HOOFDDORP, Netherlands, July 13, 2012 /CNW/ - Nordic Group announced today that it has reached an agreement with Bayer HealthCare in which Nordic will acquire Trasylol® (aprotinin injection) worldwide excluding the United States. Under this agreement, Nordic will become the Marketing Authorization Holder for aprotinin in the relevant Territories. This follows the opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) from February 2012, recommending that the marketing authorisation for aprotinin should be reinstated in the European Union. The recommendation took into account a full review of the benefits and risks of all antifibrinolytic medicines, which found that the results of the study on which the suspension of aprotinin was based were unreliable. This positive opinion is expected to be ratified by the European Commission later in 2012. Nordic will be managing global supplies of aprotinin in the relevant Territories.
The CHMP has recommended lifting the suspension for aprotinin in the following indication:
Aprotinin is indicated for prophylactic use to reduce blood loss and blood transfusion in adult patients who are at high risk of major blood loss undergoing isolated cardiopulmonary bypass graft surgery (i.e., coronary artery bypass graft surgery that is not combined with other cardiovascular surgery). Aprotinin should only be used after careful consideration of the benefits and risks, and the consideration that alternative treatments are available. Since 2007 both Nordic (which was already marketing an aprotinin product) and Bayer have maintained compassionate limited access programmes in some 16 countries. In September 2011, the marketing authorisation for aprotinin was reinstated in Canada.
About Nordic Group BV
The Nordic Group is a privately owned, fast growing, fully integrated, pan-European pharmaceutical company, with a strong focus on the development and commercialization of niche hospital and orphan products and services that cater to the specific needs of clients and patients. In addition to its sales and marketing companies in 14 European countries, operating under the name of Nordic Pharma and Nordic Drugs, the Nordic Group operates as well a number of specialized Pharmaceutical Services companies, specialized in product development, manufacturing, supply logistics, clinical studies and regulatory activities. These companies are operating under the name of Prague Clinical Services, QPharma, Disphar and Indeus. Since its creation, Nordic has enjoyed an average growth of 20% in revenues, and it pursues its expansion through organic growth and strategic collaborations. Additional information can be obtained by visiting Nordic Group's website at http://www.nordicpharmagroup.com.
For further information: