BioWorld International Correspondent

BORNHEIM, Germany - MediGene AG entered into an exclusive European marketing agreement with Atrix Laboratories Inc. for three products based on Leuprogel to treat advanced prostate cancer, one of which is the subject of a new drug application filing with the FDA.

The agreement pushes Martinsried, Germany-based MediGene closer to its first drug commercialization.

Atrix, of Fort Collins, Colo., will receive license fees and payments for clinical, regulatory and sales milestones that could amount to approximately US$20 million, including the purchase of US$4 million in shares of Atrix's common stock. In addition, Atrix will receive royalty payments based on MediGene's sales of the Leuprogel products and will manufacture Leuprogel for MediGene, which has an option to develop and market Leuprogel for additional indications.

The product for which the NDA was filed is a one-month application. Phase III trials for the three-month and four-month applications of Leuprogel are in progress and Atrix expects to submit an NDA for the Leuprogel three-month product later this year, MediGene said.

The liquid Leuprogel products, after subcutaneous injection, form a solid polymeric implant under the skin. The implant provides sustained release of leuprolide acetate as the implant itself is bioabsorbed. Leuprolide is a luteinizing hormone-releasing hormone. Sustained levels of leuprolide decrease testosterone levels to suppress tumour growth in patients with hormone-responsive prostate cancer, MediGene stated.

MediGene plans to launch Leuprogel in Europe in the second half of 2003, the same year as its genital warts drug Polyphenon. "This will support our goal to reach break-even in 2004," MediGene's CEO Peter Heinrich said in a prepared statement.

For distribution of Leuprogel products, MediGene initially does not want to establish its own sales force.

"In countries with high potentials of sales - the United Kingdom, Germany, Spain, France and Italy - we will [work with] a contract sales organization to sell the products," MediGene's vice president of business development, Martin Pvhlchen, told BioWorld International. In countries with lower sales potential, sublicensing to partners would be an option for distribution.

Analysts at Goldman Sachs in London forecast peak Leuprogel sales in Europe at EUR50 million, MediGene spokeswoman Christine Bohner said.