By Don Long
Genentech Inc., in two recent product fights with competitors, garnered an apparent victory in the scientific arena but lost a decision in the courtroom.
In the first, Genentech, of South San Francisco, beat back a challenge to Activase, its keystone thrombolytic agent, by competitor Retavase, produced by Boehringer Mannheim GmbH.
A year ago Boehringer Mannheim, of Mannheim, Germany, launched a GUSTO III study to prove Retavase clinically superior to Activase, but results released last weekend demonstrated only equivalent effectiveness. GUSTO stands for Global Utilization Studies for Thrombolysis of Occluded Arteries.
While these findings might be considered a draw, Genentech interpreted the test results to mean Activase was still the superior product in treating acute myocardial infarction (AMI).
In the second battle, the U.S. Court of Appeals for the Federal Circuit Friday vacated an injunction sought by Genentech against Novo Nordisk A/S, of Bagsvaerd, Denmark.
That injunction was intended to block Novo from U.S. marketing and sales of Norditropin, a human growth hormone which competes with Genentech's growth hormone products, Nutropin and Protropin. Genentech controls 75 percent of the $350 million American growth hormone market.
Besides overturning the injunction, the appeals court instructed the U.S. District Court to dismiss claims that Norditropin infringes upon a Genentech patent.
While the appeals court decision clearly favored Novo, it will not bring a quick end to the patent litigation that has been ongoing for at least two years.
Steve Zelson, vice president and director of corporate patents for Novo in the U.S., told BioWorld Today the recent decision resolves infringement issues in the second of two patent controversies. But he noted two more patents remain contested by Genentech.
"There are no other injunctions in force today [by Genentech]," he said, meaning Novo will continue to sell and market Norditropin in the U.S.
While the company felt "comfortable" it would prevail in those two unresolved decisions, Zelson said they present "complex legal and technical issues." Predicting settlement this year would be "too soon," he added.
Though approved by the FDA in May 1995, Norditropin did not see U.S. launch until February of this year because of the litigation by Genentech. Product rollout came on Feb. 20 after Novo won suspension of a temporary injunction sought by Genentech.
Norditropin has been available in 66 countries worldwide since 1988. Its use is indicated for long-term treatment of children with growth failure due to inadequate secretion of endogenous growth hormone (produced by the pituitary gland), and it has been used to treat more than 30,000 children, according to the company.
Genentech also blocked the U.S. sale of Bio-Tropin, an FDA-approved growth hormone produced by Bio-Technology General, of Iselin, N.J. Bio-Tropin is on the market outside the U.S.
Boehringer Mannheim claims 'milestone'
The results of the Retavase trial supported by Boehringer Mannheim were presented at the American College of Cardiology annual meeting in Anaheim, Calif., Monday by Eric J. Topol, chairman of cardiology at the Cleveland Clinic and principal investigator for the study.
Retavase was given to 10,139 patients, and 4,921 patients received Activase. After 30 days, 7.43 percent of the patients treated with Retavase died, compared with 7.22 percent among those receiving Activase.
Additionally, the total intracranial hemorrhage rate for Retavase was 0.91 percent compared with 0.88 percent for Activase. Total stroke rate was 1.67 percent for Retavase and 1.83 percent for Activase.
Those results were interpreted as showing no statistical difference, compared with results of earlier Rapid 2 trials that indicated Retavase performed better than Activase but used much smaller populations. (See BioWorld Today, March 21, 1995, p.1.)
Based on the more recent GUSTO III results, Activase must be considered the "standard of care in the management of AMI," David Stump, Genentch's vice president of clinical research, said in a prepared statement. He added he saw "no reason for physicians to change their prescribing habits."
He noted Activase last year was the first therapy to receive FDA approval for the treatment of acute ischemic stroke.
Countering Stump's remarks, George Glatcz, senior product manager for Boehringer Mannheim, said in a prepared statement the studies confirmed the effectiveness of Retavase. He said his company expected to find "equivalence."
He also claimed easier use in the operating room for Retavase compared with Activase.
Last December Genentech won an intellectual property rights battle against Boehringer Mannheim and two other companies -- Celltech Group plc, of Slough, England, and Glaxo Wellcome plc, of London -- when the European Patent Office upheld Genentech's "broad claims" related to preparation of TPA, or Activase. Boehringer Mannheim is a subsidiary of Bermuda-based Corange Ltd.
That decision effectively concluded the patent battle overseas, ongoing since 1989, when Genentech was granted its European patent for Activase.
Genentech's stock (NYSE:GNE) closed Monday at $55.75, unchanged. *