Thursday, Feb 28, 1991

Judge Requires Beecham To Abide By Court Promises Concerning ISIS-3 Ads

SOUTH SAN FRANCISCO, Calif., Feb. 28, 1991 -- SmithKline Beecham told the U.S. District Court in San Francisco that all future promotional materials about the ISIS-3 study will specify that the t-PA used in the clinical trial was duteplase. Federal Judge D. Lowell Jensen late this afternoon issued an order which adopts the representations made by SmithKline Beecham in a hearing this morning about a complaint brought by Genentech concerning Beecham's advertising. The judge noted that any future hardships to Genentech have been substantially mitigated by concessions instituted by Beecham at Genentech's request.

Genentech had filed a lawsuit on Monday, February 25, with respect to a series of Beecham ads implying that a forthcoming clinical trial of heart attack drugs compared Beecham's product, Eminase®, to Genentech's Activase® alteplase. In fact, the trial, known as ISIS-3, did not involve Activase, but instead used a non-human version of t-PA (duteplase), that has not been licensed for use anywhere in the world and that is chemically different from Activase. Results of that trial are to be presented at the American College of Cardiology meeting to be held in Atlanta starting Saturday.

"The court proceedings help to ensure an honest and open discussion of scientific information, free from ambiguity," said G. Kirk Raab, Genentech president and chief executive officer. "Cardiologists must determine for themselves the value of ISIS-3. We are confident that an accurate scientific discussion will enhance that process."

The judge did not grant Genentech a temporary restraining order Thursday, but wrote the following in his order as the reasoning:

"Any future hardship to Genentech has been substantially mitigated by concessions instituted by defendants at Genentech's behest.

"For example, defendant MCR [an agent of Beecham] stated in court that it has re-edited its prior video production to eliminate the mistakes complained of by Genentech, and that it will edit similar mistakes out of future video productions. In light of these concessions, the possibility of confusion based on misstatement or misrepresentation in MCR's video productions has been substantially eliminated.

"SmithKline has made similar concessions as to future publications," Jensen continued. "The only substantial flaw in SmithKline's print ads identified by Genentech is SmithKline's use of the general term 'tPA' to refer to the specific tPA duteplase. SmithKline has substantially mitigated any hardship that might arise from its use of the general term 'tPA' by promising that 'all future SmithKline promotional materials about ISIS-3, or about tPA generally, will specify the type of tPA -- alteplase or duteplase -- appropriate in the specific context.' "

Genentech, Inc. is a leading biotechnology company focusing on the development, manufacture and marketing of pharmaceuticals produced by recombinant DNA technology.

Editor's note: A complete copy of Judge Jensen's order is available upon request.

# # #