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GENSIA FILES NDA FOR ARASINE AS PLANNED WITH THE U.S. FOOD AND DRUG ADMINISTRATION (FDA)

 SAN DIEGO, Jan. 4 /PRNewswire/ -- Gensia Pharmaceuticals Inc. (NASDAQ: GNSA) today announced that, as planned, it submitted a New Drug Application (NDA) for Arasine (TM) in patients undergoing coronary bypass graft surgery (CABG) with the U.S. Food and Drug Administration on Dec. 30, 1992. Gensia also expects to file a Marketing Authorization Application (MAA) under the "List B" guidelines established by the Committee for Proprietary Medicinal Products (CPMP) in the European Community in mid-January 1993, followed by a regulatory submission in Canada and regulatory submissions to the members of the European Free Trade Association by the end of the first quarter of this year.
 "We are pleased to have reached this very important milestone for our company, the submission of the NDA for Arasine, the first of our class of compounds called adenosine regulating agents (ARAs), developed by Gensia," said David F. Hale, chairman, president and chief executive officer of Gensia Pharmaceuticals Inc.
 Gensia also plans to file a computer-assisted NDA for Arasine, called a CANDA, during the first quarter of this year. A CANDA provides the FDA with a sophisticated system and database which affords direct access to the clinical data by FDA reviewers. Also, as previously announced, Gensia plans to begin in January a new multicenter clinical trial with patients undergoing CABG as additional support for the use of the drug in this indication. The company plans to complete this study by the end of 1993 or during the first half of 1994.
 Gensia is continuing with plans to begin by mid-1993, a multicenter Phase 3 clinical trial with Arasine in patients undergoing non-cardiac surgery who are at high risk of developing cardiovascular complications.
 Another product being developed by Gensia, the GenESA System, is currently being tested in multicenter Phase 3 clinical trials with three commonly used methods for the diagnosis of coronary artery disease: ECG, echocardiography and radionuclide imaging. Patient enroln?t in one study using the GenESA System with ECG was completed at year-end 1992. Patient enrollment in a similar trial using the GenESA System with echocardiography is expected to be completed in January 1993, and patient enrollment using the GenESA System with radionuclide imaging as well as certain other clinical trials is expected to be completed during the first quarter of 1993. Assuming positive results in these trials, Gensia plans to submit an NDA in the United States and comparable regulatory submissions in Canada and Western Europe in the second half of 1993, according to Hale. 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.
 Gensia Pharmaceuticals 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- 1/4/93
 /CONTACT: Elizabeth A. Gard of Gensia Pharmaceuticals, 619-546-8300/
 (GNSA)


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

JL-TM -- SD002 -- 1178 01/04/93 09:01 EST
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Date:Jan 4, 1993
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