Printer Friendly

GENSIA ANNOUNCES PLANS TO FILE REGULATORY SUBMISSIONS FOR THE GENESA(R) SYSTEM

 SAN DIEGO, Aug. 4 /PRNewswire/ -- Gensia Inc. (NASDAQ: GNSA) today announced that, based on the company's analysis of safety and efficacy results with the GenESA System in international multicenter Phase 3 clinical trials, it plans to file regulatory submissions in the United States, Western Europe and Canada for the GenESA System for use in the diagnosis of coronary artery disease, in conjunction with electrocardiography (ECG), echocardiography (echo) and radionuclide imaging. Based on the results of these trials, the company believes that the sensitivity of the GenESA System, when used in conjunction with each of these modalities, is similar to exercise stress testing in the diagnosis of coronary artery disease. In a 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, closed-loop, drug delivery system designed to pharmacologically stress the heart to aid in the diagnosis of coronary artery disease.
 "We are pleased to proceed with our plan to file a New Drug Application (NDA) for the GenESA System in the United States as well as regulatory submissions in Europe and Canada. After our filings are made, the GenESA System will be our second cardiovascular product submitted to regulatory authorities within the last twelve months," said David F. Hale, chairman, president and chief executive officer of Gensia Inc. "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. The results from the Phase 3 clinical program were consistent with those in Phase 2 clinical trials using ECG and echocardiography in patients with coronary artery disease. The device also performed well in the Phase 3 clinical trials and generally appeared to be well received by clinicians because of its features which provided convenience and accurate control of drug delivery to achieve a target heart rate," added Hale.
 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.
 Gensia plans to file an NDA for the GenESA System in the diagnosis of coronary artery disease with the U.S. Food and Drug Administration in the fourth quarter of 1993, followed by a Marketing Authorization Application (MAA) to the Medicinal Control Agency (MCA) in the United Kingdom under the Committee for Proprietary Medicinal Products (CPMP) "high tech" procedure as a Group "B" product by the end of 1993. The company also plans to submit MAAs to each of the 12 members of the European Community and to the five countries which are members of the European Free Trade Association as well as a New Drug Submission (NDS) in Canada in the first quarter of 1994. The drug and device will be submitted together as one package for review by the FDA.
 Gensia was notified in May 1993 by the CPMP in Europe that the GenESA System would be reviewed under the "high tech" procedure as a Group "B" product. Group "B" products are pharmaceutical products representing significant innovation, such as the first of a new class of drugs, drugs which treat diseases in which no adequate therapy exists, or those prepared in unique dosage forms. The "high tech" procedure coordinates the review of these pharmaceutical products in countries which are members of the European Community (EC).
 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.
 Many of these patients may then be tested using echocardiography, a widely used ultrasound imaging modality for evaluating heart structure and function, or a radionuclide imaging, which involves the injection of 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 echo 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.
 Future opportunities for use of the GenESA System are for pre- operative screening of patients undergoing major non-cardiac surgery who have risk factors for coronary artery disease, the evaluation of angioplasty both before and after the procedure, and for the monitoring and evaluation of patient progress after a heart attack or cardiac surgery.
 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.
 -0- 8/4/93
 /CONTACT: Elizabeth A. Gard of Gensia, 619-546-8300/
 (GNSA)


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

LS-JL -- SD007 -- 9528 08/04/93 16:38 EDT
COPYRIGHT 1993 PR Newswire Association LLC
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1993 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:PR Newswire
Date:Aug 4, 1993
Words:1015
Previous Article:GENSIA REPORTS 1993 SECOND QUARTER RESULTS
Next Article:SOFTWARE TOOLWORKS REPORTS 41-PERCENT GAIN IN REVENUES FOR THE JUNE QUARTER; QUARTERLY LOSS NARROWS TO -2 CENTS PER SHARE
Topics:

Terms of use | Copyright © 2017 Farlex, Inc. | Feedback | For webmasters