Lantheus has launched its perflutren-based ultrasound contrast agent in India through a deal with J.B. Chemicals & Pharmaceuticals Ltd.

N. Billerica, Mass.-based Lantheus inked a multi-year deal with 35-year-old pharmaceutical company J.B. Chemicals, headquartered in Mumbai, Lantheus said Thursday. Terms of the deal were not announced.

The Indian company sells drugs and contrast agents throughout India, other parts of Asia, Africa and Eastern Europe; and had $165 million in revenue last year, the company said.
The contrast agent, called Definity, is used on patients with poor heart sonograms to better visualize heart anatomy and understand heart function in ultrasound images, Lantheus said. Currently, up to one-fifth of resting echocardiography scans will be suboptimal, Lantheus said, so the agent could help reduce the need for follow-up studies.

In India, but not the United States, the agent is also cleared to help spot focal lesions in the liver and kidney.

The contrast agent contains extremely tiny bubbles, smaller than blood cells, that scatter sound, providing good acoustic contrast, Dr. Mark Hibberd, senior director of global medical affairs and pharmacovigilance at Lantheus, told DOTmed News.

"It lights up anything that carries blood much more easily than blood itself does," he said.

Since its 2001 launch in the United States, it has been given to 2.5 million patients, Lantheus said.

In October 2007, the class of perflutren-based microscphere drugs Definity belongs to, including Optison by GE, got a black box warning for very rare but serious and sometimes fatal heat and lung problems that appeared to be associated with its use.

At the U.S. Food and Drug Administration's request, Lantheus performed three follow-up safety studies, with the last one wrapping up earlier this year, Hibberd said.

"These studies did not show any new evidence of risks associated with use of Definity," Hibberd said. Lantheus said the evidence, including results from a 1,000-person study that found no deaths or serious adverse events associated with the agent, was sent to the agency.

Definity was developed by DuPont Pharmaceuticals, Hibberd said, but was acquired and launched by Bristol-Myers Squibb Medical Imaging after it took over DuPont's pharmaceutical business in 2001. Bristol-Myers' medical imaging portfolio was then bought by Avista Capital Partners and became Lantheus in 2008.

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