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news.Drug resistance-focused biopharmaceutical firm BioAlliance Pharma has been granted FDA orphan drug status for one of its lead products, doxorubicin Transdrug, for the treatment of a deadly form of liver cancer.
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The FDA decision is significant as orphan drug designation creates favorable conditions for the development of drugs for diseases affecting less than 200,000 people in the US, including financial incentives for the company involved.
A similar designation, with similar advantages, was granted in the European Union by the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMEA) in late 2004.
BioAlliance’s doxorubicin Transdrug is currently completing phase I/II clinical testing in the EU for treatment of hepatocellular carcinoma (HCC), a form of liver cancer for which there is no approved therapy.
The company’s Transdrug technology employs a proprietary polymer formulated as a nanoparticle to deliver a proven active cancer drug (doxorubicin) to the site of the liver tumor via a catheter placed in the hepatic artery.
“The orphan drug designation for doxorubicin Transdrug in the US is another important milestone for patients suffering from HCC and for BioAlliance,” said Dr Dominique Costantini, president and CEO of BioAlliance Pharma. “Orphan drug designation in both the US and the EU makes development commercially viable and provides multiple incentives for BioAlliance to undertake further clinical trials.”