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FDA Approves Eligard (Leuprolide Acetate) 6-Month Formulation For Prostate Cancer
VANCOUVER, BC -- December 15, 2004 -- CANADA-QLT Inc. (NASDAQ: QLTI; TSX: QLT) announced today that the company has received approval from the U.S. Food and Drug Administration (FDA) for Eligard® 45mg (leuprolide acetate for injectable suspension) six-month formulation, for the palliative treatment of advanced prostate cancer. Similar to the other Eligard products, this approval came in 10 months, well ahead of the standard 12-month review.
Eligard depot is a member of a class of drugs known as luteinizing hormone-releasing hormone agonists, also called LHRH agonists. Eligard works by lowering the levels of testosterone in the body, which may result in a reduction of symptoms related to the disease.
The six-month Eligard product is the first of its kind to be approved for prostate cancer by the FDA. With the 6-month formulation physicians and patients now have the flexibility to choose a more convenient formulation when receiving treatment. Eligard is already approved for 1-month (7.5mg), 3-month (22.5mg) and 4-month (30mg) depots. Eligard competes in the LHRH market for prostate cancer, which represents a market of approximately $680 million in the U.S. Sanofi-Aventis markets Eligard in the U.S. "We are excited to announce the approval of Eligard 6-month in less than one month of closing our deal," said Paul Hastings, President and Chief Executive Officer of QLT Inc.
"With the approval of the 6-month Eligard product line, we are building on the competitive momentum of the Eligard franchise. We expect to launch Eligard 6-month in the first quarter of 2005," said Mike Duncan, President of QLT USA, Inc.
Sustained levels of leuprolide decreases 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 45mg, like other hormonal treatments for prostate cancer, causes a transient increase in serum concentrations of testosterone during the first week of treatment. Patients may experience worsening of symptoms or onset of new signs and symptoms during the first few weeks of treatment. Response to Eligard 45mg should be monitored by measuring serum concentrations of testosterone and prostate specific antigen periodically.
SOURCE: QLT Inc.
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