17, 2010
Lynne Taylor
Personalised medicine development is occupying a growing role in the clinical pipelines of drug developers and leading companies to change their R&D paradigms, including how they make "go/no-go" decisions, according to a new study.
"Early indications show that development of personalised medicines is commanding more resources and fomenting more organizational change than is generally appreciated outside the industry," according to Christopher-Paul Milne, associate director at the US Tufts Center for the Study of Drug Development (CSDD) and author of the study, which appears in the newly-published November/December issue of the Tufts CSDD Impact Report.
The study notes that the scientific, regulatory, commercial and practical challenges confronting developers in creating personalised medicines are significant and, as a result, approaches taken by individual companies in the pursuit of these new medicines vary greatly. In particular, developers are working with academic medical centres to better understand disease mechanisms and identify strata of target populations, and with diagnostics developers to augment in-house capabilities, says Dr Milne.
His findings also reveal that:
- the magnitude of resources required to create personalised medicines means developers must team with multiple external partners, presenting challenges for project stewardship and intellectual property rights;
- biomarkers are increasingly being used to better understand patient response, but companies still cannot use biomarker data to support approval until the regulators' capacity to evaluate it catches up to the science;
- oncology leads other therapeutic areas in the number of personalised medicines on the market as well as in the pipeline, with the expectation that within the decade all oncology drugs will have a related diagnostic; and
- other key therapeutic areas in which personalised medicine is making headway include cardiovascular, central nervous system and immunologic therapies. Elsewhere, personalised medicine development is just getting started for metabolic and respiratory therapies, as well as virology, the study notes.
PricewaterhouseCoopers has forecast that the US market for personalised medicine will grow around 11% a year from a value of $232 billion in 2009 and could reach $425 billion by 2015, while earlier this month a report from UBM Canon Data Products Group projected that sales of biomarkers for use in clinical trials will grow 37.6% by 2015.
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