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Eligard(R) (leuprolide acetate) 6-Month Formulation Approved in Germany
VANCOUVER, CANADA -- December 1, 2006 -- QLT USA, Inc., a subsidiary of QLT Inc., announced today that the Eligard(R) 45 mg 6-month formulation has been approved in Germany.
In September 2005, Astellas Pharma Inc. filed a Marketing Authorization Application for the Eligard (45 mg) 6-month product with the German pharmaceutical regulatory authority, BfArM. Eligard is already approved in Germany and other European countries for the one-month (7.5 mg) and three-month (22.5 mg) formulations.
"The six-month formulation provides physicians with a new convenient option for patients," said Bob Butchofsky, President and Chief Executive Officer of QLT Inc. "Eligard sales have been strong recently and we believe that this new approval will help contribute to future product growth."
Through the first nine months of 2006, Eligard worldwide sales have been approximately US$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. Reimbursement in Germany for the six-month formulation is expected upon launch.
About Eligard
Eligard -- a palliative treatment for advanced prostate cancer, incorporates a luteinizing hormone-releasing hormone agonist, or LHRH agonist -- known as leuprolide acetate with QLT USA's proprietary Atrigel(R) Delivery System. The Atrigel technology allows for sustained delivery of leuprolide acetate for periods ranging from one to 6 months.
Eligard works by lowering the levels of testosterone in the body, which may result in a reduction of symptoms related to the disease. Sustained levels of leuprolide decrease testosterone levels to suppress tumor growth in patients with hormone-responsive prostate cancer. The liquid Eligard products are injected subcutaneously with a small gauge needle, forming a solid implant in the body that slowly releases leuprolide as the implant is bioabsorbed.
Eligard is a registered trademark of Sanofi-Synthelabo Inc.
SOURCE: QLT Inc.
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