Who Owns Streptase?

Streptokinase has the longest history of any thrombolytic agent. The story begins in 1933, when William Smith Tillett, a microbiologist at New York University, discovered that beta-hemolytic streptococci produce a substance that activates the human fibrinolytic system. Tillett and his student Sol Sherry pursued this observation over the following decades, laying the groundwork for streptokinase as a therapeutic agent.

Initial clinical applications in the 1950s and 1960s focused on combating fibrinous pleural exudates, hemothorax, and tuberculous meningitis. In 1958, Sherry and colleagues began using streptokinase in patients with acute myocardial infarction, shifting the therapeutic focus from palliation to active clot dissolution. Early trials using intravenous streptokinase infusion produced conflicting results, and the drug's immunogenicity, derived from bacterial protein, complicated repeated use.

The commercial production of streptokinase was carried out by two European companies. Behring-Werke, based in Marburg, Germany (part of Farbwerke Hoechst), manufactured streptokinase under the brand name Streptase. Kabi Pharmacia, based in Stockholm, Sweden, manufactured the drug under the brand name Kabikinase. Both companies supplied streptokinase for the major clinical trials of the 1970s and 1980s.

The FDA approved streptokinase for acute myocardial infarction in 1977. In the United States, Streptase was marketed by Hoechst-Roussel Pharmaceuticals, based in Somerville, New Jersey, while Kabikinase was marketed by Kabi Group, based in Greenwich, Connecticut. A 1979 New England Journal of Medicine article described streptokinase and urokinase as the two thrombolytic agents recently approved by the FDA.

The European Cooperative Study Group for Streptokinase Treatment in Acute Myocardial Infarction published results in 1979 demonstrating that streptokinase reduced mortality at six months when administered to patients admitted to coronary care units within 12 hours of symptom onset. The study was supported by Behring-Werke and Kabi AB, which provided the drug as Streptase and Kabikinase respectively.

The landmark GISSI trial, published in 1986 by the Gruppo Italiano per la Sperimentazione della Streptochinasi nell'Infarto Miocardico, validated streptokinase as an effective treatment for acute MI and established a fixed protocol for its use. This large Italian multicenter trial demonstrated a significant mortality reduction with early streptokinase administration and established the drug as a standard treatment worldwide.

Streptokinase remained the dominant thrombolytic agent globally until the late 1980s, when recombinant tissue plasminogen activators began to emerge. The GUSTO trial, published in 1993, compared alteplase (Genentech's Activase) against streptokinase and found a modest survival advantage for alteplase, though at a substantially higher cost. This triggered a gradual shift away from streptokinase in developed markets.

The Streptase brand eventually came under the ownership of CSL Behring. In Canada, CSL Behring marketed Streptase until the product was cancelled from the market in 2012. DrugBank classifies streptokinase in the "Withdrawn" category, reflecting its discontinuation in many developed markets. The product's marketing authorization was cancelled in Canada in 2012, and similar withdrawals occurred in other developed markets.

Despite its displacement in developed countries, streptokinase remains on the World Health Organization's List of Essential Medicines and continues to be used in developing nations where its low cost compared to recombinant alternatives makes it an accessible option for acute MI treatment. Generic streptokinase is manufactured by several companies in India and other countries.