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Trials & Filings

Pharmalink Gets Orphan Status for Busulipo

Busulfan formulation improves safety for bone marrow transplantation

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Pharmalink AB has received orphan drug designation from the FDA for Busulipo, a conditioning agent for use in cancer patients prior to hematopoietic stem cell transplantation (HSCT; also known as bone marrow transplantation). The Company is currently preparing for registration trials with an optimized formulation of Busulipo as part of its plans to advance the product towards the market.

Busulipo was developed by Pharmalink as a liposome/lipid complex formulation that improves the safety and stability of the chemotherapy agent busulfan, and is aimed at becoming the new gold standard for use in conditioning prior to HSCT. An early Busulipo formulation has successfully undergone clinical trials, with more than 90 patients treated.

More than 18,000 American patients underwent HSCT in 2010, and those numbers are expected to increase in the years to come as more patients become eligible for the procedure.

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