Streptokinase equal to TPA

Article Abstract:

A recent study showed that tissue plasminogen activator (TPA) is no more effective than streptokinase for thrombolysis (dissolving blood clots) when given to heart attack patients. The study, which was sponsored by the United States National Association of Cardiologists and the Mario Negri Institute of Pharmacological Research in Italy, was based on reports on 20,381 heart attack patients. The patients were randomly divided into two groups and were treated either with TPA or streptokinase. Half of the patients in each group were given a subcutaneous (under the skin) injection of heparin, an anticlotting drug, 12 hours after the thrombolytic agent was given. All subjects were also given aspirin and beta blockers. The patient mortality was 8.7 percent when treated with TPA, and 9.2 percent when streptokinase was administered. When the thrombolytic agents were given with heparin, the mortality associated with TPA was 9.2 percent, and 7.9 percent with streptokinase. There were fewer allergic reactions, incidents of low blood pressure, and fewer bleeding episodes with TPA treatment. Patients given streptokinase had fewer subsequent strokes. Streptokinase is approximately one-tenth the cost of TPA, but medical practitioners in the United States prefer using TPA. However, this may change because of the large differences in cost. Recombinant TPA, produced by molecular biological techniques, is made by the drug company Genentech. Genentech has stated that the data from this Italian study may not be significant because the methods were different from the treatment that is used by 98 percent of U.S. cardiologists. U.S. cardiologists usually administer heparin along with the thrombolytic agent. Opinions are mixed on what will happen to the sales of TPA. (Consumer Summary produced by Reliance Medical Information, Inc.)

Care and treatment, Evaluation, Coronary heart disease, Fibrinolytic agents, Cardiovascular emergencies, Thrombolytic drugs, Streptokinase

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Genentech wins round two

Article Abstract:

There has been a legal battle over the patent rights of tissue plasminogen activator (TPA) between San Francisco-based Genentech and the Wellcome Foundation and the Genetics Institute of Massachusetts. TPA is a reagent made with biotechnological techniques that dissolves blood clots and is used for treatment of heart attack. Genentech's TPA is the only form of TPA that is approved for sale in the United States, with sales reaching nearly 200 million dollars in 1989. Genetics Institute has licensed a variation of TPA to Wellcome that remains in the bloodstream for longer periods of time. The Wellcome TPA is currently in preclinical testing phases. A decision was made by the courts that three of Genentech's key patents for TPA had been infringed by Wellcome. In 1987, Genentech also went to court in the United Kingdom to prevent Wellcome from infringing on the TPA patients in the United Kingdom. However, the court ruled that Genentech's wide ranging TPA patents were not valid. This shows the major differences between the biotechnology patent laws of the United States and the United Kingdom. However, all this litigation may be in vain anyway, as results of a recent Italian study showed that TPA was not any more effective than another fibrinolytic agent, streptokinase, in improving mortality. Streptokinase costs one-tenth the price of TPA. It is felt by stock analysts that thrombolytic drugs will not be making much money for any company in the future. (Consumer Summary produced by Reliance Medical Information, Inc.)

Cases, Biotechnology industry, Biotechnology industries, Intellectual property, GNE, Wellcome PLC

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Swiss company takes a 60 per cent stake in Genentech

Article Abstract:

Roche Holdings, Ltd., a Swiss health-care conglomerate spent $2.1 billion to acquire a 60 percent stake in Genentech. The takeover of Genentech, the largest US biotechnology company, is symptomatic of the troubles that Genentech has faced over the last ten years. Although highly respected for its research, Genentech has encountered difficulty translating research advances into profits. The preparation of new drugs for market is long and slow; Genentech has only two products on the market at the moment. One, tissue plasminogen activator, which dissolves blood clots in arteries, was delayed by the Food and Drug Administration (FDA) while awaiting scientific evidence of its safety, despite the fact that it is produced naturally within the body. Two other drug products, gamma interferon and an anti-AIDS drug based on the CD4 receptor, are still awaiting the completion of clinical trials. The takeover of Genentech raises two important points that affect biotechnology. First, the concern over the safety of genetically engineered drug products may simply be too conservative and cause the delay of useful drugs. Second, companies like Genentech, faced with slow development and great operating costs, may be forced to seek help from the wealth and marketing muscle of larger pharmaceutical concerns. (Consumer Summary produced by Reliance Medical Information, Inc.)

Pharmaceutical industry, Mergers, acquisitions and divestments, Roche Holding Ltd.

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