MOLOGEN AG receives Orphan Drug status for cell based gene therapy for renal cancer

The Berlin-based biotechnology company MOLOGEN today announced that the European Commission has granted orphan drug status for MOLOGEN´s cell-based treatment for renal cancer. The European Commission hereby follows the recommendation of the European Agency for the Evaluation of Medical Products, EMEA, from September 2006.

The orphan drug status ensures a ten-year marketing exclusivity within the European Union. Moreover, the company is also guaranteed a simplified, accelerated and cost-effective approval procedure under the consultative guidance of the EMEA.

“The orphan drug status confirms our innovative approach of cell based gene therapy for treatment of cancer” Professor Burghardt Wittig, Chairman of the Executive Board of MOLOGEN AG stated. “Moreover, the additional marketing exclusivity and the simplified approval procedure give us more planning reliability for further development of the product.”

The hitherto achieved results indicate extremely good tolerability and efficacy in patients with metastasizing renal cell carcinoma. In addition, the therapeutic approach has shown positive effects in a number of other cancer indications.

About renal cancer

Renal cancer refers to malignant tumors with their origin in the tissues of the kidneys. 85% of adult cases are renal cell carcinomas.
Every year, some 10-15 per 100,000 inhabitants in Western industrial countries are diagnosed with renal cancer. Men are twice as likely to be affected as women. Roughly 3% of all cancer mortalities in adults are caused by malignant kidney tumors.

About cell-based gene therapy for cancer

MOLOGEN has developed an innovative cell-based gene therapy on the basis of injecting immunomodulated tumor cells. The tumor cells are transformed by gene modification and a combination of immunomodulated molecules into a very effective gene therapy. The patient is immunized using this drug. This type of activation of the immune system is a very promising approach towards overcoming the fatal tolerance of the patient’s immune system against the cancer cells.

About MOLOGEN

MOLOGEN AG is a listed biopharmaceutical company with headquarters in Berlin (Frankfurt Stock Exchange, Regulated Market, ISIN DE0006637200). On the basis of patented technologies (MIDGE and dSLIM), MOLOGEN develops DNA-based vaccines and therapeutic agents for the prevention and treatment of a wide range of serious illnesses.

Disclaimer concerning prognoses

Certain statements in this communication contain formulations or terms referring to the future or future developments, as well as negations of such formulations or terms, or similar terminology. These are described as forward-looking statements. In addition, all information in this communication regarding planned or future results of business segments, financial classification numbers, developments of the financial situation, or other financial or statistical data contains such forward-looking statements. The company cautions prospective investors not to rely on such forward-looking statements as certain prognoses of actual future events and developments. The company is neither responsible nor liable for these forward-looking statements. It is not responsible for updating such information, which only represents the state of affairs on the day of publication.

back to the overview