US BIOPHARMA: 215 CARDIOVASCULAR DRUGS NOW IN R&D.

US BioPharmaceutical companies are currently developing 215 new medicines for heart disease and stroke, according to new industry data.

All of the new treatments are now either in human clinical trials or under review at the US Food and Drug Administration (FDA), according to the research, which has been released by the Pharmaceutical Research and Manufacturers of America (PhRMA).

The potential new treatments include:

• 30 new medicines for heart failure, which impacts an estimated 5.1 million US citizens;
• 29 for lipid disorders, such as high cholesterol, which affect nearly 100 million Americans;
• 19 for stroke, which affects more than 22,000 people each year in the US;
• 17 each for hypertension, which impacts around 78 million Americans, and for ischaemic disorders;
• 15 for peripheral vascular disease;
• 14 for pulmonary vascular disease:
• 13 for thrombosis –in 2009,  pulmonary embolism (PE) accounted for 7,040 US deaths and 2,452 deaths from deep vein thrombosis (DVT);
• 12 each for acute coronary syndrome, atherosclerosis and heart attack, affecting an estimated 7.6 million people;
• nine each for adjunctive therapies and imaging agents; and
• eight for coronary artery disease, affecting 6.8 million.

Many of these potential new medicines use cutting-edge technologies and new scientific methods, such as: - a gene therapy that uses a patient's own cells to treat heart failure; - a medicine that blocks the transfer of good high-density lipoprotein (HDL) cholesterol to bad low-density lipoprotein (LDL); and - a genetically-engineered product that dissolves clots to treat stroke.

Cardiovascular diseases (CVD) cost the US some $312.6 billion in 2009, and an estimated 83.6 million Americans - more than one in three - have one or more types of CVD, according to PhRMA. Also, 6.8 million Americans are estimated to have suffered a stroke, with about 795,000 experiencing a new or recurrent strike every year, and a death from the condition occurring once every four minutes, on average. The American Heart Association (AHA) projects that the future annual costs of stroke-related care will increase 129% to $240.6 billion by 2020 - yet 80% of strokes are preventable through control of hypertension, high cholesterol, diabetes and obesity, says the industry group.

Additionally, the cost of congestive heart failure (CHF) could more than double to $70 billion by 2030, with a projected 46% increase in incidence, from five million in 2012 to eight million in 2030. This could result in every US taxpayer - not just those with CHF - paying $244 annually for CHF expenses, in 2030, warns PhRMA.

The group points to a new study published in the American Journal of Managed Care, which finds that improved adherence to medication following the expansion of drug coverage under the federal Medicare health insurance programme's prescription drug benefit (known as Part D) has led to nearly $2.6 billion savings in medical expenditures annually among beneficiaries with CHF. However, despite the improvements in adherence following the introduction of Part D, medication use remains suboptimal, it says, and the study estimates that improving adherence to recommended levels could save Medicare another $1.9 billion annually, totalling $22.4 billion over 10 years.

Fuente: Lynne Taylor, for PharmaTimes