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SYNTEX DISAGREES WITH GERMAN REGULATORY ACTION RE CONTINUED LICENSING FOR SALE OF KETOROLAC

 PALO ALTO, Calif., June 11 /PRNewswire/ -- Syntex Corp. (NYSE: SYN) said today that its German subsidiary has been informed by regulatory authorities in Germany that they intend to revoke the licenses for the company to market the prescription pain-reliever ketorolac in Germany. Syntex disagrees with this action, which is based on the German regulatory authorities' analysis of data concerning the product's risk/benefit ratio. Syntex has three weeks in which to respond to the notification from the German authorities. Syntex has voluntarily suspended sales of ketorolac in Germany, pending receipt and evaluation of Syntex's response by the German regulatory authorities.
 Syntex provided other regulatory agencies in Europe and the United States the same data provided to Germany. A number of regulatory agencies of European countries have met and are meeting to evaluate the risk/benefit profile of ketorolac. After reviewing these data, the U.K. regulatory authorities have proposed labeling changes, and labeling changes in other countries are also likely. No country in which ketorolac is currently marketed has advised Syntex that it plans to take action similar to Germany.
 Syntex officials said that, in their opinion, the results of ongoing regulatory discussions on ketorolac in Europe will not have a material adverse effect on the current sales level of the product in the United States, where it is sold under the tradename Toradol(R).
 Total ketorolac sales in Germany, where it has been marketed under the tradename Toratex(R), were $3 million in the first nine months of Syntex's 1993 fiscal year. Ketorolac sales in Europe, excluding Germany, were $23 million during the same nine-month period. Worldwide sales during the first nine months of fiscal 1993 were $241 million.
 "We are disappointed in the German action. It is important to remember that ketorolac is a nonsteroidal anti-inflammatory drug (NSAID), used as an analgesic. Most of the serious adverse events reported have occurred in patients receiving injectable ketorolac for treatment of post-operative pain. Such patients are at high risk of adverse events related to their underlying medical and surgical conditions," Dr. Robert Roe, president, Syntex Development Research, said.
 "In an ongoing, large study designed to monitor the safety of ketorolac use, it is reassuring to observe that, so far, the study indicates that overall mortality rates are lower in the ketorolac- treated patients than in those receiving narcotics. Syntex believes that when ketorolac is used according to label instructions, it provides an important clinical benefit to physicians and patients," Roe said.
 Ketorolac intramuscular formulation and tablets were introduced in Germany in January 1992. In Germany, intramuscular ketorolac is indicated for the acute treatment of post-operative pain, and ketorolac tablets are indicated for the acute treatment of moderate to severe pain.
 Ketorolac was introduced in the United States in 1990. It is currently marketed in 28 countries and has been used in more than 16 billion patient days of therapy.
 Syntex Corp. is a multinational, research-based healthcare company dedicated to the discovery, development, manufacture and marketing of prescription medicines with approximately $2 billion in sales.
 -0- 6/11/93
 /CONTACT: Linda Thomas, 415-852-1321, or Kathleen Gary, 415-855-5924, both of Syntex/
 (SYN)


CO: Syntex Corp. ST: California IN: MTC SU:

GT -- SJ002 -- 1211 06/11/93 16:37 EST
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Date:Jun 11, 1993
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