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Executive Summary

BRISTOL-MYERS SQUIBB's CARDIOGEN-82 LAUNCH SET FOR FEBRUARY: the diagnostic imaging agent (rubidium Rb 82 generator for the elution of rubidium chloride Rb 82 injection) was one of FDA's eleventh-hour approvals at the end of 1989 ("The Pink Sheet" Jan. 1, p. 17), with Squibb Diagnostics receiving word of the agency's okay on Dec. 29. The price for Cardiogen-82 is not yet available. Cardiogen-82 is the first positron-emitting radiopharmaceutical to be approved by FDA, according to Squibb. Administered intravenously, the Rb 82 solution is used in conjunction with a positron emission tomographic (PET) scanner to obtain three dimensional images of cardiac tissue for diagnosis of a myocardial infarction. The indications section of its labeling states that Cardiogen-82 "is a myocardial perfusion agent that is useful in distinguishing normal from abnormal myocardium in patients with suspected myocardial infarction." Labeling notes that other possible uses for Cardiogen, such as determining the precise location of myocardial infarction and identifying stress-induced ischemia, have not yet been supported with adequate data from clinical trials. One of Cardiogen's principle advantages, according to Squibb, is that unlike other positron-emitting compounds, the product does not need to be prepared in an onsite cyclotron. Also, rubidium's short half-life (75 seconds) and quick clearance from the body allows rapid repeats of the imaging process. A single technician trained in PET use can administer Cardiogen, Squibb noted. Approval of the Cardiogen NDA, which had been at FDA since December 1984, comes at a time when Squibb is experiencing considerable success in the field of diagnostic imaging agents. The firm reported sales of $98 mil. through the first six months of 1989 for its nonionic contrast imaging agent Isovue ("The Pink Sheet" July 31, p. 8). The company previously has predicted that the total market for imaging agents could reach $1 bil. by 1992 ("The Pink Sheet" Jan. 30, 1989, p. 14). However, future prospects for Cardiogen-82 and other positron-emitting agents are clouded by the fact that PET technology has yet to be approved by the Health Care Financing Administration for Medicare reimbursement. With equipment costs for PET totaling several million dollars per installation, the technology and diagnostics designed to be used with it are unlikely to find a wide market without HCFA acceptance. Cardiogen-82 is also the first NDA approval for the new corporate entity Bristol-Myers Squibb. For new bride Bristol-Myers, Squibb's leadership in radiopharmaceuticals, an area where Bristol-Myers itself lacks a presence, represents one more advantage of the recent alliance.

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