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GENSIA FILES REGULATORY SUBMISSIONS FOR ARASINE AS PLANNED IN EUROPEAN MARKETS

 SAN DIEGO, Jan. 12 /PRNewswire/ -- Gensia Pharmaceuticals Inc. (NASDAQ: GNSA) today announced, as planned, it filed a Marketing Authorization Application (MAA) with the Medicines Control Agency (MCA) in the United Kingdom under the procedures of the Committee for Proprietary Medicinal Products (CPMP) in the European Community for Arasine(TM) in patients undergoing coronary artery bypass graft surgery (CABG). The company has also submitted MAAs to each of the other 11 members of the European Community and to the five countries which are members of the European Free Trade Association (EFTA). In addition, the company plans to file a regulatory submission in Canada by the end of January.
 According to David F. Hale, chairman, president and chief executive officer of Gensia Pharmaceuticals Inc., the regulatory submissions in the European Community will be made under the "List B" guidelines established by the CPMP, as Gensia was notified in October that Arasine would be reviewed under the "High Tech" procedure as a "List B" product. List B products are pharmaceutical products which regulatory authorities believe may represent significant innovations, such as the first of a new class of drugs, drugs which treat diseases in which no adequate therapy exists or drugs prepared in unique dosage forms. The "High Tech" procedure coordinates the review of pharmaceutical products in countries which are members of the European Community through the CPMP.
 "We believe the List B' status will give Arasine important recognition in the CPMP regulatory review process. We are also pleased to have filed regulatory submissions for Arasine in both the European Community and the EFTA countries which, if approved, will allow Gensia to broadly market Arasine in the major markets in Europe," said Hale.
 As previously announced, a New Drug Application (NDA) was filed with the Food and Drug Administration on Dec. 30, 1992. Gensia also plans to file a computer-assisted NDA for Arasine, called a CANDA, during mid-February of this year, A CANDA provides the FDA with a sophisticated system and data base which affords direct access to the clinical data by reviewers. Also, as previously announced, Gensia plans to begin in January a new multicenter clinical trial with patients undergoing CABG surgery 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.
 The data from the Phase 3 multicenter U.S. and international clinical trials with Arasine in patients undergoing CABG surgery is expected to be presented at the 42nd Annual American College of Cardiology in March 1993.
 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 disease.
 -0- 1/12/93
 /CONTACT: Elizabeth A. Gard of Gensia Pharmaceuticals, 619-546-8300/
 (GNSA)


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

LS -- SD003 -- 3855 01/12/93 09:06 EST
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Date:Jan 12, 1993
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