Atrix Laboratories, Inc. announced that MediGene AG, Atrix's European licensee, received marketing authorization from the German pharmaceutical regulatory authority, Bundesinstitut fur Arzneimittel und Medizinprodukte (BfArM), for the company's three-month prostate cancer product, Eligard 22.5mg (leuprolide acetate for injectable suspension). Recently, the company announced that Yamanouchi will be the pan-European sales and marketing licensee for the Eligard product line.

"This approval comes approximately a month after the Eligard 7.5mg once-a-month prostate cancer product received marketing authorization in Germany," said David Bethune, Atrix's chairman and CEO. "With this second approval, Eligard is now well positioned to compete in this large LHRH prostate cancer market."

Leuprolide acetate is a luteinizing hormone releasing hormone (LHRH) agonist. Sustained levels of leuprolide acetate decrease testosterone levels to suppress tumour growth in patients with hormone-responsive prostate cancer. The liquid Eligard product, using Atrix's proprietary Atrigel sustained- release drug delivery technology, is injected subcutaneously with a small gauge needle, forming a solid implant in the body that slowly releases leuprolide as the implant is bioabsorbed.

Eligard products, like other hormonal treatments for prostate cancer, cause 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 these products should be monitored by measuring serum concentrations of testosterone and prostate specific antigen periodically.