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GEN News Highlights : Nov 12, 2012

Pharmalink Inks Manufacturing Deal with GP Pharm

Pharmalink signed a service contract with GP Pharm which will manufacture Pharmalink’s Busulipo™. The product is under development to serve as a conditioning agent for use prior to hematopoietic stem cell transplantation (HSCT).

In addition to carrying out R&D on oncology products, GP Pharm also serves as a contract development and manufacturing firm. The agreement covers the manufacturing of Busulipo from clinical to commercial quantities.

“Busulipo is an immediate release liposome formulation that improves the safety and stability of the chemotherapy agent busulfan that is currently the gold standard for use in conditioning prior to HSCT,” explained Johan Häggblad, managing director of Pharmalink. “Busulipo allows the elimination of the toxic solvent DMA and has been designed to have a two-year shelf life and increased stability after reconstitution.”

According to Häggblad, Busulipo has undergone clinical trials involving over 90 patients. “Extensive data on efficacy, safety, and pharmacokinetics have been collected and these compare positively with historical controls,” he added.

The company’s strategy is to partner Busulipo for the U.S. market, which it has identified as having significant commercial potential.

Over 50,000 HSCTs are performed each year and myeloablation is a critical part of the treatment regimen. The concept behind Busulipo was originally developed at Karolinska Institute and was acquired by Pharmalink in 2006. Pharmalink was founded in 1991.