Roche deal tests drug cardiotoxicity on unique lab platform
cardiotoxicity testing using a cell-based platform that could play
a major role in the preclinical safety evaluation of drugs and
newly developed compounds.
The deal aims to detect any drug-induced changes in the electrical activity of the heart, such as prolongation of the QT interval, which could cause faster, slower, or irregular beating.
Cardiotoxicity has been cited as the reason 30 per cent of all drug compounds fail during testing and with this new deal Roche aim to build predictive models of toxicology to reduce this failure rate.
Under the terms of the deal, Roche will supply Cellular Dynamics International two sets of 25 compounds to test on its platform, that uses human cardiomyocytes derived from human embryonic stem cells.
Financial terms of the agreement were not released.
" The validation of the company's platform through this collaboration is the first step in using these cells in routine toxicology testing ," said Chris Kendrick-Parker, CDI's vice president of business development.
The late detection of cardiotoxic side effects, such as QT prolongation, caused by pharmacological compounds can impede drug discovery and development projects, and consequently increase their cost.
Drug development can take anywhere between 8 to 16 years, and average cost of developing a drug is now around $500m-$800m with the cost expected to hit the $1bn mark within the next four years.
Market analysis firm Frost & Sullivan has estimated the price of failure at $50m-$70m with approximately 90 per cent of clinical candidates failing at development stage The launch of new drugs with undetected cardiotoxic side effects could have hazardous consequences and could trigger lethal cardiac dysrhythmias in patients.
Testing for the potential cardiotoxic side effects of compounds at an early stage of drug development has therefore been the goal of many pharmaceutical and biotechnology companies.
Electrophysiological test systems and cellular-based fluorometric high-throughput assays are now the test of choice for cloned human cardiac ion channels.
When you consider that every drug nowadays has to undergo testing for hERG block and electrophysiological effects, the potential for this market is huge.
According to Frost and Sullivan, a better understanding of pharmacokinetic properties motivates the use of innovative solutions and early ADME/Tox screening.
As a result the European ADME/Tox technologies market is expected to grow from its current size of $384m to $776m by 2011.
