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 one-month prostate cancer product, Eligard 7.5mg (leuprolide acetate for injectable suspension, in Germany known as Leuprogel).
Germany is the largest market for LHRH therapies in Europe, so gaining German approval is a major advancement in globalizing this product," said David R Bethune, Atrix's chairman and chief executive officer. "The German market is the third largest LHRH market in the world." Bethune continued, "Medigene has expertise in achieving European regulatory approval. We look forward to approval of the three-month prostate cancer product in Germany. Additionally, Medigene is expected to work diligently to achieve approvals in other European countries under a 'mutual recognition process'. We expect Eligard will achieve a significant share of the estimated $500 million market opportunity for LHRH products in the key European countries."
In 2001, Atrix licensed European marketing rights to Medigene. Under the agreement, Atrix will receive royalty payments based on sales of the Eligard products and will manufacture Eligard at its facility in Fort Collins, Colorado. Medigene is in negotiations with a European marketing partner. Leuprolide acetate is a lutenizing 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. Measuring serum concentrations of testosterone and prostate specific antigen periodically should monitor response to these products.