Monday, Feb 25, 1991
South San Francisco, Calif. -- February 25, 1991 --Genentech, Inc. today brought suit in U.S. District Court in San Francisco to bar SmithKline Beecham Corp. from continuing false and misleading advertising surrounding the huge ISIS-3 study of heart attack drugs to be reported at a cardiology convention next week.
Genentech markets the only t-PA approved in the United States; its generic name is alteplase and the brand name is Activase®. It is a single-chain t-PA made through biotechnology, which has the same amino acid sequence as human t-PA . Genentech's t-PA was not studied in the Third International Study of Infarct Survival (ISIS-3) trial, but rather a different, experimental non-human t-PA was studied in ISIS-3.
In its complaint, Genentech asserts that Beecham's advertisements contain false representations that are intended to mislead cardiologists to believe that the results of the ISIS-3 study will provide a comparison between Genentech's t-PA, Activase, and Beecham's Eminase®.
Genentech is asking the court to restrain and enjoin Beecham, temporarily, preliminarily and permanently, from falsely advertising, promoting, or representing expressly or by implication that Genentech's Activase was tested in ISIS-3 or that the results of ISIS-3 provide a comparative mortality study between Activase and Eminase. Genentech also requested that the court order Beecham to accurately describe The Wellcome Foundation's product as duteplase or as a t-PA that is different from that marketed by Genentech.
Genentech is not requesting the court to enjoin Beecham from advertising the results of ISIS-3 or from advertising Beecham's Eminase in comparison to Genentech's t-PA. Genentech only requests the court to issue an order requiring Beecham to stop falsely representing that ISIS-3 provides any basis for comparing Eminase to the only approved t-PA, Activase, and to describe ISIS-3 accurately.
The results of the ISIS-3 trial will be presented at the American College of Cardiology meeting to be held in Atlanta March 2-7. Genentech charges that Beecham's advertising is misleading to cardiologists and may improperly affect their treatment choices in treating heart attack victims. Genentech maintains it will suffer damages if such false and misleading representations are not enjoined by the court.
The ISIS-3 clinical trial, which is financed by Beecham and Wellcome, compared three thrombolytic drugs used to dissolve clots in the coronary arteries of heart attack patients. The heart attack drugs compared in the 50,000-patient, two-year study were Beecham's Eminase, a combination of bacterial protein streptokinase and human blood-derived plasminogen; streptokinase, a purified preparation of a bacterial protein marketed in the United States by two companies; and duteplase, Wellcome's experimental tissue plasminogen activator (t-PA) , which is a double-chain, non-human variant that has not been approved anywhere in the world.
"Cardiologists should be free from deception so they can evaluate for themselves the value of the ISIS-3 study results to their practices, based on the actual drugs tested and the validity of the study design," said John P. McLaughlin, Genentech vice president and general counsel.
On a national television program targeted to physicians, Beecham first falsely stated Genentech's t-PA was used in ISIS-3 and later, in cardiology publication advertisements, it has misled cardiologists that the results of ISIS-3 will be a basis for a comparison of Eminase and t-PA, even though Genentech's product, the only approved t-PA in the United States, was not part of ISIS-3.
In its court filings, Genentech provides evidence that even though Wellcome's duteplase and Genentech's alteplase are both t-PA's, they have different chemical structures and they are administered in different dosages to patients. The dose of duteplase in ISIS-3 is only 83 percent of the FDA-approved dose of alteplase for an average patient, which may have adverse consequences on the efficacy of duteplase in ISIS-3. It is inappropriate to extrapolate results of duteplase to alteplase, since no head-to-head clinical trials between the two different t-PA's ever have been conducted. Wellcome abandoned its experimental t-PA in May 1990, following Genentech's patent case victory in federal court.
On five occasions between December 16 and January 20 on Lifetime Medical Television, a cable network seen by about 160,000 physicians, a Beecham video falsely stated that ISIS-3 is a head-to-head comparison of "alteplase," Genentech's drug, and Beecham's Eminase and streptokinase. After complaints from Genentech, the alteplase reference was removed but only one graphic reference to duteplase was inserted into the 30-minute program. The video program still states that ISIS-3 will "provide the first head-to-head comparison of thrombolytic efficacy for the three approved agents." This is untrue, since duteplase is not approved. It also is misleading since Genentech's alteplase, which is one of the three approved thrombolytic agents and the most widely prescribed, was not studied in ISIS-3.
It is understood that in seven medical journals this month, Beecham is publishing advertisements about ISIS-3 that state: "Coming Soon ... The Results of the First Comparative Mortality Study Between Eminase and t-PA." Genentech submitted the results of a market research survey to the court which shows 90 percent of cardiologists believe that Genentech's product is synonymous with t-PA. Combined with the fact that Genentech's product is the only approved t-PA in the United States, Genentech contends that Beecham's alleging of a comparison between Eminase and t-PA in ISIS-3 could mislead many cardiologists who may assume the t-PA is Genentech's when, in truth, it is not.
"The ISIS-3 trial was simply not designed to allow conclusions about Activase and no data from previously completed trials would (or even could) allow confident extrapolation of results obtained with duteplase in ISIS-3 to the use of Activase," stated Thomas Q. Garvey III, M.D., in a declaration filed with the court. Garvey, a former medical officer in the FDA's Division of Cardio-Renal Drug Products, is an expert in clinical research and comparative clinical trials. He also stated, "The SmithKline Beecham tape is deceitful and potentially dangerous. Extrapolation of results obtained with duteplase to alteplase without data from an adequately designed head-to-head comparison of the two drugs cannot be supported given the wide range of differences between the two drugs in many clinically important attributes."
Genentech charges that Beecham has caused false, deceptive and misleading representations to enter into interstate commerce in violation of the federal Lanham Act and the California Business and Professions Code. The Lanham Act, among other things, prohibits advertisements which are likely to cause confusion or deception by falsely associating one product with a different product.
Genentech, Inc. is a leading biotechnology company focusing on the development, manufacture and marketing of pharmaceuticals produced by recombinant DNA technology.*(Editor's note: Copies of the complaint are available upon request.)
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