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 SAN DIEGO, Dec. 21 /PRNewswire/ -- Gensia Inc. (NASDAQ: GNSA) today announced that, as planned, it is submitting a New Drug Application (NDA) for the GenESA System to the U.S. Food and Drug Administration (FDA) and has also submitted Marketing Authorization Applications (MAAs) under the "List B" High Tech procedure established by the Committee for Proprietary Medicinal Products (CPMP) in the European Community. The GenESA System is designed for use in the diagnosis of coronary artery disease in conjunction with the three major modalities for testing for coronary artery disease: electrocardiography (ECG), echocardiography and radionuclide imaging. Gensia also expects to submit regulatory submissions in Canada and to the members of the European Free Trade Association in the first quarter of 1994.
 "We have reached another very important milestone for our company, the second regulatory submission in 12 months for a new cardiovascular product developed by Gensia. We believe that the GenESA System has the potential to be the first pharmacological stress test to be approved for use in conjunction with all three major modalities for testing for coronary artery disease," said David F. Hale, chairman, president, and chief executive officer of Gensia Inc.
 Gensia also plans to file a computer assisted NDA (CANDA) containing the clinical data and analysis section of the application for the GenESA System in January 1994. A CANDA provides the FDA with a sophisticated system and database which affords direct access to the clinical data by FDA reviewers.
 Based on the results of international multicenter Phase 3 clinical trials, the company believes that the sensitivity of the GenESA System, when used in conjunction with each of the major modalities for testing for coronary artery disease, is similar to exercise stress testing in the diagnosis of coronary artery disease. In the separate Phase 3 clinical study designed to evaluate specificity, the GenESA System also demonstrated high specificity in correctly identifying those patients who do not have coronary artery disease. Arbutamine, the novel drug which is part of the GenESA System, was generally well tolerated by patients in these trials and the company believes the safety profile should support the use of the drug in these indications.
 The GenESA System combines arbutamine and a computer-controlled drug administration system designed to pharmacologically stress the heart to aid in the diagnosis of coronary artery disease. The GenESA Device, which is being developed by Protocol Systems Inc. and Gensia engineers, delivers arbutamine intravenously to the patient under the direction of a physician, monitors the patient's heart rate and blood pressure and controls the rate of drug delivery to obtain the desired heart rate profile, necessary for a diagnosis to be made.
 The market opportunity for the GenESA System is for use in those patients with known or suspected coronary artery disease. Currently, there are approximately 6 million exercise ECGs performed each year in the United States. Studies have shown that approximately 20 percent to 30 percent of patients who are candidates for testing for coronary artery disease are unable to exercise adequately due to physical disabilities or limitations. In addition, approximately 20 percent to 30 percent of those patients who have an exercise ECG test have inconclusive results, frequently because the patient is unable to achieve a sufficient increase in heart rate for the diagnosis of coronary artery disease.
 Patients who have known or suspected coronary artery disease may also be tested using echocardiography, a widely used ultrasound imaging modality for evaluating heart structure and function, or radionuclide imaging, which involves the injection for radioisotopes and the use of a gamma camera to detect perfusion defects indicating the presence of coronary artery disease. Market research estimates indicate that there are currently approximately 10 million echocardiography procedures performed each year in the United States. Of this number, approximately 1 million procedures involve stress echocardiography.
 Recent market research indicates that there are currently approximately 2.5 million radionuclide imaging perfusion scans performed each year in the United States for the diagnosis of coronary artery disease. These procedures are typically conducted with stress to enhance the quality of the images, which increases the sensitivity and specificity of the tests.
 Gensia Clinical Partners owns certain rights to the GenESA System technology which are subject to a purchase option by Gensia.
 Gensia Inc. is a San Diego-based biopharmaceutical company formed to discover, develop, manufacture, and market novel pharmaceutical products for the treatment and diagnosis of human diseases.
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 /CONTACT: Elizabeth G. Foster, Gensia Inc., 619-546-8300/

CO: Gensia Inc. ST: California IN: MTC SU:

JM-MF -- SD005 -- 5988 12/21/93 09:02 EST
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Publication:PR Newswire
Date:Dec 21, 1993

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