In April, Lantheus Medical Imaging (North Billerica, Massachusetts) acquired an application that was sure to not only give the company a significant lead in the contrast imaging market share, but to also make huge strides in the healthcare industry and give physicians more firepower in diagnosing cardiac the disease.

The company purchased Ablavar, a blood pool contrast agent approved for magnetic resonance angiography to evaluate aortoiliac occlusive disease in patients with known or suspected peripheral vascular disease, from Epix Pharmaceuticals (Lexington Massachusetts).

The company said it has already received FDA approval and is waiting to get the green light from the agency to launch the application.

"I think at the time we had an interest in developing new agents for medical needs," Mark Hibberd, MD, PhD, senior medical director Global Medical Affairs for Lantheus told Medical Device Daily. "We wanted to augment some already existing [applications] so acquiring MS-325 (the previous name of Ablavar) was a natural fit for us."

Lantheus said that specifically the acquisition of Ablavar was said to build on the company's imaging product portfolio and expand the company's presence to the radiology market. Under the terms of the agreement, Lantheus acquired the U.S. (including Puerto Rico), Canadian, and Australian rights to Ablavar from Epix – back in April for $28 million (Medical Device Daily, April 8, 2009).

"To get Ablavar ready to be launched by the end of the year was quite fast," Hibberd said.

Although there are many other contrast agents in existence, Lantheus says that Ablavar is the first blood pool contrast agent approved for magnetic resonance angiography.

Hibberd said that the albumin-binding properties of Ablavar make it ideal for vascular imaging allowing multiple images to be obtained using a single, low dose injection. Ablavar enables the visualization of both arterial and venous blood vessels.

Ablavar is clinically proven to produce high resolution MRA images, combining both dynamic (first pass) and steady state imaging, resulting in diagnostic accuracy comparable to X-ray angiography, the current standard of care for diagnosing vascular disease such as AIOD.

"You're able to get higher resolution images," Hibberd said. "It makes the blood bright and clearly visible. It gives better images of the blockages in the arteries and lower extremities."

Hibberd said that he believes the contrast agent will take a significant portion of market share, but did not give exact figures.

The company however has recently been pretty busy developing products in its pipeline.

In September it reported the initiation of a Phase 1 clinical study to assess the safety, dosimetry and tolerability of LMI1195, a novel F-18 small molecule tracer for imaging cardiac neuronal function, in healthy subjects, undergoing positron emission tomography PET imaging (MDD, Sept. 22, 2009).

The Phase 1 open-label, non-randomized, single-dose study will be conducted in the U.S. The study is designed to estimate the radiation dosimetry of LMI1195 in healthy subjects undergoing a PET scan. The study is set to evaluate the safety and tolerability of the tracer, gather pharmacokinetic and metabolic data, and assess PET imaging parameters and image quality, Lantheus said.

The company also said that FDA and Health Canada have approved the company's supplemental applications to qualify the Australian Nuclear Science and Technology Organization (ANSTO) as a valid supplier for low-enriched uranium (LEU)-derived molybdenum-99 (Mo-99) in the U.S. and Canada, respectively. Mo-99 is the parent isotope of technetium-99m (Tc-99m), the medical isotope used in nearly 80% of all nuclear medicine procedures. Mo-99 is produced by the irradiation of uranium "targets" in a reactor (MDD, July 10, 2009).

Lantheus says that there are only a few major worldwide suppliers of Mo-99, and most use highly-enriched uranium (HEU) targets. With these approvals, Lantheus says it will become the first domestic company to offer technetium-99m (Tc-99m) using Mo-99 derived from LEU targets to the U.S. and Canada.

Omar Ford, 404-262-5546;
omar.ford@ahcmedia.com