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Antisense Pharma receives FDA Orphan Drug Designation for Trabedersen to treat Malignant Melanoma

4th March 2013


The biopharmaceutical company Antisense Pharma GmbH announces that the
US Food and Drug Administration (FDA) has granted Orphan Drug designation for its investigational oncology
antisense compound trabedersen to treat malignant melanoma.


Previously, trabedersen has received Orphan Drug designation by the European EMA and the US FDA in
high-grade glioma (malignant brain tumor) in 2002 and in advanced pancreatic cancer in 2009.
Dr. Philippe Calais, Chief Executive Officer of Antisense Pharma comments: “We are delighted that with this
most recent designation by the FDA, Trabedersen has now orphan status for three different cancer indications.
With the orphan status and the associated marketing protection, we have achieved a core milestone
for the long-term commercial success of our oncology lead compound trabedersen.”


Dr. Hubert Heinrichs, Chief Medical Officer of Antisense Pharma elaborates: “Malignant melanoma is a very
aggressive disease with a high need for innovative, effective and well-tolerated treatment options. We are
confident that traberdersen will provide new hope to patients that suffer from malignant melanoma. Recently
published results of our Phase I/II Study1 with traberdersen demonstrated excellent tolerability and
initial encouraging survival data in patients with advanced tumors. We are currently evaluating further clinical
development of traberdersen in malignant melanoma, preferably together with a potential partner.”

www.antisense-pharma.com





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