Atrix Laboratories, Inc. announced that Sanofi-Synthelabo Canada, Atrix's licensee, has received notice of compliance (NOC) from the Therapeutic Products Directorate of Health Canada for Eligard 7.5mg and 22.5mg (leuprolide acetate for injection), one- and three-month sustained-release prostate cancer products. NOC permits these products to be sold in Canada. Sanofi-Synthelabo Canada will be responsible for marketing the products in Canada.
"As director of technical affairs, it is my responsibility to leverage our core US New Drug Application to build a worldwide franchise for Eligard," said Elyse Wolff, director of technical affairs. "This is the first ex-US approval and we look forward to repeating this success throughout the world."
The Canadian market opportunity for hormone therapy products for prostate cancer is approximately $60 million with a similar competitive landscape as the US.
Sustained levels of leuprolide decrease testosterone levels to suppress tumor growth in patients with prostate cancer. The liquid Eligard products, using Atrix's proprietary Atrigel sustained-release drug delivery technology, are injected subcutaneously with a small gauge needle, forming a solid implant in the body that slowly releases leuprolide as the implant is bio-absorbed.
Eligard 30mg, four-month prostate cancer product is currently under review by Health Canada. Eligard 7.5mg, 22.5mg and 30mg products for advance prostate cancer are currently marketed in the US by Sanofi-Synthelabo, Inc. Eligard 7.5mg and 22.5mg, 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. Measuring serum concentrations of testosterone and prostate specific antigen periodically should monitor response to these products.