BORNHEIM, Germany ¿ Medigene AG submitted a marketing authorization application for a one-month formulation of Leuprogel for the treatment of advanced prostate cancer.

It is Martinsried, Germany-based Medigene¿s first filing of an MAA. In a prepared statement, MediGene CEO Peter Heinrich called the filing ¿an extremely important strategic step toward becoming a fully integrated biopharmaceutical company.¿

In April 2001, Medigene acquired exclusive European marketing rights for three products based on Leuprogel, developed by Atrix Laboratories Inc., of Fort Collins, Colo. MediGene is responsible for all activities associated with seeking European marketing approval. (See BioWorld International, April 11, 2001.)

The MAA was submitted to the German regulatory authority, BfArM (Bundesinstitut f|r Arzneimittel und Medizinprodukte), of Bonn. BfArM is expected to act as the reference member state in the mutual recognition procedure of the European Union. After approval by BfArM, MediGene said it plans to submit MAAs to other concerned member states in the European Union.

Medigene said it expects to launch the Leuprogel one-month formulation in Germany and at least two or three additional countries in Europe in 2003.

Medigene has six additional products in clinical development. The company said it plans to file for a three-month formulation of Leuprogel with the European authorities in 2002. Medigene¿s pipeline includes Polyphenon E, for the treatment of genital warts, successfully through its first Phase III trial; Etomoxir, for the treatment of congestive heart failure, in a Phase II study; and G207, prepared for Phase II brain cancer trials. Beneath that, in Phase I/II trials are the colorectal cancer metastatic to the liver product, NV1020; an HPV vaccine to treat cervical precancerous lesions; and an AAV vaccine to treat melanoma.

Medigene has alliances with Schering AG, of Berlin, and Aventis Pharma AG, of Frankfurt, for the development and marketing of HPV and AAV tumor vaccines.

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