Cardiovascular pharmaceuticals are on the decline

By MICHAEL LEIBFRIED

LONDON – This year’s European Society of Cardiology (ESC) Congress in Munich was a stark example of exactly where the cardiovascular market space is headed. This congress fully emphasized the new and innovative technologies that are coming out on the medical device and medical technology side, while leaving the market’s pharmaceutical wing in the dust. In fact, out of the nine hours over three days and 18 seminars on cardiac therapy innovation, only one seminar, given by Amgen, spoke about a pharmaceutical interventional treatment for heart disease. Thus, if there is one message to take away from the ESC 2012 congress, it is that the pharmaceutical industry has moved away from the cardiovascular market.

Prominent talks at the Congress included ‘Multimodality Image Fusion Technology for Enhancing Complex Transcatheter Cardiac Procedures’ that was put on by Philips Healthcare, ‘Cardiac Contractility Modulation: An innovative device therapy for Heart Failure with narrow QRS’ presented by Impulse Dynamics Germany, and ‘Automated quantitative CTA software for systematic analyses of coronary artery disease’ organized by Medis Imaging Systems. All in all, these seminars followed the industry trend of shifting cardiac focus toward devices – in  particular less-invasive procedures such as transcatheterization – and  toward new software solutions that will help physicians with diagnosis. However, biotech giant Amgen did give a presentation called ‘PCSK9, a potential exciting new target for the treatment of high cholesterol,’ where they outlined the potential for using the PCSK9 enzyme that regulates LDL in humans as a target for the next generation of cholesterol-lowering therapies.

While the future of the cardiac space is in question, there are still some innovative new products hitting the market that can help patients and fill niche markets. One particularly interesting product that has already been approved in Europe is apixaban. The drug is an oral direct factor Xa inhibitor that has been shown to reduce the risk of stroke and systemic embolism.

Recent secondary analysis derived from the results of the ARISTOTLE trials, published in September 2011, was discussed at the 2012 ESC Congress. The topic for discussion was that apixaban, of which 25% is excreted by the kidneys, did not present a risk of renal impairment for patients with atrial fibrillation.

The ARISTOTLE trial was conducted to compare apixaban to warfarin in patients with atrial fibrillation. The results of the trial showed that apixaban reduced the risk of stroke and systemic embolism by 21%, mortality by 11%, and major bleeding by 31% relative to warfarin in patients with atrial fibrillation and one additional risk factor. Currently, apixaban is available in Europe under the trade name Eliquis, but approval was delayed by the US Food and Drug Administration in June of 2012.

The ARISTOTLE trial used three different avenues to look at glomerular filtration rate (GFR). The first twZoom Kobe 1 Protro