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PHASE 3 DATA PRESENTED AT THE AMERICAN COLLEGE OF CARDIOLOGY

 SAN DIEGO, March 16 /PRNewswire/ -- Gensia Pharmaceuticals Inc. (NASDAQ: GNSA) announced that the Phase 3 data from two multicenter trials on the use of Arasine in coronary artery bypass surgery was presented today at the 42nd Annual Scientific Session of the American College of Cardiology (ACC) in Anaheim, Calif. Based on the company's analysis of the U.S. Phase 3 multicenter clinical trials, Gensia believes that Arasine provides clinically important and statistically significant benefits in reducing the incidence of myocardial infarction (MI) and other adverse cardiovascular outcomes associated with coronary artery bypass surgery. In addition, Arasine demonstrated a clinically and statistically significant reduction in stroke, one of the adverse cardiovascular outcomes measured in the U.S. study. The analysis of the data from an international study conducted in Canada and seven European countries indicates that the overall results of this study, when all patients were evaluated, were not statistically significant, although clinically and statistically significant results were obtained in two important subgroups. Arasine had an excellent safety profile in these studies including a possible beneficial effect on overall mortality.
 According to David F. Hale, chairman, president and chief executive officer of Gensia, "The company believes that these data support the safety and efficacy of Arasine for use in coronary artery bypass surgery. We believe the data will be viewed by clinicians as clinically important in improving patient outcomes by reducing the overall incidence of adverse cardiovascular outcomes associated with bypass surgery, and this data formed the basis for our regulatory submissions to the authorities in the U.S., Europe and Canada."
 The two primary efficacy endpoints for the Phase 3 studies were the incidences of MI and combined adverse cardiovascular outcomes (defined as MI, cardiac death, stroke, congestive heart failure or life-threatening dysrhythmia). Because of the complexity of diagnosing MI following cardiac surgery, two different definitions of MI were used in the analyses of the Phase 3 data.
 The first definition required the presence of either of ECG changes or elevations of CK-MB levels (an enzymatic marker of cardiac damage) or autopsy diagnosed MI; the second definition which is more specific and clinically rigorous, required the presence of both ECG changes and elevations of CK-MB levels, or autopsy diagnosed MI. In a plenary session at the ACC, Dr. Dennis Mangano, principal investigator of the U.S. Phase 3 study from UCSF, presented results from the Phase 3 program. These results suggested that the low dose of Arasine did not offer any meaningful clinical benefit and consequently the results presented below represent only data from the high dose and placebo treatment groups in the U.S. Phase 3 study. Arasine reduced the incidence of MI by 72 percent (placebo 5.2 percent, Arasine 1.4 percent; p=0.018), when the more clinically rigorous definition of MI was used. This percentage reduction was similar to the 64 percent reduction in the incidence of MI in the Phase 2 study reported at last year's ACC meeting. Arasine also reduced the incidence of combined adverse cardiovascular outcomes by 62 percent (placebo 14 percent, Arasine, 5 percent; p=0.002), when the more clinically rigorous definition of MI was used. Using the less specific definition of MI, there was a reduction of 14 percent in the incidence of MI (placebo 24 percent, Arasine 21 percent; not significant), and there was a trend toward reduction in the incidence of combined adverse cardiovascular outcomes of 25 percent (placebo 30 percent, Arasine 22 percent; p=0.082). In the U.S. study, Arasine significantly reduced the incidence of stroke by 89 percent (placebo 4.2 percent, Arasine 0.5 percent; p=0.02).
 In a poster session, Dr. W.R. Eric Jamieson of the University of British Columbia presented more complete results of the International study conducted in Canada and seven European countries. When all patients were evaluated using both definitions of MI specified above, there were not statistically significant reductions in the incidence of MI. Using the first definition which required the presence of either ECG changes or elevations of CK-MB levels or autopsy diagnosed MI, the results showed an 8 percent reduction (placebo 29 percent; Arasine 27 percent). Using the second, more specific definition, which required the presence of both ECG changes and elevations of CK-MB levels, or autopsy diagnosed MI, the results showed a 23 percent reduction in the incidence of MI (placebo 6.7 percent; Arasine 5.2 percent). The company believes the CK-MB data in the international study were not reliable and confounded the interpretation of MI using any definition that included a CK-MB criterion. Therefore, in this study ECG or autopsy were considered to be the most reliable criteria for diagnosing MI. In the international study overall, there was a 19 percent reduction in the incidence of MI as defined by ECG changes or autopsy diagnosed MI which was not statistically significant (placebo 16 percent, Arasine 13 percent). However, in high-risk patients, Arasine reduced the incidence of MI, using this definition of MI, by 49 percent (placebo 19.7 percent, Arasine 10.0 percent; p=0.032). Similarly, Arasine reduced the incidence of MI as defined by ECG changes or autopsy by 55 percent in patients enrolled at Canadian centers (placebo 18.6 percent, Arasine 8.3 percent, p=0.026). In the international study the overall incidence of combined adverse cardiovascular outcomes was not reduced (placebo 19 percent, Arasine 18 percent).
 Arasine demonstrated an excellent safety profile in data obtained from more than 1,500 patients undergoing coronary artery bypass surgery in the Phase 2 and Phase 3 studies. In addition, Arasine demonstrated a clinically important and statistically significant reduction in the incidence of early postoperative death during the day of surgery and the next three postoperative days (placebo n=11, Arasine n=1; p=0.006). Total mortality was reduced by 44 percent in the overall program (placebo n=22, Arasine n=12; not significant). Except for transient increases in uric acid, there were no differences in the overall incidence of adverse events between Arasine and placebo-treated patients.
 Based upon the results of these clinical trials, Gensia made regulatory submissions for Arasine for the prevention of MI and other adverse cardiovascular outcomes in patients undergoing cardiac surgery involving cardiopulmonary bypass. A New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration at the end of 1992, followed by the submission of a Marketing Authorization Application (MAA) in the European Community under the High Tech procedure of the CPMP in January of 1993. The company also filed a MAA in January in the EFTA countries of Europe and a New Drug Submission (NDS) in Canada in March. In addition, the company submitted a computer-assisted New Drug Application (CANDA) with the FDA in the first quarter of 1993. The company is continuing to investigate the beneficial effects of Arasine in a multicenter trial in patients undergoing coronary artery bypass surgery as additional support for the use of the drug in this indication. The company expects to complete this clinical trial by the end of 1993 or during the first half of 1994. The company's program evaluating Arasine in patients undergoing non-cardiac surgery is continuing with Phase 2 approaching completion and an international, multicenter Phase 3 clinical program expected to begin in mid-1993.
 Gensia 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- 3/16/93
 /CONTACT: Elizabeth A. Gard of Gensia Pharmaceuticals, 619-546-8300/
 (GNSA)


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

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