Antitrust rules tackle SPECT agent

June 16, 1993

Nuclear medicine physicians have access to only one of two Foodand Drug Administration-approved SPECT brain agents because ofa combination of brain SPECT procedure sluggishness and U.S. antitrustregulations. Financial difficulties have apparently claimed

Nuclear medicine physicians have access to only one of two Foodand Drug Administration-approved SPECT brain agents because ofa combination of brain SPECT procedure sluggishness and U.S. antitrustregulations. Financial difficulties have apparently claimed radiopharmaceuticalfirm IMP. The company disappeared after its supplier ceased shipmentsof IMP's only product, neurological perfusion radiotracer Spectamine.

Spectamine, an iodine-123-labeled agent, was cleared for marketin the U.S. five years ago amid high expectations for brain SPECTimaging (SCAN 3/16/88). The other brain SPECT agent, technetium-labeledCeretec, was approved by the FDA a year later (SCAN 2/15/89).

Ceretec was developed by Amersham of the U.K.; Spectamine byU.S.-based Medi-Physics. In 1989, Hoffmann-La Roche sold Medi-Physicsto Amersham, but because Amersham owned Ceretec, federal antitrustregulators prevented Spectamine from being included in the sale(SCAN 10/11/89).

Spectamine was then sold to IMP, a new firm formed by the groupof researchers who developed the agent. IMP, based in Schaumburg,IL, had difficulty getting the agent off the ground, however.The firm was unable to make payments to Medi-Physics, which manufacturedSpectamine on a contract basis.

Medi-Physics, of Arlington, IL, ceased shipments of Spectaminein April of last year after IMP was unable to pay for the radiopharmaceutical(SCAN 6/17/92). IMP stopped functioning after the Medi-Physicsshipments ceased, according to a Medi-Physics spokesperson. Phonecalls to IMP reach a disconnected number.

The loss of Spectamine has not had a dramatic effect on thenuclear medicine community, according to the spokesperson. IMPwas selling about 20 doses of the radiopharmaceutical a week,mainly to a handful of clinical sites. On the other hand, $10million worth of Ceretec was sold last year, he said.

One problem with Spectamine was the product's half-life, whichwas shorter than technetium-tagged Ceretec.

Medi-Physics has no plans to resurrect Spectamine, accordingto the spokesperson.

"The (Federal Trade Commission) would never let us haveit back," he said.

Spectamine could have been a successful product had IMP beenable to weather its financial rough waters. Although brain imaging'sshare of the nuclear medicine market is in the low single digits,that number will grow to 20% to 25% of all nuclear imaging inthe years to come, according to James L. Besett, general managerof Picker International's nuclear medicine division.

"Brain imaging as part of the market, in terms of reimbursingrevenue, is still small," Besett said. "But it is goingto happen. It's just a question of when."