Nordic Pharma and Clinigen Group have signed a distribution agreement to supply aprotinin to a range of countries in the Asia-Pacific region and South Africa. The drug—also known as Trasylol—is an injection given to reduce bleeding during heart surgery. It was marred by a history of adverse events and lawsuits in the mid- to late 2000s.
The antifibrinolytic medicine can help reduce blood loss and the need for transfusions during isolated cardiopulmonary bypass grafts, the companies said in a statement.
Under the agreement, Clinigen will make aprotinin available on an unlicensed, on-demand basis for patients who lack other suitable therapeutic options. It will gain exclusive supply rights in Australia, New Zealand, Japan, Singapore, Malaysia, Taiwan, Thailand, Hong Kong and South Africa.
“Nordic Pharma is committed to improving the access to aprotinin worldwide, which is an important lifesaving product in the arsenal of patient blood management,” said Nordic Pharma CEO Hans Schram. “This collaboration with Clinigen will improve access to this medicine in a number of territories where it is currently not commercially available.”
Previously owned by Bayer HealthCare, Trasylol was the subject of dozens of lawsuits related to unnecessary deaths, with some claiming the company hid evidence of potential risks.
Bayer temporarily suspended sales in 2007 when a clinical trial was stopped early after data showed a 54% increase in chance of death. A pair of FDA advisory committees at the time recommended continued marketing, but with additional safety studies and changes to the label.
Nordic Pharma acquired the rights to Trasylol outside of the U.S. in 2012, following a safety review and recommendations from the European Medicines Agency’s Committee for Medicinal Products for Human Use that its marketing authorization be reinstated.