In September 2005, Astellas Pharma filed a marketing authorization application for the Eligard six-month product with the German pharmaceutical regulatory authority, BfArM. Eligard is already approved in Germany and other European countries for the one-month and three-month formulations.
“Eligard sales have been strong recently and we believe that this new approval will help contribute to future product growth,” said Bob Butchofsky, president and CEO of QLT.
Through the first nine months of 2006, Eligard worldwide sales have been approximately $84 million. Approval of the six-month formulation in other European countries is expected to be obtained through the mutual recognition procedure, with the German approval serving as reference.
Eligard incorporates a luteinizing hormone-releasing hormone agonist, or LHRH agonist, known as leuprolide acetate with QLT’s proprietary Atrigel Delivery System. The Atrigel technology allows for sustained delivery of leuprolide acetate for periods ranging from one to six months.