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MOLOGEN AG: Exclusivity for Cell-based Cancer Treatment |
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21 Sep 2006 |
The Berlin-based biotechnology company MOLOGEN today announced that the European Agency for the Evaluation of Medical Products, the EMEA, has recommended granting orphan drug status for MOLOGEN´s cell-based treatment for renal cancer.
BERLIN, Germany | Sep 20, 2006 | The Berlin-based biotechnology company MOLOGEN today announced that the European Agency for the Evaluation of Medical Products, the EMEA, has recommended granting orphan drug status for MOLOGEN´s cell-based treatment for renal cancer.
The recommendation is the decisive milestone for achieving orphan drug status. The status is to take effect as soon as the European Commission has confirmed the EMEA’s recommendation. This confirmation is expected to be received within the final quarter of 2006.
Orphan drug status ensures 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 EMEA’s recommendation confirms that we are on the right road with our innovative product pipeline”, commented Professor Burghardt Wittig, Chairman of the Executive Board of MOLOGEN AG. “With our cell-based gene therapy, we could in future offer a completely new form of therapy for cancer treatment.”
The results already achieved indicate extremely good tolerability and effectivity in patients with metastasising 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 tumours 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 tumours.
About cell-based gene therapy for cancer
MOLOGEN has developed an innovative cell-based gene therapy on the basis of injecting immunomodulated tumour cells. The tumour cells are transformed by gene modification and a combination of immunomodulated molecules into a very effective gene therapy. The patient is immunised 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
Die 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.
SOURCE: MOLOGEN |
