Following last month's approval by European Union regulatoryofficials for Gensia Inc.'s GenESA system, the San Diego companyhas received a license to begin marketing the product in the U.K.
The GenESA system is used with electrocardiography,echocardiography and radionuclide imaging when stress is requiredfor a diagnosis of coronary artery disease. GenESA enables patientswho cannot exercise adequately to take the stress tests.
Gensia received approval for GenESA Dec. 9 from the EuropeanCommittee for Proprietary Medicinal Products. The U.K. productlicense is the first from the 12 countries of the European Union.Gensia said it expects to receive more licenses in the first half of thisyear.
Daniel Burgess, Gensia's chief financial officer, said the companyfiled a new drug application in December 1993 with the FDA forGenESA.
Burgess said in the U.S. six million people each year need stresselectrocardiographs (ECG) and about 20 percent to 30 percent do notget them because they have difficulty exercising. For another onemillion to two million people who take the stress ECG, the test isinconclusive because the patients could not boost their heart rateshigh enough to determine a diagnosis.
Burgess added that the U.S. market for GenESA also includes aportion of another 12.5 million people who annually get eitherechocardiographs or radionuclide imaging tests.
GenESA combines the drug arbutamine and a computer-controlleddrug administration system designed to pharmacologically stress theheart to aid in the diagnosis of coronary artery disease. Gensia planson marketing the product itself in both Europe and the U.S.
Gensia's stock (NASDAQ:GNSA) closed Friday at $3.37, down 12cents. _ Charles Craig
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