IMP builds distribution of SPECT brain agent

IMP took over distribution of Spectamine, its iodine-123 brainimaging agent, from Medi-Physics following the opening of IMP'snew headquarters and distribution center in June. The new siteis located near Medi-Physics' facility in Schaumburg, IL, wherethe agent continues to be manufactured.

IMP was formed last year to acquire rights to Spectamine priorto the acquisition of Medi-Physics, a Hoffmann-La Roche company,by Amersham (SCAN 7/4/90). Amersham produces Ceretec, a technetium-labeledsingle-photon emission computed tomography brain agent and theonly other commercial SPECT brain agent besides Spectamine.

The small firm is considering cooperation with larger groupsin both manufacturing and marketing of Spectamine, said presidentJames F. Lamb. Both Mallinckrodt Medical of St. Louis and Nordionof Canada have the cyclotron capability to manufacture the iodine-labeledradiopharmaceutical, he noted. There are also several researchcyclotron facilities in the U.S. that could produce the agent.

The largest marketing challenge ahead for nuclear brain imagingis to convince neurologists of its clinical worth. The field hasnot taken off as initially expected and is lagging considerablybehind the proliferation of cardiac SPECT. Acceptance of SPECTbrain imaging varies widely among medical centers and regionsof the country, Lamb said.

"Neurological imaging hasn't caught on the way we hopedit would. We need to provide convincing data for the neurologistthat nuclear medicine can help in patient management," Lambsaid.

Neither of the two SPECT brain agents appears to be sellingas well as originally expected, he said. Despite the sluggishdemand, however, Du Pont has indicated that it will file a newdrug application for Neurolite, another technetium-labeled agent,he said.

One reason neurological SPECT imaging has been slower to developthan cardiac imaging is the relative lack of interventional proceduresin the brain. Over the long run, however, the number of drugsand surgical procedures will increase, allowing for more therapeuticoptions in response to the diagnostic information provided bythe SPECT brain scans, Lamb said.

The high use of SPECT in cardiac imaging has also led to ashortage of available cameras for use in brain imaging. An undersupplyof nuclear technologists and radiopharmacists has also dampenedSPECT use overall, he said.

"All of these problems tend to make a nuclear medicinedepartment do what it does best, which is cardiology. They (nuclearmedicine departments) are reluctant to aggressively go after thebrain imaging market," Lamb said.

Hoffmann-La Roche farmed off Spectamine to the original groupof researchers who developed the SPECT agent. Tz-Hong Lin, a partnerin IMP, was the actual inventor of Spectamine. Lamb was directorof research and development at Medi-Physics.

"We are a small handful of people with competitors likeDu Pont. It makes the game interesting," he said.

IMP sells Spectamine through nuclear pharmacies operated bySyncor and Mallinckrodt. The new distribution facility will allowit to ship the agent direct to users in areas outside of the rangeof these radiopharmacies, he said.

The firm is also considering launching an R&D program toinvestigate the next generation of brain agents. The Medi-Physicsresearchers initially intended this when Spectamine was developed,he said.

"We did research into Spectamine as the first step inan attack on the brain. We wanted to immediately go to brain-receptoragents. We would very much like to do research in that area (atIMP)," Lamb said.

If IMP does develop new agents, the firm hopes that the Foodand Drug Administration will begin to approve radiopharmaceuticalson the basis of their function rather than the imaging of particulardisease states (SCAN 9/25/91), he said.

The use of brain SPECT agents could increase if companieswere free to discuss a range of applications with non-nuclear-medicinespecialists. Since most neurologists do not attend nuclear medicinemeetings, it is difficult for them to become aware of how theseagents are used in practice. Use of the technology is dependent,therefore, on how well the nuclear physicians sell their own services,he said.

"In order to mention schizophrenia right now, you (thecompany) have to have clinical trials for schizophrenia. Thismakes it difficult to market to specialists," Lamb said.