Agreement keeps ultrasound contrast firms from fighting in growing market

Bristol-Myers Squibb Medical Imaging, one of the giants in contrast-enhanced imaging, announced it has entered into a nonexclusive cross-licensing agreement with Imcor Pharmaceutical, an innovator in the emerging field of ultrasound contrast agents. The agreement allows the companies to sell their current ultrasound products and develop new agents without risking future litigation over patent rights, said Lili A. Gordon, director of public affairs for Bristol-Myers Squibb (BMS).

The two companies currently sell products that opacify the left ventricle of the heart and help delineate endocardial borders. BMS's Definity encapsulates perfluoropropane gas in a blend of phospholipids. Imcor's Imagent contains lipid-coated perflexane microspheres.

In addition to paying $8.5 million, BMS provided Imcor the first negotiation rights to option ultrasound products that BMS decides not to develop on its own, said Dr. Taffy Williams, president and CEO of San Diego-based Imcor.

The agreement ensures that the companies will be active players in a market that they hope is on the verge of taking off. The ultrasound contrast agent market, which has been growing at a rate of 30% per year, is expected to reach $45 million in 2004. These gains have been made despite the narrowness of the niche in which these agents fit: to assess the heart when resting echocardiography has failed to reach conclusive results. A total of 10% of 17.5 million annual resting echocardiographic examinations in 2003 were suboptimal and required the administration of contrast material.

Contrast-based ultrasound techniques for assessing myocardial perfusion, such as flash or transient replenishment and phasic changes in myocardial video intensity, could expand the contrast agent market to $400 million or even as high as $1.3 billion by eliminating the need for stress echocardiography and displacing nuclear cardiology perfusion imaging. Ultrasound has the potential to capture a sizable proportion of nuclear cardiology imaging because it is low in cost, uses nonradioactive contrast, and already commands an installed base of 75,000 ultrasound machines, more than six times the number of installed nuclear medicine devices, according to a commissioned research report by RedChip Companies of Spokane, WA.

The market for ultrasound contrast agents in 2007, therefore, could include 10% of the 18.9 resting echocardiographic tests that are projected to be suboptimal, 100% of the estimated 2.84 million stress echocardiographic tests, and 10% of 6.9 million myocardial perfusion tests.

"The range of exams in the nuclear space that would be candidates for ultrasound contrast runs from 20% to 100%, depending on how the product opportunities play out. So the numbers could add up very quickly to be a substantial market for myocardial perfusion," Williams said. "Couple that with the current indication for ultrasound contrast for suboptimal echocardiographic testing, and you could easily see the market being in the $500 million-plus range."

The FDA could approve ultrasound contrast agents for use with the flash and transient replenishment myocardial perfusion techniques as early as 2006. Approval of Imagent for use with the phasic changes technique is expected in 2007, according to RedChip Analytics.

The phasic changes technique quantifies arterial blood volume by selectively enhancing arterioles with a contrast agent and identifying changes in brightness or video intensity within the arterioles during the cardiac cycle. The procedure is done while a patient is at rest. The flash and intermittent replenishment techniques are used to analyze the refilling rate of contrast material after the delivery of sonographic pulses during contrast administration or on a triggered basis.